Savient's Puricase found to substantially reduce plasma urate levels in patients with gout

By Angela McDaniels

Seattle, Nov. 14 - Savient Pharmaceuticals Inc. said that patients with elevated blood uric acid levels and treatment-resistant gout who were treated with its investigational drug Puricase in a phase 2 trial had substantial and sustained reduction in plasma urate levels.

The 12-week, multicenter trial assigned one of four different doses of intravenous Puricase to 41 patients with hyperuricemia and severe gout who are unresponsive to or intolerant of conventional therapy.

In addition, two case studies from the trial show anecdotal photographic evidence that treatment with Puricase unexpectedly resolved tophi, the nodular deposits of urate that can cause pain, local ulceration, disfigurement and joint destruction, the company said.

"Lowering urate levels is an important goal in treating gout because urate deposits in joint spaces provoke attacks of this painful and often disabling disease," lead investigator John S. Sundy of Duke University Medical Center said in a company news release.

Phase 2 study results will be presented on Wednesday at the American College of Rheumatology 2005 annual meeting in San Diego.

In February 2001, Savient received Orphan Drug designation from the U.S. Food and Drug Administration for Puricase, and the company said it expects to initiate its phase 3 clinical testing program during the first quarter of 2006.

Pharmaceutical company Savient is based in East Brunswick, N.J., and develops therapeutic products that address unmet medical needs.

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