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FDA Warning Letter to Genzyme Related to the Allston Manufacturing Facility
Date:3/3/2009

Has No Foreseeable Impact on Aldurazyme Sales

NOVATO, Calif., March 3 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the FDA warning letter issued to Genzyme addressing deficiencies related to Genzyme's Allston Landing manufacturing facility during an inspection performed in September and October 2008 has no foreseeable impact on the supply of Aldurazyme. The warning letter does not require Genzyme to recall or quarantine product. BioMarin and Genzyme have sufficient quantities of finished product on hand to meet current demand and can fill additional product at a qualified alternate fill finish supplier. BioMarin is also qualifying a third supplier, which it expects to be approved later this year and has no concerns on maintaining sufficient levels of Aldurazyme inventory. BioMarin does not expect that the situation at the Allston manufacturing facility will have any impact on Aldurazyme sales.

About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises three approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of sickle cell disease
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SOURCE BioMarin Pharmaceutical Inc.
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