News

Medigene receives positive decision on marketing authorisation for Veregen® in 8 additional European countries

Press release

  • Marketing authorisation in two of the biggest European markets (UK and Italy) and six further EU countries secured
  • Additional market launches in Europe in the second half of 2015

Martinsried/Munich, February 20, 2015. Medigene AG (MDG1, Frankfurt, Prime Standard) announces that the Veregen® (sinecatechins) ointment marketing authorisation applications were positively assessed by the regulatory authorities of eight additional European countries within the mutual recognition procedure, including two of the biggest European pharma markets (UK and Italy). This binding decision guarantees that national marketing authorisations will be formally granted by the respective regulatory authorities within the next months in the UK, Ireland, Italy, Portugal, Croatia, Latvia, Lithuania and Estonia. With this decision Medigene largely completed the marketing approval processes of Veregen® in Europe. The successive launch of Veregen® ointment for the treatment of genital warts in these new territories is anticipated to start in the second half of 2015.

In addition to the US, Veregen® is also available in 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 14 additional European countries and in Israel.

About Veregen®: Veregen® (sinecatechins) is a topical ointment for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. The product contains a concentrate of catechins with a complex defined composition extracted from green tea leaves. Sinecatechins 10% & 15% Ointment (Veregen®) have been included in the 2012 European Guideline for the Management of Anogenital Warts.  In addition, in its 2010 Sexually Transmitted Diseases Treatment Guidelines, the US Centers for Disease Control and Prevention includes sinecatechins 15% Ointment (Veregen®) as an option for treating external 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 focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partners. Medigene has various drug candidates in clinical development and it is developing highly innovative treatment platforms. 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.

Contact
Julia Hofmann, Anja Clausnitzer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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