Genzyme Statement Regarding Results of FDA Advisory Committee Meeting on the Use of Phosphate Binders in Chronic Kidn... ( CAMBRIDGE Mass. Oct. 16 /- Genzym...)

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Genzyme Statement Regarding Results of FDA Advisory Committee Meeting on the Use of Phosphate Binders in Chronic Kidney Disease

Date:10/16/2007

CAMBRIDGE, Mass., Oct. 16 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) today participated in the FDA's Cardiovascular and Renal Products Advisory Committee meeting, during which the committee voted 8 to 4, with one abstaining, to recommend that the FDA extend the indications for phosphate binders to use in pre-dialysis patients with hyperphosphatemia.

Genzyme markets Renagel(R) (sevelamer hydrochloride), the most prescribed phosphate binder in the United States, and is pursuing approval for Renvela(TM) (sevelamer carbonate), a next-generation, buffered form of sevelamer. The FDA is expected to act this month on a New Drug Application seeking marketing approval for the use of Renvela in patients on dialysis. Genzyme also plans to pursue approval of Renvela for hyperphosphatemic patients with CKD who are not on dialysis. The company has successfully completed studies of Renvela in both dialysis and pre-dialysis patients.

"We are pleased that the committee recognizes that there is a benefit to treating hyperphosphatemic patients prior to the initiation of dialysis," said Genzyme Chief Medical Officer Richard Moscicki. "Genzyme has always been committed to continuing clinical studies on sevelamer, and this is evidenced by our strong post-marketing research investment in the product to date. We remain focused on making this product available to all patients who can benefit from it, and we look forward to working collaboratively with the FDA to determine the most appropriate pathway for doing so."

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
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