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Author Topic: Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis  (Read 29330 times)

ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« on: October 19, 2009, 07:17:53 PM »

[*QUOTE*]
---------------------------------------------------------------------------------------------
Title: USE OF CORRINOIDS IN TOPICAL TREATMENT OF SKIN DISEASES
European Patent EP0705102
Abstract:
Abstract not available for EP0705102
Abstract of corresponding document: US5798341
PCT No. PCT/EP94/01951 Sec. 371 Date Mar. 25, 1996 Sec. 102(e) Date Mar.
25, 1996 PCT Filed Jun. 15, 1994 PCT Pub. No. WO94/28907 PCT Pub. Date
Dec. 22, 1994Use of compounds of the Formula in which R stands for CN, OH,
CH3 or H2O for topical treatment of skin diseases and hair growth
disturbances as well as a pharmaceutical formulation containing, in
addition to standard carrier and/or dilution substances, compounds in
accordance with Formula I as defined in claim 1 and a synthetic or
vegetable-based oil or fat.

Domestic Patent References:
Arthritis treatment.
- - EP0055118

Inventors:
Klingelholler, Karsten (Eintrachtstrasse 39, Wuppertal, D-42275, DE)
Application Number:
EP19940918874
Publication Date:
08/20/1997
Filing Date:
06/15/1994
View Patent Images:
Download PDF EP0705102        PDF help
Export Citation:
Click for automatic bibliography generation
Assignee:
Klingelholler, Karsten (Eintrachtstrasse 39, Wuppertal, D-42275, DE)
International Classes:
(IPC1-7): A61K31/68
Foreign References:WO/1994/013252A                                METHOD FOR STIMULATING PRODUCTION OF
HEME OXYGENASE USING VITAMIN B12
DE1922192A
DE2325809A
DE2505114A
DE3210669A
3548057                                TOPICAL ADMINISTRATION OF VITAMIN B12
3577537

Other References:
J.NUTR., Bd.92, Nr.2, Juni 1967 Seiten 261 - 266 E.E.HOWE ET AL.
'Percutaneous Absorption of Vitamin B12 in the Rat and Guinea Pig'
'Vitamin Compendium' 1976 , VITAMINS AND CHEMICALS DEPARTMENT,
F.HOFFMANN-LA ROCHE & CO. LTD. , BASLE, SWITZERLAND siehe Seite 110 -
Seite 115
CHEMICAL ABSTRACTS, vol. 88, no. 11, 13. März 1978, Columbus, Ohio, US;
abstract no. 72417f, R.G.GADZHIEV ET AL. 'Status of blood electrolytes in
patients with allergic dermatitis'
Attorney, Agent or Firm:
Christophersen, Ruth (Kapellstrasse 12, Düsseldorf, 40479, DE)
Claims:
1. Use of compounds characterized by the Formula I in which R stands for
CN, OH, CH3 or H2O, in combination with a synthetic or vegetable oil or
fat for production of a medicament for the topical treatment for
inflammatory and hyperproliferative dermatological illnesses, respectively
cutaneous manifestations of illnesses which are immunologic in origin.

2. Use in accordance with claim 1, characterized by the case, that the
inflammatory and hyperproliferative dermatological illnesses, respectively
cutaneous manifestations of illnesses which are immunologic in origin are
psoriasis, atopic dermatitis, contact dermatitis and other eczematous
dermatitises, seborrhoeic dermatitis, neurodermatitis, decubitus, lichen
planus, pemphigus, bullate pemphigoid, epidermolysis bullosa, urticaria,
angioedemas, vasculitides, erythema, cutaneous, eosinophilias, lupus
erythematosus.

3. Use in accordance with claim 1 and/or 2 characterized by use of
standard carrier and/or dilution substances.

Description:

Die Erfindung betrifft eine neue Verwendung von Corrinoiden zur
Herstellung eines Medikaments zur topischen Behandlung von
Hauterkrankungen, insbesondere von entzündlichen und hyperproliferativen
Hauterkrankungen bzw. kutanen Manifestationen immunologisch bedingter
Erkrankungen, z.B. von: Psoriasis, atopischer Dermatitis,
Kontakt-Dermatitis und anderen ekzematösen Dermatitiden, seborrhoeischer
Dermatitis, Neurodermitis, Decubitus, Lichen planus, Pemphigus, bullosem
Pemphigoid, Epidermolysis bullosa, Urticaria, Angioödemen, Vasculitiden,
Erythemen, kutanen Eosinophilien, Lupus erythematodes sowie von Alopecia
areata und Haarwachstumsstörungen.

Die Behandlung von Hauterkrankungen, insbesondere von chronischen
Hauterkrankungen, stellt in der Medizin ein großes Problem dar, da sie nur
sehr begrenzt heilbar sind. Die Behandlung dieser Erkrankungen verschafft
in vielen Fällen den Patienten nur eine geringe Linderung, in vielen
Fällen ist gar kein Heilungserfolg zu beobachten. Hinzukommt, daß eine
Vielzahl der eingesetzten Wirkstoffe wie z. B. Kortison starke
Nebenwirkungen aufweisen.

Aus dem Stand der Technik sind Mittel bekannt, die u. a. Vitamin B 12 als
einen Bestandteil enthalten. So wird beispielsweise in der EP-A-0 055 118
ein Mittel beschrieben, das Vitamin B 12 enthält und zur Behandlung von
Arthritis und Psoriasis eingesetzt wird.

DE-A-3 210 669 offenbart ein pharmazeutisches Mittel zur Behandlung von
Hautkrankheiten, Schleimhauterkrankungen und Nagelwuchsstörungen. Das
Mittel besteht im wesentlichen aus Orotsäure oder einem Salz davon und
Inosin. Als weiteren Bestandteil kann das Mittel Vitamin B 12 enthalten.

Diese Druckschriften befassen sich jedoch nicht mit der topischen
Behandlung von chronischen Hauterkrankungen.

Aufgabe der vorliegenden Erfindung ist es, einen wirksamen Wirkstoff zur
Behandlung von Hauterkrankungen, insbesondere der oben aufgezählten zur
Verfügung zu stellen, der möglichst keine Nebenwirkungen zeigt.

Überraschenderweise wurde nur gefunden, daß Verbindungen mit der Formel I
in der
R für CN, OH, CH 3 oder H 2 O stehen, in Verbindung mit einem
synthetischen oder pflanzlichen Öl oder Fett zur Herstellung eines
Medikaments zur topischen Behandlung von von entzündlichen und
hyperproliferativen Hauterkrankungen bzw. kutanen Manifestationen
immunologisch bedingter Erkrankungen,
z.B. von: Psoriasis, atopischer Dermatitis, Kontakt-Dermatitis und anderen
ekzematösen Dermatitiden, seborrhöischer Dermatitis, Neurodermitis,
Decubitus, Lichen planus, Pemphigus, bullosem Pemphigoid, Epidermolysis
bullosa, Urticaria, Angioödemen, Vasculitiden, Erythemen, kutanen
Eosinophilien, Lupus erythematodes sowie von Alopecia areata und
Haarwachstumsstörungen eine hervorragende Wirkung zeigen.


Die Verbindungen mit der Formel I sind auch unter der Bezeichnung
Cobalamine oder Vitamin B 12 bekannt. Sie werden in der Medizin z. B. zur
Behandlung von perniziöser Anämie oral oder subkutan in Form von Tabletten
bzw. als Injektionslösung verabreicht.

Für die obige Verwendung hängt die zu verabreichende Dosis von der
verwendeten Verbindung, der Verabreichungsart sowie der Behandlungsart ab.
Es werden sehr gute Ergebnisse erhalten, wenn eine oder mehrere
Verbindungen mit der Formel I mit einer Konzentration von 1 x 10 -4 bis 1
x 10 -2 Gew.-% einmal oder mehrmals täglich lokal verabreicht werden. Die
Darreichungsformen können die in der pharmazeutischen Industrie üblichen
Träger- bzw. Verdünnungstoffe enthalten. Beispiele von geeigneten
galenischen Formen sind Lösungen, Emulsionen, Suspensionen, Lotionen,
Gele, Salben oder Cremes.

Die Verbindungen mit der Formel I werden in Kombination mit einem
synthetischen oder natürlich vorkommendem Öl oder Fett appliziert. Als
besonders geeignet hat sich die Verwendung von pflanzlichen Ölen,
insbesondere von Mandelöl, Erdnußöl, Sesamöl, Olivenöl, Weizenkeimöl,
Maiskeimöl, Diestelöl, Sojaöl, Sonnenblumenöl, Kokosfett, Avocadoöl,
Palmkernöl und Kakaobutter erwiesen.

Die Wirkungen der Verbindungen mit der Formel I ist aus den folgenden
Tests ersichtlich:
Beispiele

Herstellung einer Salbe :
------------------------------
350 ml Avocadoöl, 350 ml dest. Wasser, 70 ml
D-Panthenol, 525 mg Cyanocobalamin, 175mg Hydroxycobalamin
und 100 g Emulgator, z. B. erhältlich unter den Handelsnamen Euxyl K,
Lamecreme oder Emulsan,
vermischt und anschließend auf 1000 ml aufgefüllt.


Beispiel 1
Wirkung bei Psoriasis

Bei einer Gruppe von 10 Probanden, die unter Psoriasis leiden, wurde die
oben hergestellte Salbe 3 mal täglich auf die erkrankten Hautstellen
aufgetragen. Die Wirkung der erfindungsgemäßen Salbe auf die erkrankte
Haut wurde für eine Hautfläche von 10 cm 2 beobachtet.

Applikation/Tage         erkrankte Hautfläche/cm 2
1         10
5         9
10         8
20         4
25         2
30         0

Beispiel 2
Wirkung bei Neurodermitis

Wie in Beispiel 1 wurde bei einer Gruppe von 10 Probanden, die unter
Neurodermitis leiden, die oben hergestellte Salbe 3 mal täglich auf die
erkrankten Hautstellen aufgetragen. Die Wirkung der erfindungsgemäßen
Salbe auf die erkrankte Haut wurde für eine Hautfläche von 10 cm 2
beobachtet.

Applikation/Tage         erkrankte Hautfläche/cm 2
1         10
5         8
10         6
20         4
25         2
30         0



Aus den obigen Beispielen ist ersichtlich, daß die erfindungsgemäße
Verwendung von Verbindungen mit der Formel I nicht nur lindert sondern die
erkrankten Hautflächen in einem relativ kurzem Zeitraum auf eine Fläche
bis zu 0 cm 2 vermindert.
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[*/QUOTE*]

mehr:
http://www.freepatentsonline.com/EP0705102.html
.

ama

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  • Posts: 1108
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #1 on: October 19, 2009, 07:23:03 PM »

http://www.wipo.int/pctdb/en/wo.jsp?WO=1994028907&IA=EP1994001951&DISPLAY=DESC

[*QUOTE*]
---------------------------------------------------------------------------------------------
(WO/1994/028907) USE OF CORRINOIDS IN TOPICAL TREATMENT OF SKIN DISEASES
Biblio. Data
Description
Claims
National Phase
Notices
Documents
Note: OCR Text
Note: Text based on automatic Optical
Character Recognition processes. Please
use the PDF version for legal matters
WO 1994028907 19941222



Patentanmeldung

Verwendung von Corrinoiden zur topischen Anwendung bei

Hauterkrankungen

Die Erfindung betrifft eine neue Verwendung von Corrinoiden zur topischen Behandlung von Hauterkrankungen, insbesondere von entzündlichen und hyperproliferativen Hauterkrankungen bzw. kutanen Manifestationen immunologisch bedingter Erkrankungen, z.B. von: Psoriasis, atopischer Dermatitis, Kontakt-Dermatitis und anderen ekzematösen Dermatitiden, seborrhoeischer Dermatitis, Neurodermitis, Decubitus, Liehen planus, Pemphigus, bullosem Pemphigoid, Epidermolysis bullosa, Urticaria, Angioödemen, Vasculitiden, Erythemen, kutanen Eosinophilien, Lupus erythematodes sowie von Alopecia areata und Haarwachstumsstörungen.

Die Behandlung von Hauterkrankungen, insbesondere von chronischen Hauterkrankungen, stellt in der Medizin ein großes Problem dar, da sie nur sehr begrenzt heilbar sind. Die Behandlung dieser Erkrankungen verschafft in vielen Fällen den Patienten nur eine geringe Linderung, in vielen Fällen ist gar kein Heilungserfolg zu beobachten. Hinzukommt, daß eine Vielzahl der eingesetzten Wirkstoffe wie z. B. Kortison starke Nebenwirkungen aufweisen.

Aufgabe der vorliegenden Erfindung ist es, einen wirksamen Wirkstoff zur Behandlung von Hauterkrankungen, insbesondere der oben aufgezählten zur Verfügung zu stellen, der möglichst keine Nebenwirkungen zeigt.

Überraschenderweise wurde nur gefunden, daß Verbindungen mit der Formel I

ORIGINALUNTERLAGEN

 

in der

R für CN, OH, CH3 oder H20 stehen, bei der topischen Behandlung von Hauterkrankungen, insbesondere von entzündlichen und hyperproliferativen Hauterkrankungen bzw. kutanen Manifestationen immunologisch bedingter Erkrankungen, z.B. von: Psoriasis, atopischer Dermatitis, Kontakt-Dermatitis und anderen ekzematösen Dermatitiden, seborrhöischer Dermatitis, Neurodermitis, Decubitus, Liehen planus, Pemphigus, bullosem Pemphigoid, Epidermolysis bullosa, Urticaria, Angioödemen, Vasculitiden, Erythemen, kutanen Eosinophilien, Lupus erythematodes sowie von Alopecia areata und Haarwachstumsstörungen eine hervorragende Wirkung zeigen.

Die Verbindungen mit der Formel I sind auch unter der Bezeichnung Cobalamine oder Vitamin B1 bekannt. Sie werden in der Medizin z. B. zur Behandlung von perniziöser Anämie oral oder subkutan in Form von Tabletten bzw. als Injektionslösung verabreicht.

Für die obige Verwendung hängt die zu verabreichende Dosis von der verwendeten Verbindung, der Verabreichungsart sowie der

Behandlungsart ab. Es werden sehr gute Ergebnisse erhalten, wenn eine oder mehrere Verbindungen mit der Formel I mit einer Konzentration von 1 x 10~4 bis 1 x 10~2 Gew.-% einmal oder mehrmals täglich lokal verabreicht werden. Die Darreichungsformen können die in der pharmazeutischen Industrie üblichen Träger- bzw. Verdünnungstoffe enthalten. Beispiele von geeigneten galenischen Formen sind Lösungen, Emulsionen, Suspensionen, Lotionen, Gele, Salben oder Cremes.

Die Verbindungen mit der Formel I werden bevorzugt in Kombination mit einem synthetischen oder natürlich vorkommendem Öl appliziert. Als besonders geeignet hat sich die Verwendung von pflanzlichen Ölen, insbesondere von Mandelöl, Erdnußöl, Sesamöl, Olivenöl, Weizenkeimöl, Maiskeimöl, Diestelöl, Sojaöl, Sonnenblumenöl, Kokosfett, Avocadool, Palmkernöl und Kakaobutter erwiesen.

Ein weiterer Gegenstand der vorliegenden Erfindung ist eine pharmazeutische Zusammensetzung enthaltend Verbindungen mit der Formel I und ein pflanzliches Öl oder Fett.

Die Wirkungen der Verbindungen mit der Formel I ist aus den folgenden Tests ersichtlich:


Beispiele

Herstellung einer Salbe: 350 ml Avocadool, 350 ml dest. Wasser, 70 ml D-Panthenol, 525 mg Cyanocobalamin, 175mg Hydroxycobalamin und 100 g Emulgator, z. B. erhältlich unter den Handelsnamen Euxyl K, Lamecreme oder Emulsan, vermischt und anschließend auf 1000 ml aufgefüllt.

Beispiel 1

Wirkung bei Psoriasis

Bei einer Gruppe von 10 Probanden, die unter Psoriasis leiden, wurde die oben hergestellte Salbe 3 mal täglich auf die erkrankten Hautstellen aufgetragen. Die Wirkung der erfindungsgemäßen Salbe auf die erkrankte Haut wurde für eine Hautfläche von 10 cm2 beobachtet.

Applikation/Taσe erkrankte Hautfläche/cm-2-

1 10

5 9

10 8

20 4

25 2

30 0

Beispiel 2

Wirkung bei Neurodermitis

Wie in Beispiel 1 wurde bei einer Gruppe von 10 Probanden, die unter Neurodermitis leiden, die oben hergestellte Salbe 3 mal täglich auf die erkrankten Hautstellen aufgetragen. Die Wirkung der erfindungsgemäßen Salbe auf die erkrankte Haut wurde für eine Hautfläche von 10 cm2 beobachtet.

Applikation/Taσe erkrankte Hautflache/cm—

1 10

5 8

10 6

20 4

25 2

30 0

Aus den obigen Beispielen ist ersichtlich, daß die erfindungsgemäße Verwendung von Verbindungen mit der Formel I nicht nur lindert sondern die erkrankten Hautflächen in einem relativ kurzem Zeitraum auf eine Fläche bis zu 0 cm2 vermindert.
---------------------------------------------------------------------------------------------
[*/QUOTE*]

.

ama

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  • Posts: 1108
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #2 on: October 21, 2009, 05:07:12 PM »

In der Sendung "hart aber fair" gab es heute Zunder. Das Rezept wird in der Web-Site von "hart aber fair" wie folgt angegeben:
 
http://www.wdr.de/tv/hartaberfair/extra/martens_rezept.php5

[*QUOTE*]
---------------------------------------------------------------------------------------------
hart aber fair
Extra

Rezept für die B12-Creme

Die B12-Creme ist noch nicht auf dem Markt zu bekommen – aber Ihr Arzt hat die Möglichkeit, die Creme für Sie bei einem Apotheker anrühren zu lassen.

Unser Gast Klaus Martens nennt folgende Zutaten:
0,07 g Vitamin B12
46 g Avocado-Öl
45,42 g Wasser
8 g Tegocare PS
0,26 g Kaliumsorbat
0,25 g Zitronensäure
---------------------------------------------------------------------------------------------
[*/QUOTE*]


Der allereinfachste Test ist übrigens das obige Rezept OHNE das B12 darin. dann sieht man, ob das B12 überhaupt etwas bewirkt, oder ob die Zitronensäure und das Kaliumsorbat, die ja eine gewisse Wirkung haben, nämlich eine keimtötende, schon etwas gegen Neurodermitis ausrichten.

Dann wäre das B12 nur eine Beigabe zum Verteuern und das Rezept könnte sich jeder für ein paar Cent selbst anrühren. Kaliumsorbat ist, ebenso wie Zitronensäure, ein Konservierungsmittel. Sorbinsäure gibt es als "Einmachhilfe" mit der E-Nummer E200 im Supermarkt.
.
« Last Edit: October 21, 2009, 05:16:04 PM by ama »
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ama

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  • Posts: 1108
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #3 on: October 21, 2009, 05:19:31 PM »

Interessant ist in diesem Zusammenhang die im April bekannt gewordene Studie in den USA, wo man Neurodermitis (vor allem auch sehr schwere Fälle) ganz einfach mit Chlorbleiche behandelt hat:

http://www.northwestern.edu/newscenter/stories/2009/04/pallereczema.html

[*QUOTE*]
---------------------------------------------------------------------------------------------
April 27, 2009 | Research

MEDIA CONTACT: Marla Paul at marla-paul@northwestern.edu
Whiter Laundry and a Surprising New Treatment for Kids’ Eczema
Amy Paller

CHICAGO--- It's best known for whitening a load of laundry. But now simple household bleach has a surprising new role: an effective treatment for kids' chronic eczema.  

Chronic, severe eczema can mar a childhood. The skin disorder starts with red, itchy, inflamed skin that often becomes crusty and raw from scratching. The eczema disturbs kids' sleep, alters their appearance and affects their concentration in school. The itching is so bad kids may break the skin from scratching and get chronic skin infections that are difficult to treat, especially from methicillin-resistant Staphylococcus aureus (MRSA).

Researchers from the Northwestern University Feinberg School of Medicine have discovered powerful relief in the form of diluted bleach baths. It's a cheap, simple and safe treatment that drastically improves the rash as well as reduces flare-ups of eczema, which affects 17 percent of school-age children.  

The study found giving pediatric patients with moderate or severe eczema (atopic dermatitis) diluted bleach baths decreased signs of infection and improved the severity and extent of the eczema on their bodies. That translates into less scratching, fewer infections and a higher quality of life for these children.

The typical treatment of oral and topical antibiotics increases the risk of bacterial resistance, something doctors try to avoid, especially in children. Bleach kills the bacteria but doesn't have the same risk of creating bacterial resistance.

Patients on the bleach baths had a reduction in eczema severity that was five times greater than those treated with placebos over one to three months, said Amy S. Paller, M.D., the Walter J. Hamlin Professor and chair of dermatology, and professor of pediatrics, at the Feinberg School. Paller also is an attending physician at Children's Memorial Hospital.

The study will be published in the journal Pediatrics April 27.

“We’ve long struggled with staphylococcal infections in patients with eczema,” Paller said. She noted more than two-thirds of eczema patients have evidence of staphylococcus on their skin, the bacteria that most commonly causes infection and worsens the eczema. "This study shows that simple household bleach, which we think decreases the staphylococcus on the skin, can help these children."

In the study, Paller and researchers treated 31 pediatric patients (6 months to 17 years old) who had eczema and a bacterial staph infection for 14 days with oral antibiotics. Half of the patients received bleach in their bath water (half a cup per full standard tub), while the other half received a look-alike placebo. Patients were also instructed to put a topical antibiotic ointment or placebo control into their nose (where the staphylococcus can also grow) for five sequential days of each month. All were instructed to bathe in the bleach twice a week, and soak for five to 10 minutes for three months.

Paller said bathing in the diluted bleach bath water was surprisingly odor-free because of the small amount of bleach added. “In our clinics, no one had the just-out-of-the-swimming pool smell,” she said.

The research team saw such rapid improvement in the kids taking the real bleach baths that they terminated the study early because they wanted the children getting the placebo to get the same relief.

"The eczema kept getting better and better with the bleach baths and these baths prevented it from flaring again, which is an ongoing problem for these kids," Paller said.  "We presume the bleach has antibacterial properties and decreased the number of bacteria on the skin, which is one of the drivers of flares."    

Northwestern researchers launched the study to confirm their hunch about the potential of bleach baths, "since bleach has been used by hospitals in the past few years as a disinfectant to decrease MRSA," Paller said.    

One interesting finding in the study was the eczema on the body, arms and legs improved dramatically with the bleach baths, but the face, which was not submerged in the bath, did not improve, further evidence of the positive effect of the bath.

As a result of the study, Paller suggests that kids who have eczema on their face close their eyes and mouths and dunk under the water to help improve the lesions. In her practice, patients have found that even daily bleach baths are well tolerated. The bleach baths may also be useful for individuals with frequent staphylococcus infection, whether related to eczema or not, and in adults with eczema and recurrent infections.

(Paller's study was funded by investigator-initiated research grants from the Society for Pediatric Dermatology and the Neutrogena Corporation.)

To help treat a rising number of severe cases of eczema, Northwestern's Feinberg School has recently opened an Eczema Care & Education Center. The new center offers patients one-on-one instruction for treating eczema, while a support group helps patients and their families cope with the emotional aspects of the disease.

“This is a disorder that can drive people crazy,” said Peter Lio, M.D., director of the Eczema Care & Education Center and an assistant professor of dermatology and of pediatrics at the Feinberg School. “Eczema beats people down."

Lio said he just worked with an 11-year-old girl who had missed a half-year of school because of her severe eczema. "As we were working with her and demonstrating how to treat her skin, she started weeping," he said. "Between the tears, she said ‘I’m crying because I know I’m going to get better.’ ”

Scientists believe eczema may be triggered by urban pollutants and toxins and/or allergies, and certainly shows a genetic tendency. “We don’t have all the answers and are still learning about this disease," Lio said. He also is a physician at Children's Memorial Hospital and Northwestern Memorial Hospital.
---------------------------------------------------------------------------------------------
[*/QUOTE*]


Dies ist der Text der Studie:

http://pediatrics.aappublications.org/cgi/content/full/123/5/e808?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=amy+paller&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT

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« Last Edit: October 21, 2009, 05:20:55 PM by ama »
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ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #4 on: October 21, 2009, 10:28:30 PM »

.



Beda Stadler ist mein Held!



Beda Stadler hat absolute Super-Kommentare losgelassen in der Sendung "hart - aber fair", in der sich diesmal Frank Plasberg als Gastgeber bis auf die Knochen blamiert hat...

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ama

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  • Posts: 1108
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #5 on: October 22, 2009, 06:24:06 PM »

[*QUOTE*]
------------------------------------------------------------------------------------
Für den Vertreter der Pharmaindustrie war die Sache klar: "Herzlichen Glückwunsch, dass was ein genialer Marketingcoup", sagte Siegfried Throm, Geschäftsführer des Verbandes forschender Pharmaunternehmen. "Davon können unsere Marketingabteilungen noch etwas lernen." Throm bezweifelte den Nutzen des Mittels und berichtete von seiner erfolglosen Suche nach Studien, die die Wirksamkeit der Salbe bestätigen würden.

Selbst die Kritiker der Pharmalobby mochten an die neue Salbe nicht so recht glauben. Professor Beda Stadler, einem Immunologen, der die Pharmaindustrie zuvor bereits als „bösen Buben“ bezeichnet hatte, gingen auch die eingespielten, herzerweichenden Bilder eines an Neurodermitis erkrankten und von Kopf bis Fuß in Verbände eingewickelten Kindes deutlich zu weit.

"Herr Plasberg, was Sie hier abziehen, ist wirklich eine Schande: Sie missbrauchen ein Kind. Das Kamerateam und der Regisseur hätten dem Kind die blöde Salbe aufstreichen sollen, dann wäre es ja jetzt anscheinend wieder gesund. Wenn man so tut, dass ein blödes Avocadoöl mit etwas Vitaminen drin eine schwere Krankheit vom Erdboden verschwinden lässt, dann ist das Betrug", platze es aus ihm heraus.
------------------------------------------------------------------------------------
[*/QUOTE*]

mehr:
http://www.welt.de/fernsehen/article4931010/Wie-die-Impfdebatte-zur-Schleichwerbung-verkommt.html

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ama

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  • Posts: 1108
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #6 on: October 23, 2009, 09:03:12 AM »

[*QUOTE*]
------------------------------------------------------------------------------------
Pressemitteilung vom 22.10.2009 | 17:33
Deutscher Neurodermitis Bund

Wirbel um Regividerm


Die ARD sendete am 19.10.2009 um 21:00 Uhr, immerhin zur Primetime, einen Bericht unter dem Motto: "Heilung nicht gewollt". Es geht hierbei um eine Reportage des Autors Klaus Martens, in der versucht wird zu schildern, wie die Pharmaindustrie die Einführung eines angeblich wirksamen Mittels gegen Neurodermitis über viele Jahre lang verhinderte, um so eigene Präparate in Schutz zu nehmen.

"Schade, dass sich jetzt auch schon eine öffentlich-rechtliche Sendeanstalt völlig kritiklos für solche PR-Aktionen hergibt", so Thomas Schwennesen, 1. Vorsitzender des Deutschen Neurodermitis Bundes e.V., Hamburg, -
 
"Es ist eine Schande und blanker Zynismus, dass die PR-Einführung eines normalen Hautpflege-Produktes sich der Pharmaschelte als Aufhänger für eigene Geschäfte bedient."

Der Autor vergleicht in seiner Reportage sog. Calicineurininhibitoren ( Wirkstoffe: Pimecolimus und Tacrolimus) die nach 10-jähriger Forschungsarbeit und nach allen erforderlichen Studiendurchläufen weltweit als Medikament, auch für Kinder einsetzbar, anerkannt sind mit einem Gemisch aus B12 und Avocado-Öl.
Dazu soll das Produkt noch für Neurodermitis und Psoriasis gleichermaßen erfolgreich eingesetzt werden können.

Neurodermitis ist eine chronische Hauterkrankung, die mit entzündlichen Hautvorgängen und gestörtem Immunsystem einhergeht. Umwelteinflüsse können eine große Rolle spielen. Die Schuppenflechte ist eine ebenso schwere und chronische Hauterkrankung, deren Ursache leider auch noch nicht wissenschaftlich erforscht wurde. Beide Erkrankungen haben verschiedene medizinische Therapieansätze sind aber nicht heilbar. Die dargestellte Produktmischung soll nun das alles auch noch ohne Nebenwirkungen schaffen.

Pharmakologisch ist die Äußerung unhaltbar, dass ein Produkt wirkt ohne jegliche Nebenwirkung.

Die ARD hat mit diesem Beitrag den etwa fünf Millionen Neurodermitikern einen Bärendienst erwiesen und sich selbst journalistisch ins Abseits gestellt.


Nährere Informationen:
Deutscher Neurodermitis Bund e.V.
Thomas Schwennesen, 1. Vorsitzender
Baumkamp 18
22299 Hamburg
E-Mail: <info[bat]neurodermitis-bund.de>
http://www.neurodermitis-bund.de
-----------------------------------------------------------------------------------
[*/QUOTE*]

Quelle:
http://www.pressrelations.de/new/standard/dereferrer.cfm?r=387661

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« Last Edit: October 23, 2009, 09:03:50 AM by ama »
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ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #8 on: October 24, 2009, 06:48:51 PM »

Per Email:

"Ich habe es ja gewußt: Die Konservierungsmittel Kaliumsorbat und
Zitonensäure spielen eine erhebliche Rolle. Hier nun steht etwas über den pH-Wert: 4-4,5! Das Zeug MUSS ja eine Wirkung auf die Hautbesiedelung haben!"


Dazu diese Quellenangabe:
 
http://www.pharmazeutische-zeitung.de/fileadmin/nrf/PDF/1-Cyanocobalamin_Haut.pdf

[*QUOTE*]
------------------------------------------------------------------------
Neues Rezeptur-Formularium
ABDA &#8211; Bundesvereinigung Deutscher Apothekerverbände
Pharmazeutisches Laboratorium &#61591; Govi-Verlag
Pharmazeutischer Verlag GmbH
Carl-Mannich-Straße 20
Postfach 5360
Telefax: 06196/928-330
65760 Eschborn
65728 Eschborn
E-Mail: nrf@govi.de
http://www.dac-nrf.de
[...]
*2006 GOVI
Stand: 20.10.2009

Rezepturhinweise:
Cyanocobalamin zur Anwendung auf der Haut
Relevante NRF-Monographien und -Texte:
&#61623;       Allgemeine Hinweise I.2.1.1. Einwaagekorrektur
&#61623;       Allgemeine Hinweise I.6. Dermatika &#8211; Zubereitungen zur kutanen Anwendung
Relevante Rezepturhinweise im Internet (www.dac-nrf.de):
&#61623;       Umstrittene Rezepturen und Nischenarzneimittel
Wirkung / Anwendung:
Beanspruchte Wirkung bei Neurodermitis und Psoriasis.
Physikalische, chemische, galenische Eigenschaften:
&#61623;       geruch- und geschmacklose, dunkelrote, nadelförmige oder prismatische Kristalle,
&#61623;       stark hygroskopisch, Wassergehalt bis zu 12 %,
&#61623;       Stabilitätsoptimum bei pH 4,5 bis 5 (1),
&#61623;       wenig löslich in Wasser und Ethanol, unlöslich in Aceton, Chloroform und Ether (2).
1       Bedarf und Nutzen/Risiko-Beurteilung
Aus Apotheken gibt es Nachfragen zur Rezeptur einer
&#8222;Vitamin-B12-Avocadoöl-Creme&#8220;, besonders
im Zusammenhang mit Presse- und Fernsehberichten (3). Ein Medizinprodukt soll ab Mitte
November im Handel verfügbar sein (4).
[...]

1.2.1 Klinische Studien
Es liegen Daten zu zwei klinischen Studien vor, die die Wirksamkeit des Cyanocobalamins belegen sollen. Die Patientenkollektive waren mit 13 und 48 Patienten jedoch recht klein und der Beobachtungszeitraum auf wenige Wochen begrenzt (5, 6).
[...]

3     Stabilität
Wässrige Lösungen von Cyanocobalamin sind zwischen pH 4,5 und 5 stabil und können bei 120 °C 20 min sterilisiert werden. Bei anderen pH-Werten und höheren Temperaturen erfolgt Zersetzung (1). Unter Lichteinfluss wird die Cyanid-Gruppe unter Bildung von Aquocobalamin abgespalten.
Dieses Zersetzungsprodukt ist reaktiver gegenüber Reduktionsmitteln (z. B. Ascorbinsäure, reduzierenden Zuckern), sodass eine rasche Gehaltsminderung zu beobachten ist.
[...]

4.1 Plausible Rezepturvorschläge
Rezepturen könnten angefertigt werden unter Verwendung
&#61623;     einer lipophilen Grundlage, wie Hydrophober Basiscreme DAC, oder &#61623;     einer mit Avocadoöl aufgefetteten Basiscreme DAC (1 T. Öl und 5 T. Creme).
Die Verwendung der Hydrophoben Basiscreme DAC hat den Vorteil, dass durch die Konservierung mit Sorbinsäure bzw. Kaliumsorbat und Citronensäure bereits ein pH-Wert von 4 bis 4,5 vorliegt.
[...]
------------------------------------------------------------------------
[*/QUOTE*]


In der Website der Firma, die das Zeug vermarktet (Mavena ist der Produktionsbetrieb):

http://www.regividerm.de/fragen-und-antworten/

[*QUOTE*]
------------------------------------------------------------------------
Welcher Wirkstoff ist in Regividerm® Salbe?

Der Wirkstoff in Regividerm® Salbe ist Cyanocobalamin, auch Vitamin B12 genannt. Regividerm® Salbe ist das erste und einzige Präparat mit diesem Wirkstoff für die äußerliche Behandlung von Neurodermitis und Psoriasis. Die Verwendung dieses Wirkstoffes für topische Hautpräparate ist patentrechtlich geschützt.
------------------------------------------------------------------------
[*/QUOTE*]


Da würde ich mal sagen wollen, daß das zwei ganz dicke Lügen sind.

Erstens ist "DER" Wirkstoff in der Salbe NICHT das B12, sondern die anderen Stoffe spielen eine ERHEBLICHE ROLLE, indem sie den pH-Wert der Haut verschieben.

Zweitens ist Vitamin B12 schon vor Jahrzehnten in der Behandlung von Haut benutzt worden.

ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #9 on: October 25, 2009, 09:07:32 PM »

Unter den verschiedenen Cremes und Salben mit B12 drin (ja, es gibt so einige), fällt diese auf:

http://www.naturaltreasure.net/mall/vitamin_cremes.php

[*QUOTE*]
------------------------------------------------------------------------
BioEntopic Vitamin B12 Crèmes Creams Methylcobalamin


Vitamin B-12 Creme - Cream
High Potency Natural 2 ounces-60ml
Our Price $14.99     2 for $25     Buy 4 Jars for $46

600 mcg methylcobalamin in a Liposome Carrier System is greater then 5000 mcg B12 taken orally.

Vitamin B12 is a water soluble micronutrient. Studies show vitamin B12 is the most deficient vitamin in the human body and lack of methylcobalamin causes degeneration of the brain and spinal cord. Meat is the primary source of Vitamin B12 therefore; strict vegetarians are more prone to B12 deficiency. Also, poor diet, age and many drugs are prime culprits behind B12 deficiency. The medical community does not understand B12 deficiencies and are reluctant to prescribe B12.

             1 Jar $14.99
             2 Jars $25 ($12.50 each)
     4 Jars $46 ($11.50 each)
 



Research shows the active form of B12 methylcobalamin has the unique ability to regenerate nerves without adverse side effects because B12 facilitates methylation which is the process that creates and maintains nerves and brain chemicals. The methylation process also converts homocysteine to methionine which contributes to healthy cardiovascular functions. Many people are unable to utilize the cyancobalamin form of B12 because cyancobalamin needs to be converted into methylcobalamin for the methylation process to take place

Studies show oral supplements including sublingual* are extremely inefficient. It is estimated that oral or sublingual absorption of vitamin B12 is less then one percent.

While B12 injections have the highest estimated absorption rate at ninety-nine percent, B12 injections are expensive and available by prescription only.

BioEntopic™ utilizes a liposome delivery system which provides a 90 percent absorption rate through the skin. Liposomes are used as delivery systems for pharmaceutical products like the nicotine patch. Liposomes are hollow tubes of phospholipids that are over 200 times smaller than human skin cells. The desired ingredients such as vitamin B12 are encapsulated in the liposome’s creating a superior delivery with a consistent absorption rate. Listed below are some of the benefits of B12 methylcobalamin supplementation:

• Essential for red blood cells and is necessary for the metabolism of carbohydrates and fats.
• Helps to lower homocysteine, studies show homocysteine as high risk factor for heart disease, stroke, arthritis, Alzheimer’s disease and diabetes.
• Prevents nerve damage by contributing to the formation of the myelin sheath.
• Maintains fertility.
• Restores balance and stamina, studies also show it may help those who suffer from sleep disorders and depression. Fatigue is often the sign of B12 deficiency

BioEntopic™ Vitamin B12 crème delivers 600 mcg per ¼ tsp. application.

SUGGESTED USE: Each 1/4 teaspoon creme provides 600 mcg of B-12. Apply to clean dry skin. The creme has pink hue and is non-staining. The color may vary from batch to batch and does not affect the potency or quality of the product.

INGREDIENTS: Purified Water Lanol (Coco Caprylate/Caprate from vegetable origin), Montanov 68 (cetearylglucoside from vegetable origin), Natural Omega Oils (Sunflower, Hemp, Evening Primrose) Phospholipids (natural liposome carrier system) Grapefruit Seed Extract, Capryloyl Glycin/Undecylenoyl Glycin (vegetable origin antimicrobial,) Potassium Sorbate (powder from ash trees and potassium salt), Methylcobalamin (B12).
------------------------------------------------------------------------
[*/QUOTE*]


Sagenhaft, wozu so eine Creme gut sein soll. Sogar gegen Alzheimer...

[*QUOTE*]
------------------------------------------------------------------------
Listed below are some of the benefits of B12 methylcobalamin supplementation:

• Essential for red blood cells and is necessary for the metabolism of carbohydrates and fats.
• Helps to lower homocysteine, studies show homocysteine as high risk factor for heart disease, stroke, arthritis, Alzheimer’s disease and diabetes.
• Prevents nerve damage by contributing to the formation of the myelin sheath.
• Maintains fertility.
• Restores balance and stamina, studies also show it may help those who suffer from sleep disorders and depression. Fatigue is often the sign of B12 deficiency
------------------------------------------------------------------------
[*/QUOTE*]

Allerdings ist da das magische Wort "supplementation". Das kann nämlich auch "in Nahrungsergänzung" bedeuten. Die Creme ist aber keine!


[*QUOTE*]
------------------------------------------------------------------------
INGREDIENTS:
Purified Water
Lanol (Coco Caprylate/Caprate from vegetable origin),
Montanov 68 (cetearylglucoside from vegetable origin),
Natural Omega Oils (Sunflower, Hemp, Evening Primrose)
Phospholipids (natural liposome carrier system)
Grapefruit Seed Extract,
Capryloyl Glycin/Undecylenoyl Glycin (vegetable origin antimicrobial,)
Potassium Sorbate (powder from ash trees and potassium salt),
Methylcobalamin (B12).
------------------------------------------------------------------------
[*/QUOTE*]

Also Waser, Öle, Emulgatoren, Kleinkram. Und irgendwie auch B12.

UND Kaliumsorbat!

Als Öle nicht das einfallslose Avocadoöl, sondern das einfallslose Sonnenblumenöl, Hanföl und - OLALA! - Nachtkerzenöl. Das ist in Heilerkreisen sehr beliebt.
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« Last Edit: October 25, 2009, 09:11:36 PM by ama »
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ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #10 on: October 26, 2009, 11:26:03 AM »

Hier kommt eine harte Retourkutsche:


http://www.openpr.de/news/364027/Spezialklinik-Neukirchen-im-TV-Heilung-unerwuenscht-Wie-Pharmakonzerne-ein-Medikament-verhindern.html

[*QUOTE*]
------------------------------------------------------------------------
Spezialklinik Neukirchen im TV: "Heilung unerwünscht. Wie Pharmakonzerne ein Medikament verhindern"
Gesundheit & Medizin
Pressemitteilung von: Spezialklinik Neukirchen
PR Agentur: Umweltrundschau

Quelle: Kötztinger Umschau
Dieses Bild im Großformat speichern

(openPR) - Mehr über die "Klinik für die Verzweifelten" ...

Vitamin B12 kann wirksam Neurodermitis-Symptome lindern - aber nicht heilen
Spezialklinik Neukirchen: setzt auf integratives Therapiekonzept

Unerträglicher Juckreiz und trockene, schuppige Haut - schon Säuglinge und Kleinkinder können unter Neurodermitis leiden. Deshalb hoffen viele Betroffene auf Hilfe durch ein kortisonfreies Präparat mit Vitamin B12, über das in der TV-Dokumentation "Heilung unerwünscht. Wie Pharmakonzerne ein Medikament verhindern" berichtet wurde. Bereits seit über 20 Jahren verwendet die ebenfalls im Beitrag vorgestellte Spezialklinik Neukirchen im Bayerischen Wald Cremes und Salben mit diesem Inhaltsstoff. Allerdings ist das nur ein Bestandteil des erfolgreichen und einzigartigen Therapiekonzeptes der "Klinik für die Verzweifelten".

"Wir können nach unseren langjährigen Erfahrungen bestätigen, dass Vitamin B12 hochwirksam ist, um Symptome von Schuppenflechte und Neurodermitis zu lindern. Bereits seit über 20 Jahren setzen wir Cremes und Salben mit diesem Inhaltsstoff ein. Diese lassen wir nach unseren Rezepturen in der Apotheke anrühren", erklärt Univ.-Doz. Dr. John Ionescu, Gründer und wissenschaftlicher Leiter der Spezialklinik Neukirchen. Gleichzeitig warnt Ionescu davor, allzu große Hoffnung auf Heilung durch eine Salbe zu setzen. "Es gibt leider kein Allheilmittel für Neurodermitis oder Schuppenflechte. Eine einzelne lokale Therapie, die nur die Hautsymptome behandelt, bietet kaum eine Chance auf dauerhafte Beschwerdefreiheit. Zu zahlreich sind die Faktoren, die an der Entstehung der Erkrankung und ihren Symptomen beteiligt sind."



Deshalb setzt die Spezialklinik Neukirchen auf ein aufwändiges Diagnostik- und integratives Therapiekonzept, dass die Auslöser der Erkrankung aufspürt und behandelt. Dabei geht die Klinik im Bayerischen Wald einen eigenen Weg: Auf die Gabe von Kortisonpräparaten, Immunsuppressiva (Biologicals), Zytostatika sowie UV-Bestrahlungen wird verzichtet.

Etwa 800 Patienten mit Neurodermitis, darunter ca. 400 Kinder sowie mehr als 500 Psoriasis Patienten, werden jährlich in der Klinik behandelt. Die drei- bis vierwöchige stationäre Therapie wird von allen Krankenkassen anerkannt. Nahezu alle Patienten verlassen die Klinik beschwerdefrei. Bei 80 Prozent von ihnen bleibt die Beschwerdefreiheit langfristig oder dauerhaft, das heißt länger als zweieinhalb Jahre, bestehen. "Der komplex aufgebaute, stationäre Aufenthalt in der Spezialklinik schenkte schon verzweifelten Müttern und resigierenden Patienten das Lächeln zurück und wird von vielen Krankenkassen, Ärzten und Patientenorganisationen" empfohlen, freut sich der Spezialist.

Für weitere Informationen: www.spezialklinik-neukirchen.de, Telefon 09947 280

Link zum Beitrag:
http://mediathek.daserste.de/daserste/servlet/content/3161202?pageId=487910&moduleId=799280&categoryId=&goto=1&show=


ACHTUNG REDAKTIONEN:
Das Bild- und Textmaterial ist in Zusammenhang mit dieser Meldung honorarfrei zur Verwendung. Wir bitten jedoch um einen Hinweis, wie Sie den Beitrag eingesetzt haben.

KONTAKT
Spezialklinik Neukirchen GmbH & Co. KG
Krankenhausstr. 9
93453 Neukirchen b. Hl. Blut
Telefon: 09947 / 280
Telefax: 09947 / 28109
E-Mail: info (at) spezialklinik-neukirchen.de
Web: www.spezialklinik-neukirchen.de

Curriculum vitae: Univ.-Doz. Dr. John G. Ionescu ist Gründer und wissenschaftlicher Leiter der Spezialklinik Neukirchen. Er zählt zu den renommiertesten Experten in den Bereichen der Allergologie und Immunbiologie. Dr. John G. Ionescu studierte Immunbiologie und Biochemie an der Universität in Bukarest. Danach folgten Weiterbildungen in Kanada und Promotion (Biochemie) in Saarbrücken. Im Anschluss war Dr. Ionescu als Forschungsleiter einer deutschen Hautklinik bei Aschaffenburg tätig. Im Jahr 1986 gründete Dr. John G. Ionescu die Spezialklinik Neukirchen bei Heiligen Blut, deren Betätigungsfeld schwierige Neurodermitis- und Psoriasisformen, allergisches Asthma, Akne, Kollagenosen, Hyperaktivität bei Kindern sowie Umwelterkrankungen durch Schadstoffe wie Pestizide, Holzschutzmittel, Schwermetalle und Zusatzstoffe aus der Nahrung ist. Aufgrund seiner wissenschaftlichen Tätigkeit und der mehr als 140 Veröffentlichungen in deutschen und internationalen Fachzeitschriften wurde Dr. Ionescu zum Professor für klinische Biochemie an der Capital University in Washington D.C. (USA) ernannt. Von 1998 bis 2006 war Dr. Ionescu als Professor für klinische Biochemie und Oxidology tätig. Im März 2006 erfolgte die Ernennung zum Associate Professor für Integrative Medizin und Gerontologie an der Universität für Medizin und Pharmazie "Carol Davila" in Bukarest. Seit 2007 ist er regelmäßig als Gastprofessor für Ernährungsmedizin an der Donau-Universität in Krems, Österreich tätig. Herr Dr. Ionescu ist Mitglied der Europäischen Akademie für Allergologie und klinischer Immunologie, Mitglied der Amerikanischen Akademie für Umweltmedizin und der Englischen Gesellschaft für Allergologie, Umwelt- und Ernährungsmedizin, deren Amerikanischen Akademie für Anti-Aging Medizin sowie im wissenschaftlichen Beirat der Europäischen Gesellschaft für Anti-Aging Medizin.
------------------------------------------------------------------------
[*/QUOTE*]


Unter Hinweis auf den Bericht im WDR sinngemäß: "Kennen wir, funktionert, machen wir schon seit 20 Jahren.. ABER wir machen es besser, weil wir mehr Dinge beachten."

Selbst wenn es in dieser Pressemeldung ein Datum gäbe, ich sehe es nicht. Auf jeden Fall ist es eine Reaktion auf den Fernsehbeitrag, wurde also nach diesem veröffentlicht.

Wichtig ist auch der Hinweis auf das Zielgebiet "Schuppenflechte und Neurodermitis", für das Klingelhöller  beansprucht, SEINE Salbe sei die erste und einzige dafür.


Schauen wir mal, welche Bröselsteine des Klingelhöllerschen Kartenhauses als nächste zerstauben.
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« Last Edit: October 26, 2009, 11:27:09 AM by ama »
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ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #11 on: November 18, 2009, 10:05:33 AM »

http://www.wipo.int/pctdb/en/wo.jsp?wo=1994028907

[*QUOTE*]
------------------------------------------------------------------------
(WO/1994/028907) USE OF CORRINOIDS IN TOPICAL TREATMENT OF SKIN DISEASES
Biblio. Data
Description
Claims
National Phase
Notices
Documents

Permanent Link
Bookmark this page
Latest bibliographic data on file with the International Bureau
Permanent Link
Bookmark this page
Pub. No.:          WO/1994/028907          International Application No.:          PCT/EP1994/001951
Publication Date:    22.12.1994    International Filing Date:    15.06.1994
Chapter 2 Demand Filed: 11.01.1995

IPC:    A61K 31/70 (2006.01), C07H 23/00 (2006.01)
Applicant:    KLINGELHÖLLER, Karsten [DE/DE]; (DE).
Inventor:    KLINGELHÖLLER, Karsten; (DE).
Agent:    CHRISTOPHERSEN, Ruth; Eichendorffstrasse 6, D-40474 Düsseldorf (DE).
Priority Data:        P 43 19 629.2         15.06.1993         DE

Title:    
(EN) USE OF CORRINOIDS IN TOPICAL TREATMENT OF SKIN DISEASES

(DE) VERWENDUNG VON CORRINOIDEN ZUR TOPISCHEN ANWENDUNG BEI HAUTERKRANKUNGEN
Abstract:    
(EN) The invention pertains to the use of compounds of formula (I), where R is CN, OH, CH¿3? or H¿2?O, in topical treatment of skin diseases and hair-growth disorders, and to a pharmaceutical preparation which contains, besides common carriers and/or diluents, compounds of the above formula (I) and a vegetable oil or fat.

(DE) Verwendung von Verbindungen mit der Formel (I), in der R für CN, OH, CH¿3? oder H¿2?O stehen, zur topischen Behandlung von Hauterkrankungen und Haarwachstumsstörungen sowie eine pharmazeutische Zusammensetzung, die neben üblichen Träger- und/oder Verdünnungsstoffen Verbindungen mit der obigen Formel (I) und ein pflanzliches Öl oder Fett enthält.
Designated States:    AU, BR, BY, CA, CZ, FI, HU, JP, KP, KR, NO, PL, RU, SK, UA, US.
European Patent Office (EPO) (AT, BE, CH, DE, DK, ES, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE).
Publication Language:    German (DE)
Filing Language:    German (DE)
------------------------------------------------------------------------
[*/QUOTE*]

ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #12 on: November 18, 2009, 10:17:26 AM »

http://www.wipo.int/pctdb/en/wo.jsp?wo=2003002104

[*QUOTE*]
------------------------------------------------------------------------
(WO/2003/002104) USE OF CORRINOIDS IN THE TREATMENT OF SKIN DISEASES
Biblio. Data
Description
Claims
National Phase
Notices
Documents

Permanent Link
Bookmark this page
Latest bibliographic data on file with the International Bureau
Permanent Link
Bookmark this page
Pub. No.:          WO/2003/002104          International Application No.:          PCT/EP2002/007067
Publication Date:    09.01.2003    International Filing Date:    26.06.2002
Chapter 2 Demand Filed: 27.01.2003

IPC:    A61K 31/714 (2006.01)
Applicants:    REGENERATIO PHARMA AG [DE/DE]; Kleine Klotzbahn 23, 42105 Wuppertal (DE) (All Except US).
KLINGELHÖLLER, Karsten [DE/DE]; (DE) (US Only).
Inventor:    KLINGELHÖLLER, Karsten; (DE).
Agent:    CHRISTOPHERSEN & PARTNER; Kapellstrasse 12, 40479 Düsseldorf (DE).
Priority Data:        101 30 846.9         28.06.2001         DE

Title:    
(EN) USE OF CORRINOIDS IN THE TREATMENT OF SKIN DISEASES

(DE) VERWENDUNG VON CORRINOIDEN ZUR ANWENDUNG BEI HAUTERKRANKUNGEN
Abstract:    
(EN) The invention relates to the use of the compounds of formula (I), wherein R represents CN, OH, CH¿3? or H¿2?O, for building up and improving the resistance of the skin. The compounds are particularly suitable for prophylaxis in cases where a predisposition for chronic skin diseases exists, for the prophylaxis and treatment of allergic skin reactions, for the treatment of acute skin lesions, for example burns and wounds, as well as for skin aging and for the treatment of degenerate cells, such as in canceroses, benign and/or malign tumors.

(DE) Es wird die Verwendung von Verbindungen mit der Formel (I), in der R für CN, OH, CH¿3? oder H¿2?O stehen, zum Aufbau und Verbesserung der Widerstandsfähigkeit der Haut beansprucht. Die Verbindungen eignen sich insbesondere zur Prophylaxe bei Disposition für chronische Hauterkrankungen zur Prophylaxe und Behandlung von allergischen Hautreaktionen zur Behandlung von akuten Hautschäden, z.B. bei Verbrennungen und Wunden, sowie bei Hautalterung und bei der Behandlung von entarteten Zellen, wie bei Cancerosen, gutartigen und/oder bösartigen Tumoren.
Designated States:    AL, AU, BA, BG, BR, CA, CN, CZ, EE, GE, HU, ID, IL, IN, JP, KP, KR, LT, LV, MX, NO, NZ, PH, PL, RO, SI, SK, US, YU, ZA.
Eurasian Patent Organization (EAPO) (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (EPO) (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, TR).
Publication Language:    German (DE)
Filing Language:    German (DE)
------------------------------------------------------------------------
[*/QUOTE*]

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ama

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Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #13 on: November 18, 2009, 10:22:54 AM »

https://register.epoline.org/espacenet/application;jsessionid=7F65A69637F4218036C8C93C28E05BDF.RegisterPlus_prod_1?number=EP02751075&tab=main

[*QUOTE*]
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EP1401454 - USE OF CORRINOIDS IN THE TREATMENT OF SKIN DISEASES    
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Status    Examination is in progress
Database last updated on   17.11.2009
Most recent event    07.07.2009     New entry: Renewal fee paid      
Applicant(s)    For all designated states
Regeneratio Pharma GmbH
Franzstrasse 1a
42857 Remscheid / DE
[2006/45]
Former [2004/14]    For all designated states
Regeneratio Pharma AG
Kleine Klotzbahn 23
42105 Wuppertal / DE
Inventor(s)    01 / KLINGELHÖLLER, Karsten
Eintrachtstrasse 39
42275 Wuppertal / DE
[2004/14]
Representative(s)    Christophersen, Ruth , et al
Christophersen & Partner Patentanwälte Feldstrasse 73
40479 Düsseldorf / DE
[2004/14]
Application number, filing date    02751075.9     26.06.2002
[2004/14]
WO2002EP07067
Priority number, date    DE20011030846     28.06.2001
[2004/14]
Filing language    DE
Procedural language    DE
Publication    Type :     A2   Application without search report
No. :    EP1401454
Date :    09.01.2003
[2004/14]
Type :     A2   Application without search report
No. :    WO03002104
Date :    09.01.2003
[2004/14]
International search report:    Date:     20.03.2003
Authority:     EP
Classification    International     A61K31/714     [2004/14]
Designated contracting states    AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LI, LU, MC, NL, PT, SE, TR    [2004/14]
Extension states    LT    21.11.2003
LV    21.11.2003
SI    21.11.2003
Title    German     VERWENDUNG VON CORRINOIDEN ZUR ANWENDUNG BEI HAUTERKRANKUNGEN    [2004/14]
    English     USE OF CORRINOIDS IN THE TREATMENT OF SKIN DISEASES    [2004/14]
    French     UTILISATION DE CORRINOIDES POUR ADMINISTRATION EN CAS DE MALADIES CUTANEES    [2004/14]
Entry into regional phase    21.11.2003     National basic fee paid      
21.11.2003     Designation fee(s) paid      
21.11.2003     Examination fee paid      
Examination procedure    27.01.2003     Request for preliminary examination filed
International Preliminary Examining Authority: EP
21.11.2003     Examination requested
17.05.2006     Despatch of a communication from the examining division (Time limit: M06)
16.03.2007     Reply to a communication from the examining division
11.01.2008     Despatch of a communication from the examining division (Time limit: M08)
28.10.2008     Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time
18.12.2008     Reply to a communication from the examining division
Request for further processing for:    

16.03.2007     Full payment received (date of receipt of payment)
Request granted
13.04.2007     Decision despatched
The application is deemed to be withdrawn due to failure to reply to the examination report
18.12.2008     Full payment received (date of receipt of payment)
Fees paid    Renewal fee
22.07.2004     Renewal fee   patent year  03
28.06.2005     Renewal fee   patent year  04
21.06.2006     Renewal fee   patent year  05
29.06.2007     Renewal fee   patent year  06
30.06.2008     Renewal fee   patent year  07
25.06.2009     Renewal fee   patent year  08
Penalty fee
Additional fee for renewal fee
30.06.2004     03   M06   Fee paid on   22.07.2004
Cited in    International search    [XD] US5798341    
     [X] DE3210669    
     [X] GB1264509    
     [X] DE2325809    
     [X] DE2505114    
     [X] US4387093    
     [X] US6110472    
     [X] US6117119    
     [XP] WO0203942    
     [ ]  See also references of EP 1401454A2
    Examination    US6194452    
     NL9101406    
       - DATABASE WPI Week 199314, Derwent Publications Ltd., London, GB; Class B05, AN 1993-114987 & NL 9 101 406 A (VUNDERINK A.) 16 März 1993
       - See also references of WO 03002104A2
------------------------------------------------------------------------
[*/QUOTE*]

.

ama

  • Jr. Member
  • *
  • Posts: 1108
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #14 on: January 16, 2010, 02:52:02 PM »

.




Neu auf http://www.kindersprechstunde.at/blog/

Alte Preziosen: die frühen Studien zu Vitamin B12 und Hautkrankheiten

http://www.kindersprechstunde.at/blog/?p=49




.

wilma

  • Jr. Member
  • *
  • Posts: 32
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #15 on: March 24, 2010, 03:24:08 PM »

Die rosa Wundersalbe (früher mit Namen Regividerm, heute Mavena B12 Salbe) ist vom BfArM als Arzneimittel eingestuft worden:
 
http://www.kuhrtgesagt.de/2010/03/bfarm-stuft-wundersalbe-regividerm-als-arzneimittel-ein/

http://www.apotheke-adhoc.de/Nachrichten/Wissenschaft%20und%20Forschung/10009.html

http://www.deutsche-apotheker-zeitung.de/recht/news/2010/03/24/bfarm-stuft-vitamin-b12-salbe-mavenaR-b12-als-arzneimittel-ein.html

BfArM stuft Vitamin-B12-Salbe Mavena® B12 als Arzneimittel ein

Stuttgart - Um die Frage zu klären, ob es sich bei dem inzwischen unter dem Namen Mavena® B12 Salbe (vormals Regividerm) erhältlichen Medizinprodukt um ein zulassungspflichtiges Arzneimittel handelt, hatte die Bezirksregierung Düsseldorf das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) um Stellungnahme gebeten. Sie liegt inzwischen vor. Danach stuft das BfArM Mavena® B12 Salbe als Arzneimittel ein. Das Inverkehrbringen als Medizinprodukt wurde jedoch noch nicht untersagt.

...
Logged

ama

  • Jr. Member
  • *
  • Posts: 1108
Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #16 on: March 26, 2010, 07:25:22 AM »

Dazu paßt die Größtmauligkeit derer von und zu Medienfürst:

[*QUOTE*]
--------------------------------------------------------------------------
Subject: ARD und ZDF gegen Werbeverbot : Werbung entlastet die Gebührenzahler
From:    ARD-Pressedienst@ard.de
Date:    Fri, March 26, 2010 11:50 am
To:      ARD-Pressedienst@slnweb02.swr.de
--------------------------------------------------------------------------


ARD und ZDF gegen Werbeverbot : Werbung entlastet die Gebührenzahler


Der ARD-Vorsitzende Peter Boudgoust und der ZDF-Intendant Markus Schächter
haben sich nach einem Spitzengespräch für eine Versachlichung der
Diskussion über Werbung im öffentlich-rechtlichen Rundfunk ausgesprochen.
Der Vorsitzende der ARD, SWR-Intendant Peter Boudgoust sagte in Mainz, bei
den in der letzten Zeit geäußerten Forderungen nach einem Verbot von
Werbung und Sponsoring bei ARD und ZDF werde völlig außer Acht gelassen,
dass die damit verbundenen Einnahmen vom Gesetzgeber vorgegeben seien und
in erster Linie der Entlastung der Rundfunkgebühr um rund 450 Millionen
Euro pro Jahr dienten. Boudgoust: "Um es klar und deutlich zu sagen: Bei
einer  politisch gewollten Umsetzung dieser Idee geht das zu Lasten der
Gebührenzahler oder eben des Programms." Boudgoust erklärte weiter, die
Interessen der kommerziellen Rundfunkveranstalter seien bereits durch die
Ermöglichung entgeltlicher Produktplatzierung sehr weitreichend
berücksichtigt worden. Außerdem würde entfallende Werbung keineswegs
automatisch zu den Privatsendern wandern, wie das aktuelle Beispiel
Frankreich eindrücklich zeige.

ZDF-Intendant Schächter wies darauf hin, dass sich die werbetreibende
Wirtschaft massiv für den Erhalt der Werbung bei den öffentlich-rechtlichen
Sendern ausgesprochen hat. Schächter: "Für die deutsche Wirtschaft sind die
Programme von ARD und ZDF unabdingbar, um bestimmte interessante
Zielgruppen im TV und Hörfunk zu erreichen. Viele Untersuchungen haben
außerdem gezeigt, dass sich die Zuschauer an der ohnehin begrenzten Werbung
nicht stören." Umfragen zeigten, so Schächter, dass sich die meisten
Zuschauer nicht gegen Werbung an sich aussprechen, sondern nur gegen ein
Übermaß an Werbung, insbesondere Unterbrecherwerbung. Die Entscheidung läge
beim Gesetzgeber, die Konsequenzen sollten aber gründlich abgewogen werden.



Rückfragen an:

ARD-Pressestelle (SWR)
Tel: 0711/ 929 - 1022/ 1023
E-Mail: pressestelle@ard.de

ZDF-Pressestelle
Tel: 06131/70-2120
E-Mail: presse@zdf.de
--------------------------------------------------------------------------
[*/QUOTE*]


Die Gebührenzahler würde es GANZ SICHER mehr entlasten, wenn man nicht so viel Mist produzieren und Geld dafür verprassen würde, wie ARD und ZDF es ungeniert treiben.

Eine Reduzierung des Programms auf die Hälfte ist sofort und völlig problemlos möglich. Einfach mal den Mist weglassen, Herr Intendant!

Und ganz besonders:

Einfach mal den Mist weglassen, Frau WDR-Intendant Monika Piel!


.

tipsy toaster

  • Jr. Member
  • *
  • Posts: 53
Re: Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #17 on: July 29, 2010, 02:44:01 PM »

Karsten Klingelhöller bleibt im rosa Business - hier gehts zu den neuen Aktivitäten.

“How do you spell Klingelholler?”
http://kindersprechstunde.wordpress.com/2010/07/29/how-do-you-spell-klingelholler/

Vorsicht, lang - und viiiiiiiiiiiiieeeeeeeeeel Material ;-)
Logged

Borodor

  • Jr. Member
  • *
  • Posts: 234
Klingelhölleritis in den USA - Teil 1
« Reply #18 on: September 13, 2010, 11:28:56 AM »

Wie mach ich das Zitat jetzt richtig? Das Ding ist irre lang.


[*****QUOTE*****]
ISSUER INFORMATION AND DISCLOSURE STATEMENT
Macada Holding, Inc.
Formerly Tri Star Holdings, Inc. until 8-2009, formerly Rapid Fitness, Inc. until 8-2008,
formerly Amore TV, Inc. until 5-07, formerly Global Web TV, Inc. (New) until 1-06,
formerly QOL Holdings, Inc. until 10-05, formerly Global Web TV Inc.(Old) until 12-
03, formerly Liquidics, Inc. until 12-01, formerly Future Projects IV, Corp. until 4-00.
State of incorporation change Florida to Nevada concurrent with name change
A Nevada Corporation
CUSIP: 554187104
CIK: 0001470243
ISSUER’S EQUITY SECURITIES
As of March 31, 2010
Common Stock
1,000,000,000 Common Shares authorized, par value $0.0001 per share
21,255,536 Common Shares issued and outstanding
Preferred Stock
100,000,000 Preferred Shares authorized, par value $0.0001 per share
19,000,000 Preferred Shares issued and outstanding
Macada Holding, Inc. is responsible for the content of this Initial Company Information
and Disclosure Statement. The securities described in this document are not registered
with, and the information contained in this statement has not been filed with, or
approved by, the U.S. Securities and Exchange Commission.
NO DEALER, SALESMAN OR ANY OTHER PERSON HAS BEEN
AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY
REPRESENTATIONS NOT CONTAINED HEREIN IN CONNECTION WITH
THE COMPANY. ANY REPRESENTATIONS NOT CONTAINED HEREIN
MUST NOT BE RELIED UPON AS HAVING BEEN MADE OR AUTHORIZED
BY THE COMPANY.
DELIVERY OF THIS INFORMATION FILE, AT ANY TIME DOES NOT
IMPLY THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS
OF ANY TIME SUBSEQUENT TO THE DATE FIRST WRI'I"I`EN ABOVE.
1
COPIES OF THIS INFORMATION AND DISCLOSURE STATEMENT ARE
AVAILABLE FROM THE ISSUER UPON REQUEST.
2
Table of Contents
Section
One
Part A
Item I
Item II
Item III
General Considerations
Issuers’ Initial Disclosure Obligations
6
6
6
6
6
7
7
7
9
11
11
11
17
56
69
69
76
77
78
79
General Company Information
The exact name of the Issuer and its predecessor (if any)
The address of the Issuer’s principal executive offices
The jurisdiction(s) and date of the Issuer’s incorporation or
organization
Part B
Share Structure
Item IV
The exact title and class of securities outstanding
Item V
Par or stated value and description of the security
Item VI
The number of shares or total amount of the securities
outstanding for each class of securities authorized.
Part C
Business Information
Item VII
The name and address of the transfer agent
Item VIII
The nature of the Issuer’s business
Item IX
The nature of products or services offered
Item X
The nature and extent of the Issuer’s facilities
Part D
Management Structure and Financial Information
Item XI
The name of the chief executive officer, members of the
board of directors, as well as control persons
Item XII
Financial information for the Issuer’s most recent fiscal
period.
Item XIII
Similar financial information for such part of the two
preceding fiscal years as the Issuer or its predecessor has
been in existence
Item XIV
Beneficial Owners
Item XV
The name, address, telephone number, and email address of
each of the following outside providers that
advise the Issuer on matters relating to the operations,
business development and disclosure:
Item XVI
Management’s Discussion and Analysis or Plan of Operation
Part E
Issuance History
Item XVII List of securities offerings and shares issued for services in
the past two years.
Part F
Exhibits
Item XVIII Material Contracts
3
87
87
Item XIX
Item XX
Item XXI
Articles of Incorporation and Bylaws.
Purchases of Equity Securities by the Issuer and Affiliated
Purchasers
Issuer’s Certifications
4
ISSUER INFORMATION AND DISCLOSURE STATEMENT
______
Macada Holding, Incorporated
Formerly Tri Star Holdings, Inc. until 8-2009, Formerly Rapid Fitness, Inc. until 8-2008,
Formerly Amore TV, Inc. until 5-07, Formerly Global Web TV, Inc. (New) until 1-06,
Formerly QOL Holdings, Inc. until 10-05, Formerly Global Web TV Inc.(Old) until 12-
03, Formerly Liquidics, Inc. until 12-01, Formerly Future Projects IV, Corp. until 4-00.
State of incorporation change Florida to Nevada concurrent with name change
A Nevada Corporation
______
Cautionary Note Regarding Forward-Looking Statements
Information set forth in this Initial Company Information and Disclosure Statement (the
“Initial Disclosure Statement”) contains forward-looking statements, which involve a
number of risks and uncertainties that could cause our actual results to differ materially
from those reflected in the forward-looking statements. Forward-looking statements can
be identified by use of the words “expect,” “project,” “may,” “might,” potential,” and
similar terms. Macada Holding, Inc. (“MCDA”, “we” or the “Company”) cautions
readers that any forward-looking information is not a guarantee of future performance
and that actual results could differ materially from those contained in the forward-
looking information. Forward-looking statements involve a number of risks,
uncertainties or other factors beyond MCDA’ control. These factors include, but are not
limited to, our ability to implement our strategic initiatives, economic, political and
market conditions and price fluctuations, government and industry regulation, U.S. and
global competition and other factors. We undertake no obligation to update any forward-
looking statement, whether as a result of new information, future events or otherwise.
5
Section One: Issuers’ Initial Disclosure Obligations
Part A General Company Information
Item I The exact name of the issuer and its predecessor (if any).
Macada Holding, Incorporated
Formerly Tri Star Holdings, Inc. until 8-2009, formerly Rapid Fitness, Inc. until 8-2008,
formerly Amore TV, Inc. until 5-07, formerly Global Web TV, Inc. (New) until 1-06,
formerly QOL Holdings, Inc. until 10-05, formerly Global Web TV Inc.(Old) until 12-
03, formerly Liquidics, Inc. until 12-01, formerly Future Projects IV, Corp. until 4-00.
State of incorporation change Florida to Nevada concurrent with name change. A
Nevada Corporation
Item II The address of the issuer’s principal executive offices.
4701 North Federal Highway - Suite 430
Pompano Bch, Fl, 33064
Phone 954-782-2056
Fax 954-582-2890
www.bio-skin.us
www.erhunit.com
www.tristargold.com
www.lyfepet.com
www.thenhscenter.com
Item III The jurisdiction(s) and date of the issuer’s incorporation or organization.
State of Incorporation: Nevada
Jurisdiction of Incorporation: United States
Year of Incorporation: 2000
6
Part B Share Structure
Item IV The exact title and class of securities outstanding.
In answering this item, provide the exact title and class of each class of outstanding
securities. In addition, please provide the CUSIP and trading symbol.
Item V Par or stated value and description of the security.
A. Par or Stated Value. Provide the par or stated value for each class of
outstanding securities.
B. Common or Preferred Stock.
Common Stock $0.0001 par value
CUSIP: 554187104
Trading symbol: MCDA
Preferred Stock $0.0001 par value
1. For common equity, describe any dividend, voting and preemption rights.
The Issuer's authorized Common Stock consists of 1,000,000,000 shares of Common
Stock. The common shares are entitled to one vote per Share on all matters to be
voted upon by shareholders and, upon issuance in consideration of full payment, are
non-assessable. In the event of liquidation, dissolution or winding up of the Issuer,
the shareholders are entitled to share ratably in all assets remaining after payment of
liabilities. Common shares do not have cumulative voting rights with respect to the
election of directors.
Dividend Rights
Each Share is entitled to dividends if, as and when dividends are declared by the
Company's Board of Directors. It is not the current expectation of the Company to
pay dividends. Dividends are not payable on the convertible preferred.
7
Directors' Liability
As authorized by the applicable provisions of Nevada corporate law, each director or
officer of the Company will be indemnified by the Company against expenses
(including attorneys’ fees), judgments, fines and amounts paid in settlement actually
and reasonably incurred by him in connection with the defense or settlement of any
threatened, pending or completed action, suit or proceeding whether civil, criminal,
administrative or investigative in which he is involved by reason of the fact that he is
or was a director or officer of the Company; such indemnification, of course, is
conditioned upon such officer or director having acted in good faith and in a manner
that s/he reasonably believed to be in or not opposed to the best interests of the
Company and, with respect to any criminal action or proceeding, if s/he had no
reasonable cause to believe that such conduct was unlawful. The articles of
incorporation, as amended, provides that no director of the Company shall be
personally liable to the Company or any of its Shareholders for monetary damages
for any breach of fiduciary duty as a director, except with respect to: (i) any breach
of the director's duty of loyalty to the Company or its Shareholders; (ii) for acts or
omissions that are not in good faith or involve intentional misconduct or a knowing
violation of the law; (iii) violation of Nevada corporate law; or (iv) for any
transaction from which the director derived an improper personal benefit. In effect,
such articles authorize the Company to indemnify any person to the fullest extent
permitted by Nevada corporate law.
On the basis of federal and/or state statutes, (a) shareholders in a corporation have
the right, subject to the provisions of the Federal Rules of Civil Procedure and
jurisdictional requirements, to bring class actions in federal court to enforce their
rights under federal securities laws; and (b) Shareholders who have suffered losses
in connection with the purchase or sale of their shares may be able to recover such
losses from a corporation's management where the losses result from a violation by
the management of SEC Rule 10b-5, promulgated under the Securities Exchange
Act of 1934, as amended. It should be noted, however, that in endeavoring to
recover damages in such actions, it would be generally difficult to establish as a
basis for liability that the Company's management has not met such a standard. This
is due to the broad discretion given the directors and officers of a corporation to act
in its best interest. The SEC has stated that, to the extent any exculpatory or
indemnification provision purports to include indemnification for liabilities arising
under the Securities Act of 1933, as amended, it is the opinion of the SEC that such
indemnification is contrary to public policy and, therefore, unenforceable.
Shareholders who may, in the future, believe that the Company's management may
have violated applicable law regarding fiduciary duties should consult with their
8
own counsel as to their evaluation of the status of the law at such time.
2. For preferred stock, describe the dividend, voting, conversion and liquidation
rights as well as redemption or sinking fund provisions.
The Company's Articles of Incorporation authorize the issuance of 100,000,000
shares of preferred stock. The outstanding Convertible Preferred Stock has super
voting rights of twenty to one and is convertible one for one into Common Shares.
3. Describe any other material rights of common or preferred stockholders.
None.
4. Describe any provision in issuer’s charter or by-laws that would delay, defer or
prevent a change in control of the issuer.
There are no provisions in the Issuer’s charter or by-laws that would delay, defer or
prevent a change in control of the issuer other than as described herein.
Item VI The number of shares or total amount of the securities outstanding for
each class of securities authorized.
Common Stock
(i) Period end date
Period ended
March 31, 2010
1,000,000,000
7,565,536
5,574,426
Last fiscal year
ended December
31, 2009
`1,000,000,000
7,565,536
5,574,426
Previous fiscal year
ended December
31, 2008
1,650,000,000
1,619,771,335
1,152,189,149
(ii) Number of
shares authorized;
(iii) Number of
shares outstanding;
(iv) Freely tradable
shares (public
float);
9
(v) Total number of
beneficial
shareholders; and
(vi) Total number of
shareholders of
record.
449
449
404
Preferred Stock
(i) Period end date
Period ended
March 31, 2010
100,000,000
87,000,000
0
Last fiscal year
ended December
31, 2009
100,000,000
87,000,000
0
Previous fiscal year
ended December
31, 2008
50,000,000
50,000,000
0
(ii) Number of
shares authorized;
(iii) Number of
shares outstanding;
(iv) Freely tradable
shares (public
float);
(v) Total number of
beneficial
shareholders; and
(vi) Total number
of shareholders of
record.
5
5
5
10
Part C Business Information
Item VII The name and address of the transfer agent.
Stalt, Inc. acts as the Company’s registrar and transfer agent and it is located at 671 Oak
Grove Avenue, Suite C, Menlo Park, California 94025.
Stalt, Inc. is registered under the Exchange Act
Item VIII The nature of the issuer’s business.
In describing the issuer’s business, please provide the following information:
A. Business Development. Describe the development of the issuer and material
events during the last three years so that a potential investor can clearly
understand the history and development of the business. If the issuer has not been
in business for three years, provide this information for any predecessor company.
This business development description must also include:
1. the form of organization of the issuer (e.g., corporation, partnership, limited
liability company, etc.);
The Issuer is a corporation.
2. the year that the issuer (or any predecessor) was organized;
The Issuer was organized in 2000.
3. the issuer’s fiscal year end date;
December 31
4. whether the issuer (or any predecessor) has been in bankruptcy, receivership or
any similar proceeding;
11
The Issuer has not been in bankruptcy or receivership.
5. any material reclassification, merger, consolidation, or purchase or sale of a
significant amount of assets;
In January, 2009, the Issuer sold multiple mining properties and mineral rights claims to
UC Hub Group, Inc. in consideration of 190,000,000 shares of that company’s common
stock, and August 14, 2009 the transaction was canceled by mutual agreement due to the
UC Hub's inability to finance the development of the mines and all the mining properties
were returned to the Issuer.
On March 22, 2010, the Issuer purchased all of the equity of Pembroke Gun and Range,
LLC.
In April, 2010, the Issuer sold the assets of Lyfetec, Inc. for 50 million shares of Strata
Capital Corporation’s common stock. Strata has since completed a 15:1 reverse split.
(3,333,333 new shares) Strata trades in the Pink Sheets OTC Market. The Issuer
anticipates distributing a portion of the Strata Capital common stock received from t he
sale to the Issuer's shareholders of record. See “Risk Factors.”
On June 4, 2010, the Issuer agreed to acquire the assets and liabilities of The Natural
Health Solutions Center for 4,000,000 shares of the Issuer's Common Stock. If the
average closing value of the Issuer's Common Stock on the last four trading days of
2010 do not equal or exceed $0.50, additional shares shall be issued so that all shares
issued as consideration equal $2,000,000 at market value. The transaction is scheduled
to close in July, 2010.
6. any default of the terms of any note, loan, lease, or other indebtedness or
financing arrangement requiring the issuer to make payments;
The Issuer is in default on a convertible debenture for $309,000.00. The Issuer is in
default of payment of salaries in the amount of $409,000.00 since March 2009.
In May 2010, the convertible debenture was sold to another holder and the Issuer signed
a $3,000,000 equity line of credit with Manhattan Capital Corp, LLC. for two years. The
convertible debenture was made by Amore TV, Inc., predecessor to Macada Holdings,
Inc., March 15, 2007 in the amount of $309,000.00 and bears interest at the prime rate of
interest as reported by Citibank on the issue date plus three points. The note is
12
convertible at the lowest bid price of the Issuer's Common Stock on the conversion date.
7. any change of control;
Anthony Mellone, Jr. now has 7,000,000 shares of Preferred Stock of the Issuer, Ronald
Ritter now has 7,000,000 shares of Preferred Stock of the Issuer Antonio Mellone, Sr.
now has 3,000,000 shares of Preferred Stock of the Issuer, and Donna Yamin and has
2,000,000 shares of Preferred Stock of the Issuer. These holders of the Issuer's Preferred
Stock agreed to cancel a total of 58 million shares of the Preferred Stock without
consideration in February, 2010.
8. any increase of 10% or more of the same class of outstanding equity securities;
On June 7, 2010, the holder of the Issuer's convertible note converted the note into 26
million shares of the Issuer's Common Stock.
9. any past, pending or anticipated stock split, stock dividend, recapitalization,
merger, acquisition, spinoff, or reorganization;
The Issuer's shares were decreased by a 1 for 50 split, payable December 15, 2003. The
Issuer's shares were increased by a 22 for 1 split, ex-dividend on January 27, 2006. The
Issuer's shares were decreased by a 1 for 100 reverse split, ex-date November 20, 2006.
The Issuers shares were decreased by a 1 for 100 split, payable May 11, 2007. The
Issuer's shares were decreased by a 1 for 500 reverse split payable August 20, 2009.
See also above for further information on mergers and acquisitions.
10. any delisting of the issuer’s securities by any securities exchange or deletion
from the OTC Bulletin Board; and
None.
11. any current, past, pending or threatened legal proceedings or administrative
actions either by or against the issuer that could have a material effect on the
issuer’s business, financial condition, or operations and any current, past or
pending trading suspensions by a securities regulator. State the names of the
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principal parties, the nature and current status of the matters, and the amounts
involved.
The Issuer's Lyfetec subsidiary has entered into a lease for 11,000 square feet of space at
760 East McNab Road, Pompano Beach, Florida 33062. There is litigation pending
regarding this lease. The Issuer is in the process of moving to other property.
For the purpose of this section a “shell company” means an issuer, other than a
business combination related shell company, as defined by Securities Act Rule 405,
or an asset-backed issuer, as defined by Item 1101(b) of Regulation AB, that has:
(1) No or nominal operations; and
(2) Either:
(A) No or nominal assets;
(B) Assets consisting solely of cash and cash equivalents; or
(C) Assets consisting of any amount of cash and cash equivalents and nominal
other assets.
B. Business of Issuer. Describe the issuer’s business so a potential investor can
clearly understand it. To the extent material to an understanding of the issuer,
please also include the following:
1. the issuer’s primary and secondary SIC Codes;
Primary SIC
5047 Medical, Dental, and Hospital Equipment and Supplies
Establishments primarily engaged in the wholesale distribution of surgical and
other medical instruments, apparatus, and equipment; dentist equipment;
artificial limbs; operating room and hospital equipment; X-ray machines; and
other electro medical equipment and apparatus used by physicians and in
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hospitals. Also included in this industry are establishments primarily engaged in
the wholesale distribution of professional supplies used by medical and dental
practitioners.
2. if the issuer has never conducted operations, is in the development stage, or is
currently conducting operations;
The issuer is in the development stage except with respect to Pembroke Gun & Range.
3. whether the issuer is or has at any time been a “shell company”;
The Issuer is not and has not been a “shell company.”
4. the names of any parent, subsidiary, or affiliate of the issuer, and its business
purpose, its method of operation, its ownership, and whether it is included in the
financial statements attached to this disclosure statement;
Subsidiaries
The Issuer owns three subsidiaries: (1) Pembroke Gun & Range, LLC, (2) Lyfetec, Inc.,
and (3) Tri Star Holdings Group, Inc.
Lyfetec, Inc. has three divisions, (1) LyfePet division companion animal medical care,
(2) ERHU Division Emergency mobile hospital units, and (3) Bio-Skin.
Tri Star Holdings Group, Inc. owns the Issuer's mining assets.
5. the effect of existing or probable governmental regulations on the business;
See “Risk Factors” and “Business.”
6. an estimate of the amount spent during each of the last two fiscal years on
research and development activities, and, if applicable, the extent to which the cost
of such activities are borne directly by customers;
The Issuer estimates that it has spent approximately $65,000.00 per year in research and
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development in the last two fiscal years. None of these costs have been borne directly by
customers.
See also “Risk Factors.”
7. costs and effects of compliance with environmental laws (federal, state and
local); and
See “Risk Factors.”
8. the number of total employees and number of full-time employees.
The Issuer had seven full-time employees and one part-time employee, including our
officers, as of March 31, 2010.
Workers are provided to the Issuer through various local staffing agencies or are
retained directly as independent contractors. None of the Issuer's employees are
represented by a labor union. The Issuer also relies on the services of outside consultants
for services.
The Issuer will outsource our sales and marketing efforts to independent contractors,
primarily to individuals who work on a part-time basis and are paid per hour worked on
per project for a fixed cost.
In order for the Issuer to attract and retain quality personnel, the Issuer anticipates that it
will have to offer competitive salaries to future employees. The Issuer anticipates an
employment base of 25 full and part time employees during the next 12 months.
As the Issuer continues to expand, the Issuer will incur additional cost for personnel.
This projected increase in personnel is dependent upon generating revenues and
obtaining sources of financing. There is no guarantee that the Issuer will be successful in
raising the funds required or generating revenues sufficient to fund the projected
increase in the number of employees.
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Item IX The nature of products or services offered.
In responding to this item, please describe the following so that a potential investor
can clearly understand the products and services of the issuer:
A. principal products or services, and their markets;
See “Business.”
B. distribution methods of the products or services;
See “Business” and “status of any publicly announced new product or service.”
C. status of any publicly announced new product or service;
The Issuer incorporates by reference all of the items posted on the Pink Sheets OTC
Market at http://www.otcmarkets.com/stock/MCDA/news
See “Business.”
D. competitive business conditions, the issuer’s competitive position in the
industry, and methods of competition;
See ”Risk Factors” and “Business.”
E. sources and availability of raw materials and the names of principal suppliers;
The Issuer believes that its raw materials are generally available from a number of
suppliers. See also “Risk Factors.”
F. dependence on one or a few major customers;
The Issuer believe that is not dependent on one or a few major customers. See “Risk
Factors” and “Business.”
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G. patents, trademarks, licenses, franchises, concessions, royalty agreements or
labor contracts, including their duration; and
See “Risk Factors” and “Business.”
H. the need for any government approval of principal products or services and the
status of any requested government approvals.
See also “the effect of existing or probable governmental regulations on the business,
“Business,” and “Risk Factors.“
U.S. Government Regulation
The research and development, manufacture and marketing of human therapeutic and
diagnostic products are subject to regulation, primarily by the FDA and by comparable
authorities in other countries. These national agencies and other federal, state and local
entities regulate, among other things, research and development activities (including
testing in animals and in humans) and the testing, manufacturing, handling, labeling,
storage, record keeping, approval, advertising and promotion of the products that we are
developing. Noncompliance with applicable requirements can result in various adverse
consequences, including, delay in approving or refusal to approve product licenses or
other applications, suspension or termination of clinical investigations, revocation of
approvals previously granted, fines, criminal prosecution, recall or seizure of products,
injunctions against shipping products and total or partial suspension of production
and/or refusal to allow a company to enter into governmental supply contracts.
The Drug Development Process
The FDA, and comparable agencies in other countries, requires that pharmaceutical and
certain other therapeutic products undergo significant clinical experimentation and
clinical testing, known as clinical trials or clinical studies, prior to their marketing or
introduction to the general public.
Below, we describe the principal framework in which clinical studies are conducted, as
well as describe a number of the parties involved in these studies.
Protocols. Before commencing human clinical studies, the sponsor of a new drug must
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submit an investigational new drug application, or IND, to the FDA. The application
contains what is known in the industry as a protocol. A protocol is the blueprint for each
drug study. The protocol sets forth, among other things, the following:




who must be recruited as qualified participants;
how often to administer the drug;
what tests to perform on the participants; and
what dosage of the drug to give to the participants.
Institutional Review Board. All clinical studies must be approved by an institutional
review board, which is an independent committee of professionals and lay persons. The
institutional review board’s role is to protect the rights of the participants in clinical
studies by reviewing protocols and other aspects.
Clinical Trials. Human clinical studies or testing of a potential drug are generally
done in four stages known as Phase I through Phase IV testing. The names of the phases
are derived from the regulations of the FDA (or equivalent). Generally, there are
multiple studies conducted in each phase.
Phase I. Phase I studies involve testing a drug or product on a limited number of
healthy participants, typically 20 to 80 people at a time. Phase I studies determine a
drug’s basic safety and tolerability and include biological analyses to determine how the
drug is absorbed by, and eliminated from, the body. This phase lasts an average of six
months to a year.
Phase II. Phase II trials involve testing up to a relatively small number of
participants (typically a few dozen to a few hundred) who suffer from the targeted
disease or condition. Phase II testing typically lasts an average of one to two years. In
Phase II, the drug is tested to determine its safety and effectiveness for treating a specific
illness or condition. Phase II testing also involves determining acceptable dosage levels
of the drug. If Phase II studies show that a new drug has an acceptable range of safety
risks and probable effectiveness, the drug’s sponsor will continue to review the
substance in Phase III studies.
Phase III. Phase III studies involve testing large numbers of participants, typically
several hundred to several thousand persons. The purpose is to verify effectiveness and
long-term safety on a large scale. These studies generally last two to three years. Phase
III studies are conducted at multiple locations or sites. Like the other phases, Phase III
requires the site to keep detailed records of data collected and procedures performed.
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New Drug Approval. The results of the clinical trials are submitted to the FDA
(or equivalent) as part of a new drug application (“NDA”). Following the completion of
Phase III studies, assuming the sponsor of a potential product in the United States
believes it has sufficient information to support the safety and effectiveness of its
product, it submits an NDA to the FDA requesting that the product be approved for
marketing. The application is a comprehensive, multi-volume filing that includes the
results of all clinical studies, information about the drug’s composition, and the
sponsor’s plans for producing, packaging and labeling the product. The FDA’s review
of an application can take a few months to many years, with the average review lasting
18 months. Once approved, drugs and other products may be marketed in the United
States, subject to any conditions imposed by the FDA.
Phase IV. The FDA may require that the sponsor conduct additional clinical trials
following new drug approval. The purpose of these trials, known as Phase IV studies, is
to monitor long-term risks and benefits, study different dosage levels or evaluate safety
and effectiveness. In recent years, the FDA has increased its reliance on these trials.
Phase IV studies usually involve thousands of participants. Phase IV studies also may
be initiated by the company sponsoring the new drug to gain broader market value for an
approved drug. For example, large-scale trials may also be used to prove effectiveness
and safety of new forms of drug delivery for approved drugs. Examples may be using
an inhalation spray versus taking tablets or a sustained-release form of medication
versus capsules taken multiple times per day.
Other U.S. Regulations
Various Federal and state laws, regulations, and recommendations relating to safe
working conditions, laboratory practices, the experimental use of animals, and the
purchase, storage, movements, import, export, use, and disposal of hazardous or
potentially hazardous substances, including radioactive compounds and infectious
disease agents, are used in connection with our research or applicable to our activities.
They include, among others, the United States Atomic Energy Act, the Clean Air Act,
the Clean Water Act, the Occupational Safety and Health Act, the National
Environmental Policy Act, the Toxic Substances Control Act, and Resources
Conservation and Recovery Act, national restrictions on technology transfer, import,
export, and customs regulations, and other present and possible future local, state, or
federal regulation. The extent of governmental regulation which might result from
future legislation or administrative action cannot be accurately predicted.
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RISK FACTORS
______
You should carefully consider the risks described below as well as the other information
included or incorporated by reference in this document. The risks described below are
not the only risks facing us. Additional risks and uncertainties not currently known to us
or that we currently deem to be immaterial may also materially and adversely affect our
business operations. Any of the following risks could materially adversely affect our
business, financial condition or results of operations. In such case, investors may lose
all or part of their original investment.
RISKS RELATED TO OUR COMPANY
We have a history of significant net operating losses and may never achieve
profitability.
We have a history of significant net operating losses. We cannot assure you that we will
ever achieve profitability. Even if we do achieve profitability, we cannot assure you that
we will be able to sustain or increase profitability on a quarterly or annual basis in the
future. Revenues and profits, if any, will depend upon various factors, including whether
we will be able to successfully implement our sales, marketing, and advertising
strategies. We may not achieve our business objectives and the failure to achieve such
goals would have an adverse impact on us. In addition, an inability to achieve
profitability could have a detrimental effect on the long term capital appreciation of our
common stock.
Our independent auditors have expressed a reservation as to whether we can continue
as a going concern.
Our independent auditors’ report on our financial statements states that our recurring
losses and lack of revenue generation to date raise substantial doubt about our ability to
continue as a going concern. Our ability to continue as a going concern is dependent on
our ability to raise additional capital or generate revenues to sustain our operations.
There is no guarantee that we will be able to raise enough capital or generate revenues to
sustain our operations.
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There can be no assurance that we will be able to generate or secure sufficient
funding to successfully execute our business plan. Currently, we only have negligible
cash and we continue to incur significant losses.
The working capital requirements associated with our business plan will continue to be
significant. The primary requirements are for sales, marketing, and advertising efforts.
We estimate that we will need to spend approximately $500,000 per year for the next
two years to execute our business plan. We will need to raise additional capital in the
next twelve months to fully implement our sales, marketing, and advertising strategy. If
we do not have sufficient cash from operations, funds available under credit facilities
and/or the ability to raise cash through the sale of debt and/or equity securities, or if we
cannot issue our capital stock on terms suitable to us, we will be unable to pursue our
business strategy, which could have a material adverse effect on our ability to increase
our company’s revenue and net income (or reduce our net loss, as applicable) and on our
company’s financial condition and results of operations.
If we are unable to attract and retain qualified personnel with experience in our
industries, our business could suffer.
Our current and future success depends in part on our ability to identify, attract,
assimilate, hire, train and motivate professional, highly-skilled scientific and technical
personnel for our research, development and engineering efforts, as well as managerial,
and sales and marketing personnel with experience in our industries. If we fail to attract
and retain the necessary technical, managerial, and sales and marketing personnel, we
may not develop a sufficient customer base to adequately develop our proposed
operations, and, as a result, could have a material adverse effect on our company.
Our success depends on our management team.
Our company’s operations are dependent on the continued efforts of our Board of
Directors and our executive officers, including our President and Chief Executive
Officer. If any of these individuals becomes unwilling or unable to continue their
employment or association with us, our business could be affected materially and
adversely. Furthermore, there can be no assurance that our management team will be
successful in managing the operations of the company or be able to effectively
implement our business strategy. Failure of our management group to successfully
manage the operation of our company or to effectively implement our business strategy
could have a material adverse effect on our company’s financial condition and results of
operations. We have no key man life insurance on any of our executives.
22
We currently have existing material weaknesses in our internal control over financial
reporting. If we are unable to improve and maintain the quality of our system of
internal control over financial reporting, any deficiencies could materially and
adversely affect our ability to report timely and accurate financial information about
us.
As a public company, we incur significant legal, accounting and other expenses that we
would not incur as a private company. In addition, if we register our stock, the
Sarbanes−Oxley Act, as well as rules subsequently implemented by the Securities and
Exchange Commission and the NASDAQ Stock Market, have imposed various new
requirements on public companies, including requiring establishment and maintenance
of effective disclosure and financial controls and changes in corporate governance
practices. Our management and other personnel will need to devote a substantial amount
of time to these compliance initiatives. Moreover, these rules and regulations have
increased our legal and financial compliance costs and will make some activities more
time consuming and costly. For example, we expect these rules and regulations to make
it more difficult and more expensive for us to obtain director and officer liability
insurance, and we may be required to incur substantial costs to maintain the same or
similar coverage.
We are responsible for establishing and maintaining effective disclosure controls and
procedures and adequate internal control over financial reporting, in each case as
prescribed by applicable SEC rules and regulations. Together, these elements are
intended to provide reasonable (but not absolute) assurance regarding the reliability of
our financial reporting. Management has determined that our disclosure controls and
procedures were not effective and that we have material weaknesses in our internal
control over financial reporting. Since the time we determined that our disclosure
controls and procedures were not effective and identified the material weaknesses in our
internal control over financial reporting, we have devoted significant time to developing
remedial measures to address these deficiencies. Although we believe that these
measures have strengthened our disclosure controls and procedures and our internal
control over financial reporting, we cannot be certain that they will ensure that we
maintain effective disclosure controls and procedures or adequate internal control over
our financial reporting in future periods. Any failure to maintain such effective
disclosure controls and procedures or adequate internal control over financing reporting
could adversely impact our ability to report our financial results on a timely and accurate
basis. If we are no longer able to report our financial results on a timely and accurate
basis, we may erode our investors’ understanding of and confidence in our financial
reporting, as well as face severe consequences from regulatory authorities, either of
which may have a material adverse affect on our business and a negative effect on the
trading price of our stock.
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If the markets for our products do not develop and expand as we anticipate, demand
for our products may decline, which would negatively impact our results of operations
and financial performance.
The markets for our products are characterized by rapidly changing technologies,
evolving industry standards and frequent new product introductions. Our success is
expected to depend, in substantial part, on the timely and successful introduction of new
products, upgrades of current products to comply with emerging industry standards, our
ability to acquire technologies needed to remain competitive and our ability to address
competing technologies and products. In addition, the following factors related to our
products and the markets for them could have an adverse impact on our results of
operations and financial performance:
• The inability to maintain a favorable mix of products;
• The anticipated level of demand for our products by our customers does not
continue. While this demand has been increasing in recent quarters, there is no assurance
that this upward trend can be sustained. A leveling or declining demand or an
unanticipated change in market demand for products based on a specific technology
would adversely affect our ability to sustain recent operating and financial performance;
and
• The inability to continue to develop new product lines to address our customers’
diverse needs and the several market segments in which we participate. This requires a
high level of innovation, as well as the accurate anticipation of technological and market
trends.
Changes in our manufacturing processes or those of our contractors and suppliers
could significantly reduce our manufacturing yields and product reliability.
The manufacture of our products involves highly complex and precise processes,
requiring production in highly controlled, arid clean environments. In some cases,
existing manufacturing techniques, which involve substantial manual labor, may be
insufficient to achieve the volume or cost targets of our customers. We or our suppliers
will need to develop new manufacturing processes and techniques to achieve targeted
volume and cost levels. While we continue to devote substantial efforts to the
improvement of our manufacturing techniques and processes, we may not achieve
manufacturing volumes and cost levels in our manufacturing activities that will fully
satisfy customer demands.
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We may experience difficulties that may delay or prevent our development,
introduction or marketing of new or enhanced products.
We intend to continue to invest in product and technology development. The
development of new or enhanced products is a complex and uncertain process. We may
experience research and development, manufacturing, marketing and other difficulties
that could delay or prevent our development, introduction or marketing of new products
or enhancements. We cannot be certain that:
• any of the products under development will prove to be effective in clinical
trials;
• we will be able to obtain, in a timely manner or at all, regulatory approval to
market any of our products that are in development or contemplated;
• any of such products can be manufactured at acceptable cost and with
appropriate quality; or
• any such products, if and when approved, can be successfully marketed.
The factors listed above, as well as manufacturing or distribution problems, or other
factors beyond our control, could delay new product launches. In addition, we cannot
assure you that the market will accept these products. Accordingly, there is no assurance
that our overall revenues will increase if and when new products are launched.
We currently have limited revenue sources. A reduction in revenues of any of our key
products would cause our revenues to decline and could materially harm our
business.
We expect a small number of our key products, which will likely shift over time, to
continue to account for a significant portion of our net revenues for the foreseeable
future. As a result, continued market acceptance and popularity of these products are
critical to our success, and a reduction in demand due to, among other factors, the
introduction of competing products by our competitors, the entry of new competitors, or
end-users' dissatisfaction with the quality of our products, could materially and
adversely affect our financial condition and results of operations.
We could be subject to costly and time-consuming product liability actions. We carry
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no insurance coverage.
If our products do not function as anticipated, whether as a result of the design of these
products, unanticipated health consequences or side effects, or misuse or mishandling by
third parties, of such products, or because of faulty or contaminated supplies, they could
injure the vaccines and as a result subject us to product liability lawsuits. Claims against
us also could be based on failure to perform as anticipated. Any product liability claim
brought against us, with or without merit, could have a material adverse effect on us.
Even a merit less or unsuccessful product liability claim could be time consuming,
expensive to defend and could result in the diversion of management's attention from
managing our core business or result in associated negative publicity.
Our business exposes us to potential product liability risks that are inherent in the
testing, manufacturing and marketing of biopharmaceutical products. We cannot be
certain that we will be able to maintain adequate product liability insurance at a
reasonable cost. In addition, we have no clinical trial liability insurance for our clinical
trials. Any insurance coverage we do have may not be sufficient to satisfy liability
resulting from product liability claims. A successful product liability claim or series of
claims could have a material adverse impact on our business, financial condition and
results of operations.
If we are unable to successfully compete in the highly competitive biopharmaceutical
industry, our business could be harmed.
We operate in a highly competitive environment, and we expect the competition to
increase further in the future. Our competitors include large pharmaceutical and
biotechnology companies and academic research institutions worldwide. Many of these
competitors have greater resources than us. New competitors may also enter into the
markets in which we currently compete. Accordingly, even if we are successful in
launching a product, we may not be able to outperform a competing product for any
number of reasons, including the possibility that the competitor may: (1) have launched
its competing product first or the competing product may have, or be perceived as
having, better efficacy, stronger brand recognition, or other advantages; (2) have greater
access to certain raw materials; (3) have more efficient manufacturing processes and
greater manufacturing capacity; (4) have greater marketing capabilities; (5) have greater
pricing flexibility; (6) have more extensive research and development and technical
capabilities; (7) have proprietary patent portfolios or other intellectual property rights
that may present an obstacle to our conduct of business; or (7) have greater knowledge
of local market conditions where we seek to increase our international sales.
The technologies applied by our competitors and us are rapidly evolving, and new
developments frequently result in price competition and product obsolescence. In
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addition, we may be impacted by competition from generic forms of our products,
substitute products or imports of products from lower-priced markets.
We may not achieve our projected development goals in the time frames we announce
and expect. If we fail to achieve one or more milestones as contemplated, the market
price of our common shares could decline.
We set goals for and make public statements regarding our anticipated timing of the
accomplishment of objectives material to our success, such as the commencement and
completion of clinical trials and other milestones. The actual timing of these events can
vary dramatically due to factors such as delays or failures in our clinical trials, the
uncertainties inherent in the regulatory approval process and delays in achieving
manufacturing or marketing arrangements sufficient to commercialize our products. We
may not complete our clinical trials or make regulatory submissions or receive
regulatory approvals as planned. Also, we may not be able to adhere to our currently
anticipated schedule for the launch of any of our products. If we fail to achieve one or
more milestones as contemplated, the market price of our shares could decline.
If any of our third-party suppliers or manufacturers cannot adequately meet our
needs, our business could be harmed.
While we use raw materials and other supplies that are generally available from multiple
commercial sources, certain raw materials that we use may be in short supply or difficult
for suppliers to produce in accordance with our specifications. If the third-party
suppliers were to cease production or otherwise fail to supply us with quality raw
materials, and we were unable to contract on acceptable terms for these materials with
alternative suppliers, our ability to deliver our products to the market would be adversely
affected.
In addition, if we fail to secure long-term supply sources for some of the raw materials
we use, our business could be harmed.
From time to time, concerns are raised with respect to potential contamination of
biological materials that are supplied to us. These concerns can further tighten market
conditions for materials that may be in short supply or available from limited sources.
Moreover, regulatory approvals to market our products may be conditioned upon
obtaining certain materials from specified sources. Any efforts to substitute material
from an alternate source may be delayed by pending regulatory approval of such
alternate source. Although we work to mitigate the risks associated with relying on sole
suppliers, there is a possibility that material shortages could impact product development
and production.
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We will need additional capital to expand the production capacity for our existing
products, to continue development of our product pipeline and to market existing and
future products on a large scale. We cannot guarantee that we will find adequate
sources of capital in the future.
We will need to raise additional funds from the capital markets to finance equipment
expenditures, to acquire intellectual property, to expand the production capacity for our
existing products, to continue the development and commercialization of our product
candidates and for other corporate purposes. Although we believe that we have adequate
near-term cash resources, we will need to undertake significant future financings in
order to: (1) establish and expand manufacturing capabilities; (2) proceed with the
research and development of other vaccine products, including clinical trials of new
products; (3) acquire interests in other companies. (4) Commercialize our products,
including the marketing and distribution of new and existing products; (5) seek and
obtain regulatory approvals; (6) develop or acquire other product candidates or
technologies; (7) protect our intellectual property; and (8) finance general and
administrative and research activities that are not related to specific products under
development.
If we continue to raise additional funds by issuing equity securities, it will result in
further dilution to our existing shareholders, because the shares may be sold at a time
when the market price is low and shares issued in equity financing transactions will
normally be sold at a discount to the current market price. Any additional equity
securities issued also may provide for rights, preferences or privileges senior or
otherwise preferential to those of holders of our existing common shares. Unforeseen
problems including materially negative developments relating to, among other things,
disease developments, product sales, new product rollouts, clinical trials, research and
development programs, our strategic relationships, our intellectual property, litigation,
regulatory changes in our industry, the market generally or general economic conditions,
could interfere with our ability to raise additional funds or materially adversely affect
the terms upon which such funding is available.
If we raise additional funds by issuing debt securities, these debt securities would have
rights, preferences and privileges senior to those of holders of our common shares, and
the terms of the debt securities issued could impose significant restrictions on our
operations. If we raise additional funds through collaborations and licensing
arrangements, we might be required to relinquish significant rights to certain of our
technologies, marketing territories, product candidates or products that we would
otherwise seek to develop or commercialize ourselves, or be required to grant licenses
on terms that are not favorable to us. In the past, we have also received research grants
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Logged

Borodor

  • Jr. Member
  • *
  • Posts: 234
Klingelhölleritis in den USA - Teil 2
« Reply #19 on: September 13, 2010, 11:30:18 AM »

on terms that are not favorable to us. In the past, we have also received research grants
28
to finance the development of our products. We may not receive additional grants in the
future.
We do not know whether additional financing will be available to us on commercially
acceptable terms when needed. If adequate funds are not available or are not available
on commercially acceptable terms, we may be unable to continue developing our
products. In any such event, our ability to bring a product to market and obtain revenues
could be delayed and competitors could develop products sooner than we do.
We depend on our key personnel, the loss of whom would adversely affect our
operations. If we fail to attract and retain the talent required for our business, our
business will be materially harmed.
We are a small company and we depend to a great extent on principal members of our
management and scientific teams. If we lose the services of any key personnel, the loss
could significantly impede the achievement of our research and development objectives
and delay our product development programs and the approval and commercialization of
our product candidates. We do not currently have any key man life insurance policies.
We have entered into employment agreements with our executive officers under which
they have agreed to restrictive covenants relating to non-competition and non-
solicitation. These employment agreements do not, however, guarantee that we will be
able to retain the services of our executive officers in the future. In addition, recruiting
and retaining additional qualified scientific, technical and managerial personnel and
research partners will be critical to our success. Competition among biopharmaceutical
and biotechnology companies for qualified employees intense and turnover rates are
high. There is currently a shortage of employees with expertise in our areas of research
and clinical and regulatory affairs, and this shortage is likely to continue. We may not be
able to retain existing personnel or attract and retain qualified staff in the future. If we
fail to hire and retain personnel in key positions, we may be unable to develop or
commercialize our product candidates in a timely manner.
We may encounter difficulties in managing our growth, which could adversely affect
our results of operations.
We will experience a period of rapid and substantial growth that may place and, if such
growth continues, will continue to place a strain on our administrative and operational
infrastructure. If we are unable to manage this growth effectively, our business, results
of operations or financial condition may be materially and adversely affected. Our
ability to manage our operations and growth effectively requires us to continue to
improve our operational, financial and management controls, reporting systems and
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procedures and hiring programs. We may not be able to successfully implement these
required improvements.
International expansion may be costly, time consuming and difficult. If we do not
successfully expand internationally, our growth strategy and prospects would be
materially and adversely affected.
We may enter into selected international markets and intend to continue to expand the
sales of our products into new international markets. In expanding our business
internationally, we have entered and intend to continue to enter markets in which we
have limited or no experience and in which our brand may be less recognized. To further
promote our brand and generate demand for our products so as to attract distributors in
international markets, we expect to spend significantly more on marketing and
promotion than we do in our existing domestic markets. We may be unable to attract a
sufficient number of distributors, and our selected distributors may not be suitable for
selling our products. Furthermore, in new markets we may fail to anticipate competitive
conditions that are different from those in our existing markets. These competitive
conditions may make it difficult or impossible for us to effectively operate in these
markets. If our expansion efforts in existing and new internal markets are unsuccessful,
our growth strategy and prospects would be materially and adversely affected.
We are exposed to other risks associated with international operations, including: (1)
political instability; (2) economic instability and recessions; (3) changes in tariffs; (4)
difficulties of administering foreign operations generally; (5) limited protection for
intellectual property rights; (6) obligations to comply with a wide variety of foreign laws
and other regulatory approval requirements; (7) increased risk of exposure to terrorist
activities; (8) financial condition, expertise and performance of our international
distributors; (9) export license requirements; (10) unauthorized re-export of our
products; (11) potentially adverse tax consequences; and (12) inability to effectively
enforce contractual or legal rights.
We may undertake acquisitions, which may have a material adverse effect on our
ability to manage our business, and may end up being unsuccessful.
Our growth strategy may involve the acquisition of new production lines, technologies,
businesses, products or services or the creation of strategic alliances in areas in which
we do not currently operate. These acquisitions could require that our management
develop expertise in new areas, new geographies, manage new business relationships
and attract new types of customers. Furthermore, acquisitions may require significant
attention from our management, and the diversion of our management's attention and
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resources could have a material adverse effect on our ability to manage our business. We
may also experience difficulties integrating acquisitions into our existing business and
operations. Future acquisitions may also expose us to potential risks, including risks
associated with: (1) the integration of new operations, services and personnel; (2)
unforeseen or hidden liabilities; (3) the diversion of resources from our existing
businesses and technologies; (4) our inability to generate sufficient revenue to offset the
costs of acquisitions; and (5) potential loss of, or harm to, relationships with employees
or customers, any of which could significantly disrupt our ability to manage our business
and materially and adversely affect our business, financial condition and results of
operations.
Increases in demand for our products could require us to expend considerable
resources to meet the demand or harm our customer relationships if we are unable to
meet demand.
If we experience significant or unexpected increases in the demand for our products, we
and our suppliers may not be able to meet that demand without expending additional
capital resources. These capital resources could involve the cost of new machinery or
even the cost of new manufacturing facilities. This would increase our capital costs,
which could adversely affect our earnings. Our suppliers may be unable or unwilling to
expend the necessary capital resources or otherwise expand their capacity. In addition,
new manufacturing equipment or facilities may be required to meet required FDA
standards before they can be used to manufacture our products. To the extent we are
unable to obtain or are delayed in meeting such standards, our ability to meet the
demand for our products could be adversely affected.
If we or our suppliers are unable to develop necessary manufacturing capabilities in a
timely manner, our net sales could be adversely affected. Failure to cost-effectively
increase production volumes, if required, or lower than anticipated yields or production
problems encountered as a result of changes that we or our suppliers make in our
manufacturing processes to meet increased demand, could result in shipment delays or
interruptions and increased manufacturing costs, which could also have a material
adverse effect on our revenues and profitability.
Our inability to meet customer demand for our products could also harm our customer
relationships and impair our reputation within the industry. This, in turn, could have a
material adverse effect on our business and prospects.
There can be no assurance that our distributors will be able to market our products.
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There is no assurance that our distributors will be able to successfully market our
products. Our agreement with them is recent, and we do not have any relationship or
history with the company prior to entering into the agreement. Further, we have not been
provided with a letter of credit or other guarantees of their financial ability to
successfully market our products.
Our current products may have certain side effects. If side effects associated with our
current or future products are not identified prior to their marketing and sale, we may
be required to withdraw such products from the market, perform lengthy additional
clinical trials or change the labeling of our products, any of which could hinder or
adversely affect our ability to generate revenues.
Our current products have certain side effects. If significant side effects of our
medicines are identified after they are marketed and sold, regulatory authorities may
withdraw or modify their approvals of such medicines; we may be required to
reformulate these medicines, change the ways in which they are marketed, conduct
additional clinical trials, change the labeling of these medicines or implement changes to
obtain new approvals for our manufacturing facilities; we may be less successful in
tendering processes used by hospitals for medicine purchases; we may have to recall
these medicines from the market and may not be able to re-launch them; we may
experience a significant decline in sales of the affected products; our reputation may
suffer; and we may become a target of lawsuits.
The occurrence of any of these events would harm our sales of these medicines and
substantially increase the costs and expenses of marketing these medicines, which in
turn could cause our revenues and net income to decline. In addition, if any severe side
effects are discovered to be associated with another manufacturer's used to treat medical
conditions similar to those that our medicines are used to treat, the reputation and,
consequently, sales of our medicines could be adversely affected.
We may not be able to obtain manufacturing or marketing approval for our future
products, and failure to obtain approvals for our future products could materially
harm our business prospects.
All medicines must be approved by the Food and Drug Administration, or the FDA,
before they can be manufactured, marketed or sold. The FDA requires a pharmaceutical
manufacturer to have successfully completed clinical trials of a new medicine and
demonstrated its manufacturing capability before approval to manufacture that new
medicine is granted. Clinical trials are expensive and their results are uncertain. In
addition, the FDA and other regulatory authorities may apply new standards for safety,
32
manufacturing, labeling, marketing and distribution of future products. Complying with
these standards may be time-consuming and expensive. Furthermore, our future
products may not be efficacious or may have undesirable or unintended side effects,
toxicities or other characteristics that may preclude us from obtaining approval or may
prevent or limit their commercial use. As a result, we may not be able to obtain FDA or
other governmental approvals for our future products on a timely basis or at all. Even if
we do obtain approvals, such approvals may be subject to limitations on the indicated
uses for which we may market a product, which may limit the size of the market for
such a product.
The failure to maintain our relationships with our existing customers or the failure to
obtain new customers could negatively affect our revenues and decrease our earnings
or have an adverse impact on our business.
We maintain purchase orders for the sales of our products to our customers. Although
we have entered into agreements to supply our customers, we cannot assure that such
agreements will be renewed when the terms of such agreements expire or that our
relationships with our customers will be maintained on satisfactory terms or at all. The
failure to maintain our relationships with our customers or the failure to obtain new
customers could negatively affect our revenues and decrease our earnings or have an
adverse impact on our business.
We rely on a limited number of suppliers and the loss of any of our suppliers, or
delays or problems in the supply of materials used in our products, could materially
and adversely affect our business, financial condition, results of operations and
growth prospects.
We generally rely on a limited number of suppliers for most of the primary materials
used in our products. Our suppliers may not be able to supply the necessary materials
without interruption and we may not have adequate remedies for such failure, which
could result in a shortage of our products. If one of our suppliers fails or refuses to
supply us for any reason, it could take time and expense to obtain a new supplier. In
addition, our failure to maintain existing relationships with our suppliers or to establish
new relationships in the future could negatively affect our ability to obtain the materials
used in our products in a timely manner. The search for new suppliers could potentially
delay the manufacture of our products, resulting in shortages in the marketplace and may
cause us to incur additional expense. Failure to comply with applicable legal
requirements subjects our suppliers to possible legal or regulatory action, including
shutdown, which may adversely affect their ability to supply us with the materials we
need for our products. Any delay in supplying, or failure to supply, materials for our
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products by any of our suppliers could result in our inability to meet the commercial
demand for our products, and could adversely affect our business, financial condition,
results of operations and growth prospects.
Government regulators and regulations could adversely affect our business.
The formulation, manufacturing, packaging, labeling, advertising, distribution, and sale
of our product, as well as other dietary supplements, are subject to regulation by a
number of federal, state, and local agencies, including but not limited to the Food and
Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”). See
“Business-Regulation” for more information. These agencies have a variety of
procedures and enforcement remedies available to them, including but not limited to:

Initiating investigations;

Issuing warning letters and cease and desist orders;

Demanding recalls;

Initiating adverse publicity;

Requiring corrective labeling or advertising;

Requiring consumer redress and/or disgorgement;

Seeking injunctive relief or product seizures;

Initiating judicial actions; and
34

Imposing civil penalties or commencing criminal prosecution.
Federal and state agencies have in the past used these types of remedies in regulating
participants in the dietary supplement industry, including the imposition by federal
agencies of monetary redress in the millions of dollars. Adverse publicity related to
dietary supplements may result in increased regulatory scrutiny, undermine or eliminate
the acceptance of our product by consumers and lead to the initiation of private lawsuits.
Product recalls could result in unexpected expense of the recall and any legal
proceedings that might arise in connection with the recall.
Our failure to comply with applicable laws could also subject us to severe legal
sanctions that could have a material adverse effect on our business and results of
operations. Specific action taken against us could result in a material adverse effect on
our business and results of operations. Furthermore, a state could interpret product
claims that are presumptively valid under federal law are nonetheless illegal under that
state’s regulations.
Future laws or regulations may hinder or prohibit the production or sale of our
existing product and any future products.
We may be subject to additional laws or regulations in the future, such as those
administered by the FDA, FTC, or other federal, state, or local regulatory authorities.
Laws or regulations that we consider favorable may be modified or repealed. Current
laws or regulations may be amended or interpreted more stringently. The FDA has
proposed extensive good manufacturing practice regulations for dietary supplements. We
are unable to predict the nature of such future laws, regulations, or interpretations, nor
can we predict what effect they may have on our business. Possible effects or
requirements could include, but are not limited to, the following:

The reformulation of products to meet new standards;

Additional ingredient restrictions;

Additional claim restrictions;
35

The recall or discontinuance of products unable to be reformulated;

Imposition of additional good manufacturing practices and/or record keeping
requirements;

Expanded documentation of the properties of products; and

Expanded or different labeling or scientific substantiation.
Any such requirements could have material adverse effects on our business, financial
condition, or results of operations.
Unfavorable publicity could materially hurt our business and the value of your
investment.
We are highly dependent upon consumers’ perceptions of the safety, quality, and efficacy
of our products, as well as products distributed by other companies. Future scientific
research or publicity may not be favorable to our industry or any particular product, or
consistent with earlier research or publicity. Future reports or research that are perceived
less favorably or that question such earlier research could have a material adverse effect
on us. Because of our dependence upon consumer perceptions, adverse publicity
associated with illness or other adverse effects resulting from the consumption of our
product or any similar products distributed by other companies could have a material
adverse impact on us. Such adverse publicity could arise even if the adverse effects
associated with such products resulted from failure to consume such products as
directed. We may be unable to counter the effects of negative publicity concerning the
efficacy of our product. Adverse publicity could also increase our product liability
exposure.
We are and will continue to be subject to the risk of investigatory and enforcement
action by the FTC, which could have a negative impact upon the price of our stock.
36
We will always be subject to the risk of investigatory and enforcement action by the
FTC based on our advertising claims and marketing practices. The FTC routinely
reviews product advertising, including websites, to identify significant questionable
advertising claims and practices. The FTC has brought many actions against dietary
supplement companies based upon allegations that applicable advertising claims or
practices were deceptive and/or not substantiated. If the FTC initiates an investigation,
the FTC can initiate pre-complaint discovery that may be nonpublic in nature. Such an
investigation: (i) may be very expensive to defend, (ii) may be lengthy, and (iii) may
result in an adverse ruling by a court, administrative law judge, or in a publicly disclosed
consent decree.
If we are unable to attract, train, retain and motivate our prescription medicine and
OTC medicine salespeople, sales of our products may be materially and adversely
affected.
We rely on our salespeople and distributors, who will be dispersed across the country,
to market our products to the regional distributors as well as hospitals and retail
pharmacies. We believe that our current sales have resulted, to a significant extent, from
the dedication, efforts and performance of our salespeople. We believe that our future
success will depend on those same factors. If we are unable to attract, train, retain and
motivate our prescription medicine and OTC medicine salespeople, sales of our products
may be materially and adversely affected.
RISKS RELATED TO OUR INDUSTRY
Our industry is highly competitive.
We face intense competition in our business. We expect that we will face additional
competition from large, existing competitors and from a number of companies that may
enter our markets. Since some of the markets in which we compete are characterized by
rapid growth and rapid technology changes, smaller niche and start-up companies may
become our principal competitors in the future. We must invest in research and
development, expand our manufacturing and marketing capabilities, and continue to
improve customer service and support in order to remain competitive. While we expect
to undertake the investment and effort in each of these areas, we cannot assure that we
will be able to maintain or improve our competitive position. There can be no assurance
that we will be able to compete successfully with such entities in the future.
Many of our competitors and potential competitors have superior resources, which
37
could place us at a cost and price disadvantage. Thus, we may never realize revenues
sufficient to sustain our operations, and we may fail in our business and cease
operations.
Many of our competitors and potential competitors may have significant competitive
advantages, including greater market presence, name recognition, superior financial,
technological and personnel resources, superior services and marketing capabilities, and
superior manufacturing capabilities. Some of these competitors are household names. As
a result, some of our competitors and potential competitors could raise capital at a lower
cost than we can, and they may be able to adapt more swiftly to new or emerging
technologies and changes in customer requirements, take advantage of acquisitions and
other opportunities more readily, and devote greater resources to the development,
marketing, and sale of products than we can. Market consolidation may create additional
or stronger competitors and may intensify competition. Also, our competitors’ and
potential competitors’ greater brand-name recognition may require us to price our
services at lower levels in order to win business. Our competitors’ and potential
competitors’ financial advantages may give them the ability to reduce their prices for an
extended period of time if they so choose.
Technological advances and regulatory changes may erode revenues that could be
derived from our proposed operations, which could increase competition and put
downward pressure on prices for our proposed products.
New technologies and regulatory changes, particularly those relating to pharmaceutical
and biotech products, if any, could impair our prospects, put downward pressure on
prices for our in vitro diagnostics products, and adversely affect our operating results. In
addition, the competition in our market from the existing developers and manufacturers
of in vitro diagnostics products with technologically advanced processes may place
downward pressure on prices for such products, which can adversely affect our
operating results. In addition, we could face competition from other companies we have
not yet identified or which may later enter into the market with technologically
advanced processes. If we are not able to compete effectively with these industry
participants, our operating results would be adversely affected.
The need to obtain regulatory approvals and respond to changes in regulatory
requirements could adversely affect our business.
Many of our proposed and existing products are subject to regulation by the FDA and
other governmental or public health agencies. In particular, we are subject to strict
governmental controls on the development, manufacture, labeling, distribution and
marketing of our products. In addition, we are often required to obtain approval or
38
registration with foreign governments or regulatory bodies before we can import and sell
our products in foreign countries.
The process of obtaining required approvals or clearances from governmental or public
health agencies can involve lengthy and detailed laboratory testing, human clinical trials,
sampling activities and other costly, time- consuming procedures. These approvals can
require the submission of a large amount of clinical data which may require significant
time to obtain. It is also possible that a product will not perform at a level needed to
generate the clinical data required to obtain an approval or clearance. The submission of
an application to the FDA or other regulatory authority does not guarantee that an
approval or clearance to market the product will be received. Each authority may impose
its own requirements and delay or refuse to grant approval or clearance, even though a
product has been approved in another country or by another agency.
Moreover, the approval or clearance process for a new product can be complex and
lengthy. This time span increases our costs to develop new products as well as the risk
that we will not succeed in introducing or selling them in the United States or other
countries.
Failure to comply with FDA or other regulatory requirements may require us to
suspend production of our products or institute a recall which could result in higher
costs and a loss of revenues.
We can manufacture and sell many of our products, both in the United States and
internationally, only if we comply with regulations of government agencies such as the
FDA. We have implemented quality assurance and other systems that are intended to
comply with applicable regulations.
\Although we believe that we have adequate processes in place to ensure compliance
with these requirements, the FDA or other regulatory bodies could force us to stop
manufacturing or selling our products if it concludes that we are out of compliance with
applicable regulations. The FDA and other regulatory bodies could also require us to
recall products if we fail to comply with applicable regulations, which could force us to
stop manufacturing such products. Such actions by the FDA could adversely affect our
revenues.
Our success depends on our ability to protect our proprietary technology.
Our industry places considerable importance on obtaining patent, trademark and trade
secret protection, as well as other intellectual property rights, for new technologies,
39
products and processes. Our success depends, in part, on our ability to develop and
maintain a strong intellectual property portfolio or obtain licenses to patents for products
and technologies both in the United States and in other countries.
As appropriate, we intend to file patent applications and obtain patent protection for our
proprietary technology. These patent applications and patents will cover, as applicable,
compositions of matter for our products, methods of making those products, methods of
using those products and apparatus relating to the use or manufacture of those products.
We will also rely on trade secrets, know-how and continuing technological
advancements to protect our proprietary technology.
We do not currently have any confidentiality agreements with our employees,
consultants, advisors and collaborators. However, in the future we intend to adopt a
policy that would require such persons and entities to enter into such agreements with
us. When we do this, these parties may not honor these agreements and we may not be
able to successfully protect our rights to unpatented trade secrets and know-how. Others
may independently develop substantially equivalent proprietary information and
techniques or otherwise gain access to our trade secrets and know-how.
Some of our current employees, including scientific and management personnel, were
previously employed by competing companies. Although we encourage and expect all of
our employees to abide by any confidentiality agreement with a prior employer,
competing companies may allege trade secret violations and similar claims against us.
We may collaborate with universities and governmental research organizations which,
as a result, may acquire part of the rights to any inventions or technical information
derived from collaboration with them.
To facilitate development and commercialization of a proprietary technology base, we
may need to obtain licenses to patents or other proprietary rights from other parties.
Obtaining and maintaining such licenses may require the payment of substantial
amounts. In addition, if we are unable to obtain these types of licenses, our product
development and commercialization efforts may be delayed or precluded.
We may incur substantial costs and be required to expend substantial resources in
asserting or protecting our intellectual property rights, or in defending suits against us
related to intellectual property rights. Disputes regarding intellectual property rights
could substantially delay product development or commercialization activities. Disputes
regarding intellectual property rights might include state, federal or foreign court
litigation, as well as patent interference, patent reexamination, patent reissue, or
40
trademark opposition proceedings in the United States Patent and Trademark Office.
Opposition or revocation proceedings could be instituted in a foreign patent office. An
adverse decision in any proceeding regarding intellectual property rights could result in
the loss or limitation of our rights to a patent, an invention or trademark.
RISKS RELATED TO GOVERNMENT REGULATION
We may not be able to comply with applicable good manufacturing practice
requirements and other regulatory requirements, which could have a material adverse
affect on our business, financial condition and results of operations.
We are required to comply with applicable good manufacturing practice regulations,
which include requirements relating to quality control and quality assurance as well as
corresponding maintenance, record-keeping and documentation standards.
Manufacturing facilities must be approved by governmental authorities before we can
use them to commercially manufacture our products and are subject to inspection by
regulatory agencies.
If we fail to comply with applicable regulatory requirements at any stage during the
regulatory process, including following any product approval, we may be subject to
sanctions, including: (1) fines; (2) product recalls or seizure; (3) injunctions; (4) refusal
of regulatory agencies to review pending market approval applications or supplements to
approval applications; (5) total or partial suspension of production; (6) civil penalties;
(7) withdrawals of previously approved marketing applications; and (8) criminal
prosecution.
We could be adversely affected by healthcare reform legislation.
Third-party payers for medical products and services, including state and federal
governments, are increasingly concerned about escalating health care costs and can
indirectly affect the pricing or the relative attractiveness of our products by regulating
the maximum amount of reimbursement they will provide for diagnostic testing
services. In recent years, pressure has been increasing for the U.S. government to enact
comprehensive healthcare reform. These proposals have been wide-ranging on both
state and federal levels. We are unable to predict whether any such legislation may be
enacted in the U.S. or elsewhere or what effect such legislation may have on
reimbursement rates for our products. If reimbursement amounts for diagnostic testing
services are decreased in the future, such decreases may reduce the amount that will be
reimbursed to hospitals or physicians for such services and consequently could place
constraints on the levels of overall pricing, which could have a material effect on our
41
sales and/or results of operations.
The availability and amount of reimbursement for our products and services and the
manner in which government and private payers may reimburse for our products is
uncertain.
Coverage and reimbursement for products and services under Medicare are determined
pursuant to regulations promulgated by the Centers for Medicare & Medicaid Services
(“CMS”) and pursuant to CMS’s sub regulatory coverage and reimbursement
determinations. It is difficult to predict how CMS will apply those regulations and sub
regulatory determinations to our products. Moreover, the methodology under which
CMS makes coverage and reimbursement determinations is subject to change,
particularly because of budgetary pressures facing the Medicare program.
Even if our products are approved for marketing in the U.S., if we are unable to obtain
or retain coverage and adequate levels of reimbursement from Medicare or from private
health plans, our ability to successfully market such products in the U.S. will be
adversely affected. The manner and level at which the Medicare program reimburses for
services related to our products (e.g., administration services) also may adversely affect
our ability to market or sell any of our products that may be approved for marketing in
the U.S.
Efforts to contain or reduce health care costs have resulted in many legislative and
regulatory proposals at both the federal and state level, and it is difficult to predict
which, if any, of these proposals will be enacted, and, if so, when. Cost control
initiatives by governments or third party payers could decrease the price that we receive
for any one or all of our products.
42
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
Some of our technology is not patented. If we are unable to protect our technologies
from competitors with patents or other forms of intellectual property protection, our
business may be harmed.
Our success depends, in part, on our ability to protect our proprietary technologies. We
try to protect the technology that we consider important to our business by filing PRC
patent applications and relying on trade secret and pharmaceutical regulatory protection.
The process of seeking patent protection can be lengthy and expensive, and we cannot
assure you that our pending patent applications, or any patent applications we may make
in the future in respect of other products, will result in issued patents, or that any patents
issued in the future will be able to provide us with meaningful protection or commercial
advantage. Our patent applications may be challenged, invalidated or circumvented in
the future.
In addition to patents, we rely on trade secrets and proprietary know-how to protect our
intellectual property. We have entered into confidentiality agreements (which include, in
the case of employees, non-competition provisions) with many of our employees,
consultants, outside scientific collaborators, sponsored researchers and other advisors.
These agreements provide that all confidential information developed or made known to
the individual during the course of the individual's relationship with us is to be kept
confidential and not disclosed to third parties except in specific circumstances. In the
case of our employees, the agreements provide that all of the technology which is
conceived by the individual during the course of employment is our exclusive property.
These agreements may not provide meaningful protection or adequate remedies in the
event of unauthorized use or disclosure of our proprietary information. In addition, it is
possible that third parties could independently develop information and techniques
substantially similar to ours or otherwise gain access to our trade secrets.
We cannot assure you that our current or potential competitors, many of whom have
substantial resources and have made substantial investments in competing technologies,
do not have and will not develop, products that compete directly with our products
despite our intellectual property rights.
Intellectual property rights and confidentiality protections may not be effective.
Policing unauthorized use of proprietary technology is difficult and expensive, and we
might need to resort to litigation to enforce or defend patents issued to us or to determine
the enforceability, scope and validity of our proprietary rights or those of others. The
experience and capabilities of the courts in handling intellectual property litigation
43
varies, and outcomes are unpredictable. Further, such litigation may require significant
expenditures of cash and management efforts and could harm our business, financial
condition and results of operations. An adverse determination in any such litigation
could materially impair our intellectual property rights and may harm our business,
prospects and reputation.
We may be exposed to infringement or misappropriation claims by third parties, which,
if determined adversely to us, could cause substantial liabilities to us, or we may be
unable to sell some of our products.
Our commercial success also depends significantly on our ability to operate without
infringing the patents and other proprietary rights of third parties. Even after reasonable
investigation, we may not know with certainty whether we have infringed upon a third
party's patent due to the complexity of patent claims, the inadequacy of patent clearance
search procedures and the fact that a third party may have filed a patent application
without our knowledge while that product was under development by us. The
publication of discoveries in the scientific or patent literature frequently occurs
substantially later than the date on which the underlying discoveries were made and
patent applications were filed. There may also be technologies licensed to us or acquired
by us that are subject to infringement, misappropriation or other claims by others which
could damage our ability to rely on such technologies.
If a third party claims that we infringe upon its proprietary rights, any of the following
may occur: (1) we may become involved in time-consuming and expensive litigation,
even if the claim is without merit; (2) we may become liable for substantial damages for
past infringement if a court decides that our technology infringes upon a competitor's
patent; (3) a court may prohibit us from selling or licensing our product without a
license from the patent holder, which may not be available on commercially reasonable
terms, if at all, or which may require us to pay substantial royalties or grant cross
licenses to our patents; (4) we may have to reformulate our product so that it does not
infringe upon others' patent rights, which may not be possible or could be very
expensive and time-consuming; and (5) we may be subject to injunctions prohibiting the
manufacture and sale of our products or the use of our technologies.
If any of these events occurs, our business will suffer and the market price of our
common shares could decline.
44
FINANCIAL RISKS
We will need additional financing.
Our development schedule could be delayed if we are unable to fund our acquisition
activities. We believe we will need to raise additional funds to achieve full commercial
operation. We do not know whether we will be able to secure additional funding, or
funding on terms acceptable to us.
We face financial risk, including the risk of high leverage.
Our development and operation will entail uncertain cash flows. We may spend
relatively large amounts on marketing and other expenses. All of these factors and more
will result in substantial financial risk. See "Business."
We may be subject to the risks normally associated with debt financing, including the
risk that payments of principal and interest on borrowings may leave us with insufficient
cash to operate or to pay distributions.
We intend to make use of a very high degree of financial leverage. We could become
more highly leveraged because our organizational documents contain no limitation on
the amount of debt we may incur.
The use of a high degree of leverage will increase our sensitivity to increases in interest
rates. Increases in interest rates may increase our interest expense and adversely affect
our cash flow and our ability to service our indebtedness and make distributions to our
stockholders.
There is no assurance that we will profit from our recent sale of the Lyfetec, Inc.
division assets.
In February 2010, we sold the assets of our Lyfetec, Inc. division to Strata Capital
Corporation in exchange for 50,000,000 shares (before the 1:15 reverse split) of Strata
Capital common stock, par value $0.000001. These shares are restricted securities under
Rule 144. Strata Capital has filed a registration statement with the Securities and
Exchange Commission to obtain financing. There is no assurance that Strata Capital will
be able to raise funds and there is no assurance that we will profit from the sale of the
Strata Capital shares we have received.
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RISKS INHERENT IN THE COMPANY
We indemnify our officers and directors.
Our By-Laws provide for the indemnification of officers and directors relating to their
activities for the Company to the fullest extent permitted under the Nevada General
Corporation Code. These provisions may have the effect of providing indemnity in
connection with suits brought by parties other than the Company against an officer or
director who has been grossly negligent, though he acted in good faith and in the
Company’s interests.
We rely upon a few officers.
We are wholly dependent on the personal abilities of our officers in order to develop and
conduct our operations. Our success will be largely dependent on the personal efforts of
our key officers and directors. The loss of the services of any of these officers would
have a material adverse effect on our business and prospects. Our success also may be
dependent, in part, upon our ability to hire and retain additional qualified sales and
marketing personnel. There can be no assurance that we will be able to hire or retain
such necessary personnel. See "Management."
Our present shareholders will retain control.
Our present control shareholders own a majority of the outstanding Common and
Preferred Stock with a majority of the voting rights of the Company. As a result of this
percentage of ownership, the existing shareholders will be able to control our
management at least for the foreseeable future. The Common Stock purchasers will not
have the right to elect our directors and the Company's control will stay with the current
shareholders. These control shareholders will have full voting control of the Company
and the Board of Directors.
The liability of our directors and officers is limited.
Our Articles of Incorporation include provisions to eliminate, to the full extent permitted
by Nevada corporate law as in effect from time to time, the personal liability of our
directors for monetary damages arising from a breach of their fiduciary duties as
directors. The Articles of Incorporation also includes provisions to the effect that
(subject to certain exceptions) the Company shall, to the maximum extent permitted
46
from time to time under Nevada law, indemnify, and upon request shall advance
expenses to, any director or officer to the extent that such indemnification and
advancement of expenses is permitted under such law, as it may from time to time be in
effect. In addition, our By-Laws require us to indemnify, to the full extent permitted by
law, any of our directors, officers, employees or agents for acts which such person
reasonably believes are not in violation of our corporate purposes as set forth in the
Articles of Incorporation. As a result of such provisions in the Articles of Incorporation
and the By-Laws, stockholders may be unable to recover damages against our directors
and officers for actions taken by them which constitute negligence, gross negligence or a
violation of their fiduciary duties, which may reduce the likelihood of stockholders
instituting derivative litigation against directors and officers and may discourage or deter
stockholders from suing our directors, officers, employees and agents for breaches of
their duty of care, even though such action, if successful, might otherwise benefit us and
our stockholders.
Our Board of Directors may unilaterally implement changes in our investment and
financing policies that may affect the interests of our stockholders.
Our investment and financing policies, and our policies with respect to other activities,
including growth, debt, capitalization, and operating policies, are determined by the
Board of Directors. Although the Board of Directors has no present intention to do so,
these policies may be amended or revised from time to time at the discretion of the
Board of Directors without notice to stockholders or a vote of our stockholders.
Accordingly, stockholders have no direct control over changes in our policies and
changes in our policies may affect them.
We are dependent on external sources of capital.
In order to achieve our business plan and to grow, we will need constant infusions of
additional capital. We will need to fund our future capital needs, including capital for
property development and acquisitions, from sources other than income from operations.
We therefore will have to rely on third-party sources of debt and equity capital
financing, which may not be available on favorable terms or at all. Our access to third
party sources of capital depends on a number of things, including conditions in the
capital markets generally and the market’s perception of our growth potential and our
current and potential future earnings. Additional equity offerings may result in
substantial dilution of stockholders’ interests, and additional debt financings may
substantially increase leverage. Further, there is no assurance that we will be able to
successfully access capital.
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RISKS RELATED TO INVESTMENT IN OUR SECURITIES
If securities or industry analysts do not publish research or reports about our
business, or publish negative reports about our business, our stock price and trading
volume could decline.
The trading market for our common stock may depend on the research and reports that
securities or industry analysts publish about us or our business. We do not have any
control over these analysts. If one or more of the analysts who cover us downgrade our
stock or change their opinion of our stock, our stock price would likely decline. If one or
more of these analysts cease coverage of our company or fail to regularly publish reports
on us, we could lose visibility in the financial markets, which could cause our stock
price or trading volume to decline.
A significant portion of our total outstanding shares of Common Stock is restricted
from immediate resale but may be sold into the market in the near future. This could
cause the market price of our Common Stock to drop significantly, even if our
business is doing well.
Sales of a substantial number of shares of our Common Stock in the public market could
occur at any time. These sales, or the perception in the market that the holders of a large
number of shares of Common Stock intend to sell shares, could reduce the market price
of our Common Stock.
The Common Stock may experience substantial dilution from conversion of the4
outstanding Preferred Stock and Convertible Debenture.
The Company has 21 million shares of Convertible Preferred Stock outstanding and also
a Convertible Debenture. The Convertible Preferred Stock is convertible on a share for
share basis into Common Stock. The Convertible Debenture is convertible at the bid
price of the Common Stock at the time of conversion. The conversion of one or both of
these securities would result in substantial dilution to the existing holders of Common
Stock.
A decline in the price of our Common Stock could affect our ability to raise further
working capital and adversely impact our operations.
A prolonged decline in the price of our Common Stock could result in the reduction in
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our ability to raise capital through the sale of equity securities. Any reduction in our
ability to raise equity capital in the future would force us to reallocate funds from other
planned uses and would have a significant negative effect on our business plans and
operations, including our ability to develop new products and continue our current
operations. If our stock price declines, we may not be able to raise additional capital or
generate funds from operations sufficient to meet our obligations.
We do not intend to pay dividends; you will not receive funds without selling shares.
We have never declared or paid any cash dividends on our capital stock and do not
intend to pay dividends in the foreseeable future. We intend to invest our future
earnings, if any, to fund our growth. Therefore, you may not receive any funds without
selling your shares.
You may experience dilution if we issue additional securities,
If we issue additional shares, you may find your holdings diluted, which if it occurs,
means that you will own a smaller percentage of our company. Further, any issuance of
additional securities to various persons or entities in lieu of cash payments will lead to
further dilution.
Because we may be subject to the “penny stock” rules, you may have difficulty in
selling our common stock.
Because our stock price is less than $5.00 per share, our stock may be subject to the
SEC’s penny stock rules, which impose additional sales practice requirements and
restrictions on broker-dealers that sell our stock to persons other than established
customers and institutional accredited investors. The application of these rules may
affect the ability of broker-dealers to sell our common stock and may affect your ability
to sell any common stock you may own.
According to the SEC, the market for penny stocks has suffered in recent years from
patterns of fraud and abuse. Such patterns include:
· Control of the market for the security by one or a few broker-dealers that are often
related to the promoter or issuer;
· Manipulation of prices through prearranged matching of purchases and sales and false
and misleading press releases;
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· “Boiler room” practices involving high pressure sales tactics and unrealistic price
projections by inexperienced sales persons;
· Excessive and undisclosed bid-ask differentials and markups by selling broker-dealers;
and
· The wholesale dumping of the same securities by promoters and broker-dealers after
prices have been manipulated to a desired level, along with the inevitable collapse of
those prices with consequent investor losses.
Additionally, we may be subject to short selling, manipulation by others, defamation and
other false statements by stock “bashers” on stock chat websites, and the regulations of
the the Pink Sheets OTC markets, all of which may be outside our control.
As an issuer of “penny stock” the protection provided by the federal securities laws
relating to forward looking statements does not apply to us.
Although the federal securities law provide a safe harbor for forward-looking
statements made by a public company that files reports under the federal securities laws,
this safe harbor is not available to issuers of penny stocks. As a result, if we are a penny
stock we will not have the benefit of this safe harbor protection in the event of any based
upon an claim that the material provided by us contained a material misstatement of fact
or was misleading in any material respect because of our failure to include any
statements necessary to make the statements not misleading.
The volatility of and limited trading market in our common stock may make it difficult
for you to sell our common stock for a positive return on your investment.
The public market for our common stock has historically been very volatile. Any future
market price for our shares is likely to continue to be very volatile. Further, our common
stock is not actively traded, which may amplify the volatility of our stock. These factors
may make it more difficult for you to sell shares of common stock.
The registration and potential sale, either pursuant to a prospectus or pursuant to
Rule 144, by certain of our selling stockholders of a significant number of shares
could encourage short sales by third parties.
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There may be significant downward pressure on our stock price caused by the sale or
potential sale of a significant number of shares by certain of our selling stockholders
which could allow short sellers of our stock an opportunity to take advantage of any
decrease in the value of our stock. The presence of short sellers in our common stock
may further depress the price of our common stock.
If the selling stockholders sell a significant number of shares of common stock, the
market price of our common stock may decline. Furthermore, the sale or potential sale
of the offered shares pursuant to a prospectus and the depressive effect of such sales or
potential sales could make it difficult for us to raise funds from other sources.
Fluctuations in our operating results may affect our stock price and ability to raise
capital.
Our operating results for any given quarter or fiscal year should not be relied upon as an
indication of future performance. Quarter to quarter comparisons of our results of
operations may not be meaningful as a result of (i) our limited operating history and (ii)
the emerging nature of the markets in which we compete. Our future results will
fluctuate, and those results may fall below the expectations of investors and may cause
the trading price of our common stock to fall. This may impair our ability to raise
capital, should we seek to do so. Our quarterly results may fluctuate based on, but not
limited to, the following factors: (1) our ability to attract and retain customers; (2)
negative publicity about our industry, events, or products; (3) seasonal fluctuations in
our business; (4) intense competition; (5) changes in pricing policies; (6) regulatory
actions and legal proceedings; (7) our ability to control certain costs; (8) our ability to
attract, train and retain skilled management, as well as strategic, technical and creative
professionals; (9) the availability of working capital and the amount and timing of costs
relating to our expansion; and (10) general economic conditions and economic
conditions specific to our businesses.
Our stock price could decline further because of the activities of short sellers.
Our stock has historically attracted significant interest from short sellers. The activities
of short sellers could further reduce the price of our stock or inhibit increases in our
stock price.
Our stock, the Company and its management have also been attacked by people who
post negative comments on the Internet. These people are known collectively as
“bashers.” They are often anonymous. Our stock may be adversely affected by such
activities and we may not be able to take effective action against them.
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Logged

Borodor

  • Jr. Member
  • *
  • Posts: 234
Klingelhölleritis in den USA - Teil 3
« Reply #20 on: September 13, 2010, 11:33:04 AM »

activities and we may not be able to take effective action against them.
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Our stock price and operations may be affected by potential stock manipulation.
We believe certain parties are acting in a manner to attempt to denigrate our business for
personal profit. We believe certain parties may have engaged in actions intended to
cause harm to the Company, and certain parties have made efforts to decrease the
market price of our common stock. To the extent such parties engage in any such actions
or take any other actions to interfere with our existing and/or prospective business
relationships with regulators, vendors, media, partners, customers, lenders, or others, our
business, prospects, financial condition and results of operations may suffer, and the
price of our common stock may trade at prices below those that might prevail in the
absence of any such efforts.
We will need to make additional investments in financial processes and staffing in
order to ensure that our internal controls over financial reporting are effective.
We intend to assess its internal controls over financial reporting. Our internal controls
over financial reporting had several material weaknesses, which we will need to correct
in future periods, requiring us to invest additional resources in financial processes and
staffing. If we attempt to list our stock on the OTC BB, current regulations of the
Securities and Exchange Commission, or SEC, will require us to include this assessment
in our future annual reports from now on. An independent attestation of the internal
control over financial reporting will be required for our annual reports.
We cannot assure you that our stock price will not decline.
The market price of our Common Stock could be subject to significant fluctuations.
Among the factors that could affect our stock price are:
• quarterly variations in our operating results;
• changes in revenue or earnings estimates or publication of research reports by
analysts;
• failure to meet analysts’ revenue or earnings estimates;
• speculation in the press or investment community;
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• strategic actions by us or our competitors, such as acquisitions or restructurings;
• actions by institutional or mutual fund stockholders;
• domestic and international economic factors unrelated to our performance;
• our failure to achieve and maintain profitability;
• changes in market valuations of similar companies;
• announcements by us or our competitors of significant contracts, new products,
acquisitions, commercial relationships, joint ventures or capital commitments;
• the loss of major customers or product or component suppliers;
• the loss of significant partnering relationships;
• product liability lawsuits or product recalls; and
• general market, political and economic conditions.
In the past, following periods of volatility in the market price of a company’s securities,
securities class action litigation has often been instituted. A securities class action suit
against us could result in substantial costs and divert our management’s time and
attention, which would otherwise be used to benefit our business.
The stock markets in general, and the markets for biotechnology stocks in particular,
have experienced extreme volatility that has often been unrelated to the operating
performance of particular companies. These broad market fluctuations may adversely
affect the trading price of our Common Stock. In particular, we cannot assure you that
you will be able to resell your shares at any particular price, or at all.
We presently do not intend to pay cash dividends on our Common Stock.
We currently anticipate that no cash dividends will be paid on the Common Stock in the
foreseeable future. While our dividend policy will be based on the operating results and
capital needs of the business, it is anticipated that all earnings, if any, will be retained to
finance the future expansion of the our business.
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The volatility of our stock price could lead to losses by shareholders
The market price of our Common Shares has been subject to wide fluctuations. Such
fluctuations in market price may continue in response to: (i) quarterly and annual
variations in operating results; (ii) announcements of technological innovations or new
products that are relevant to our industry; (iii) changes in financial estimates by
securities analysts; or (iv) other events or factors. In addition, financial markets
experience significant price and volume fluctuations that particularly affect the market
prices of equity securities of many technology companies. These fluctuations have often
resulted from the failure of such companies to meet market expectations in a particular
quarter, and thus such fluctuations may or may not be related to the underlying operating
performance of such companies. Broad market fluctuations or any failure of our
operating results in a particular quarter to meet market expectations may adversely affect
the market price of our Common Shares. Occasionally, periods of volatility in the
market price of a company’s securities may lead to the institution of securities class
action litigation against a company. Due to the volatility of our stock price, we may be
the target of such securities litigation in the future. Such legal action could result in
substantial costs to defend our interests and a diversion of management’s attention and
resources, each of which would have a material adverse effect on our business and
operating results.
We may become involved in litigation that may materially adversely affect us
From time to time in the ordinary course of our business, we may become involved in
various legal proceedings, including commercial, product liability, employment, class
action and other litigation and claims, as well as governmental and other regulatory
investigations and proceedings. Such matters can be time-consuming, divert
management’s attention and resources and cause us to incur significant expenses.
Furthermore, because litigation is inherently unpredictable, the results of any such
actions may have a material adverse effect on our business, operations or financial
condition.
We will trade on the Pink Sheets OTC Market which entails numerous risks.
We will trade on the Pink Sheets OTC Market which entails numerous risks, including
but not limited to the following: Pink Sheets has experienced computer failures and
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malfunctions in the past, causing securities quoted there to be misquoted or not quoted at
all. Pink Sheets has a system of rating companies and can rate our stock “Caveat
Emptor” for many reasons which are out of our control, or for no reason at all. Pink
Sheets can label us “Caveat Emptor” or “Toxic” for the actions of others, such as short
selling, or making unauthorized spam promotional campaigns. There are no clear
standards for being placed on Caveat Emptor and no clear standards for being removed.
Generally, stock buyers will avoid buying Caveat Emptor stocks and the stocks
experience substantial market declines after being so labeled. Finally, if the Company is
unable to obtain the necessary audited financial statements, the Company may be unable
to escape the Pink Sheets. In the last year, the Issuer was placed in “Caveat Emptor”
status by Pink Sheets and this was removed after the Issuer posted certain disclosures on
the Pink Sheets.
The price of our stock may be manipulated or affected by the actions of others beyond
our control.
Small companies such as ours may be subject to market manipulation, such as naked
short selling, or having the Depository Trust Clearing Corporation place a “chill” on
transferring the stock, or having broker-dealers place restrictions on trading the stock or
by having clearing firms refuse to process stock transactions.. We may not have the
resources to fight or stop these actions.
The price of our stock may be volatile, and a shareholder's investment in our common
stock could suffer a decline in value.
There could be significant volatility in the volume and market price of our stock, and
this volatility may continue in the future. Our stock is listed in the Pink Sheets OTC
market and there is a greater chance for market volatility for securities that trade on the
Pink Sheets as opposed to a national exchange or quotation system. This volatility may
be caused by a variety of factors, including the lack of readily available quotations, the
absence of consistent administrative supervision of "bid" and "ask" quotations and
generally lower trading volume. In addition, factors such as quarterly variations in our
operating results, changes in financial estimates by securities analysts or our failure to
meet our or their projected financial and operating results, litigation involving us,
general trends relating to the beverage industry, actions by governmental agencies,
national economic and stock market considerations as well as other events and
circumstances beyond our control could have a significant impact on the future market
price of our common stock and the relative volatility of such market price.
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The market for penny stocks has experienced numerous frauds and abuses which
could adversely impact investors in our stock.
Pink Sheets securities are frequent targets of fraud or market manipulation, both because
of their generally low prices and because reporting requirements are less stringent than
those of the stock exchanges or NASDAQ.
Patterns of fraud and abuse include: (1) Control of the market for the security by one or
a few broker-dealers that are often related to the promoter or issuer; (2) Manipulation of
prices through prearranged matching of purchases and sales and false and misleading
press releases; (3) “Boiler room" practices involving high pressure sales tactics and
unrealistic price projections by inexperienced sales persons; (4) Excessive and
undisclosed bid-ask differentials and markups by selling broker-dealers; and (5)
Wholesale dumping of the same securities by promoters and broker-dealers after prices
have been manipulated to a desired level, along with the inevitable collapse of those
prices with consequent investor losses.
Our management is aware of the abuses that have occurred historically in the penny
stock market.
Item X The nature and extent of the issuer’s facilities.
The goal of this section is to provide a potential investor with a clear understanding
of all assets, properties or facilities owned, used or leased by the issuer.
In responding to this item, please clearly describe the assets, properties or facilities
of the issuer, give the location of the principal plants and other property of the
issuer and describe the condition of the properties. If the issuer does not have
complete ownership or control of the property (for example, if others also own the
property or if there is a mortgage on the property), describe the limitations on the
ownership.
If the issuer leases any assets, properties or facilities, clearly describe them as
above and the terms of their leases.
The Issuer's Lyfetec subsidiary has entered into a lease for 11,000 square feet of space at
760 East McNab Road, Pompano Beach, Florida 33062. The rent is $5,000 per month
and the property consists of 11,000 square feet with 11 offices, a conference room with a
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kitchen area and three warehouses. The lease requires a deposit of $20,000 and is for a
three-month term with a purchase agreement. There is litigation pending regarding this
lease. The Issuer is in the process of moving to other premises.
CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING
INFORMATION
______
This document contains forward-looking statements within the meaning of the “safe
harbor” provisions of the Private Securities Litigation Reform Act of 1995. Reference is
made in particular to the description of our plans and objectives for future operations,
assumptions underlying such plans and objectives, and other forward-looking statements
included in this prospectus. Such statements may be identified by the use of forward-
looking terminology such as “may,” “will,” “expect,” “believe,” “estimate,”
“anticipate,” “intend,” “continue,” or similar terms, variations of such terms or the
negative of such terms. Such statements are based on management’s current
expectations and are subject to a number of factors and uncertainties, which could cause
actual results to differ materially from those described in the forward-looking
statements. Such statements address future events and conditions concerning product
development, capital expenditures, earnings, litigation, regulatory matters, markets for
products and services, liquidity and capital resources and accounting matters. Actual
results in each case could differ materially from those anticipated in such statements by
reason of factors such as future economic conditions, changes in consumer demand,
legislative, regulatory and competitive developments in markets in which we and our
subsidiaries operate, and other circumstances affecting anticipated revenues and costs, as
more fully disclosed in our discussion of risk factors.
We expressly disclaim any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect any change in
our expectations with regard thereto or any change in events, conditions or
circumstances on which any such statement is based. Additional factors that could cause
such results to differ materially from those described in the forward-looking statements
are set forth in connection with the forward-looking statements.
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BUSINESS
______
The Company
Macada Holdings Inc. is designed to grow its businesses to the point where they become
their own self sustaining entities and can then generate large revenues on their own.
Currently we are focused on two subsidiaries as we believe they both have an excellent
upside potential in profitable and solid markets: LyfeTec, Inc. and Pembroke Gun &
Range.
LyfeTec, Inc.
Technology
Our subsidiary, LyfeTec, Inc., has purchased the ownership and rights to patents here in
the United States for certain cancer treatment products. Lyfetec intends to redesign the
products with their ingredients for aging and cell rejuvenation, which will be retested for
FDA approval.
We have signed a Purchase Agreement for three medical formulas with a German Bio-
Chemist for skin disease and cancer treatment products. We have the rights to patent all
three formulas in the United States under the Lyfetec name.
Dr. Karsten Klingelhoeller, a bio-chemist, created these three skin disease treatment
products. Dr. Klingelhoeller, who presently holds four doctors degrees, has completed
U.S. and European clinical trials and patents on a variety of cancer and skin products
throughout his career.
The formulas were acquired by our wholly-owned subsidiary Lyfetec, Inc. They have
anti-aging and skin cell rejuvenation additives that have been added for Lyfetec's new
Bio-Skin product line. Before Lyfetec's request to add anti-aging and skin cell
rejuvenation additives, Dr. Karsten's formulas meet FDA and CE safety standards to
treat melanoma - neurodermatitis / atopic dermatitis - psoriasis - cradle cap and other
conditions. Lyfetec, Inc. will be re-testing with the new additives for the Lyfetec Bio-
Skin line which will be marketed as a treatment lotion-shampoo and soap while entering
Stage I of FDA new clinical trials to support and verify its CE and FDA documentation
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with the prior products which treats many types of skin diseases and some skin cancers.
BioSkin
We will market our BioSkin products primarily to persons affected by two diseases:
psoriasis and atopic dermatitis. We may also develop cosmetic products for sale by
others.
Psoriasis
Psoriasis is a chronic, non-infectious that affects mainly the skin. It commonly causes
red, scaly patches to appear on the skin, although some patients have no dermatological
symptoms. The scaly patches caused by psoriasis are areas of inflammation and
excessive skin production. Skin rapidly accumulates at these sites and takes on a silvery-
white appearance. Plaques frequently occur on the skin of the elbows and knees, but can
affect any area including the scalp, palms of hands and soles of feet, and genitals.
Persons Affected by Psoriasis
Country
Unites Stat
France
United Kingdom
Germany
Total of above
HBS (market research)
% affected
2.0
4.0
3.3
2.7
Number
5,500,000
1,200,000
1,200,000
1,800,000
9,700,000
Atopic Dermatitis
Atopic dermatitis (AD; a type of eczema) is an inflammatory, chronically relapsing,
non-contagious and puritic skin disorder.
The skin of a patient with atopic dermatitis reacts abnormally and easily to irritants,
food, and environmental allergens and becomes red, flaky and very itchy. It also
becomes vulnerable to surface infections caused by bacteria. The skin on the flexural
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surfaces of the joints (for example inner sides of elbows and knees) are the most
commonly affected regions in people.
Atopic dermatitis is a familial and chronic disease and its symptoms can increase or
disappear over time. Atopic dermatitis in older children and adults is often confused
with psoriasis. Atopic dermatitis afflicts humans, particularly young children; it is also a
well-characterized disease in domestic dogs.
Although there is no cure for atopic eczema, and its cause is not well understood, it can
be treated very effectively in the short term through a combination of prevention
(learning what triggers the allergic reactions) and drug therapy.
August 2001 - Page 3
Persons Affected by Atopic Dermatitis
Country
Unites States
France
United Kingdom
Germany
Total of above
HBS (market research)
% affected
8.0
9.0
12.5
8.8
Number
8,900,000
1,800,000
1,800,000
2,300,000
14,800,000
Cradle Cap
Cradle cap (infantile or neonatal seborrhoeic dermatitis, also known as crusta lactea,
milk crust, honeycomb disease) is a yellowish, patchy, greasy, scaly and crusty skin rash
that occurs on the scalp of recently born babies. It is usually not itchy, and does not
bother the baby. Cradle cap most commonly begins sometime in the first three months.
The rash is often prominent around the ear, the eyebrows or the eyelids. It may appear in
other locations as well, where it is called seborrhoeic dermatitis rather than cradle cap. It
is extremely common, with about half of all babies affected. Most of them have a mild
version of the disorder. Severe cradle cap is rare.
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Marketing
In the United States, we intend to primarily sell our products to mass merchandisers
such as Wal-Mart Stores, Inc., or “Wal-Mart,” and Target Corporation, or “Target,”
major drug store chains such as Walgreen Co., or “Walgreens,” CVS Caremark
Corporation, or “CVS,” and Rite-Aid Corp., or “Rite-Aid”, and select food retailers. We
will also develop direct marketing such as an Internet site and direct response
advertising.
We believe our products will provide attractive profit margins for retailers and should
enjoy retail shelf space. Internationally, we will sell in developed countries such as
Canada, the United Kingdom, Puerto Rico and Mexico and through distributors,
licensees and joint venture relationships in many countries.
Our goal is to enter markets where we have an opportunity to leverage our product's
unique capabilities.
We will advertise our products primarily on television, in magazines and on the radio.
We will strive to achieve cost efficiencies in our advertising by being opportunistic in
our purchase of media while continuously controlling production costs. Advertising
media will be selected based upon our ability to efficiently and effectively reach the core
target audience for each product.
Additionally, we may use cooperative programs with retailers to further enhance
consumer awareness of our products and brands. We also utilize consumer promotions
such as direct mail programs targeted at specific audiences, like parents, as well as on-
package offers to encourage trial and repeat purchase at the point-of-sale.
Competition
Our main competitors in the OTC pharmaceuticals market may include such companies
as Wyeth Corp., Procter & Gamble Co., GlaxoSmithKline plc, Colgate-Palmolive Co.,
Chattem, Inc., Bayer AG and Johnson & Johnson. We will compete on the basis of
superior product performance.
Part of our strategy to offset the level of competition is to develop certain products and
brands that focus on niche or sub-segments of larger markets. By focusing on these
areas, we believe we are able to limit the degree of competition we face, as many of
these smaller markets do not draw the attention of the large multinational consumer
product companies, or they choose not to dedicate resources to these smaller, albeit
potentially profitable brands.
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Manufacturing
We expect to use third party contract manufacturers. Our products will be packaged by
third-party manufacturers for resale by us to our customers. We do not expect to have
difficulties in obtaining raw materials. Lyfetec is in the first stage with a top South
Florida cosmetic laboratory with regards to outsource the manufacturing of the Bio-Skin
line which help treat skin diseases.
Patents and trademarks
We intend to develop the equity in our patents and trademarks through various means.
We consider our trademarks to be material assets, and the registration and protection of
our trademarks in the aggregate to be important to our business, in that the success of
certain of our products is due at least in part to the goodwill associated with our primary
brand names. We intend to register or apply to register our of these trademarks, both in
the United States and in foreign countries. Generally, registered trademarks have a
perpetual life, provided that they are renewed on a timely basis and continue to be used
properly as trademarks. We intend to maintain our trademark registrations so long as
they remain valuable to our business.
Many of the products we refer to as patented in this document use patented technology
that we license from third parties and do not own. While we believe our patents and
patent licenses to be important, we do not consider our business as a whole to be
dependent on such patent licenses or patent protection. Other than commercially
available software licenses, which are important to our business, and the patent licenses
previously mentioned, we do not believe that any of our licenses to third-party
intellectual property are material to our business, taken as a whole. We may be involved
in various intellectual property claims and legal actions arising in the ordinary course of
business.
Government regulation
The testing, manufacturing, quality control, packaging, labeling, advertising,
distribution, import, export, sale and storage of our OTC pharmaceutical, medical
device, dietary supplement and cosmetic products are subject to extensive regulation by
various federal agencies, including the FDA and the FTC. Failure to comply with
applicable requirements could result in administrative and judicial sanctions including,
among other things, warning letters, untitled letters, fines and other monetary penalties,
product recalls, product seizures, suspension of production or distribution, delays or
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refusals to approve pending applications, injunctions, criminal prosecution, limiting or
eliminating claims we can make for our products and/or judicial or administrative
orders.
OTC pharmaceutical products
Many of our products are regulated as over-the-counter, or OTC, drugs. Under the
Federal Food, Drug, and Cosmetic Act, or the “FDCA,” “new drugs” are subject to pre-
market approval by the FDA. The FDCA defines a “new drug” as a drug that is not
generally recognized among scientifically qualified experts as safe and effective for use
under the conditions stated in its labeling. The FDA’s OTC drug review is designed to
determine whether certain OTC active ingredients and formulations are generally
recognized as safe and effective when marketed for identified indications and
appropriately labeled. If so, the OTC drug is not a new drug, and therefore, does not
require approval from the FDA prior to marketing. If not, FDA approval is required
prior to marketing the drug.
The FDA’s determinations in the OTC review are promulgated as regulations, known as
final monographs, for categories of OTC drugs. Prior to making a determination about a
category of drugs, the FDA engages in a public process to collect and evaluate
information on general recognition of safety and effectiveness. As part of that process, it
publishes a proposed regulation, known as a tentative final monograph, or “TFM,”
which identifies categories of drugs that it tentatively believes to be safe and effective
and not misbranded (“category I”), those about which it does not have enough
information to make a determination (“category III”), and those that it believes are not
safe and effective (“category II”). Following publication of a TFM, there is an
opportunity for the public to provide more information about the drug. The FDA’s
tentative determination in a TFM therefore does not always predict its final
determination.
Until a monograph becomes final, the FDA generally allows, as a matter of enforcement
discretion, the marketing without approval of products that are being considered as part
of the OTC review. In some cases, however, the FDA may promulgate, while a
monograph process is pending, a final regulation prohibiting the marketing of products
in category II, or otherwise determine that, for safety or effectiveness reasons, such
products may not be marketed. The FDA does not generally permit the marketing of
unapproved OTC drugs that are not the subject of a final monograph or are not being
considered as part of the OTC review.
Our products will be are marketed pursuant to the OTC review, and many of our
products are addressed in monographs that have not yet become final. We face the risk
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that the FDA could finalize any of these TFMs with conditions that our products do not
meet. We also face the risk that the FDA could determine that one or more of our
products is not being considered as part of the OTC review. For our OTC
pharmaceutical products that are sold according to final monographs, we cannot deviate
from the conditions described in the final monograph, such as changes in approved
active ingredient levels or labeling claims, unless we obtain pre-marketing approval
from the FDA. If any of our products were found not to be in compliance with a final
monograph or are not contemplated in any monograph, we would not be able to continue
to market the product unless and until we reformulate or re-label the product to meet the
conditions of the finalized monograph, which may not be possible, or we obtain
approval of a new drug application, or “NDA,” or an abbreviated new drug application,
or “ANDA,” to continue to market our existing formulation. The submission of a
marketing application would require the preparation and submission of clinical tests,
which would be time consuming and expensive, and might not result in approval. If we
were not able to reformulate or re-label our product, or obtain FDA approval of an
NDA, we would be required to discontinue selling the affected product.
Cosmetic Products
We may sell products that are regulated as cosmetics, which are regulated under the
FDCA. There are fewer regulatory requirements for cosmetics than for drugs, medical
devices or dietary supplements. A cosmetic is any article (other than soap) intended to
be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to any
part of the human body for cleansing, beautifying, promoting attractiveness or altering
the appearance. The use of certain ingredients in cosmetics is restricted. All ingredients
are required to be safe, and the product must be labeled in accordance with regulations.
Cosmetic products and ingredients are not subject to FDA pre-market approval with the
exception of color additives. However, an express or implied claim that a cosmetic will
diagnose, cure, mitigate, treat or prevent a disease, or that it affects the structure or
function of the body, may cause the FDA to view the product as a drug rather than as a
cosmetic.
Other FDA requirements
In addition to requirements governing whether products can be marketed, we are subject
to various other FDA regulatory requirements. For example, drugs and medical devices
are subject to good manufacturing practices, or “GMP,” regulations that govern how
manufacturers design and manufacture products and exercise quality control over the
manufacturing process. GMP regulations for dietary supplements have been
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promulgated and will be effective in the near future. The FDA regularly inspects
manufacturers to determine compliance with these GMP regulations. Product labeling
claims must not be false or misleading and may not promote the product for uses that
would require pre-market approval or clearance. For some products, adverse events and
product malfunctions that could cause or contribute to injury must be reported.
FTC regulation
Our promotional activities, claims, and materials are regulated by the FTC under the
Federal Trade Commission Act, which prohibits unfair and deceptive acts and practices,
including claims that are false, misleading, or inadequately substantiated.
Environmental Regulation
We are subject to a broad range of frequently changing federal, state and local
environmental, health and safety laws and regulations, including those governing
discharges to air, soil and water, the handling and disposal of, and exposure to,
hazardous substances and the investigation and remediation of contamination resulting
from the release of hazardous substances. We believe that our business operations and
facilities are in material compliance with all applicable environmental, health and safety
laws and regulations, though future expenditures may continue to be necessary in order
to maintain such compliance. However, some of our former facilities are currently
involved in environmental investigations and remediations resulting from past releases
of hazardous substances or the presence of other contaminants. While we do not believe
that any investigation or remediation obligations that we have identified will have a
material adverse effect on our operating results or financial condition, there can be no
assurance provided that such obligations will not arise in the future.
EHRU
The Issuer's Emergency Response Hospital Units Division has developed a first-of-its-
kind Emergency Medical Response Mobile Hospital Unit (the ERHU). This product
stems from the ERHU division manager’s work on the set of the original Star Trek
series, for which the team erected a futuristic medical facility and sick bay. The mobile
hospital unit has the ability to offer temporary emergency life support, medical and
pharmaceutical products and services and communicate via secured wireless
technology. The unit uses a unique plastic and air capillary system to maintain building
65
integrity.
LyfePet
The Issuer's LyfePet division offers an arsenal of products and services in the animal test
kits and products. The Issuer believes that it will pioneer a new era in the pet care health
screening and monitoring and that the resulting use of these products by consumers will
vastly improve pet health outcomes.
Natural Health Solutions
Lyfetec, Inc., on June 2, 2010, signed a letter of intent to purchase a whole food
supplement company called Natural Health Solutions to add a new line of Lyfetec
products and formulas to its asset base. Natural Health Solutions is generating revenues.
Lyfetec's goal is to help consumers to address current discomforts, and to prevent future
illness and disease by ensuring nutritional needs through effective supplementation.
On the website, consumers will find information about ways they can confirm the
benefits of each of the products that the company offers. Consumers will also find
supporting research that will help them understand how the company's supplements
work to improve one's health, immune system, and overall energy level.
David Luther is the founder of The Natural Health Solutions Center. He founded the
Center a few years ago after becoming very interested in what could be accomplished in
improving human health through the utilization of nature based products. His scientific
background (Bachelor of Science Degree from Princeton University) and work
experience have been helpful in doing this research.
His mission ultimately became to determine which of the many available alternative
technologies and products are most effective in helping the human body improve and
maintain its health. He has a Naturopathic Physician on staff, as well as consulting
relationships, to help develop protocols for addressing a number of health issues.
The Lyfetec product lines will co-brand and launch nationally and internationally with
the Bio-Skin and the Natural Health Solutions Center websites to start branding the
products through the Internet and under the Lyfetec products name while finalizing the
closing of the acquisition of Natural Health Solutions Center.
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Medical Anti-Bacterial Coating Formula
Lyfetec, Inc. has signed a purchase agreement for a medical anti-bacterial coating
formula which will help minimize or prevent staph infections and most infectious
bacteria. This patented formula design has yielded overwhelming results at the
University of Switzerland. The new product line will save the lives of people across the
globe who will otherwise die from staph infections while receiving hospital treatments.
This product will go into production and distribution and is not a research and
development operation. The integration of the formula can stand alone or be infused into
other products such as surgical equipment, paints, detergents, air filtration systems and
many other anti-bacteria products.
England reports 320,000 such infections. Professor Gastmeier estimates 14,000 cases
per year of MRSA in Germany and at 1.7 million cases per year in the United States, a
large increase in patients with the MRSA infections.
Nosocomial infections have considerable significance for the hospitals in Germany.
They extend the length of time spent in hospitals, more expensive therapy and endanger
the lives of many people. Preventive measures have therefore remained a high priority.
PhytoBionic offers its customers not only production technology and environmental
benefits through the patented coating technology. Complete coating systems and
solutions are PhytoBionic customized developed and delivered in series and reduce
complexity and customer costs.
Inventor Christan Maas, a bio-chemist, created this bacteria coating which protects and
sterilizes. Nosocomial infections are identified as a problem, jeopardizing the life of
many patients. Endowment of implantable biomaterials with antimicrobial activity as
well as a genuine germ-free environment is mandatory as bacterial microorganisms
show substantially increasing rates of resistance.
Pembroke Gun & Range
Pembroke Gun & Range has been at the same location for 30 years. Pembroke is a full
service gun range and retail sales organization supplying a demanding firearms market
in Southern Florida. Pembroke has an extensive array of firearms, accessories,
classroom facilities, an 18-lane indoor range and a friendly staff. We service the public,
private and law enforcement. With the largest indoor range in Southern Florida.
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Pembroke's annual sales in 2009 were $1,398,000 and we project sales to hit $1,600,000
for 2010.
Competition is limited to one public indoor range within a three mile radius and four
public indoor ranges within a 10 mile radius (two of which have less than five lanes).
Due to the nature of the business and a moratorium on building gun ranges in Broward
county as well as legislative and environmental challenges this leaves us in a very
unique position.
During 2009, sales rose in the firearms industry as a whole by 18% with some firearms
manufacturers seeing a 200% increase. As a distributor, we experienced a 22% growth
at our location.
Full time management is in place with a staff of 10 employees and the support of many
local private instructors. We are constantly expanding and growing our business.
Currently we are establishing an online shopping cart and beginning to sell through
online established businesses such as gunbroker.com. With the expansion of our training
facilities we will have an in house group dedicated to training individuals in the security
industry. This will bring a constant sales revenue and new source of shooters to the
range, as individuals learn security skills and are required to renew them annually by
state law. We also have many other arrangements in the works with local security and
law enforcement agencies and their principles.
Currently we are looking to expand the business, we have a profitable model for a gun
range and are looking to purchase other range and sales locations for firearms as well as
ammunition manufacturing. With the current shortage of ammunition we will be able to
supply our own ranges with much needed ammunition and eventually supply the open
market as capacity allows.
We plan to begin ammunition manufacturing to fulfill the demand for ammunition
worldwide.
Tri-Star
Tri-Star is the Issuer's mining subsidiary. The Issuer incorporates by reference the
information provided on the website http://www.tristargold.com
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Part D Management Structure and Financial Information
Item XI The name of the chief executive officer, members of the board of directors,
as well as control persons.
The goal of this section is to provide an investor with a clear understanding of the
identity of all the persons or entities that are involved in managing, controlling or
advising the operations, business development and disclosure of the issuer, as well
as the identity of any significant shareholders.
A. Officers and Directors. In responding to this item, please provide the following
information for each of the issuer’s executive officers, directors, general partners
and control persons, as of the date of this information statement:
1. Full name; Ronald Ritter, Chairman, CEO
2. Business address; 760 E. Mc Nab, Pompano Beach, Fl 33060
3. Employment history (which must list all previous employers for the past 5 years,
positions held, responsibilities and employment dates);
Mr. Ritter has held various positions for the Issuer since 2010 and has operated
Pembroke Gun and Range for over two years and for three years prior to that he was a
financial consultant for that company. Mr. Ritter has been in management for over 30
years. He has run single as well as multiple locations with annual volumes in excess of
$200 million. Having worked in a variety of different industries, Food Service,
Pharmaceutical Manufacturing, Firearms Industry, Financial Services and Sales, give
him a very well rounded perspective. He has served as a Vice President of Operations,
CEO, and President in a variety of different industries.
None.
4. Board memberships and other affiliations;
5. Compensation by the issuer; and At this time all officers’ salary has been reduced
to between $500.00 to a $1000.00 a week.
6. Number and class of the issuer’s securities beneficially owned by each such
person.
3,000,000 shares of Common Stock.
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1. Full name; Anthony Mellone, Jr., President
2. Business address; 4701 N. Federal Hwy. - Suite 430, Pompano Beach, Fl 33060
3. Employment history (which must list all previous employers for the past 5 years,
positions held, responsibilities and employment dates);
Mr. Mellone co-founded Global TV, Inc. and Macada has operated that company for
over 5 years. Mr. Mellone was the founder of Global Triad, Inc. and of several other
companies. He has been the driving force in companies for the development and
breakthrough for designs in the worldwide delivery of high speed Internet services and
video on demand. Over the past few years Mr. Mellone, Jr. has designed and
implemented the engineering of the revolutionary RF Video Magic video card that will
permit the transmission of DVD quality video entertainment to private residences and
business locations. Standardization and economies of scale are necessary for low cost
delivery systems to reach the home and small business market. Mr. Mellone, Jr. is an
accomplished inventor. In his capacity as President, the Issuer expects that he will
continue to create and research promising technologies and opportunities for the
Company. Mr. Mellone has more than 20 years of experience in the entertainment
industry. He has numerous key contacts in several types of industries and will be a key
resource for negotiating and acquiring product. His technical experience will lend itself
to the future development of the company, using the same platforms in VOD and IPTV
market to promote our products. The Issuer believes that his contacts and understanding
of the technology and delivery system will be a strong advantage for the company by
facilitating product delivery and adding excitement. Mr. Mellone, Jr. has been with the
Issuer for over five years.
4. Board memberships and other affiliations;
None.
5. Compensation by the issuer; and At this time all officers’ salary has been reduced
to between $500.00 to a $1000.00 a week.
6. Number and class of the issuer’s securities beneficially owned by each such
person.
3,035,536 shares of Common Stock
B. Legal/Disciplinary History. Please identify whether any of the foregoing persons
have, in the last five years, been the subject of:
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1. A conviction in a criminal proceeding or named as a defendant in a pending
criminal proceeding (excluding traffic violations and other minor offenses);
2. The entry of an order, judgment, or decree, not subsequently reversed,
suspended or vacated, by a court of competent jurisdiction that permanently or
temporarily enjoined, barred, suspended or otherwise limited such person’s
involvement in any type of business, securities, commodities, or banking activities;
3. A finding or judgment by a court of competent jurisdiction (in a civil action), the
Securities and Exchange Commission, the Commodity Futures Trading
Commission, or a state securities regulator of a violation of federal or state
securities or commodities law, which finding or judgment has not been reversed,
suspended, or vacated; or
4. The entry of an order by a self-regulatory organization that permanently or
temporarily barred, suspended or otherwise limited such person’s involvement in
any type of business or securities activities.
None of the foregoing persons has, in the past five years, been the subject of:
1. A conviction in a criminal proceeding or named as a defendant in a pending criminal
proceeding (excluding traffic violations and other minor offenses);
2. The entry of an order, judgment, or decree, not subsequently reversed, suspended or
vacated, by a court of competent jurisdiction that permanently or temporarily enjoined,
barred, suspended or otherwise limited such person’s involvement in any type of
business, securities, commodities, or banking activities;
3. A finding or judgment by a court of competent jurisdiction (in a civil action), the
Securities and Exchange Commission, the Commodity Futures Trading Commission, or
a state securities regulator of a violation of federal or state securities or commodities
law, which finding or judgment has not been reversed, suspended, or vacated; or
4. The entry of an order by a self-regulatory organization that permanently or
temporarily barred, suspended or otherwise limited such person’s involvement in any
type of business or securities activities.
C. Disclosure of Family Relationships. Describe any family relationships4 among
and between the issuer’s directors, officers, persons nominated or chosen by the
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issuer to become directors or officers, or beneficial owners of more than five
percent (5%) of the any class of the issuer’s equity securities.
Antonio Mellone, Sr. is the father of Anthony Mellone, Jr. Mr. Mellone, Sr. owns
preferred and common stock of the Issuer as an investor and as a retired ex-officer.
D. Disclosure of Related Party Transactions. Describe any transaction during the
issuer’s last two full fiscal years and the current fiscal year or any currently
proposed transaction, involving the issuer, in which (i) the amount involved exceeds
the lesser of $120,000 or one percent of the average of the issuer’s total assets at
year-end for its last three fiscal years and (ii) any related person had or will have a
direct or indirect material interest. Disclose the following information regarding
the transaction:
1. The name of the related person and the basis on which the person is
related to the issuer;
2. The related person’s interest in the transaction;
3. The approximate dollar value involved in the transaction (in the case of
indebtedness, disclose the largest aggregate amount of principal outstanding during
the time period for which disclosure is required, the amount thereof outstanding as
of the latest practicable date, the amount of principal and interest paid during the
time period for which disclosure is required, and the rate or amount of interest
payable on the indebtedness);
4. The approximate dollar value of the related person’s interest in the transaction;
and
5. Any other information regarding the transaction or the related person in the
context of the transaction that is material to investors in light of the circumstances
of the particular transaction.
Instruction to paragraph D of Item XI:
1. For the purposes of paragraph D of this Item XI, the term “related person”
means any director, executive officer, nominee for director, or beneficial owner of
more than five percent (5%) of any class of the issuer’s equity securities,
immediate family members5 of any such person, and any person (other than a
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tenant or employee) sharing the household of any such person.
2. For the purposes of paragraph D of this Item XI, a “transaction” includes, but is
not limited to, any financial transaction, arrangement or relationship (including
any indebtedness or guarantee of indebtedness) or any series of similar
transactions, arrangements or relationships.
3. The “amount involved in the transaction” shall be computed by determining the
dollar value of the amount involved in the transaction in question, which shall
include:
a. In the case of any lease or other transaction providing for periodic payments or
installments, the aggregate amount of all periodic payments or installments due on
or after the beginning of the issuer’s last fiscal year, including any required or
optional payments due during or at the conclusion of the lease or other transaction
providing for periodic payments or installments; and
b. In the case of indebtedness, the largest aggregate amount of all indebtedness
outstanding at any time since the beginning of the issuer’s last fiscal year and all
amounts of interest payable on it during the last fiscal year.
4. In the case of a transaction involving indebtedness:
a. The following items of indebtedness may be excluded from the calculation of the
amount of indebtedness and need not be disclosed: amounts due from the related
person for purchases of goods and services subject to usual trade terms, for
ordinary business travel and expense payments and for other transactions in the
ordinary course of business; and
b. Disclosure need not be provided of any indebtedness transaction for beneficial
owners of more than five percent (5%) of any class of the issuer’s equity securities
or such person’s family members.
5. Disclosure of an employment relationship or transaction involving an executive
officer and any related compensation solely resulting from that employment
relationship or transaction need not be provided. Disclosure of compensation to a
director also need not be provided.
6. A person who has a position or relationship with a firm, corporation, or other
entity that engages in a transaction with the issuer shall not be deemed to have an
73
indirect material interest for purposes of paragraph D of this Item XI where:
a. The interest arises only:
i. From such person’s position as a director of another corporation or organization
that is a party to the transaction; or
ii. From the direct or indirect ownership by such person and all other related
persons, in the aggregate, of less than a ten percent (10%) equity interest in
another entity (other than a partnership) which is a party to the transaction; or
iii. From both such position and ownership; or
b. The interest arises only from such person’s position as a limited partner in a
partnership in which the person and all other related persons have an interest of
less than ten percent (10%), and the person is not a general partner of and does
not hold another position in the partnership.
7. Disclosure need not be provided pursuant to paragraph D of this Item XI
if:
a. The transaction is one where the rates or charges involved in the transaction are
determined by competitive bids, or the transaction involves the rendering of
services as a common or contract carrier, or public utility, at rates or charges fixed
in conformity with law or governmental authority;
b. The transaction involves services as a bank depositary of funds, transfer agent,
registrar, trustee under a trust indenture, or similar services; or
c. The interest of the related person arises solely from the ownership of a class of
equity securities of the issuer and all holders of that class of equity securities of the
issuer received the same benefit on a pro rata basis.
8. Include information for any material underwriting discounts and commissions
upon the sale of securities by the issuer where any of the specified persons was or is
to be a principal underwriter or is a controlling person or member of a firm that
was or is to be a principal underwriter.
In February, 2010, three shareholders of the Issuer's Convertible Preferred Stock, Mr.
Anthony Mellone, Jr., Mr. Anthony Mellone, Sr. and Donna Yamin, agreed to cancel at
74
total of 58 million shares of such stock without consideration to them.
There are no other related party transactions.
E. Disclosure of Conflicts of Interest. Describe any conflicts of interest. Describe
the circumstances, parties involved and mitigating factors for any executive officer
or director with competing professional or personal interests.
There are no such conflicts of interest.
Item XII Financial information for the issuer’s most recent fiscal period.
Instruction to Item XII: The issuer shall post the financial statements required by
this Item XII through the OTC Disclosure and News Service under the appropriate
report name for the applicable period end. (If the financial statements relate to a
fiscal year end, publish it as an “Annual Report,” or if the financial statements
relate to a quarter end, publish it as a “Quarterly Report” or “Interim Report”)
The issuer must state in its disclosure statement that such financial statements are
incorporated by reference. The issuer must also (i) provide a list in the disclosure
statement describing the financial statements that are incorporated by reference,
(ii) clearly explain where the incorporated documents can be found, and (iii)
provide a clear cross-reference to the specific location where the information
requested by this Item can be found in the incorporated documents.
The issuer shall provide the following financial statements for the most recent fiscal
period (whether fiscal quarter or fiscal year).
1) balance sheet;
2) statement of income;
3) statement of cash flows;
4) statement of changes in stockholders’ equity;
5) financial notes; and
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6) audit letter, if audited
Foreign private issuers that have furnished financial statements pursuant to Rule
12g3-2(b) under the Exchange Act can provide those same financial statements as
an alternative to U.S. GAAP. For information regarding U.S. GAAP, see
http://cpaclass.com/gaap/gaap-us-01a.htm.
The financial statements requested pursuant to this item shall be prepared in
accordance with generally accepted accounting principles (GAAP)6 by persons
with sufficient financial skills.
Information contained in annual financial statements will not be considered
current more than 90 days after the end of the issuer’s fiscal year immediately
following the fiscal year for which such statement are provided, or with respect to
quarterly financial statements, more than 45 days after the end of the quarter
immediately following the quarter for which such statements are provided.
The Issuer incorporates by reference the annual report of Pembroke Gun & Range, LLC
for the period ended December 31, 2009, and posted on the Pink Sheets OTC Market
website on May 5, 2010.
The Issuer incorporates by reference the annual report of Pembroke Gun & Range, LLC
for the period ended December 31, 2009, and posted on the Pink Sheets OTC Market
website on May 5, 2010.
These statements can be found at
http://www.otcmarkets.com/stock/MCDA/financials
Item XIII Similar financial information for such part of the two proceeding fiscal
years as the issuer or its predecessor has been in existence.
Please provide the financial statements described in Item XII above for the issuer’s
two preceding fiscal years.
Instruction to Item XIII: The issuer shall either (i) attach the financial statements
required by this Item XIII to its initial disclosure statement or (ii) post such
financial statements through the OTC Disclosure and News Service as a separate
report under the name of “Annual Report” for the applicable fiscal year end. The
issuer must state in its disclosure statement that such financial statements are
76
incorporated by reference. The issuer must also (x) provide a list in the disclosure
statement describing the financial statements that are incorporated by reference,
(y) clearly explain where the incorporated documents can be found and (z) provide
a clear cross-reference to the specific location where the information requested by
this Item can be found in the incorporated documents.
Item XIV Beneficial Owners.
Provide a list of the name, address and shareholdings of all persons beneficially
owning more than five percent (5%) of any class of the issuer’s equity securities.
To the extent not otherwise disclosed, if any of the above shareholders are
corporate shareholders, provide the name and address of the person(s) owning or
controlling such corporate shareholders and the resident agents of the corporate
shareholders.
As of March 31, 2010:
Name and Address (1)
Ronald Ritter
Anthony Mellone, Jr.
Anthony Mellone, Sr.
Donna Yamin
Totals
Number of Shares Held
3,000,000 Common
7,000,000 Preferred
3,035,536 Common
7,000,000 Preferred
5,000,000 Preferred
2,000,000 Preferred
Common
Preferred 21,000,000
Percentage of Class
Outstanding
20.6% Common
33.3% Preferred
20.8% Common
33.3% Preferred
23.8% Preferred
9.5% Preferred
41.4% Common
100.0% Preferred
(1) The mailing address of all of the above shareholders is 760 E. Mc Nab, Pompano
Beach, Fl, 33060.
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Subsequent to March 31, 2010, Manhattan Capital Corp, LLC acquired 26 million
shares of the Issuer's Common Stock by conversion of a portion of a convertible
debenture.
The Issuer has also entered into an term sheet letter of intent with Manhattan Capital
Corp, LLC whereby Manhattan would provide an Equity Line of Credit for up to
$3,000,000 of the Issuer's Common Stock over a 24 month period. The agreement
requires the Issuer to register its Common Stock with the U.S. Securities and Exchange
Commission. There is no assurance that the Issuer will be able to register its Common
Stock.
Item XV The name, address, telephone number, and email address of each of the
following outside providers that advise the issuer on matters relating to operations,
business development and disclosure:
1. Investment Firm
Manhattan Capital Corp., LLC
235 E. 87th St., Suite 1H
New York, NY 10128
3. Counsel
Bradley E. Essman, Esq.
118 E Tarpon Avenue
St. Petersburg, FL 33705
(727) 768-2121
bradessman@essmanlaw.com
4. Accountant or Auditor - the information shall clearly (i) describe if an outside
accountant provides audit or review services, (ii) state the work done by the outside
accountant and (iii) describe the responsibilities of the accountant and the
responsibilities of management (i.e. who audits, prepares or reviews the issuer’s
financial statements, etc.). The information shall include the accountant’s phone
number and email address and a description of the accountant’s licensing and
78
qualifications to perform such duties on behalf of the issuer.
General accounting services
Montgomery Coscia Greilich, LLC
2500 Dallas Parkway, Suite 300
Plano, TX 75093
(972) 378-0400
Montgomery Coscia Greilich is a full-service professional accounting firm with
expertise in traditional accounting services as well as mergers, acquisitions, divestitures
and systems consulting. They recognize that the level of success in meeting financial
objectives rests with the people making decisions. With individual areas of specialized
skills, knowledge, experience and interests, MCG functions as a financial team.
SEC Auditors
Daszkal Bolton LLP
2401 NW Boca Raton Boulevard
Boca Raton, FL 33431
direct: 561.953.1481
main: 561.367.1040
fax: 561.961.2781
email: jnovick@daszkalbolton.com
website: www.daszkalbolton.com
Daszkal Bolton LLP is the leading certified public accounting and consulting firm
serving South Florida. For over 18 years we have been providing financial leadership,
guidance and advice to individuals, families, corporations and non profit organizations.
Consistently ranked as one of the Top 25 accounting firms in the region, Daszkal Bolton
LLP offers a unique blend of experience, technical knowledge and personalized
service. Our firm provides complex technical & forensic accounting, domestic &
international tax planning, state and local tax services, assurance solutions, litigation
support, valuations, due diligence, M&A assistance, and other consulting services.
5. Public Relations Consultant(s)
None.
79
6. Investor Relations Consultant
None.
7. Any other advisor(s) that assisted, advised, prepared or provided information
with respect to this disclosure statement - the information shall include the
telephone number and email address of each advisor.
None.
Item XVI Management’s Discussion and Analysis or Plan of Operation.
Instructions to Item XVI
Issuers that have not had revenues from operations in each of the last two fiscal
years, or the last fiscal year and any interim period in the current fiscal year for
which financial statements are furnished in the disclosure statement, shall provide
the information in paragraphs A and C of this item. All other issuers shall provide
the information in paragraphs B and C of this item.
The discussion and analysis shall focus specifically on material events and
uncertainties known to management that would cause reported financial
information not to be necessarily indicative of future operating results or of future
financial condition.
Issuers are not required to supply forward-looking information. This is
distinguished from presently known data that will impact upon future operating
results, such as known future increases in costs of labor or materials. This latter
data may be required to be disclosed.
A. Plan of Operation.
1. Describe the issuer’s plan of operation for the next twelve months. This
80
description should include such matters as:
i. a discussion of how long the issuer can satisfy its cash requirements and whether
it will have to raise additional funds in the next twelve months;
The Issuer currently has negligible cash resources and must raise additional funds to
achieve its goals.
ii. a summary of any product research and development that the issuer will
perform for the term of the plan;
See “Business.”
iii. any expected purchase or sale of plant and significant equipment; and
See “Business.”
iv. any expected significant changes in the number of employees.
See “Employees.”
B. Management’s Discussion and Analysis of Financial Condition and Results of
Operations.
1. Full fiscal years. Discuss the issuer's financial condition, changes in financial
condition and results of operations for each of the last two fiscal years. This
discussion should address the past and future financial condition and results of
operation of the issuer, with particular emphasis on
Logged

Borodor

  • Jr. Member
  • *
  • Posts: 234
Klingelhölleritis in den USA - Teil 4
« Reply #21 on: September 13, 2010, 11:35:46 AM »

number and email address and a description of the accountant’s licensing and
78
qualifications to perform such duties on behalf of the issuer.
General accounting services
Montgomery Coscia Greilich, LLC
2500 Dallas Parkway, Suite 300
Plano, TX 75093
(972) 378-0400
Montgomery Coscia Greilich is a full-service professional accounting firm with
expertise in traditional accounting services as well as mergers, acquisitions, divestitures
and systems consulting. They recognize that the level of success in meeting financial
objectives rests with the people making decisions. With individual areas of specialized
skills, knowledge, experience and interests, MCG functions as a financial team.
SEC Auditors
Daszkal Bolton LLP
2401 NW Boca Raton Boulevard
Boca Raton, FL 33431
direct: 561.953.1481
main: 561.367.1040
fax: 561.961.2781
email: jnovick@daszkalbolton.com
website: www.daszkalbolton.com
Daszkal Bolton LLP is the leading certified public accounting and consulting firm
serving South Florida. For over 18 years we have been providing financial leadership,
guidance and advice to individuals, families, corporations and non profit organizations.
Consistently ranked as one of the Top 25 accounting firms in the region, Daszkal Bolton
LLP offers a unique blend of experience, technical knowledge and personalized
service. Our firm provides complex technical & forensic accounting, domestic &
international tax planning, state and local tax services, assurance solutions, litigation
support, valuations, due diligence, M&A assistance, and other consulting services.
5. Public Relations Consultant(s)
None.
79
6. Investor Relations Consultant
None.
7. Any other advisor(s) that assisted, advised, prepared or provided information
with respect to this disclosure statement - the information shall include the
telephone number and email address of each advisor.
None.
Item XVI Management’s Discussion and Analysis or Plan of Operation.
Instructions to Item XVI
Issuers that have not had revenues from operations in each of the last two fiscal
years, or the last fiscal year and any interim period in the current fiscal year for
which financial statements are furnished in the disclosure statement, shall provide
the information in paragraphs A and C of this item. All other issuers shall provide
the information in paragraphs B and C of this item.
The discussion and analysis shall focus specifically on material events and
uncertainties known to management that would cause reported financial
information not to be necessarily indicative of future operating results or of future
financial condition.
Issuers are not required to supply forward-looking information. This is
distinguished from presently known data that will impact upon future operating
results, such as known future increases in costs of labor or materials. This latter
data may be required to be disclosed.
A. Plan of Operation.
1. Describe the issuer’s plan of operation for the next twelve months. This
80
description should include such matters as:
i. a discussion of how long the issuer can satisfy its cash requirements and whether
it will have to raise additional funds in the next twelve months;
The Issuer currently has negligible cash resources and must raise additional funds to
achieve its goals.
ii. a summary of any product research and development that the issuer will
perform for the term of the plan;
See “Business.”
iii. any expected purchase or sale of plant and significant equipment; and
See “Business.”
iv. any expected significant changes in the number of employees.
See “Employees.”
B. Management’s Discussion and Analysis of Financial Condition and Results of
Operations.
1. Full fiscal years. Discuss the issuer's financial condition, changes in financial
condition and results of operations for each of the last two fiscal years. This
discussion should address the past and future financial condition and results of
operation of the issuer, with particular emphasis on the prospects for the future.
The discussion should also address those key variable and other qualitative and
quantitative factors that are necessary to an understanding and evaluation of the
issuer. If material, the issuer should disclose the following:
i. Any known trends, events or uncertainties that have or are reasonably likely to
have a material impact on the issuer's short-term or long-term liquidity;
81
The Issuer faces numerous uncertainties in the development of its business plan. See
“Risk Factors.” The Issuer faces the immediate need to raise funds to execute its
business plan.
ii. Internal and external sources of liquidity;
The Issuer expects that its Pembroke Gun & Range subsidiary will continue to be
profitable and expand its sales and net income. The Issuer expects that it may be able to
make sales of its cosmetic products in the next quarter and beyond to supply it with
revenues and cash flow.
iii. Any material commitments for capital expenditures and the expected sources of
funds for such expenditures;
The Issuer does not intend to make commitments for capital expenditures in advance of
having expected sources of funds for such expenditures. The Issuer expects that its
cosmetic products may provide cash flows for capital expenditures in the foreseeable
future.
iv. Any known trends, events or uncertainties that have had or that are reasonably
expected to have a material impact on the net sales or revenues or income from
continuing operations;
See “Risk Factors.”
v. Any significant elements of income or loss that do not arise from the issuer's
continuing operations;
None.
vi. The causes for any material changes from period to period in one or more line
items of the issuer's financial statements; and
There have been no significant changes in these factors during the first quarter of 2010
other than as described herein.
82
vii. Any seasonal aspects that had a material effect on the financial condition or
results of operation.
The Issuer does not expect to be materially affected by seasonal factors.
2. Interim Periods. Provide a comparable discussion that will enable the reader to
assess material changes in financial condition and results of operations since the
end of the last fiscal year and for the comparable interim period in the preceding
year.
The Issuer is engaged in a new program of expansion that will require additional funds
to be successful. See “Business.”
C. Off-Balance Sheet Arrangements.
1. In a separately-captioned section, discuss the issuer’s off-balance sheet
arrangements that have or are reasonably likely to have a current or future effect
on the issuer's financial condition, changes in financial condition, revenues or
expenses, results of operations, liquidity, capital expenditures or capital resources
that is material to investors. The disclosure shall include the items specified in
paragraphs C(1)(i), (ii), (iii) and (iv) of this Item XVI to the extent necessary to an
understanding of such arrangements and effect and shall also include such other
information that the issuer believes is necessary for such an understanding.
i. The nature and business purpose to the issuer of such off-balance sheet
arrangements;
ii. The importance to the issuer of such off-balance sheet arrangements in respect
of its liquidity, capital resources, market risk support, credit risk support or other
benefits;
iii. The amounts of revenues, expenses and cash flows of the issuer arising from
such arrangements; the nature and amounts of any interests retained, securities
issued and other indebtedness incurred by the issuer in connection with such
arrangements; and the nature and amounts of any other obligations or liabilities
(including contingent obligations or liabilities) of the issuer arising from such
83
arrangements that are or are reasonably likely to become material and the
triggering events or circumstances that could cause them to arise; and
iv. Any known event, demand, commitment, trend or uncertainty that will result in
or is reasonably likely to result in the termination, or material reduction in
availability to the issuer, of its off-balance sheet arrangements that provide
material benefits to it, and the course of action that the issuer has taken or
proposes to take in response to any such circumstances.
2. As used in paragraph C of this Item XVI, the term off-balance sheet
arrangement means any transaction, agreement or other contractual arrangement
to which an entity unconsolidated with the issuer is a party, under which the issuer
has:
i. Any obligation under a guarantee contract that has any of the characteristics
identified in paragraph 3 of FASB Interpretation No. 45, Guarantor's Accounting
and Disclosure Requirements for Guarantees, Including Indirect Guarantees of
Indebtedness of Others (November 2002) ("FIN 45"), as may be modified or
supplemented, and that is not excluded from the initial recognition and
measurement provisions of FIN 45 pursuant to paragraphs 6 or 7 of that
Interpretation;
ii. A retained or contingent interest in assets transferred to an unconsolidated
entity or similar arrangement that serves as credit, liquidity or market risk support
to such entity for such assets;
iii. Any obligation, including a contingent obligation, under a contract that would
be accounted for as a derivative instrument, except that it is both indexed to the
issuer's own stock and classified in stockholders' equity in the issuer's statement of
financial position, and therefore excluded from the scope of FASB Statement of
Financial Accounting Standards No. 133, Accounting for Derivative Instruments
and Hedging Activities (June 1998), pursuant to paragraph 11(a) of that Statement,
as may be
modified or supplemented; or
iv. Any obligation, including a contingent obligation, arising out of a variable
interest (as referenced in FASB Interpretation No. 46, Consolidation of Variable
Interest Entities (January 2003), as may be modified or supplemented) in an
unconsolidated entity that is held by, and material to, the issuer, where such entity
provides financing, liquidity, market risk or credit risk support to, or engages in
84
leasing, hedging or research and development services with, the issuer.
Instructions to paragraph C of Item XVI
i. No obligation to make disclosure under paragraph C of this Item XVI shall arise
in respect of an off-balance sheet arrangement until a definitive agreement that is
unconditionally binding or subject only to customary closing conditions exists or, if
there is no such agreement, when settlement of the transaction occurs.
ii. Issuers should aggregate off-balance sheet arrangements in groups or categories
that provide material information in an efficient and understandable manner and
should avoid repetition and disclosure of immaterial information. Effects that are
common or similar with respect to a number of off-balance sheet arrangements
must be analyzed in the aggregate to the extent the aggregation increases
understanding. Distinctions in arrangements and their effects must be discussed to
the extent the information is material, but the discussion should avoid repetition
and disclosure of immaterial information.
iii. For purposes of paragraph C of this Item XVI only, contingent liabilities arising
out of litigation, arbitration or regulatory actions are not considered to be off-
balance sheet arrangements.
iv. Generally, the disclosure required by paragraph C of this Item XVI shall cover
the most recent fiscal year. However, the discussion should address changes from
the previous year where such discussion is necessary to an understanding of the
disclosure.
In satisfying the requirements of paragraph C of this Item XVI, the discussion of
off-balance sheet arrangements need not repeat information provided in the
footnotes to the financial statements, provided that such discussion clearly cross-
references to specific information in the relevant footnotes and integrates the
substance of the footnotes into such discussion in a manner designed to inform
readers of the significance of the information that is not included within the body of
such discussion.
There are no such off-balance sheet arrangements.
85
Part E Issuance History
Item XVII List of securities offerings and shares issued for services in the past two
years.
List below any events, in chronological order, that resulted in changes in total
shares outstanding by the issuer (1) within the two-year period ending on the last
day of the issuer’s most recent fiscal year and (2) since the last day of the issuer’s
most recent fiscal year.
The list shall include all offerings of securities, whether private or public, and shall
indicate:
(i) The nature of each offering (e.g., Securities Act Rule 504, intrastate,
etc.);
(ii) Any jurisdictions where the offering was registered or qualified;
(iii) The number of shares offered;
(iv) The number of shares sold;
(v) The price at which the shares were offered, and the amount actually paid
to the issuer;
(vi) The trading status of the shares; and
(vii) Whether the certificates or other documents that evidence the shares contain a
legend (1) stating that the shares have not been registered under the Securities Act
and (2) setting forth or referring to the restrictions on transferability and sale of
the shares under the Securities Act.
The list shall also include all shares or any other securities or options to acquire
such securities issued for services in the past two fiscal years and any interim
periods, describing (1) the securities, (2) the persons or entities to whom such
securities were issued and (3) the services provided by such persons or entities.
With respect to private offerings of securities, the list shall also indicate the identity
of the persons who purchased securities in such private offering; provided,
86
however, that in the event that any such person is an entity, the list shall also
indicate (a) the identity of each natural person beneficially owning, directly or
indirectly, more than five percent (5%) of any class of equity securities of such
entity and (b) to the extent not otherwise disclosed, the identity of each natural
person who controlled or directed, directly or indirectly, the purchase of such
securities for such entity.
The Issuer made an offering under SEC Rule 504 from June 2008 to September, 2009.
The offering was qualified in Minnesota. The number of shares to be sold varied
according to the market price and the number that was sold was 1,070,000,000 in 2008
and 1,530,000,000 in 2009, at an average price of $0.0002, before giving effect to the
one for 500 reverse split of the Issuer in 2009. The shares were free trading pursuant to
Rule 504(b)(1) and no legend was placed on the certificates. All securities were
purchased by Gendarme Capital, LLC,. 515 Excelsior Blvd., St Louis Park, MN 55416.
In April, 2010, the Issuer issued 350,627 shares of its restricted Common Stock to
Bradley E. Essman, Esq. For legal services and 350,627 shares of its restricted Common
Stock to John Lux for financial consulting services.
The Issuer has outstanding a convertible debenture that was issued made by Amore TV,
Inc., predecessor to Macada Holdings, Inc., on March 15, 2007 in the amount of
$309,000.00 and bears interest at the prime rate of interest as reported by Citibank on
the issue date plus three points. The debenture is convertible at the lowest bid price of
the Issuer's Common Stock on the conversion date. Manhattan Capital Corp, LLC, the
holder of the debenture, acquired 26 million shares of the Issuer's Common Stock by
conversion of a portion of a convertible debenture.
On April 12, 2010, the Issuer was assigned certain technology rights from Karsten
Klingellioller in exchange for 1,000,000 shares of the Issuer's restricted Common Stock
and certain cash payments. The amount of such stock may be adjusted according to the
market price of the Issuer's free trading stock.
On April 28, 2010, the Issuer was assigned certain technology rights from Dr. Christian
Maas in exchange for 1,000,000 shares of the Issuer's restricted Common Stock and
certain cash payments. The amount of such stock may be adjusted according to the
market price of the Issuer's free trading stock.
87
Part F Exhibits
The following exhibits must be either described in or attached to the disclosure
statement:
Item XVIII Material Contracts.
A. Every material contract, not made in the ordinary course of business, that will
be performed after the disclosure statement is posted through the OTC Disclosure
and News Service or was entered into not more than two years before such posting.
Also include the following contracts:
1) Any contract to which directors, officers, promoters, voting trustees, security
holders named in the disclosure statement, or the Designated Advisor for
Disclosure are parties other than contracts involving only the purchase or sale of
current assets having a determinable market price, at such market price;
2) Any contract upon which the issuer’s business is substantially dependent,
including but not limited to contracts with principal customers, principal
suppliers, and franchise agreements;
3) Any contract for the purchase or sale of any property, plant or equipment for
consideration exceeding 15 percent of such assets of the issuer; or
4) Any material lease under which a part of the property described in the
disclosure statement is held by the issuer.
B. Any management contract or any compensatory plan, contract or arrangement,
including but not limited to plans relating to options, warrants or rights, pension,
retirement or deferred compensation or bonus, incentive or profit sharing (or if not
set forth in any formal document, a written description thereof) in which any
director or any executive officer of the issuer participates shall be deemed material
and shall be included; and any other management contract or any other
compensatory plan, contract, or arrangement in which any other executive officer
of the issuer participates shall be filed unless immaterial in amount or significance.
C. The following management contracts or compensatory plans need not be
included:
1) Ordinary purchase and sales agency agreements;
88
2) Agreements with managers of stores in a chain organization or similar
organization;
3) Contracts providing for labor or salesmens' bonuses or payments to a class of
security holders, as such; and
4) Any compensatory plan that is available to employees, officers or directors
generally and provides for the same method of allocation of benefits between
management and non-management participants
Item XIX Articles of Incorporation and Bylaws.
A. A complete copy of the issuer’s articles of incorporation or in the event that the
issuer is not a corporation, the issuer’s certificate of organization. Whenever
amendments to the articles of incorporation or certificate of organization are filed,
a complete copy of the articles of incorporation or certificate of organization as
amended shall be filed.
B. A complete copy of the issuer’s bylaws. Whenever amendments to the bylaws
are filed, a complete copy of the bylaws as amended shall be filed.
Item XX Purchases of Equity Securities by the Issuer and Affiliated Purchasers.
A. In the following tabular format, provide the information specified in paragraph
(B) of this Item XX with respect to any purchase made by or on behalf of the issuer
or any "Affiliated Purchaser” (as defined in paragraph (C) of this Item XX) of
shares or other units of any class of the issuer's equity securities.
ISSUER PURCHASES OF EQUITY SECURITIES
Period
Column (d)
Column © Total
Column (b)
Column (a)
n8umber of
Maximum
Total number of Average price
number o(or
Shares (or
shares (or Units) per Paid per
approximate
Units)
Share (or Unit)
purchased
purchased as dollars value) of
part of publicly shares (or Units)
89
announced plans that may yet be
or programs purchased under
the plans or
programs.
Month #1
(identify
beginning and
ending dates)
Month #2
(identify
beginning and
ending dates)
Month #3
(identify
beginning and
ending dates)
Total
None
None
B. The table shall include the following information for each class or series of
securities for each month included in the period covered by the report:
1. The total number of shares (or units) purchased (Column (a)). Include in this
column /all issuer repurchases, including those made pursuant to publicly
announced plans or programs and those not made pursuant to publicly announced
plans or programs. Briefly disclose, by footnote to the table, the number of shares
purchased other than through a publicly announced plan or program and the
nature of the transaction (e.g., whether the purchases were made in open-market
transactions, tender offers, in satisfaction of the company's obligations upon
exercise of outstanding put options issued by the company, or other transactions).
2. The average price paid per share (or unit) (Column (b)).
3. The total number of shares (or units) purchased as part of publicly announced
repurchase plans or programs (Column (c)).
4. The maximum number (or approximate dollar value) of shares (or units) that
may yet be purchased under the plans or programs (Column (d)). Instructions to
90
paragraphs (B)(3) and (B)(4) of this Item XX:
a. In the table, disclose this information in the aggregate for all plans or programs
publicly announced.
b. By footnote to the table, indicate:
i. The date each plan or program was announced;
ii. The dollar amount (or share or unit amount) approved;
iii. The expiration date (if any) of each plan or program;
iv. Each plan or program that has expired during the period
covered by the table; and
v. Each plan or program the issuer has determined to terminate prior to
expiration, or under which the issuer does not intend to make further purchases.
C. For purposes of this Item XX, “Affiliated Purchaser” means:
1. A person acting, directly or indirectly, in concert with the issuer for the purpose
of acquiring the issuer's securities; or
2. An affiliate who, directly or indirectly, controls the issuer's purchases of such
securities, whose purchases are controlled by the issuer, or whose purchases are
under common control with those of the issuer; provided, however, that “Affiliated
Purchaser” shall not include a broker, dealer, or other person solely by reason of
such broker, dealer, or other person effecting purchases on behalf of the issuer or
for its account, and shall not include an officer or director of the issuer solely by
reason of that officer or director's participation in the decision to authorize
purchases by or on behalf of the issuer.
No purchases of equity securities by the Issuer and affiliated persons. Anthony Mellone,
Jr., Ronald Ritter, Antonio Mellone, Sr., and Donna Yamin, holders of the Issuer's
Convertible Preferred Stock, agreed to cancel a total of 58 million shares of the
Preferred Stock without consideration in February, 2010.
91
Item XXI Issuer’s Certifications.
The issuer shall include certifications by the chief executive officer and chief
financial officer of the issuer (or any other persons with different titles, but having
the same responsibilities).
The certifications shall follow the format below:
I, Anthony Mellone, Jr., President, certify that:
1. I have reviewed this disclosure statement of Macada Holding, Inc.;
2. Based on my knowledge, this disclosure statement does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made,
not misleading with respect to the period covered by this disclosure statement; and
3. Based on my knowledge, the financial statements, and other financial information
included or incorporated by reference in this disclosure statement, fairly present in all
material respects the financial condition, results of operations and cash flows of the
issuer as of, and for, the periods presented in this disclosure statement.
Date: June 30, 2010
_____________________________
Anthony Mellone, Jr., President
92

[*****/QUOTE*****]


Quelle:
https://www.otciq.com/otciq/ajax/showFinancialReportById.pdf?id=33485


Ob die Recherchepfeifen im Staate D wie bisher hinter dem letzten Loch pflöten oder ob denen doch noch ein Licht aufgeht?
Logged

tipsy toaster

  • Jr. Member
  • *
  • Posts: 53
Re: Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #22 on: September 14, 2010, 11:12:14 AM »

.

Gut lesbare Info, zahlreiche Quellen inklusive dem magischen PWC-Gutachten )"$936 Millionen") zum Thema gibt es hier:

“How do you spell Klingelholler?”
http://kindersprechstunde.wordpress.com/2010/07/29/how-do-you-spell-klingelholler/



Aktuelle Pressemeldung von Macada
http://kindersprechstunde.wordpress.com/2010/08/09/aktuelle-pressemeldung-von-macada/

B12Bio-Skin Trademark: Registration Refused by USPTO
http://kindersprechstunde.wordpress.com/2010/09/06/b12bio-skin-trademark-registration-refused-by-uspto/

A Comment by Ron Ritter?
http://kindersprechstunde.wordpress.com/2010/09/09/a-comment-by-ron-ritter/

One More Failure: “LyfeTec, Inc.” Trademark Registration Failed
http://kindersprechstunde.wordpress.com/2010/09/13/one-more-failure-lyfetec-inc-trademark-registration-failed/

.
Logged

tipsy toaster

  • Jr. Member
  • *
  • Posts: 53
Re: Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #23 on: October 04, 2010, 02:17:55 PM »

Die ach so gut verträgliche rosa Hühnerkacke ist nicht so harmlos, wie Klaus Martens im WDR und Mavena bzw. Regeneratio Pharma es das Publikum bzw. den Kranken glauben machen möchten.

Aus Foren und auch den dürftigen klinischen Studien sind Häufigkeit und Schwere der Nebenwirkungen von Regividerm bzw. Mavena B12 Salbe ersichtlich.

Ein kürzlich in einer dermatologischen Fachzeitschrift erschienener Fallbericht beschreibt nun, dass es nach Regividerm-Anwendung wegen heftiger Nebenwirkungen zur Krankenhaus-Einweisung kam, und dass bei dem Patienten eine umfangreiche Therapie erforderlich war.

Mehr:
Krankenhausreif nach 5 Tagen Regividerm®
http://kindersprechstunde.wordpress.com/2010/10/04/krankenhausreif-nach-5-tagen-regividerm%C2%AE/
Logged

tipsy toaster

  • Jr. Member
  • *
  • Posts: 53
Re: Klingelhöllers Rezeptur einer Salbe gegen Neurodermitis
« Reply #24 on: October 08, 2010, 03:09:18 PM »

Herr Klingelhöller war wohl nicht sehr wählerisch bei der Auswahl seines neuen Geschäftspartners. Oder wusste er etwa, dass Anthony Mallone massiv Dreck am Stecken hat?

http://kindersprechstunde.wordpress.com/2010/10/08/klingelhollers-krimineller-geschaftspartner-in-der-falle-des-fbi/


<quote>
----------------------------
Klingelhöllers krimineller Geschäftspartner in der Falle des FBI

Was wusste Karsten Klingelhöller von den illegalen Finanz-Manipulationen seines Geschäftspartners Anthony Mellone?

Klingelhöller hat an Mellones Firma LyfeTec (Tochter der Macada Holding) drei “medical treatment formulas” verkauft (unser Bericht). Es soll um die Behandlung von Psoriasis und Neurodermitis gehen. Klingelhöller und Anthony Mellone haben im April 2010 einen Vertrag geschlossen (wir berichteten).

Und gestern flogen Anthony Mellone und einige seiner Konsorten wegen illegaler Aktivitäten am Penny Stocks Markt auf. Die Falle von undercover arbeitenden FBI-Beamten schnappte zu. Die SEC (US Securities and Exchange Commission) klagt Mellone und andere Personen wegen illegaler Kickbacks an. Ziel der Aktivitäten von Mellone & Co. war die Manipulation von Aktienkursen und Handelsvolumen zum Nachteil von nichtsahnenden Investoren.

.........
------------------------
</quote>


Full Story:
http://kindersprechstunde.wordpress.com/2010/10/08/klingelhollers-krimineller-geschaftspartner-in-der-falle-des-fbi/
Logged

Julian

  • Boltbender
  • Jr. Member
  • *
  • Posts: 764
TERMIN: 24.1.2014 --- Insolvenzverfahren REGENERATIO PHARMA Aktiengesellschaft
« Reply #26 on: January 09, 2014, 11:12:17 AM »

Aus den Insolvenzbekanntmachungen - man kann nicht direkt zu den Suchergebnissen verlinken.

Harte Zahlen: Forderungen der Gläubiger: 1,5 Mio; vorhanden: 59000 Euro, und davon gehen noch die
Gerichtskosten und Kosten für Insolvenzverwalter ab.


[*quote*]
Amtsgericht Wuppertal, Aktenzeichen: 145 IN 126/04

In dem Insolvenzverfahren über das Vermögen

der im Handelsregister des Amtsgerichts Wuppertal unter HRB 9680
eingetragenen REGENERATIO PHARMA Aktiengesellschaft, Kleine Klotzbahn
23, 42105 Wuppertal, gesetzlich vertreten durch den Vorstand Osman
Burak Akdikmen, Hainstraße 155, 42109 Wuppertal

wird der Schlussverteilung zugestimmt.

Termin für eine abschließende Gläubigerversammlung (Schlusstermin) zur
Erörterung der Schlussrechnungslegung des Insolvenzverwalters, zur
Erhebung von Einwendungen gegen das Schlussverzeichnis, zur
Entscheidung der Insolvenzgläubiger über die nicht verwertbaren
Gegenstände der Insolvenzmasse, zur Anhörung der Gläubigerversammlung
über die Festsetzung der Vergütung des Insolvenzverwalters, wird
bestimmt auf

Freitag, 24.01.2014, 11:00 Uhr,

im Gebäude des Amtsgerichts Wuppertal, Eiland 2, 42103 Wuppertal, 2.
Etage, Sitzungssaal A234.

Das Schlussverzeichnis sowie die Schlussrechnung des
Insolvenzverwalters liegen nebst dem gerichtlichen Prüfungsvermerk zur
Einsicht der Beteiligten auf der Geschäftsstelle des Insolvenzgerichts
Wuppertal, Eiland 2, 42103 Wuppertal, Altbau, Zimmer Nr. A282 aus.

Nach dem Schlussverzeichnis beträgt die Summe der festgestellten
Forderungen der Insolvenzgläubiger im Rang des § 38 InsO insgesamt
1.527.086,08 €.


Für die Verteilung an die Gläubiger steht ein Betrag von 59.260,79 €
zur Verfügung. Hiervon sind jedoch vorab noch die restlichen
Masseverbindlichkeiten (u.a. Gerichtskosten und die Vergütung des
Insolvenzverwalters) in Abzug zu bringen.

Die Vergütung und die zu erstattenden Auslagen des Insolvenzverwalters
sind festgesetzt worden (§§ 63, 64 InsO). Der vollständige Beschluss
kann in der Geschäftsstelle des Insolvenzgerichts Wuppertal, Eiland 2,
42103 Wuppertal, Altbau, Zimmer Nr. A282 eingesehen werden.

145 IN 126/04
Amtsgericht Wuppertal, 16.12.2013

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Ayubsi

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  • Posts: 2
Arndt Krienen und die Patente der Regeneratio Pharma
« Reply #27 on: January 10, 2014, 11:52:26 AM »

[*quote*]
Arndt Krienen und die Patente der Regeneratio Pharma

Das Europäische Patentamt hat den Sicherungsübereignungsvertrag und zugehörige weitere Dokumente veröffentlicht:
https://register.epo.org/application?documentId=ESJOXGEX0278654&number=EP10158215&lng=en&npl=false

Arndt Krienen (Remscheid) hat seit 2004 diverse Arbeiten für Regeneratio Pharma GmbH erledigt. Zur Absicherung der Ansprüche von Krienen an Regeneratio übereignete Regeneratio das Eigentum an sämtlichen Patenten und Patentanmeldungen, Markenrechten und Zulassungsunterlagen an Herrn Krienen. Es wurde unbedingtes Stillschweigen über diesen auf den 1.9.2010 datierten Vertrag vereinbart.

Der Antrag auf Eintragung eines dinglichen Rechts zu Gunsten von Herrn Krienen ging am 26.11.2011 beim EPO in München ein, betreffend die Patentanmeldungen
02 751 075.9
10 158 215.3
10 158 218.7

Bemerkenswert in diesem Zusammenhang ist die bereits zum 15.9.2011 erfolgte Eintragung einer Zwangsvollstreckungsmaßnahme zu Gunsten von MMS Medical Management & Services AG, Hergiswil, Schweiz für die bereits oben genannten europäischen Patentanmeldungen
02 751 075.9
10 158 215.3
10 158 218.7
Veröffentlichung ebenfalls beim Europäischen Patentamt, nachzulesen unter
https://register.epo.org/application?documentId=ER8TBR805212679&number=EP10158215&lng=en&npl=false

Der Hintergrund zu dieser Zwangsvollstreckungsmaßnahme ist nachzulesen unter
https://register.epo.org/application?documentId=ESAZO17M1071679&number=EP10158215&lng=en&npl=false
[/quote*]




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