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Genzyme Receives FDA Response Letter on Synvisc-One(TM)
Date:11/13/2007

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
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SOURCE Genzyme Corporation
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