Approval in U.S. to be Delayed
CAMBRIDGE, Mass., Nov. 13 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that it has received a letter from the U.S.
Food and Drug Administration requesting additional analyses and data
regarding the marketing application for Synvisc-One(TM) in the United
States. The company now expects that approval of the next-generation
Synvisc(R) (hylan G-F 20) to be delayed in the U.S. until at least the
second half of 2008.
Synvisc-One is a single treatment of Synvisc that is intended to
provide up to six months of pain relief from osteoarthritis (OA) of the
knee. Genzyme believes that Synvisc-One will simplify osteoarthritis pain
management and provide added patient convenience, while reducing the
overall cost of therapy and offering a treatment option that will expand
the benefits of viscosupplementation to a broader number of patients.
Genzyme has filed for approval of Synvisc-One in Europe and, if granted
a CE mark there, will pursue marketing approvals in wider geographies in
Asia and Latin America.
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 more than 9,500 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
In 2006 and 2007, Genzyme was selected by FORTUNE as one of the "100 Best
Companies to Work for" in the United States.
With many established products and services helping patients in nearly
90 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 diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
This press release contains forward-looking statements, including
Genzyme's expectation for receipt of US marketing approval of Synvisc-One
and the revised timing thereof, its belief that a single-injection regimen
of Synvisc will simplify pain management, provide additional patient
convenience, reduce costs and expand the viscosupplementation market, and
Genzyme's plans to pursue marketing approvals in additional jurisdictions.
These statements are subject to risks and uncertainties that could cause
actual results to differ materially from those projected. These risks and
uncertainties include, among others, Genzyme's ability to adequately
respond to the questions raised by the FDA and to do so in a timely
fashion, the extent to which the FDA determines that Synvisc-One can
appropriately be approved for marketing in the US, the extent to which the
government and private insurers recognize the benefits of Synvisc-One and
maintain or otherwise implement reimbursement policies that reflect these
benefits, and the risks and uncertainties described in reports filed by
Genzyme with the U.S. Securities and Exchange Commission, including without
limitation the factors discussed under the caption "Risk Factors" in
Genzyme's Quarterly Report on Form 10-Q for the quarter ended September 30,
2007. 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 the statements.
Genzyme(R) and Synvisc(R) are registered trademarks and Synvisc-One(TM)
is a trademark of Genzyme Corporation. All rights reserved.
Genzyme's press releases and other company information are available at
http://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.
Media Contact: Investor Contact:
Maria Cantor Patrick Flanigan
(617) 768-6690 (617) 768-6563
SOURCE Genzyme Corporation
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Related links:
http://www.genzyme.com
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media, Maria Cantor, +1-617-768-6690, or
Investors, Patrick Flanigan, +1-617-768-6563, both of Genzyme
Corporation
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