Merck Serono says Phenoptin Phase III diet study results for children positive |
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Published
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Tue, 16 Jan 2007 16:05
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LONDON (AFX) - Merck Serono said results were positive from the Phase III diet study of Phenoptin in 4-12 year old patients.Phenoptin is an investigational oral small molecule, being developed in partnership with BioMarin, for the treatment of patients with phenylketonuria.Merck Serono said the results show that all pre-specified efficacy and safety endpoints of the double-blind, placebo-controlled study were met.Phenoptin treatment caused a significant increase in phenylalanine tolerance as well as a reduction in blood phenylalanine levels, it said.In addition, the data showed that Phenoptin was well tolerated in younger PKU patients who were under dietary control.BioMarin and Merck Serono remain on track to file the New Drug Application in the US and Marketing Authorization Application in Europe for Phenoptin in the second and third quarters of 2007, respectively.Under the terms of the agreement with BioMarin, Merck Serono said it has exclusive rights to market Phenoptin worldwide outside of the US and Japan.BioMarin has exclusive rights to market Phenoptin in the US.newsdesk@afxnews.comcmlCOPYRIGHTCopyright AFX News Limited 2006. 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.AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited
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Serono to drop out of SMI as of Feb 13 