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BioMarin Announces FDA Approval for Kuvan

le for PKU patients. For more information about the BioMarin Patient and Physician Support Program, please call 877-MY-KUVAN (877.695.8826). For more information about Kuvan, please visit

Conference Call

BioMarin will host a conference call and webcast to discuss the Kuvan approval today, Thursday, December 13, at 5:00 p.m. ET. This event can be accessed on the investor section of the BioMarin website at

Date: December 13, 2007

Time: 5:00 p.m. ET

U.S. / Canada Dial-in Number: 800.510.9661

International Dial-in Number: 617.614.3452

Participant Code: 95299072

Replay Dial-in Number: 888.286.8010

Replay International Dial-in Number: 617.801.6888

Replay Code: 61294597

About Kuvan

Kuvan(TM) (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 potential treatment option for approximately 30 percent to 50 percent of the estimated 50,000 identified PKU patients in the developed world.

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 market exclusivity in the United States. In November 2007, Merck Serono submitted a Marketing Authorization Application (MAA) to the EMEA for sapropterin dihydrochloride as an oral treatm

SOURCE BioMarin Pharmaceutical Inc.
Copyright©2007 PR Newswire.
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