AnGes MG Submits Naglazyme BLA to Japanese Ministry of Health

BioMarin Pharmaceutical announced that AnGes MG, BioMarin’s marketing and distribution partner in Japan, has submitted a biologics license application (BLA) for Naglazyme to the Japanese Ministry of Health, Labor and Welfare for the treatment of MPS VI, a genetic disorder that leads to cellular, tissue and organ dysfunction.

BioMarin said it established a marketing and distribution agreement with AnGes in December 2006, through which AnGes obtained exclusive rights to market Naglazyme (galsulfase) in the Japanese market.

According to BioMarin, Naglazyme was approved by the FDA in May 2005 and by the European Commission in January 2006.