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Medigene and Azanta enter Agreement for Commercialization of Veregen® in the Nordic Countries

Market launch in Denmark, Sweden, Finland and Norway scheduled for early 2013

Martinsried/Munich, June 14, 2012. Medigene AG (Frankfurt, Prime Standard; XETRA: MDG) and the Danish pharmaceutical company, Azanta A/S, have entered an exclusive agreement for the supply and marketing of Veregen® for the treatment of genital and perianal warts in Denmark, Sweden, Norway, Finland, and Iceland. Medigene will benefit from a one-time upfront payment, the supply of the finished product as well as double-digit royalties on sales of Veregen® in these countries.

Azanta is planning to launch Veregen® in Denmark, Sweden, Finland, and Norway in early 2013. Marketing authorization applications for these and several other European countries were positively assessed by the respective regulatory authorities in March 2012. Market approvals for Sweden and Norway have already been granted, and Medigene anticipates that the other national marketing authorizations will be formally granted within the next few months. The marketing authorization applications for Iceland and several other countries are in preparation.

Dr. Frank Mathias, Chief Executive Officer of Medigene AG, commented: "We are delighted that Azanta, a fast-growing, specialty pharma company, will commercialize Veregen® in the Nordic countries. With their local expertise, we should be able to quickly penetrate the Scandinavian pharmaceutical market with our innovative product, and continue to broaden the distribution of Veregen® throughout Europe".

Dr. Claus Møller, Chief Executive Officer of Azanta A/S, commented: "Veregen® supplements Azanta's existing women's and men's healthcare portfolio, and the product is optimally suited for our company's specialty pharma marketing and growth strategy. Veregen® will play a key role in our company, and will contribute to a further enhancement of our positioning in the Nordic region".

Veregen® is already being marketed successfully in the USA (by Fougera), Germany and Austria (by Abbott), and Spain (by Bial). Marketing authorizations in additional countries are granted or expected within the next few months. Medigene has entered into several marketing partnerships for Veregen across Europe, Asia, and America and is planning to continue this global licensing strategy.

About Veregen®: Veregen® (previously Polyphenon E® ointment), a topical treatment for external genital or perianal warts, contains a concentrate of catechins with a complex defined composition extracted from green tea leaves. Medigene acquired the 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 regulatory approval process. Sinecatechins 15% ointment (Veregen®) is recommended as an 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.

Azanta A/S is a privately owned specialty pharma company primarily operating within oncology, women's and men's health and addiction medicine. The vision of Azanta A/S is to become an international market leader within specialty pharma products and innovative pharmaceutical products. Azanta A/S currently markets or makes available nine specialty pharma products, including Nimoral, a hypoxic radio sensitizer for the treatment of head and neck cancer patients undergoing primary radiotherapy. In addition, Azanta A/S has a portfolio of low risk development projects for commercialization within a shorter time period.

For further information, please visit www.azanta.com.

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.

For more information, please visit www.medigene.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® 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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Contact Medigene
Julia Hofmann & Kerstin Langlotz
Tel.: +49 - 89 - 20 00 33 - 33 01
Fax: +49 - 89 - 20 00 33 - 29 20
Email: investor@medigene.com

Contact Azanta
Claus Møller
Tel:  + 45 - 70 25 95 45
Fax: + 45 - 70 25 95 46
Email:   info@azanta.com

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