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MHRA Completes Review of CTA and Issues Notice of Acceptance for BMN 673 for Genetically-Defined Cancers
Date:12/2/2010

NOVATO, Calif., Dec. 2, 2010 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has completed review of the Clinical Trial Application (CTA) and has issued a notice of acceptance for BMN 673 for genetically-defined cancers.  The company expects to initiate a Phase 1/2 trial by the first quarter of 2011.

"BMN 673 has been proven to be highly active in mouse xenograft models of human cancer and appears to have superior potency, selectivity, and bioavailability as compared to other products in development," said Hank Fuchs, Chief Medical Officer of BioMarin.  "We are eager to get this trial underway and to identify specific tumor types that are more susceptible to treatment with BMN 673.  We have built a deep R&D pipeline and remain focused on successfully and expeditiously executing on the programs."

About BioMarinBioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine phosphate), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Other product candidates include GALNS (N-acetylgalactosamine 6-sulfatase)
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SOURCE BioMarin Pharmaceutical Inc.
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