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news.BioMarin Pharmaceutical has reported that AnGes MG, its marketing and distribution partner in Japan, has submitted a biologics license application for Naglazyme, a treatment for Maroteaux-Lamy syndrome, 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 approved by the FDA in May 2005 and by the European Commission (EC) in January 2006.
As the first drug approved for Maroteaux-Lamy syndrome (MPS VI), the FDA and the EC have both designated Naglazyme as an orphan drug, conferring seven years of market exclusivity in the US and 10 years of market exclusivity in the EU. In addition, Naglazyme obtained orphan designation in June 2007 from Japan’s Ministry of Health, Labour and Welfare.
“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,” said Stephen Aselage, senior vice president of global commercial development at BioMarin.
MPS VI 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, 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.