Pursues Additional Approvals Globally for Dialysis and Earlier Stage
Chronic Kidney Disease Patients
CAMBRIDGE, Mass., March 6 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) today announced the U.S. launch of the phosphate binder Renvela(R) (sevelamer carbonate) for dialysis patients, as well as significant progress in its international efforts to secure additional approvals for the product.
Genzyme has submitted a marketing authorization application to the European Medicines Agency seeking approval of Renvela for the control of serum phosphorus in chronic kidney disease patients regardless of whether they are on dialysis. This application, which includes both tablet and powder formulations, must be validated before it will be accepted for review.
Genzyme anticipates that the application will be validated by the end of this month, and the review period is expected to take approximately 15 months. The first E.U. launch of Renvela is anticipated in the third quarter of 2009. Genzyme also applied for approval of Renvela tablets for dialysis patients in the key South American market of Brazil late last year, and will continue to pursue additional approvals internationally.
In the United States, Genzyme is engaged in active discussions with the Food and Drug Administration to expand Renvela's labeling to include chronic kidney disease patients with hyperphosphatemia who are not on dialysis. At the FDA's request, the three companies that currently market phosphate binders for dialysis patients are working collaboratively to provide information that will assist the agency in defining the appropriate earlier stage chronic kidney disease patient population.
Genzyme had previously anticipated 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 patients and associated with increased risk of cardiovascular morbidity and mortality. Sevelamer provides the added benefit of significant LDL cholesterol reduction.
Sevelamer 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. The National Kidney Foundation's 2003 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Bone Metabolism and Disease in CKD recommend sevelamer as a first-line treatment option to control phosphorus. Sevelamer hydrochloride is currently used by more than 350,000 patients worldwide.
Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride) are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Sevelamer 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. Common adverse events reported with sevelamer include vomiting, nausea, diarrhea, dyspepsia, abdominal pain, and constipation. Other events reported include pruritus, rash, fecal impaction, and intestinal obstruction. Drug- drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take sevelamer. Patients should be informed to take sevelamer with meals and to adhere to their prescribed diets. For more information on Renvela or Renagel, please see Full Prescribing Information, call Genzyme Medical Information at 1-800-847-0069 or visit http://www.renagel.com or http://www.renvela.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 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 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.
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, without limitation, statements about the potential approval and launch of Renvela(R) in the E.U. and internationally and plans for, and the potential approval of, new indications and formulations of Renvela(R) in the U.S. 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 timing of discussions with regulatory authorities regarding the approval of Renvela(R); the timing and content of submissions to and decisions made by regulatory authorities relating to Renvela(R); further analysis of clinical trial data; the results of other studies and whether such results are consistent with this data; the actual efficacy and safety of the powder formulation of Renvela(R); the outcome of discussions with the FDA regarding the approval of Renvela(R) for use in non-dialysis chronic kidney disease patients and the timing of such discussions; the availability and extent of third-party reimbursement for Renvela(R); and the 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 in Genzyme's Annual Report on Form 10-K for the year ended December 31, 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 these statements.
Genzyme's press releases and other company information are available at http://www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
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