Martinsried/Munich, April 07, 2009. The U.S. Patent and Trademark Office (USPTO) has granted an extension of patent no. US 5,795,911 for Veregen® (Polyphenon E® Ointment) by 1,300 days, i.e. approx. 3.5 years. This means that the US patent, originally granted until April 2017, will now lapse in October 2020. This basic patent protects the treatment of genital warts with catechins from green tea. It is listed in the U.S. Food and Drug Administration's (FDA) Orange Book, the approved drug list, under VEREGEN®, SINECATECHINS, OINTMENT, TOPICAL 15%.
Veregen® was developed for the treatment of genital warts, a disease caused by human papilloma viruses, and also has the potential to be developed for other skin diseases as well. It has been marketed in the US for the treatment of external genital warts and is distributed by MediGene's marketing partner Nycomed US Inc. In Germany, Spain, and Austria the drug is currently going through the approval process. In the event of a positive decision, applications for further approvals in other European countries based on this decision can be submitted.
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: "Since the beginning of this year, the full-blown US launch of Veregen® by our marketing partner is in progress. An extension of the basic patent is of particular importance for the product's success on the US market. This long-term patent protection now provides us with over ten years market exclusivity for Veregen® in the USA. In addition, we are expecting to obtain the approval for the drug in some European countries, which will open up additional sales potential."
The patent application was filed by the Cancer Institute Chinese Academy of Medical Sciences and the Japanese company Mitsui Norin. MediGene acquired the exclusive license and continued Veregen's preclinical and clinical development until it obtained FDA approval. Nycomed US Inc. acquired the marketing and sales exclusive license for Veregen® in the US. Distribution is handled by Nycomed's PharmaDerm division. MediGene retains the marketing rights for all countries except for the USA.
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 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 registered 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, Prime Standard: MDG, TecDAX) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market, which are being distributed by partner companies. MediGene has several drug candidates in clinical development, including EndoTAG(TM)-1, which could offer substantial sales returns. In addition, the company has numerous projects in research and pre-clinical development and possesses innovative platform technologies. MediGene focuses on the research and development of novel drugs for the treatment of cancer and autoimmune diseases.
Contact MediGene AG
Fax:+49 - 89 - 85 65 - 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 85 65 - 3324
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