UPDATE 1-Genzyme wins European approval of Renvela
* Says Renvela will miss mid-2009 pre-dialysis US approval
* Says 2009 forecast will not be affected
* Genzyme shares off 41 cents
NEW YORK, June 12 (Reuters) - Genzyme Corp (GENZ.O: Quote, Profile, Research) said on Friday it received European approval of Renvela, a newer version of its Renagel drug to help control the level of phosphate in the blood of chronic kidney disease patients.
The approval covers both tablet and powder formulations of the drug for kidney patients not yet on dialysis with high serum phosphorus levels 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 which can lead to the calcification of tissues in patients with chronic kidney disease, a condition in which 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.
But Genzyme said Renvela 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. Continued...
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