A high-tech product from green tea
Veregen®, originally developed under the name Polyphenon E® Ointment,
gives MediGene a second drug on the market. Veregen® has been
available in the U.S. for the treatment of external genital warts since
December 2007. In the fi rst quarter of 2009, MediGene’s sales partner
Nycomed US, Inc. began actively marketing the drug. The company took
over MediGene’s sales partner Bradley Pharmaceuticals, Inc. at the end
of 2007. Veregen® makes MediGene the fi rst German biopharmaceutical
company with a drug on the American market. In Europe, the product is
undergoing the approval process in Germany, Austria, and Spain. Veregen®
is MediGene’s fi rst in-house clinical development.
Unlike most other drugs, Veregen® does not consist of one single active
substance. In fact, it is a concentrate of catechines with a complex
defi ned composition. These natural substances are extracted from green
tea leaves in a patented process. During clinical development, Veregen®
tested in the treatment of genital warts showed high and sustained effi
cacy as well as a low recurrence rate. The results relevant to approval
were obtained in an international phase III development program, during
which more than 1,000 patients in 14 countries were medicated with
Veregen® at different dosages. Genital warts are benign, but painful and
disfi guring skin tumors in the genital and anal areas. The sexually transmitted
disease is caused by human papilloma viruses. Approximately
30 million people worldwide are infected by these viruses. Genital warts
are one of the fastest spreading venereal diseases worldwide.
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Outlook
A decision on the ongoing approval application in Germany, Spain, and
Austria is expected soon. Once this process is concluded,
the company can also apply for approval in other European countries
on this basis. MediGene AG has already entered into a marketing partnership with the Spanish company Juste S.A.Q.F. for the commercialization of Veregen® in Spain and Portugal.
Changes in a skin tumor induced by Veregen®
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HPV infection of skin cells induces formation of warts |
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Polyphenon® penetrates the skin, unfolds its immuno-modulatory effect and also directly acts on infected cells |
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Messengers (Cytokines, Interferones) are released |
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Cells of the immune system invade and destroy infected cells |
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Veregen® is the US brandname of the drug. |
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The European marketing authorization application is made out to the name of Polyphenon E® Ointment. |
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Veregen® is a trademark of MediGene AG.
Polyphenon E® is a trademark of Mitsui Norin Co., Ltd.
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