Healthcare Industry News: S.A.
News Release - July 29, 2008
European Commission Grants Marketing Authorization for MediGene's Drug Oracea
MARTINSRIED/MUNICH, Germany, July 29, 2008 (Healthcare Sales & Marketing Network) -- MediGene AG (Frankfurt:MDG.F ) announced that the European Commission haS.A.ted 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.A.e 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.A.d 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.A.quisition 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 subS.A.ce doxycycline (tetracycline) is released in such a way that it haS.A. anti-inflammatory effect without affecting the body's normal bacteria. Therefore treatment with Oracea(r) led to significantly fewer adverse effects than eS.A.lished tetracycline therapies. Moreover there has been no development of any bacterial resiS.A.ce during the clinical trials. Oracea(r) therefore offers physicianS.A.d patientS.A.new therapeutic option in the treatment of rosacea.
About Rosacea: Rosacea iS.A. inflammatory diS.A.e of the facial skin, especially in the center part of the face. The onset of the diS.A.e is uS.A.ly between the age of 30 - 40, and it iS.A.chronic, episodic diS.A.e. The cause of rosacea is still unknown, and both genetic predisposition and outside influenceS.A.pear to be involved in the onset of the diS.A.e. About 15 million people in Europe are affected by rosacea.
This press release contains forward-looking S.A.ements representing the opinion of MediGene as of the date of this release. The actual resultS.A.hieved by MediGene may differ significantly from the S.A.ements made herein. MediGene is not bound to update any of these forward-looking S.A.ements. 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.F ) 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 reS.A.ch and pre-clinical development and possesses innovative platform technologies. MediGene concentrates on reS.A.ching and developing novel drugs for the treatment of cancer and autoimmune diS.A.es.
Source: MediGene
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