European Commission Grants Marketing Authorization for MediGene’s Drug Oracea
MARTINSRIED/MUNICH, Germany, July 29, 2008 (PRIME NEWSWIRE) — MediGene AG (Frankfurt:MDG) announced that the European Commission has acted on the recommendation by the European regulatory authority EMEA of April 2008, and granted marketing authorization for the drug Oracea(r) for the treatment of rosacea. The regulatory authorities in the individual countries are to implement this decision within 30 days by granting domestic approvals.
The first domestic approvals for Oracea(r) will be granted in Germany, UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg, and the Netherlands. Oracea(r) has been successful on the U.S. market since 2006. MediGene is currently negotiating on this drug with potential buyers and marketing partners. MediGene acquired the pan-European marketing rights to the drug from the U.S. company, CollaGenex, Inc., in 2006. On April 11, 2008, Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, announced that its U.S. holding company, Galderma Laboratories, Inc., completed its acquisition of CollaGenex Pharmaceuticals, Inc. As a result of the transaction, CollaGenex has become a wholly owned subsidiary of Galderma Laboratories.
About Oracea(r): Oracea(r) is the first approved drug for systemic long-term treatment of rosacea with inflammatory lesions. In clinical trials Oracea(r) was characterized by high efficacy and safety. By its innovative and low-dosed administration, the active substance doxycycline (tetracycline) is released in such a way that it has an anti-inflammatory effect without affecting the body’s normal bacteria. Therefore treatment with Oracea(r) led to significantly fewer adverse effects than established tetracycline therapies. Moreover there has been no development of any bacterial resistance during the clinical trials. Oracea(r) therefore offers physicians and patients a new therapeutic option in the treatment of rosacea.
About Rosacea: Rosacea is an inflammatory disease of the facial skin, especially in the center part of the face. The onset of the disease is usually between the age of 30 – 40, and it is a chronic, episodic disease. The cause of rosacea is still unknown, and both genetic predisposition and outside influences appear to be involved in the onset of the disease. About 15 million people in Europe are affected by rosacea.
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. MediGeneO is a trademark of MediGene AG, this trademark is licensed in select locations only. Oracea(r) is a registered trademark of CollaGenex Pharmaceuticals Inc.
MediGene AG is a publicly quoted (Frankfurt:MDG) 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. Another drug candidate has just received official recommendation for marketing authorization by the EMEA. MediGene has several drug candidates in clinical development. Moreover, the company has projects in research and pre-clinical development and possesses innovative platform technologies. MediGene concentrates on researching and developing novel drugs for the treatment of cancer and autoimmune diseases.
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