CAMBRIDGE, Mass., Nov. 13 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 regardingthe marketing application for Synvisc-One(TM) in the United States. Thecompany now expects that approval of the next-generation Synvisc(R) (hylan G-F20) 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 provideup to six months of pain relief from osteoarthritis (OA) of the knee. Genzymebelieves that Synvisc-One will simplify osteoarthritis pain management andprovide added patient convenience, while reducing the overall cost of therapyand offering a treatment option that will expand the benefits ofviscosupplementation to a broader number of patients.
Genzyme has filed for approval of Synvisc-One in Europe and, if granted aCE mark there, will pursue marketing approvals in wider geographies in Asiaand Latin America.
One of the world's leading biotechnology companies, Genzyme is dedicatedto making a major positive impact on the lives of people with seriousdiseases. Since 1981, the company has grown from a small start-up to adiversified enterprise with more than 9,500 employees in locations spanningthe globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen toreceive the National Medal of Technology, the highest honor awarded by thePresident 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 90countries, Genzyme is a leader in the effort to develop and apply the mostadvanced technologies in the life sciences. The company's products andservices are focused on rare inherited disorders, kidney disease,orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitmentto innovation continues today with a substantial development program focusedon these fields, as well as immune disease, infectious disease, and otherareas of unmet medical need.
This press release contains forward-looking statements, includingGenzyme's expectation for receipt of US marketing approval of Synvisc-One andthe revised timing thereof, its belief that a single-injection regimen ofSynvisc will simplify pain management, provide additional patient convenience,reduce costs and expand the viscosupplementation market, and Genzyme's plansto pursue marketing approvals in additional jurisdictions. These statementsare subject to risks and uncertainties that could cause actual results todiffer materially from those projected. These risks and uncertainties include,among others, Genzyme's ability to adequately respond to the questions raisedby the FDA and to do so in a timely fashion, the extent to which the FDAdetermines that Synvisc-One can appropriately be approved for marketing in theUS, the extent to which the government and private insurers recognize thebenefits of Synvisc-One and maintain or otherwise implement reimbursementpolicies that reflect these benefits, and the risks and uncertaintiesdescribed in reports filed by Genzyme with the U.S. Securities and ExchangeCommission, including without limitation the factors discussed under thecaption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for thequarter ended September 30, 2007. We caution investors not to place unduereliance on the forward-looking statements contained in this press release.These statements speak only as of the date of this press release, and weundertake no obligation to update or revise the statements.
Genzyme(R) and Synvisc(R) are registered trademarks and Synvisc-One(TM) isa trademark of Genzyme Corporation. All rights reserved.
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