Medigene's Drug Veregen® receives market approval in Serbia


Market launch planned for second half of 2012

Martinsried/Munich, May 31, 2012. Medigene AG (MDG, Frankfurt, Prime Standard) (MDG, Frankfurt, Prime Standard) announced today that Veregen® for the treatment of genital warts has obtained market approval in Serbia. Market launch of Veregen® by Medigene's partner Pharmanova in Serbia is scheduled to take place during the second half of 2012.

Veregen® is currently available on the US, German, and Austrian markets. Market launch in Spain is in preparation. In Switzerland, the reimbursable price is currently negotiated. In addition, marketing authorization applications for an additional 17 European countries were assessed positively by the regulatory authorities in March 2012. Medigene expects that the national marketing authorizations will be formally granted by the respective regulatory authorities within the next few months.

Medigene has entered into several marketing partnerships for Veregen®, including Fougera for the United States; Abbott for Germany, Austria, and Switzerland; Laboratoires Expanscience for France; and a number of other partners across Europe, America, and Asia. Medigene is planning to continue this global licensing strategy.

Veregen®: Veregen® (previously Polyphenon E® ointment), a topical treatment for external genital warts, contains 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 Epitome Pharmaceuticals, Inc. in 1999, and was solely responsible for the drug's successful preclinical and clinical development, as well as the approval process. Sinecatechins 15% ointment (Veregen®) is recommended as a possible option for treating genital warts in the US Department of Health and Human Services Center for Disease Control and Prevention's Sexually Transmitted Diseases Treatment Guidelines 2010.


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® are registered trademarks of Medigene AG. Polyphenon E® is a 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: MDG, prime standard) biotechnology company headquartered in Martinsried/Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to have revenues from marketed products, which are distributed by partner companies. It has two drug candidates in clinical trials and is developing an innovative vaccine technology.

Julia Hofmann & Kerstin Langlotz
Tel.: +49 - 89 - 20 00 33 - 33 01
Fax: +49 - 89 - 20 00 33 - 29 20

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