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Genzyme Launches Renvela(R) in the U.S. for Dialysis Patients
Date:3/6/2008

nticipated filing a supplemental New Drug Application for Renvela's use in non-dialysis patients during the first half of 2008. Given the current discussions with the FDA, it will not be necessary for the company to file an sNDA for this indication. However, Genzyme anticipates the Renvela label expansion will take place within a similar timeframe had it gone a more traditional route. During the second quarter, Genzyme also plans to file for U.S. approval of the powder formulation of the product, which may make it easier for patients to comply with their prescribed treatment program.

"We are very pleased with the progress we've made to date on our comprehensive global plan for Renvela," stated John P. Butler, president, Genzyme Renal. "The U.S. launch in dialysis, the E.U. and Brazil filings, and the positive nature of our current conversations with the FDA represent significant steps forward as we work to make this important product available to all patients who can benefit from it."

Renvela is a next-generation version of Renagel(R) (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States. It is a calcium-free, metal-free, non-absorbed phosphate binder and is available in the U.S. as 800mg tablets. Renvela offers all of the advantages of Renagel with the benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within KDOQI recommended ranges. Patients on Renvela, however, were more likely to maintain bicarbonate levels within the recommended KDOQI ranges, and had a lower incidence of gastrointestinal adverse events.

About Renagel and Renvela

Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate) both control serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Controlling serum phosphorus is an important element in the care of dialysis patients. Elevated serum phosphorus levels are common in dialysis
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SOURCE Genzyme Corporation
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