MediGene says EU postpones approval of skin disease treatment Oracea |
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Tue, 31 Jul 2007 07:50
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MARTINSRIED, Germany - MediGene AG said an EU committee postponed a decision on whether to grant European marketing authorization for skin disease treatment Oracea, for which the company acquired pan-European marketing rights from CollaGenex Pharmaceuticals Inc last year.The Coordination Group for Mutual Recognition and Decentralised Procedures did not reach an unanimous decision and has therefore referred the procedure to the Committee for Medicinal Products for Human Use (CHMP), the company said in a statement last night.The CHMP's decision-making process usually takes about six months, it said.'MediGene does not expect this development to have any impact on the forecast for the company's overall result for the financial year 2007,' it said.Oracea's annual peak sales potential in Europe is about 20 mln eurIn the US, Oracea is already approved and has been successful on the market since 2006, MediGene said.Oracea, developed by US-based CollaGenex, is used to treat rosacea with inflammatory lesions, an inflammation of the facial skin, especially in the center part of the face, that usually affects patients aged 40-50. In Europe, about 15 million people are affected by rosacea.maria.sheahan@thomson.commas/lamCOPYRIGHTCopyright AFX News Limited 2007. All rights reserved.The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
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