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November 8, 2007
By: Tim Wright
Editor-in-Chief, Contract Pharma
Merck Serono, a division of Merck KGaA, has submitted an MAA to the EMEA for sapropterin dihydrochloride (Kuvan in the U.S.) as an oral treatment for patients suffering from significant hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency. The compound is being developed in collaboration with BioMarin Pharma. Acceptance of the MAA filing triggered a $15 million milestone payment to BioMarin. Sapropterin has received orphan medicinal product designat...
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