MediGene Announces FDA Acceptance of New Drug Application for Polyphenon(R) E* Ointment for the Treatment of Genital Warts

MARTINSRIED and MUNICH, Germany and SAN DIEGO, Dec. 1
 /PRNewswire-FirstCall/ -- The German-American biotech company MediGene AG (Frankfurt, Germany; TecDAX) [MDGEF.PK] announces today that the New Drug Application (NDA) for Polyphenon(R) E* Ointment has been accepted for filing by the Food and Drug Administration (FDA). This acceptance confirms that the application was sufficiently complete to allow a substantive review by the FDA.  MediGene developed the Polyphenon(R) E* Ointment for the treatment of genital warts, a benign form of skin tumors caused by infections with various types of human papilloma viruses.

The application is based on two phase III clinical trials conducted in Europe and the Americas enrolling more than 1,000 patients. The results of these studies 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 plans to submit a Marketing Authorization Application in Europe in 2006.

"Pending approval, we plan to begin marketing Polyphenon(R) E* Ointment in the US which currently represents the largest market for the target indication. Negotiations with a potential marketing partner are well-advanced. The acceptance of the NDA will promote closing the marketing partnership", comments Peter Heinrich, CEO of MediGene AG.

Polyphenon(R) E* Ointment: The active substance in Polyphenon(R) E* Ointment is a green tea extract with a defined catechin composition. MediGene is developing this drug for the treatment of various skin tumors. For the indication genital warts, MediGene estimates the sales potential of this drug at more than 100 million Euros annually.

Genital warts: Genital warts are one of the most common and fastest spreading venereal diseases worldwide. Genital warts are benign, but disfiguring and contagious skin tumors in the genital and anal area, which are difficult to treat. Approximately 14 million people in North America and 15 million people in Europe are infected by human papilloma viruses (HPV type 6 or 11), which cause genital warts.

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGene(TM) is a trademark of MediGene AG, Polyphenon(R) E* is a trademark of Mitsui Norin.

* Temporary name while under development

MediGene AG is a publicly quoted (Frankfurt: TecDAX), German-American biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The NDA for a second drug, Polyphenon(R) E Ointment, has been submitted. In addition, MediGene has several oncological drug candidates undergoing clinical development, and possesses innovative platform technologies for drug development. MediGene's core competence lies in research into and development of novel approaches for  the treatment of various cancer and tumor diseases. 

DATASOURCE: MediGene AG



CONTACT:  Dr. Georg Donges, Public Relations, [phone], or Dr.

Michael Nettersheim, Investor Relations, [phone], both of MediGene

AG, Fax, [phone],  

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