Martinsried/Munich, February 22, 2010. The biotech company MediGene AG (Frankfurt, Prime Standard, TecDAX) has signed a license and supply agreement with Teva Pharmaceutical Industries Ltd. for the supply and commercialization of Veregen(TM) in Israel. Teva will also be responsible for registering the product in Israel, and upon successful completion of the regulatory procedures, MediGene is entitled to a milestone payment. In addition, MediGene will receive royalties on future sales of the product. Veregen(TM), for the treatment of genital warts, is MediGene’s first internally developed drug. Veregen(TM) is already available on the US market and has obtained marketing authorization in Germany.
Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: “Following our European commercialization agreements in Germany, Spain, Portugal, Austria, and Switzerland, we have now concluded our first partnership for the commercialization of Veregen(TM) outside Europe and the US. We are particularly proud to have secured Teva, one of the world’s top 20 pharmaceutical companies, for the distribution of Veregen(TM).”
Veregen(TM): Veregen(TM) (previously Polyphenon E(TM) Ointment) for the treatment of genital warts contains a concentrate of catechins with a defined composition, extracted from green tea leaves. MediGene acquired the basic rights to the active substance in Veregen(TM) 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 successful accomplishment of approval procedures for the USA and a number of European countries. The patent protection was also further upgraded by a number of proprietary inventions. In the USA the drug has been available since February 2009 and is distributed by MediGene’s marketing partner Nycomed US, Inc.
German marketing authorization for Veregen(TM) was granted in September 2009. Formal issue of marketing authorizations in Austria and Spain is expected during the next few months, since the clinical data relevant for approval were assessed positively by the regulatory authorities in these countries. Market launch in Germany is scheduled for March 2010.
In 2009 MediGene concluded a license and supply agreement with Solvay Arzneimittel GmbH for Germany, Austria, and Spain. The Spanish pharmaceutical company Juste S.A.Q.F. will distribute Veregen(TM) in Spain and Portugal. MediGene is planning to apply for marketing authorization in further European countries, and intends to conclude additional marketing agreements for countries in and outside Europe.
Information on Teva Pharmaceutical Industries Ltd. are available on www.tevapharm.com.
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.