Source: PRNewswire
Wednesday, June 17, 2009
NOVATO, Calif., June 16 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical
Inc. (Nasdaq: BMRN) announced today that the temporary interruption of bulk
production at Genzyme's Allston Landing manufacturing facility is not expected
to have any impact on Aldurazyme supply or revenue to BioMarin or Genzyme.
The last Aldurazyme fill at the Allston Landing facility was in September
2008. BioMarin has a total of approximately ten months of vialed inventory on
hand, utilizes a second fill finish supplier and a third is expected to be
qualified later this year. BioMarin manufactures Aldurazyme bulk material at
its Novato facility and has adequate inventory in bulk and vialed form to meet
expected ongoing Aldurazyme demand on a worldwide basis.
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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 PEG-PAL (PEGylated recombinant phenylalanine
ammonia lyase), which is in 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.
Forward-Looking Statement
This press release contains forward-looking statements about the business
prospects of BioMarin Pharmaceutical Inc., including, without limitation,
statements about: the development of its product candidate PEG-PAL, the
timing, design, conduct and expectations related to the PEG-PAL clinical
trials, and expectations regarding filings with regulatory agencies. 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 results of current and
planned clinical trials related to PEG-PAL; the content and timing of
decisions by the U.S. Food and Drug Administration and other regulatory
agencies, particularly with respect to PEG-PAL, 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(R), Naglazyme(R) and Kuvan(R) are a registered trademarks of
BioMarin Pharmaceutical Inc.
Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.