BioMarin partner submits Naglazyme BLA in Japan

California, USA-based BioMarin Pharmaceutical says that AnGes MG, its marketing and distribution partner in Japan, has submitted a Biologics License Application for Naglazyme (galsulfase) to the Japanese Ministry of Health, Labor and Welfare.

Stephen Aselage, senior vice president of global commercial development at BioMarin, said that "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 [also know as Maroteaux-Lamy syndrome] patients in the USA, 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 US Food and Drug Administration in May 2005 and by the European Commission 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 USA and 10 years of market exclusivity in the European Union. In addition, Naglazyme obtained orphan designation in June 2007 from the MHLW in Japan.