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Biopten (Sapropterin Dihydrochloride) Approved by Japanese Ministry of Health for the Treatment of PKU
Date:7/16/2008

NOVATO, Calif., July 16 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that Asubio Pharma Co., Ltd. (a subsidiary of Daiichi Sankyo), has received marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for a label extension of Biopten(R) (sapropterin dihydrochloride), which contains the same active ingredient as Kuvan(R) in the U.S., for the treatment of patients with phenylketonuria (PKU). BioMarin will receive a milestone payment of $1.5 million for this marketing approval along with double-digit royalties on net sales of Biopten for PKU in Japan under an exclusive license of data and intellectual property contained in the Kuvan new drug application.

"We have a long-standing relationship with Asubio as their early work on BH4 was instrumental to our success and accelerated timeline in the development and approval of Kuvan in the United States," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We are proud to work with Asubio to further expand our geographic reach and help to bring the first drug treatment option to PKU patients in Japan. We are also looking forward to the pending Kuvan approval by the EMEA, which we expect by the end of the year."

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 potential treatment option for approximately 30 percent to 50 percent of the estimated 50,000 identified PKU patients in
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SOURCE BioMarin Pharmaceutical Inc.
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