BioMarin Receives Positive Opinion from European Regulatory Authorities for Expanded Biologics Manufacturing Facility BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...

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."

BioMarin 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 approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, amifampridine phosphate (3,4-diaminopyridine phosphate), which is currently in Phase III clinical development for the treatment of LEMS in the U.S., PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, and BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. For additional information, please visit www.BMRN.com . Information on BioMarin's website is not incorporated by reference into this press release.

Forward-Looking Statement

BioMarin®, Naglazyme®, Kuvan® and Firdapse™ are registered trademarks of BioMarin Pharmaceutical Inc.

Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.

SOURCE BioMarin Pharmaceutical Inc.