Particles Detected in Vials from Genzyme's Plant Not Expected to Impact Aldurazyme or Naglazyme
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.
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
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.
CONTACT: investors, Eugenia Shen, +1-415-506-6570, or media,
+1-415-506-6594, both of BioMarin Pharmaceutical Inc.
Web Site: http://www.bmrn.com/
Posted: November 2009