CAMBRIDGE, Mass., June 18, 2007 - Genzyme Corp. (Nasdaq: GENZ) today announced the results of two new studies comparing a powder form of Renvela™ (sevelamer carbonate) to Renagel® tablets (sevelamer hydrochloride), including one trial in which patients received the powder form three times per day, and one in which it was administered once per day.
Genzyme is developing Renvela in powder form to provide an additional option for patients with chronic kidney disease in managing their phosphate levels. A New Drug Application for Renvela tablets is already on file with the FDA, and previous studies have shown that the tablet formulation provides equivalent phosphate control to Renagel in patients on dialysis and significant phosphorus control in patients with chronic kidney disease who are not on dialysis. Today’s results are the first from trials comparing the efficacy of the powder form of Renvela to Renagel tablets.
In the first powder trial, patients treated with the powder form of Renvela three times per day experienced equivalent phosphorus control to patients treated with Renagel tablets three times per day. As a result, this trial successfully met its primary endpoint.
In the second trial, patients dosed with the powder form of Renvela once per day and those treated with Renagel tablets three times per day achieved statistically significant reductions in serum phosphorus, with both groups reaching target levels for phosphorus control outlined in the K/DOQI treatment guidelines. Phosphorus levels in the Renagel arm (4.6 mg/dL) were lower than those in the Renvela arm (5.3 mg/dL), and this trial did not achieve its primary endpoint of demonstrating non-inferiority of Renvela powder dosed once per day to Renagel tablets dosed three times per day.
In both trials, the safety profile of Renvela was consistent with the previous clinical experience of patients on dialysis using Renagel.
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.”
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 ic patients with chronic kidney disease who are not on dialysis. Additionally, data showing the equivalence of sevelamer carbonate and sevelamer hydrochloride were presented at the 2007 spring clinical meeting of the National Kidney Foundation.
Renagel controls serum phosphorus in patients with CKD 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. Renagel provides the added benefit of significant LDL cholesterol reduction (32 percent).
The National Kidney Foundation’s 2003 K/DOQI guidelines for Bone Metabolism and Disease in Chronic Kidney Disease recommend sevelamer hydrochloride 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. Renagel 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. 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 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 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been 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.
Genzyme® and Renagel® are registered trademarks and RenvelaTM is a trademark of Genzyme Corporation. All rights reserved.
This press release contains forward-looking statements including, without limitation, statements about the development of Renvela™ for chronic kidney disease and alternative dosing regimens for the powder formulation of Renvela™. 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: additional analysis of the data comparing the powder form of Renvela™ to Renagel®; the results of other studies and whether such results are consistent with this data; the actual efficacy and safety of Renvela™ for chronic kidney disease; the outcome of discussions with regulatory authorities regarding clinical studies and the approval of Renvela™ for chronic kidney disease and the timing of such discussions; the timing and content of submissions to and decisions made by regulatory authorities; the availability and extent of third -party reimbursement for Renvela™; 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 Quarterly Report on Form 10-Q for the period ended March 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.