Biotech Genzyme Corp. (Nasdaq: GENZ) reported on Friday that it has received European approval for Renvela, a newer version of its Renagel drug to help control phosphate levels in the blood of chronic kidney disease patients.
Genzyme ended trading on Friday down 0.59 (0.99%) with a closing trade price of 58.76.
The approval covers both tablet and powder formulations of the drug for kidney patients not yet on dialysis with high serum phosphorus lead that can lead to heart disease.
Both Renagel and Renvela treat hyperphosphatemia, the excess of phosphate in the blood, a risk factor for cardiovascular illnesses in patients with chronic kidney disease. Renvela can also control the buildup of serum phosphorus. High serum phosphorus levels can lead to calcification of tissues, where calcium buildup causes soft tissue to harden.
Genzyme is seeking more approvals for Renvela in the international market. The drug was launched in India this quarter for patients on dialysis and was approved in Brazil this week.
In the United States, the most important market, Renvela tablets were launched for patients on dialysis last March. The company expects FDA approval of the powder form of Renvela in the second half of this year.
However, Genzyme said Renvela’s approval in the broader pre-dialysis market would miss the company’s previously stated goal of mid-2009 U.S. approval. Despite the delay, Genzyme said its 2009 earnings forecast will not be affected.
Combined sales of Renvela and Renagel were $170.6 million in the first quarter. U.S. Renvela approval in pre-dialysis patients is expected to significantly boost sales.
“We continue to believe a label expansion is forthcoming, and perceive a sizable market opportunity in this indication once approved,” said Christopher Raymond, analyst for Robert W Baird.
Joshua Sherman
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