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BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
Date:8/19/2007

NOVATO, Calif., Aug. 13 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that AnGes MG, Inc. (AnGes), BioMarin's marketing and distribution partner in Japan, has submitted a Biologics License Application (BLA) for Naglazyme(R) (galsulfase) to the Japanese Ministry of Health, Labour and Welfare.

"We are pleased to be working with AnGes to bring the first drug treatment option to MPS VI patients in Japan," said Stephen Aselage, Senior Vice President of Global Commercial Development at BioMarin. "Patient advocacy groups and medical societies in Japan have shown a strong interest in Naglazyme, and we are honored to bring this life-altering therapy to MPS VI patients in the U.S., Europe, and now to other parts of the world."

BioMarin established a marketing and distribution agreement with AnGes in December 2006, through which AnGes obtained exclusive rights to market Naglazyme in the Japanese market. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) in May 2005 and by the European Commission (EC) in January 2006. As the first drug approved for MPS VI, the FDA and EC have both designated Naglazyme as an orphan drug, conferring seven years of market exclusivity in the United States and 10 years of market exclusivity in the European Union. In addition, Naglazyme obtained orphan designation in June 2007 from the Ministry of Health, Labour and Welfare (MHLW) in Japan.

About MPS VI

MPS VI (also known as Maroteaux-Lamy syndrome) is a debilitating, life-threatening genetic disease caused by a deficiency of the enzyme N-acetylgalactosamine 4-sulfatase. This enzyme deficiency leads to the accumulation of certain complex carbohydrates, glycosaminoglycans (GAGs), in the lysosomes, giving rise to progressive cellular, tissue and organ system dysfunction. The majority of individuals with MPS VI die from disease-related complications between childhood and early adulthood. Additional informat
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SOURCE BioMarin Pharmaceutical Inc.

Copyright©2007 PR Newswire.

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