AnGes MG, Inc. Submits BLA for Naglazyme in Japan.Tokyo, Japan, Aug 15, 2007 - (JCN JCN Japan Corporate News JCN Journal of Cognitive Neuroscience JCN Journal of Cardiovascular Nursing JCN Journal of Christian Nursing JCN Job Control Number JCN Journal of Child Neurology JCN joint communications network (US DoD) ) - 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 BioMarin Pharmaceutical (NASDAQ: BMRN) is a biotechnology firm based in Novato, California. It has offices and facilities in both the US and Europe. BioMarin's core business and research is in enzyme replacement therapies. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and EC have both designated Naglazyme as an orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the , conferring seven years of market exclusivity in the United States and 10 years of market exclusivity in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . In addition, Naglazyme obtained orphan designation in June 2007 from the Ministry of Health, Labour and Welfare in Japan. JCN Newswire. All rights reserved. A division of Japan Corporate News Network K.K. |
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