News

MediGene's Veregen® launched by Solvay in Germany

  • Second product from MediGene's pipeline to be launched in Germany
  • Market approval for Austria received

 

Martinsried/Munich, March 01, 2010. The biotech company MediGene AG (Frankfurt, Prime Standard, TecDAX) announced today that Solvay Arzneimittel GmbH has initiated the German launch of Veregen® (10 % ointment) for the treatment of genital warts. Following Eligard® for the treatment of prostate cancer, Veregen® is MediGene's second drug to be made available on the German market. Veregen® is already available in the USA via MediGene's partner Nycomed US, Inc.

 

MediGene AG further announces that is has received Austrian market approval for Veregen® for the treatment of genital warts from the Austrian Federal Office for Safety in Health Care. The drug will be marketed there by Solvay as well. Market launch in Austria is expected in the middle of 2010.

 

Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: "For the first time, a drug developed by MediGene itself will be available in European pharmacies. We are delighted that from today this new treatment option will be available to German patients, and that commercialization in Austria will also start soon."

 

Dr. Wolfgang Dankert, General Manager of Solvay Arzneimittel GmbH, commented: "With Veregen® now available, we are in a position to offer an innovative product for the treatment of genital warts. There is very high medical need in this indication, and we are ideally positioned to market this product in the relevant target groups."

 

Genital warts: genital warts are one of the most common sexually transmitted diseases wordwide. It is an infectious, partially painful and disfiguring virus disease in the genital and anal areas, and in most cases is very difficult to treat. About 14 million people in North America and 15 million people in Europe are infected with human papilloma viruses which cause genital warts. The major problem occurring in both surgically as well as topically treated patients is the high recurrence rate.

 

Veregen®:

Veregen® (previously Polyphenon E® Ointment) for the topical treatment of external genital warts is a concentrate of catechins with a complex defined composition extracted from green tea leaves. MediGene acquired the basic rights to the active ingredient in Veregen® from the Canadian company Epitome Pharmaceuticals, Inc. in 1999, and was solely responsible for the drug's preclinical and clinical development, as well as for the approval process. Moreover the patent protection was further upgraded by a number of proprietary inventions.

 

In 2009 MediGene concluded a license and supply agreement with Solvay for Germany, Austria, and Switzerland. The Spanish pharmaceutical company Juste S.A.Q.F. will distribute Veregen® in Spain and Portugal, and in Israel the drug will be marketed by Teva Pharmaceutical Industries Ltd. In July 2009 the marketing approval application for Veregen® was assessed positively in the European decentralized procedure by the national regulatory authorities in Germany, Austria, and Spain. With market approvals in Germany (end 2009) and now Austria, marketing approval in Spain is expected during the next few months. MediGene is planning to apply for market approval in further European countries, and intends to conclude additional marketing agreements for countries in and outside Europe.

 

Solvay Arzneimittel GmbH is the German affiliate of Solvay Pharmaceuticals. Solvay Pharmaceuticals was acquired by Abbott on February 15th, 2010. For more information, please visit www.solvay-arzneimittel.de.

 

This press release contains forward-looking statements representing the opinion of MediGene as of the date of this release. The actual results achieved by MediGene may differ significantly from the forward-looking statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene® and Veregen(TM) are registered trademarks of MediGene AG. Polyphenon E(TM) is a registered trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.

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MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG, TecDax) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market which are distributed by partner companies. It has several drug candidates in clinical development and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs with focus on oncology.

 

Contact MediGene AG

Email: investor@medigene.com

Fax: ++49 - 89 - 85 65 - 2920

Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 - 89 - 85 65 - 3324

Dr. Georg Dönges, Investor Relations, Tel.: ++49 - 89 - 85 65 - 2946