Naglazyme Approved by Japanese Ministry of Health

BioMarin Pharmaceutical Inc. announced today that AnGes MG, Inc. (AnGes), BioMarin's marketing and distribution partner in Japan, has received approval for its Marketing Application for Naglazyme(R) (galsulfase) from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with Mucopolysaccharidosis VI ( MPS VI).

"We are proud to work with AnGes in bringing the first drug treatment option to MPS VI patients in Japan," said Stephen Aselage, Senior Vice President of Global Commercial Development at BioMarin. "We are dedicated to providing life-altering therapies to patients around the world and continue to expand our geographic footprint through our patient identification and commercialization efforts."

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. AnGes submitted a marketing application to the MHLW in August 2007. 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 MHLW in Japan.