Genzyme Corp. announced the US launch of the phosphate binder Renvela (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 authorisation 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 EU 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 labelling 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 US 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 US 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 (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 US 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.

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, diarrhoea, dyspepsia, abdominal pain, and constipation. Other events reported include pruritus, rash, foecal 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.