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FDA Warning Letter to Genzyme Related to the Allston Manufacturing Facility
Has No Foreseeable Impact on Aldurazyme Sales
Mar 3, 2009
PRNewswire-FirstCall
NOVATO, Calif.

BioMarin Pharmaceutical Inc. 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, and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase 1 clinical development for the treatment of PKU. 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

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the fill finish production of Aldurazyme and the expectations of revenue and sales related to Aldurazyme. 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: future possible complications with the manufacture of or supply chain for Aldurazyme; Genzyme Corporation's success in continuing the commercialization of Aldurazyme; 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, and the factors contained in BioMarin's reports on Form 10-Q. 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(R), Naglazyme(R) and Kuvan(R) are registered trademarks of BioMarin Pharmaceutical Inc.

  Aldurazyme(R) 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

First Call Analyst:
FCMN Contact: eshen@bmrn.com

SOURCE: BioMarin Pharmaceutical Inc.

CONTACT: Investors, Eugenia Shen, +1-415-506-6570, or Media, Susan Berg,
+1-415-506-6594, both of BioMarin Pharmaceutical Inc.


BioMarin

Diseases

Lysosomal Storage Disorders (MPS I, MPS IVA, MPS VI, CLN2 disease) PKU

Products

Palynziq®
Brineura®
Vimizim®
Kuvan®
Naglazyme®
Aldurazyme®

Patient/Physician Support Contact Information

BioMarin RareConnections
Tel: 866.906.6100
Fax: 888.863.3361
E-mail: support@biomarin-rareconnections.com

Global Medical Information

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