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Kuvan Receives Marketing Approval in the European Union
Date:12/9/2008

NOVATO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has received marketing approval for Kuvan(R) (sapropterin dihydrochloride) for the treatment of hyperphenylalaninemia (HPA) in phenylketonuria (PKU) or BH4 deficient patients from the European Commission. Merck Serono estimates that there are approximately 35,000 patients diagnosed with hyperphenylalaninemia due to PKU or BH4 deficiency in the European Union. BioMarin will receive a milestone payment of $30 million for this marketing approval along with royalties on net sales of Kuvan in the E.U.

"Along with our partner Merck Serono, we are excited to bring the first therapeutic option to manage PKU to the European market and expand the geographic reach of Kuvan," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We are focused on the continued expansion of Kuvan in the U.S. and look forward to working closely with Merck Serono on the successful launch of the product in the European market."

About Kuvan

Kuvan(R) (sapropterin dihydrochloride) Tablets are indicated in the United States 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.

Kuvan has received orphan drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Kuvan has
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SOURCE BioMarin Pharmaceutical Inc.
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