MediGene AG Receives Marketing Authorization for Veregen® in Germany

Martinsried/Munich, September 09, 2009. MediGene AG (Frankfurt: MDG, Prime Standard, TecDAX) announces that it has received German marketing authorization for Veregen® for the treatment of genital warts from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte = BfArM).




As previously announced in July 2009, the marketing authorization application for Veregen® (formerly Polyphenon E® Ointment) was assessed positively in a decentralized approval procedure by the German, Austrian, and Spanish national regulatory authorities. The formal issue of marketing authorization in Germany is the first implementation of the assessment by a national regulatory authority. Marketing authorization of Veregen® in Germany, the reference member state in this decentralized procedure, will now provide a basis for additional marketing authorization applications to be submitted in additional European countries. The issuance of formal marketing authorizations in Austria and Spain are expected within the next few months.




MediGene intends to distribute Veregen® in Germany and other European countries via marketing partners. In the USA Veregen® is already available, and is distributed by MediGene's licensee Nycomed US Inc. In addition, MediGene recently announced the conclusion of a partnership with the Spanish company Juste S.A.Q.F. for the distribution of Veregen® in Spain and Portugal.




Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: "Veregen® is MediGene's first proprietary development and German marketing authorization opens up market entry into Europe. I am confident that we will be able to conclude a marketing partnership for Germany within the next few weeks, enabling us to provide pharmacies and patients with the drug."




Veregen®: Veregen® for the treatment of genital warts contains a defined extract from green tea leaves. MediGene acquired the basic rights to the active substance in Veregen® from the Canadian company Epitome Pharmaceuticals, Inc., in 1999, and was solely responsible for the drug's successful preclinical and clinical development, as well as for the approval process. Moreover the patent protection was further upgraded by a number of proprietary inventions. The green tea leaf extract is manufactured by the Japanese company Mitsui Norin Co., Ltd. The drug's name during development was Polyphenon E® Ointment. The US market approval was made out to Veregen®, and the product is distributed in the USA under this name via MediGene's licensee Nycomed US (PharmaDerm). In Europe, marketing authorization applications under the decentralized procedure have been submitted in Germany, Austria, and Spain, and were assessed positively by the national authorities. 




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 statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene® and Veregen® are registered trademarks of MediGene AG. Polyphenon E® 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 being distributed by partner companies and has several drug candidates in clinical development, two of which provide significant sales potential. In addition, the company has numerous projects in research and pre-clinical development and possesses innovative platform technologies. MediGene focuses on the research and development of novel drugs for the treatment of cancer and autoimmune diseases.




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