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BioMarin Announces FDA Approval of Expanded Biologics Manufacturing Facility
Date:11/28/2011

NOVATO, Calif., Nov. 28, 2011 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the manufacturing facility expansion in Novato, CA.  The facility will support up to $1.0 billion in revenue for BioMarin's growing enzyme replacement therapy portfolio, which is comprised of complex glycoprotein products produced by mammalian cells.  

"We are pleased with this first cycle approval of our manufacturing facility expansion which reflects our effective interactions with regulatory authorities and the high caliber of our technical operations team," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin.  "BioMarin has a strong track record in manufacturing enzyme replacement therapies.  The approval of this facility supports the manufacturing requirements for anticipated peak sales of our commercial products and also supports several of our clinical and pre-clinical programs.  BioMarin's Novato manufacturing facilities are also producing clinical trial material for our pipeline protein products including, GALNS for MPS IV, PEG-PAL for PKU, our CNP analog for Achondroplasia and a new biologic to be disclosed at our upcoming R&D Day."

Mr. Bienaime continued, "The facility expansion will also be the initial site of commercial production for GALNS for MPS IVA, if pivotal Phase 3 results are positive in the second half of 2012. The next phase in our manufacturing capabilities expansion will occur in our recently purchased facility in Ireland.  Commercial production for some of our products in Ireland, including GALNS, will provide additional manufacturing diversity and assure adequate capacity for commercial demand of our current and future products."

The multi-product manufacturing plant in Novato was first licensed for pro
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SOURCE BioMarin Pharmaceutical Inc.
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