Orphan drug designation ensures market exclusivity for a period of seven years following market approval
Martinsried/Munich, May 20, 2009. MediGene AG (Frankfurt: MDG, Prime Standard, TecDAX) has obtained orphan drug designation from the US regulatory authority FDA (US Food and Drug Administration) for paclitaxel, the active ingredient in MediGene's drug candidate EndoTAG(TM)-1 for the indication pancreatic cancer. Orphan drug designation for EndoTAG(TM)-1 in this indication was already granted in the European Union in 2006.
Orphan drug designation in the USA permits granting of a seven-year market exclusivity following market approval. Further benefits are waiving of application fees for New drug Application, and the opportunity for a scientific exchange with the FDA about further developments in the orphan indication. In addition, a tax reduction for the clinical development expenses of the drug candidate incurred in the USA may be utilized. The orphan drug program is meant to encourage the development of therapies for rare and severe diseases.
Dr. Frank Mathias, Chief Executive Officer of MediGene AG, comments: "The orphan drug designation in the USA once more emphasizes the significance of EndoTAG(TM)-1 for the treatment of pancreatic carcinoma, which is very difficult to treat. It facilitates the future scientific exchange between MediGene and the regulatory authority. In addition, it provides financial incentives for the further development of EndoTAG(TM)-1 for the treatment of pancreatic carcinoma. The market exclusivity granted upon market approval enhances patent protection by adding independent protection against copying, thus improving our product's competitive position."
About EndoTAG(TM)-1: The drug candidate EndoTAG(TM)-1 selectively attacks blood vessels needed for the growth of tumors. It is a novel combination of positively charged liposomes - minute globules of lipid molecules - and the embedded active substance paclitaxel. EndoTAG(TM)-1 is targeted to the negatively charged cells that are specifically lining newly formed tumor blood vessels. Thus only tumor blood vessels are attacked, without harm to those in healthy tissue. At the same time EndoTAG(TM)-1 inhibits the development of new blood vessels, thereby suppressing further tumor growth.
In October 2008 MediGene reported positive results obtained in a clinical phase II trial of the drug candidate EndoTAG(TM)-1 for the treatment of pancreatic carcinoma. Since 2007, a further phase II trial of EndoTAG(TM)-1 for the treatment of triple receptor-negative breast cancer has been in progress. The results of this trial are expected for the first half of 2010.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGene(TM) and EndoTAG(TM) are trademarks of MediGene AG. This trademark may be held or licensed for specific countries.
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MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard, 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 and has several drug candidates in clinical development, two of which provide significant sales potential. 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
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Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 85 65 - 3324
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