Martinsried/Munich, July 10, 2009. MediGene AG (Frankfurt: MDG, Prime Standard, TecDAX) today announces that its Marketing Authorisation Application for the medicinal product Veregen® (formerly Polyphenon E® Ointment) for the treatment of genital warts has been assessed positively by the national regulatory authorities of Germany, Austria, and Spain. This binding decision guarantees that national Marketing Authorisations in these countries will be formally granted by the authorities within the next few months. The Marketing Authorisation of Veregen® in Germany, the Reference Member State in this Decentralized Procedure, shall provide the basis for additional Marketing Authorisations in other European countries via the Mutual Recognition Procedure.
MediGene is planning commercialization of Veregen® in Germany and other European countries via distribution partners. In the USA, Veregen® is already marketed by MediGene's licensee Nycomed US, Inc. MediGene has recently announced the conclusion of an agreement with the Spanish company Juste S.A.Q.F. for the distribution of Veregen® in Spain and Portugal.
Dr. Axel Mescheder, Chief Scientific Officer & Chief Development Officer of MediGene AG commented: "We are very pleased with this decision by the regulatory authorities. Veregen® is the first proprietary development compound of MediGene AG, and therefore this positive assessment of the first Marketing Authorisation Applications in Europe is an important milestone for our company. Following approval and launch of Veregen® in the USA, we are keen to make the product accessible to patients in Europe as soon as possible."
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 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 extract from green tea leaves 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 via MediGene's licensee Nycomed US (PharmaDerm) under this name. In Europe, Marketing Authorisation Applications under the Decentralised Procedure have been submitted in Germany, Austria, and Spain and has been 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.
Contact MediGene AG
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