Genzyme Successfully Meets First Milestones of FDA Consent Decree
November 24 2010 - 8:31AM
Business Wire
Genzyme Corporation (NASDAQ: GENZ) announced today that the
company has ended fill/finish operations within its Allston plant
for products sold in the United States, as required by the FDA
consent decree. All fill/finish activities for Cerezyme®
(imiglucerase for injection), Myozyme® (alglucosidase alfa),
Fabrazyme® (agalsidase beta) and Thyrogen® (thyrotropin alfa for
injection) for the U.S. market now take place at Genzyme’s
Waterford, Ireland plant, and at an external contract manufacturer.
With this move, all previous restrictions on the marketing and
distribution of Thyrogen within the United States have been
lifted.
All remaining fill/finish activities in Allston for products
sold outside of the United States must be ended by August 31, 2011.
Genzyme is working closely with regulatory authorities globally to
achieve this goal.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people
with serious diseases. Since 1981, the company has grown from a
small start-up to a diversified enterprise with approximately
10,000 employees in locations spanning the globe and 2009 revenues
of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in
100 countries, Genzyme is a leader in the effort to develop and
apply the most advanced technologies in the life sciences. The
company's products and services are focused on rare inherited
disorders, kidney disease, orthopaedics, cancer, transplant, and
immune disease. Genzyme's commitment to innovation continues today
with a substantial development program focused on these fields, as
well as cardiovascular disease, neurodegenerative diseases, and
other areas of unmet medical need.
Important Information
Genzyme has filed with the Securities and Exchange Commission a
Solicitation/Recommendation Statement on Schedule 14D-9 relating to
the tender offer by Sanofi-Aventis. Genzyme shareholders are
advised to read the company's Solicitation/Recommendation Statement
on Schedule 14D-9 because it contains important information.
Shareholders may obtain a free copy of the
Solicitation/Recommendation Statement on Schedule 14D-9, as well as
any other documents filed by Genzyme in connection with the tender
offer, free of charge at the SEC's website at http://www.sec.gov.
In addition, investors can obtain free copies of these documents
from Genzyme by directing a request to Genzyme at 500 Kendall
Street, Cambridge, MA 02142, Attention: Shareholder Relations
Department, or by calling 617-252-7500 and asking for the
Shareholder Relations Department.
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
1-678-999-4572 outside the United States.
Genzyme®, Cerezyme®, Myozyme®, Fabrazyme® and Thyrogen® are
registered trademarks of Genzyme Corporation. All rights
reserved.
This press release contains forward-looking statements,
including the statements regarding: our ability to secure necessary
regulatory approvals in advance of the August 31, 2011 deadline to
end fill/finish manufacturing operations at Allston for product to
be distributed outside of the United States. 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 ability to obtain necessary regulatory approvals in the United
States and throughout the world in a timely manner, the ability of
our third-party fill/finish manufacturer to successfully
fill/finish our products, and the risks and uncertainties described
in Genzyme's SEC reports filed under the Securities Exchange Act of
1934, including the factors discussed under the caption "Risk
Factors" in Genzyme's Quarterly Report on Form 10-Q for the period
ended September 30, 2010. We 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 we undertake no obligation to update or revise these
statements.
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