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United States Patent Office Allows Claims Covering the Approved Administration of Kuvan with Food
Date:9/30/2009

NOVATO, Calif., Sept. 30 /PRNewswire-FirstCall/ --BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the United States Patent and Trademark Office has allowed claims covering the approved administration of Kuvan® (sapropterin dihydrochloride) with food, based on the discovery that food increases the bioavailability of Kuvan. The company expects that the patent, which expires in 2024, will officially issue later this year.

"This food effect patent, along with the patents issued for once daily dosing and stable tablet formulation, continues to strengthen our proprietary position on Kuvan and provides protection that extends approximately ten years beyond orphan drug exclusivity," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We believe these patents will create significant barriers to therapeutically equivalent generic competition prior to their expiration."

About Kuvan

Kuvan® (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 received seven years of orphan exclusivity in the United States and ten years of market exclusivity in the E.U.

About PKU

PKU, a genetic disorder affecting approximately 50,000 diagnose
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SOURCE BioMarin Pharmaceutical Inc.
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