MARTINSRIED, Germany (Thomson Financial) - MediGene AG. said the Committee for Medicinal Products in Human Use (CHMP) has recommended European Union approval of its Oracea drug to treat rosacea, an inflammatory facial skin disease.
CHMP is part of the European Medicines Agency (EMEA), whose recommendations form the basis for the EU Commission's drug approval decisions. It usually takes about three months between a positive opinion by the EMEA and EU Commission marketing approval.
MediGene acquired European marketing rights to Oracea from CollaGenex Pharmaceuticals Inc. in 2006. The treatment was cleared to be sold in the United States in the same year. ludwig.burger@thomsonreuters.com lb/jlw COPYRIGHT Copyright Thomson Financial News Limited 2008. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
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