CAMBRIDGE, Mass., Oct. 12 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) announced that the U.S. Food and Drug Administration's Cardiovascular and Renal Products Advisory Committee will meet Tuesday to consider the use of phosphate binders in patients with chronic kidney disease (CKD) who are not on dialysis.
FDA asked the three companies that currently market phosphate binders for patients on dialysis to provide perspective that will help the agency formulate its approach to extending the use of phosphate binders to pre- dialysis patients. In a briefing package provided to the FDA and the committee, the companies have outlined their position for the committee to consider. Specifically:
-- Phosphate imbalance precedes the need for dialysis in patients with
CKD, and should be treated at the time that patients begin to
-- Left untreated, patients experiencing hyperphosphatemia prior to the
initiation of dialysis may experience progression of renal disease,
bone disorders and vascular calcification.
-- Hyperphosphatemia is an independent risk factor for cardiovascular
morbidity and mortality, and for the progression of renal failure in
the pre-dialysis population.
-- And the risk-benefit profile of appropriate early treatment of
hyperphosphatemia in CKD patients not on dialysis is favorable.
The committee is expected to vote on several questions related to the use of phosphate binders in pre-dialysis patients, concluding with a vote on whether the committee recommends that the FDA extend the indications for phosphate binders to use in these patients. The briefing package and the complete list of the FDA's questions to the advisory committee are available at: http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm
Genzyme's Phosphate Binders
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 tablets in patients on dialysis. Genzyme also plans to pursue approval of Renvela tablets for the control of serum phosphorus in patients with CKD who are not on dialysis.
A vast body of clinical evidence supports the use of sevelamer in patients on dialysis. Renagel has been shown to effectively help patients achieve the target levels for phosphorus and calcium-phosphorus product outlined in the National Kidney Foundation's 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines.
Renagel controls serum phosphorus in patients with chronic kidney disease on hemodialysis. Controlling serum phosphorus is an important element in the care of hemodialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular mortality. Sevelamer hydrochloride provides the added benefit of significant LDL cholesterol reduction (32 percent).
The National Kidney Foundation's 2003 K/DOQI guidelines recommend sevelamer as a first-line treatment option to control phosphorus. Renagel is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. Sevelamer hydrochloride is used by more than 350,000 people worldwide.
Renagel is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on hemodialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. In a 52-week study, the most common side effects included vomiting, nausea, diarrhea, and dyspepsia. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel. For more information about Renagel, including complete prescribing information, please visit http://www.renagel.com.
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 the statements regarding the impact of the positions contained in the briefing package submitted to the Advisory Committee, the expected timing of the Advisory Committee's vote on questions related to the use of phosphate binders in pre-dialysis patients and whether it recommends extension of the indications for phosphate binders for use in pre-dialysis patients, Genzyme's anticipated pursuit of approval for Renvela(TM), the expectations relating to FDA's action with respect to Genzyme's New Drug Application seeking marketing approval of Renvela(TM) tablets for use by patients on dialysis and Genzyme's plans to pursue approval of Revela(TM) tablets for control of serum phospherus in patients with chronic kidney disease who have not progressed to dialysis. 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 Advisory Committee could vote in a manner that negatively impacts use of phosphate binders, including Renagel(R) and Renvela(TM), the possibility that the Advisory Committee could delay its vote on some or all of the questions or recommendations under consideration, the possibility that the FDA action with respect to the Renvela(TM) New Drug Application is not favorable and the possibility that Genzyme's plans for Renvela(TM) use in pre- dialysis patients will not be successful. 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(R) and Renagel(R) are registered trademarks and Renvela(TM) is a trademark of Genzyme Corporation. All rights reserved.
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|SOURCE Genzyme Corporation|
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