MediGene says FDA accepts its NDA filing for genital wart ointment

By E. Janene Geiss

Philadelphia, Dec. 1 - MediGene AG announced Thursday that the New Drug Application for Polyphenon E Ointment to treat genital warts has been accepted for filing by the U.S. Food and Drug Administration.

The acceptance confirms that the application was sufficiently complete to allow a substantive review by the FDA, according to a company news release.

MediGene developed the Polyphenon E Ointment for the treatment of genital warts, a benign form of skin tumors caused by infections with various types of human papilloma viruses.

About 14 million people in North America and 15 million people in Europe are infected by human papilloma viruses that cause genital warts, which are contagious and hard to treat, officials said.

The active substance in Polyphenon E Ointment is a green tea extract with a defined catechin composition. MediGene is developing this drug to treat various skin tumors.

For the genital warts indication, MediGene estimates sales potential of more than €100 million annually, officials said.

The FDA application is based on two phase 3 clinical trials that include more than 1,000 patients in Europe and North America. The results have been presented in the course of several scientific meetings, most recently in October at the 14th Congress of the European Academy of Dermatology and Venereology in London.

MediGene said it plans to submit a Marketing Authorization Application in Europe in 2006.

"Pending approval, we plan to begin marketing Polyphenon E Ointment in the U.S., which currently represents the largest market for the target indication," said chief executive officer Peter Heinrich in the release.

Negotiations with a potential marketing partner are well-advanced and acceptance of the NDA will promote the closing of the partnership, Heinrich said.

MediGene is a German-American biotechnology company located in Martinsried, Germany, and San Diego. It has several oncology drug candidates undergoing clinical development and possesses platform technologies for drug development in the treatment of various cancer and tumor diseases.

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