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Particles Detected in Vials from Genzyme's Plant Not Expected to Impact Aldurazyme or Naglazyme
Date:11/13/2009

NOVATO, Calif., Nov. 13 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that Genzyme notified the company that, in rare circumstances, it has detected foreign particles in some products filled at the Allston Landing facility. To ensure that patients are not exposed to foreign particles during product administration, Genzyme has issued a "Dear Doctor" letter to all physicians treating patients with enzyme replacement products that it markets, including Aldurazyme. The letter states that foreign particles have been found in some vials filled at Genzyme's Allston Landing facility and reminds physicians, as a preventive measure, to use a 0.2-0.22 micron filter during administration.

For Aldurazyme, this is essentially a reminder as the Aldurazyme approved product label has always recommended the use of a 0.22 micron filter when administering the drug. Accordingly, BioMarin does not expect this letter to have any substantial effect on the usage of Aldurazyme, or on the company's financials. Due to a mutual decision by BioMarin and Genzyme, BioMarin has been transitioning Aldurazyme production to other fill finish facilities. The last fill finish of Aldurazyme at Allston Landing was in September 2008.

BioMarin is committed to taking all efforts to maximize patient safety for all of its products. Similar to the Aldurazyme label, the Naglazyme product label also recommends the use of a 0.22 micron filter prior to administering the drug to patients. Additionally, BioMarin utilizes numerous process controls to minimize the presence of particles in its products, including redundant filtration during the manufacture of drug product.

About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's pr
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SOURCE BioMarin Pharmaceutical Inc.
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