Genzyme launches Renvela in the US for dialysis patients; pursuing international approval for dialysis, CKD patients.

Genzyme, Inc., Cambridge, MA, announced it has launched its phosphate binder Renvela (sevelamer carbonate) for US dialysis patients, and says it has made significant progress in international efforts to secure additional approvals for the product. The company 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 (CKD) patients regardless of whether they are on dialysis. The company anticipates the European review will take approximately 15 months and predicts the first EU launch of Renvela will take place in the third quarter of 2009.

Genzyme also says it is engaged in active discussions with the US Food and Drug Administration (FDA) to expand Renvela's labeling to include CKD patients with hyperphosphatemia who are not on dialysis.

The company also reports that findings from a large, multicenter, observational study on long-term durability of Carticel (autologous cultured chondrocytes) in patients who had pain and functional defects in the articular cartilage in their knees were positive. The findings revealed that almost 90% of patients treated with Carticel who experienced improvement in the knee function at an early follow-up, sustained their improvement for up to almost 10 years.

Contact: Web site: www.genzyme.com