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AnGes MG, Inc. Submits BLA for Naglazyme in Japan.

Tokyo, Japan, Aug 15, 2007 - (JCN) - AnGes MG, Inc. <4563> announced August 13 that it submitted a Biologics License Application for Naglazyme (galsulfase) to the Ministry of Health, Labour and Welfare in Japan.

AnGes established a marketing and distribution agreement with BioMarin Pharmaceutical Inc. in December 2006, through which AnGes obtained exclusive rights to market Naglazyme in the Japanese market.

Naglazyme was approved by the U.S. 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 United States and 10 years of market exclusivity in the European Union.

In addition, Naglazyme obtained orphan designation in June 2007 from the Ministry of Health, Labour and Welfare in Japan.

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Publication:JCNN News Summaries
Date:Aug 15, 2007
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