( usingRenagel. With today’s res...)Genzyme Announces Results of Clinical Trials Investigating Powder,Form of Sevelamer Carbonate,Health

With today’s results, Genzyme has concluded that the powder formulation of Renvela dosed three times per day may represent a promising alternative for patients with chronic kidney disease. The company will continue to move ahead aggressively with clinical and regulatory plans for the powder formulation dosed three times per day, and these data will form part of an NDA submission in the first half of 2008.

“We are very pleased with the progress we have made to date in our multi-faceted development program for Renvela, including filing an NDA for patients on dialysis, completing a successful trial in the pre-dialysis population, and demonstrating the effectiveness of the powder formulation dosed three times per day,” said John P. Butler, president, Genzyme Renal. “Results of the once-per-day trial were greatly influenced by the strong phosphorus reduction seen in the Renagel arm, which was superior to that seen in all but one previously conducted clinical trials. While today’s results will not currently support a regulatory filing for once-per-day dosing, they are clinically meaningful and give us confidence that this approach can be effective. We will continue to work with regulatory authorities to design an appropriate clinical plan to gain approval for this dosing regimen.”

About Renvela

Renvela is a buffered form of Renagel, the most-prescribed phosphate binder in the United States. Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder, and will be available as 800mg tablets once approved. A New Drug Application for Renvela is currently under review by the US Food and Drug Administration for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

In April, Genzyme announced that a new clinical trial showed that Renvela significantly reduced serum phosphorus, calcium-phosphorus product and LDL cholesterol in hyperphosphatem
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