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Phenylketonuria
MAA Submitted to EMEA for European Marketing Authorization of Sapropterin for Hyperphenylalaninemia (HPA)
November 22nd, 2007
BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for sapropterin dihydrochloride (Kuvan(TM) in the U.S.) as an oral treatment for patients suffering from significant hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency. Acceptance of the MAA filing by the EMEA triggers a $15 million milestone payment to BioMarin, which is expected in the fourth quarter of 2007. "The MAA filing for sapropterin represents a notable milestone in our joint...
Source: Genetics & Environmental Business Week (2007-11-22)
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