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BioMarin Receives Positive Opinion from European Regulatory Authorities for Expanded Biologics Manufacturing Facility
Date:12/19/2011

NOVATO, Calif., Dec. 19, 2011 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for the company's manufacturing facility expansion in Novato, CA.  Final approval by the EMA is expected in the first quarter of 2012, which would allow for products manufactured at the facility to be distributed in the European Union.  The two Novato facilities will support up to $1.0 billion in revenue for BioMarin's growing enzyme replacement therapy portfolio. 

"We are pleased that the CHMP has recommended a positive opinion for the expanded Novato manufacturing facility on the heels of the FDA approval in late November," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin.  "As our commercial products continue to grow and our pipeline advances, this state-of-the-art facility will help support the manufacturing requirements for anticipated peak sales of our commercial products and several of our clinical and pre-clinical 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), which has been
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SOURCE BioMarin Pharmaceutical Inc.
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