Particles Detected in Vials from Genzyme's Plant Not Expected to Impact Aldurazyme or Naglazyme
NOVATO, Calif., Nov. 13 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.
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® (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; and Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is in Phase 2 clinical development for the treatment of PKU and GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase 1/2 clinical development for the treatment of MPS IVA. For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the manufacture and supply of Aldurazyme and Naglazyme and the safety profile of these products. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the actual experience in manufacturing these products, future unexpected adverse event reports, , and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2008 Annual Report on Form 10-K. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin®, Naglazyme® and Kuvan® are registered trademarks of BioMarin Pharmaceutical Inc.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
Contact: Investors: Media: Eugenia Shen Susan Berg BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc. (415) 506-6570 (415) 506-6594
SOURCE BioMarin Pharmaceutical Inc.
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