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Controlling serum phosphorous level is a serious element in the treatment of patients with chronic kidney disease patients, as the build up is associated with calcification of tissues. Renvela is a next-generation version of Renagel, a calcium-free, metal-free, non-absorbed phosphate binder, which is currently the only available calcium phosphate binders with the added benefit of a carbon buffer.
Dan Regan, Senior Vice President and General Manager of Genzyme's renal business said, "With this marketing authorization, Renvela is the first phosphate binder for patients not on dialysis approved through the centralized procedure in Europe."
The current approval is on top of the approval for Renvela, Genzyme received from Brazil earlier this week for treating patients on dialysis. The company also said it plans to seek additional approval for treating patients who are not on dialysis,in Brazil. Genzyme has also launched Renvela in India for treating chronic kidney disease patients on dialysis.
Cambridge, Massachusetts-based Genzyme has also been engaged in a series of legal proceeding related to Renvela. The company, in May, sued an Indian-based generic maker Lupin Ltd. regarding its efforts to make generic Renvela. Lupin was also earlier sued by Generic for over an earlier version related to the same kidney treatment.
In the United States, Genzyme launched Renvela tablets for patients with chronic kidney diseases on dialysis in March 2008. Genzyme also expects FDA approval of the powder formulation for Renvela during the second half of this year.
Genzyme is also indicated to be in discussions with the FDA regarding the treatment of hyperphosphatemic patients not on dialysis. The company expects the discussion to continue beyond midyear, while indicating that its 2009 guidance will not be affected by this.
Markus Ketteler, Professor of Medicine and Clinical Nephrologist, Klinikum Coburg, Academic Teaching Hospital of the University of Würzburg, Germany said, "Renvela is an important addition to the therapeutic options available to nephrologists, and gives them the opportunity to treat hyperphosphatemia earlier."
Common adverse events reported with sevelamer include vomiting, nausea, diarrhea, dyspepsia, abdominal pain, and constipation. Other events reported include pruritus, rash, fecal impaction, and intestinal obstruction.
GENZ is currently trading at $58.86, down $0.49 or 0.83%, on a volume of 0.30 million shares. In the last 52-week period, the stock traded in the range of $50.05 to $83.97, with a three-month average volume of 3.04 million shares.
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