Martinsried/Munich, March 8, 2012. MediGene AG (MDG, Frankfurt, Prime Standard) announces that the Veregen® ointment marketing authorization applications were positively assessed by the regulatory authorities of seventeen additional European countries within the mutual recognition procedure. This binding decision guarantees that national marketing authorizations will be formally granted by the respective regulatory authorities within the next months in Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Hungary, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, and Sweden. The successive launch of Veregen® ointment for the treatment of genital warts in these new territories is anticipated to start end of 2012.
Veregen® is currently available in the United States, German, and Austrian markets. In Spain, the drug has already been granted marketing approval and market launch is expected in the first six months of 2012. MediGene has entered into several marketing partnerships for Veregen®, including Fougera (formerly Nycomed) 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 in the US Department of Health and Human Services Center for Disease Control and Prevention's Sexually Transmitted Diseases Treatment Guidelines 2010 as a possible option for treating genital warts.
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 is the first German biotech company to have revenues from marketed products. It has various drug candidates in clinical development and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases.
Contact MediGene AG
Julia Hofmann, Kerstin Langlotz
Tel.: +49 - 89 - 85 65 - 33 01
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