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BioMarin Re-Acquires Rights to Kuvan in Canada From Merck Serono
Date:12/18/2007

NOVATO, Calif., Dec. 18 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that it has re-acquired the Canadian rights for tetrahydrobiopterin (BH4), including Kuvan(TM) (sapropterin dihydrochloride), from Merck Serono, a division of Merck KGaA, Darmstadt, Germany. Kuvan is an oral small molecule for the treatment of phenylketonuria (PKU) developed in partnership with Merck Serono. Based on published literature, there are approximately 1,200 to 1,500 people under the age of 40 with PKU in Canada.

"Acquiring rights to Kuvan in Canada allows BioMarin to better coordinate commercialization efforts in the North American market," said Stephen Aselage, Senior Vice President, Global Commercial Development of BioMarin. "This agreement with Merck Serono comes at an exciting time for the company and the PKU community after Kuvan was approved in the United States last week."

The terms of the agreement specify a reduction in royalties owed to BioMarin on Merck Serono sales outside the United States and Japan. Based on the structure of the amended agreement, the reduction in royalties cannot exceed an undisclosed cap.

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
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SOURCE BioMarin Pharmaceutical Inc.
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