Market approval in Greece obtained
Martinsried/Munich, 18 December 2013. Medigene AG (MDG1, Frankfurt, Prime Standard) announces that the company's marketing partner Azanta A/S will start the launch of the drug Veregen® for the treatment of genital warts in Norway this week. Market launch in Sweden is scheduled early in 2014. Pursuant to the license agreement, Medigene receives proceeds from the manufacture and supply of the ointment, as well as a double-digit percentage of the Veregen® sales revenue as royalties.
Medigene further announces that Veregen® has obtained market approval in Greece. All 17 European countries participating in the current mutual recognition procedure have granted market approvals for Veregen®. Submission of marketing authorization applications in nine additional European countries within the mutual recognition procedure is planned for 2014.
Veregen® is already available in the USA, Germany, Austria, Switzerland, Spain, Serbia, the Netherlands, and Taiwan. Market approvals for Veregen® have been granted in a number of other countries. Further market launches and approvals of Veregen® are expected in 2014. Several marketing agreements have been concluded in Europe, Asia, and America. Medigene is planning to continue this global licensing strategy to further tap the product's market potential.
About Veregen®: Veregen®, a topical treatment for external genital or perianal warts, contains a concentrate of catechins with a complex defined composition extracted from green tea leaves. In its current treatment guidelines for sexually transmitted diseases, the US Center for Disease Control and Prevention recommends Sinecatechins 15% ointment (Veregen®) as a possible option for treating genital warts. In addition, Sinecatechins 10% & 15% ointment (Veregen®) has been included in the current European guideline on the treatment of genital warts, the 2012 European Guideline for the Management of Anogenital Warts.
About Azanta: 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 for specialty pharma products and innovative pharmaceutical products. Azanta A/S currently markets nine specialty pharma products, including Nimoral, a hypoxic radiosensitizer 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 in the near term. For further information, please visit www.azanta.com.
Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near 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 a marketed product, Veregen®, which is distributed by partner companies. It has two drug candidates in clinical trials, EndoTAG®-1 and RhuDex®; and is developing an innovative vaccine technology. Further information at 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®, Veregen®, EndoTAG® and RhuDex® are registered trademarks of Medigene AG. These trademarks may be owned or licensed in select locations only.
Julia Hofmann, Claudia Burmester
Tel.: +49 - 89 - 20 00 33 - 33 01
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