FDA Approves Genzyme's Renvela(TM) for Dialysi...(pply themost advanced technologies in th...)

Date:10/22/2007

pply 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 the statements regarding Genzyme's intention to move forward with regulatory filings to gain approval for use of Renvela(TM) in earlier stages of chronic kidney disease, the initial availability of the 800mg tablet formulation of Renvela(TM), Genzyme's expectations with respect to timing of commercial launch of Renvela(TM), its pursuit of regulatory approvals in Europe, South America and other markets, the continued availability of Renagel(R), Genzyme's plans to file a supplemental New Drug Application with the FDA seeking approval of Renvela(TM) for hyperphosphatemic patients with chronic kidney disease who are not on dialysis and Genzyme's expectation that it will seek approval of a powder form of Renvela(TM). 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 inability or delay of getting regulatory approvals for future label extensions of Renvela(TM), the logistical risks associated with manufacturing and formulating the product, delays or unexpected problems with commercial launch of Renvela(TM), the medical community's acceptance of this new product, the transition from Renagel(R) to Renvela(TM), the ability to get marketing approvals in other countries, the ability to get favorable pricing and reimbursement for Renvela(TM), the ability to get approvals of an alternative formulation such as the powder form of Renvela(
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SOURCE Genzyme Corp. Copyright©2007 PR Newswire. All rights reserved

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