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Kuvan Receives Positive Opinion From CHMP for European Approval
Date:9/25/2008

Decision on Marketing Authorization Expected by End of 2008

NOVATO, Calif., Sept. 25 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has received a positive opinion for Kuvan(R) (sapropterin dihydrochloride) as an oral treatment for hyperphenylalaninemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The CHMP recommendation will be considered by the European Commission, which will deliver its final decision on the granting of marketing authorization within 67 days.

"The positive opinion from the CHMP is encouraging and bodes well for potential approval, which is on track by the end of the year, triggering a $30 million milestone payment to BioMarin," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We are excited to work with our partner Merck Serono to offer the first therapeutic option to manage PKU in the European market."

About Kuvan

Kuvan(R) (sapropterin dihydrochloride) Tablets is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.

The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe. BioMarin and Merck Serono estimate that Kuvan could be a potent
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SOURCE BioMarin Pharmaceutical Inc.
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