Exhibit 99.1
CONTACTS:
For Genzyme For BioMarin
Sally Curley (investors) Joshua Grass (investors)
(617) 591-7140 (415) 884-6777
Dan Quinn (media) Fredda Malkoff (media)
(617) 591-5849 Feinstein Kean Healthcare
(617) 577-8110
For Immediate Release
October 28, 2002
BioMarin and Genzyme Announce FDA Panel Meeting for Aldurazyme
Novato, Calif. and Cambridge, Mass. - BioMarin Pharmaceutical Inc. (Nasdaq
and Swiss SWX New Market: BMRN) and Genzyme General (Nasdaq: GENZ) today
announced that the U.S. Food and Drug Administration (FDA) has advised the
companies that their biologics license application for Aldurazyme(TM)
(laronidase) will be reviewed by the FDA's Endocrinologic and Metabolic Drugs
Advisory Committee on January 15, 2003. Genzyme also announced today that the
same panel will review its application to market Fabrazyme(TM) (agalsidase beta)
for the treatment of Fabry disease on January 13.
Aldurazyme is an investigational enzyme replacement therapy for patients
with mucopolysaccharidosis I (MPS I). A Marketing Authorization Application
(MAA) for Aldurazyme is under review at the European Agency for the Evaluation
of Medicinal Products (EMEA); the companies expect a response from EMEA in the
first half of 2003.
About MPS I
MPS I is a progressive, debilitating and fatal genetic disease caused by a
deficiency of the enzyme alpha-L-iduronidase. This deficiency leads to the
accumulation of complex carbohydrates in the lysosomes of cells, leading to the
progressive dysfunction of cellular, tissue and organ systems. Resulting
manifestations, which span a spectrum of severity, can include impaired cardiac
and pulmonary function, delayed physical development, skeletal and joint
deformities, reduced endurance, and in some cases, delayed mental function. A
majority of patients die before adulthood from complications of the disease.
BioMarin and Genzyme formed a joint venture in 1998 to develop and
commercialize Aldurazyme worldwide. Under the terms of the joint venture, if
approved for commercial sale, BioMarin will manufacture Aldurazyme and Genzyme
will have responsibility for the commercialization of the product. The companies
have obtained Orphan Drug designation and Fast Track status for Aldurazyme for
the treatment of MPS I from the FDA and orphan medicinal product designation
from the EMEA.
Genzyme General develops and markets therapeutic products and diagnostic
products and services. Genzyme General has five therapeutic products on the
market and a strong pipeline of therapeutic products in development focused on
the treatment of genetic diseases and other chronic debilitating disorders with
well-defined patient populations. Genzyme General is a division of Genzyme Corp.
BioMarin Pharmaceutical specializes in the development and
commercialization of therapeutic enzyme products to treat serious,
life-threatening diseases and conditions.
Genzyme is a registered trademark of Genzyme Corporation. Aldurazyme(TM) is a
trademark of BioMarin/Genzyme LLC. All rights reserved.
# # #
This press release contains forward-looking statements, including without
limitation statements about: decisions by the FDA and the EMEA and the expected
timing thereof; the potential approval of Aldurazyme for commercial sale; and
commercialization plans for Aldurazyme. These statements are subject to risks
and uncertainties that could cause actual results to differ materially from
those projected in these forward-looking statements. These risks and
uncertainties include, among others: the content and timing of decisions made by
the FDA and the EMEA regarding regulatory submissions for Aldurazyme; the
ability to manufacture sufficient quantities of product for commercialization
activities and to do so in a timely manner; and the continued funding of the
joint venture between Genzyme and BioMarin; and the risks and uncertainties
described in reports filed by Genzyme and BioMarin with the Securities and
Exchange Commission under the Securities Exchange Act of 1934, as amended,
including without limitation the factors contained under the caption "Factors
Affecting Future Operating Results" in Exhibit 99.2 to Genzyme Corporation's
2001 Annual Report on Form 10-K. Genzyme General Division common stock is a
series of common stock of Genzyme Corporation. Therefore, holders of Genzyme
General Division common stock are subject to all of the risks and uncertainties
described in the those reports. Genzyme and BioMarin caution investors not to
place undue reliance on the forward-looking statements contained in this press
release. These statements speak only as of the date of this press release, and
Genzyme and BioMarin undertake no obligation to update or revise the statements.
Genzyme's press releases and other company information are available at
www.genzyme.com and by calling Genzyme's investor information line at
1-800-905-4369 within the United States or 1-703-797-1866 outside the United
States.
BioMarin's press releases and other company information are available online at
http://www.biomarinpharm.com. Information on BioMarin's website is not
incorporated by reference into this press release.