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news.BioMarin Pharmaceutical has reported that AnGes MG, BioMarin's marketing and distribution partner in Japan, has submitted a biologics license application for Naglazyme to the Japanese Ministry of Health, Labour and Welfare.
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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 already approved by the FDA and European Commission (EC) for MPS VI MPS VI (also known as Maroteaux-Lamy syndrome).
Stephen Aselage, senior vice president of global commercial development at BioMarin, said: “We are pleased to be working with AnGes to bring the first drug treatment option to MPS VI patients in Japan. 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 US, Europe, and now to other parts of the world.”