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Genzyme dialysis drug gets FDA OK

SAN FRANCISCO - Genzyme Corp. won clearance from US regulators to market Renvela, a medicine for patients on kidney dialysis.

The drug was approved by the Food and Drug Administration to reduce excess buildup of phosphorus in the body, Genzyme said yesterday.

The pill is a new version of Genzyme's Renagel, reformulated to be gentler on the stomach, the company has said. Genzyme is also developing the drug for as many as 8 million to 9 million US patients who aren't on dialysis. The drug helps the body eliminate phosphorus compounds from foods during digestion, which are normally excreted by healthy kidneys.

"Renvela's an improved formulation and seems to be a vehicle to help them capture a larger portion of the market of patients with predialysis," said Christopher Raymond, an analyst with Robert W. Baird in Chicago.

Genzyme shares have climbed 16 percent this year.

An FDA advisory panel voted 8 to 4 last week to recommend Renagel and competing drugs from Shire PLC and Fresenius Medical Care AG be approved for patients with milder forms of kidney disease. The drugs are currently cleared only for patients with the most severe form, those on dialysis treatment.

Genzyme said it plans to bring Renvela to the US market for dialysis patients during the first quarter of 2008 and to apply in the second half of the year for FDA approval to expand use to patients not on dialysis.

The addition of Renvela should help Genzyme top $1 billion in annual sales to patients with chronic kidney disease by 2010, Raymond said. Renagel, approved in 1998, generated $515 million in sales in 2006, Genzyme has said. The drug is the most prescribed phosphate binder in the United States, according to the company.

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