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Patents Issued Covering Stable Tablet Formulation and Once Daily Dosing Regimen for Kuvan
Date:7/30/2009

NOVATO, Calif., July 30, /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the United States Patent Office has issued patents covering stable tablet formulation and the approved once daily dosing regimen for Kuvan(R) (sapropterin dihydrochloride) for the treatment of phenylketonuria (PKU). The patent for stable tablet formulation expires in 2025, and the patent for the once daily dosing regimen expires in 2024.

"We believe the issuance of these two patents is significant in strengthening our proprietary position on Kuvan," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "These patents provide coverage for Kuvan's formulation and approved dosing regimen that extends approximately ten years beyond orphan drug protection and we believe will prevent therapeutically equivalent competition from entering the 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 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 diagnos
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SOURCE BioMarin Pharmaceutical Inc.
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