Decision on marketing authorizations expected in the first half of 2015
Martinsried/Munich, September 30, 2014. Medigene AG (MDG1, Frankfurt, Prime Standard) announces that Marketing Authorization Applications have been filed in eight additional European countries for Veregen® Ointment using the mutual recognition procedure. The decision for marketing authorization in the UK, Ireland, Italy, Portugal, Croatia, Latvia, Lithuania and Estonia is expected in the first half of 2015. Assuming a positive decision, the individual countries will grant marketing authorization for Veregen® in the course of the subsequent national phase of the approval procedure followed by legally required pricing and reimbursement procedures in single countries.
Up to now, Veregen® is available in the USA and Canada, in 15 European countries (Germany, Austria, Switzerland, Spain, Serbia, the Netherlands, Belgium, Norway, Sweden, Denmark, Finland, Czech Republic, Slovakia, Hungary, and Poland), and in Taiwan. The drug has obtained market approval in a number of additional countries. Several marketing partnership agreements have been concluded in Europe, Asia, and the Americas.
About Veregen®: Veregen® is indicated for the treatment of external genital and perianal warts (Condylomata acuminata). Veregen® contains a proprietary mixture of catechins and other green tea components extracted from green tea leaves. Sinecatechins 10 % & 15-% Ointment (Veregen®) have been included in the European Guideline for the Management of Anogenital Warts in 2012. In addition, in its current Sexually Transmitted Diseases Treatment Guidelines, the US Centers for Disease Control and Prevention includes Sinecatechins 15% Ointment (Veregen®) as a possible option for treating genital warts.
Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. Medigene concentrates on the development of personalized T cell immunotherapies with a focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partner companies. Medigene has advanced drug candidates which are licensed to partners and additional candidates in clinical development. The company is developing highly innovative treatment platforms concentrating on cancer and autoimmune diseases. 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.
Julia Hofmann, Anja Clausnitzer
Tel.: +49 - 89 - 20 00 33 - 33 01
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