Savient Reports Positive Top-Line Results for Puricase Phase II Trial

Savient Pharmaceuticals has announced the positive top-line results of its completed Phase II trial for its lead drug candidate, Puricase.

This trial was designed to test the safety and efficacy of Puricase in patients with symptomatic gout who are intolerant of or unresponsive to conventional therapy. The company estimates approximately 35,000 to 50,000 patients in the U.S.

The FDA granted the company an orphan designation to study Puricase in this patient population. Puricase is a polyethylene glycol conjugate of recombinant porcine uricase (urate oxidase) which was studied in a recently completed Phase II trial initiated in early 2004. The primary objective of the study was to determine the most appropriate dosing for a pivotal Phase III clinical trial, upon which the registration will be based. The company believes that this objective has been achieved.

The Phase II study was a randomized, open-label, parallel design trial. Forty-one patients were randomized to receive Puricase as an intravenous infusion administered once every two weeks (4 mg or 8 mg), or once every four weeks (8 mg or 12 mg), for a three-month treatment period. At entry, the mean age of the patients was 58.1 years. Eighty-five percent of the patients were male and 83 percent were Caucasian. The mean duration of the disease history was 14 years and one or more gout tophi were present in 70 percent of the patients.