Martinsried/Munich, April 18, 2007. The biotech company MediGene AG (Frankfurt, Prime Standard: MDG) announced today that the regulatory authorities in Germany, Austria, and Spain have accepted the marketing authorization application for the Polyphenon E® Ointment for review. This means that the application was complete and submitted according to the formal requirements, and that the review procedure has started. MediGene expects approval and market launch of the product in the above mentioned countries during the first six months of 2008.
MediGene is planning commercialization of the Polyphenon E® Ointment in some selected countries through its own sales force. A marketing organization is currently being established to launch the drug Oracea®, which currently is also undergoing approval procedure, in the last six months of 2007.
Polyphenon E® Ointment is to succeed in 2008, upon approval. The drug was already approved in the USA in October 2006. Market launch by MediGene’s US marketing and development partner Bradley Pharmaceuticals is expected in the last six months of 2007.
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: „We are very glad that the European regulatory authorities have now accepted our application for review, and feel confident that, after having successfully passed the US approval procedure, we will also receive approval for the first European countries. We will make every endeavour to expedite the procedure, and cooperate closely with the authorities.”
About Polyphenon® E Ointment: The active substance in Polyphenon® E Ointment is a concentrate of catechines with a defined composition, extracted from green tea leaves. For the indication genital warts, MediGene estimates the annual peak sales potential of this drug in Europe to be about 30 million EUR.
About 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 areas, which are mostly 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. MediGeneTM is a trademark of MediGene AG, Polyphenon® E is a trademark of Mitsui Norin, Oracea® is a trademarks of CollaGenex Pharmaceuticals, Inc.
MediGene AG is a publicly quoted (Frankfurt: Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company with a drug on the market. A second drug has been approved by the FDA. A third drug was recently inlicensed from the US pharma company CollaGenex to market this drug in Europe. In addition, several drug candidates are currently in clinical development. MediGene also possesses innovative platform technologies. The company’s core competence lies in research and development of novel approaches in anti cancer therapies. Thus MediGene focuses on indications of high medical need and great economic opportunities.
Contact MediGene AG: Email: investor@medigene.com Fax: ++49 - 89 - 85 65 - 2920 Julia Hofmann/Dr. Georg Dönges, Public Relations Tel.: ++49 - 89 - 85 65 - 3317 Dr. Michael Nettersheim, Investor Relations Tel.: ++49 - 89 - 85 65 - 2946
