Healthcare Industry News: Renvela
News Release - October 16, 2007
Genzyme Statement Regarding Results of FDA Advisory Committee Meeting on the Use of Phosphate Binders in Chronic Kidney DiseaseCAMBRIDGE, Mass., Oct. 16 (HSMN NewsFeed) -- 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® (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."
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 has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President 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 90 countries, Genzyme is a leader in the effort to develop and apply 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 Genzyme's expectations regarding the timing for FDA action on its NDA seeking approval for the use of Renvela in dialysis patients, its plans to pursue approval of Renvela for treatment of CKD patients who are not on dialysis in the US and for dialysis and pre-dialysis patients globally, including expected filings in Europe and Latin America in 2008, and its clinical study plans. 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 possibility that the FDA action with respect to the Renvela NDA is not favorable or is delayed, the possibility that Genzyme's plans for Renvela use in pre-dialysis patients will not be successful, and the possibility that regulatory authorities outside the US do not grant marketing authorization for the use of Renvela in dialysis and/or pre-dialysis patients. There are also risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending June 30, 2007. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.
Genzyme® and Renagel® are registered trademarks and Renvela(TM) is a trademark of Genzyme Corporation. All rights reserved.
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