Savient Posts Positive Data on Gout Drug Puricase

Savient Pharmaceuticals(SVNT Quote) said Thursday that in two late-stage studies its drug Puricase effectively treated patients with gout who've tried other treatments with no success.

The East Brunswick, N.J., company said two phase III clinical studies, in which Puricase was given intravenously every two or four weeks, met their primary endpoints, although reaction from the IV infusion caused 9% of the patients treated with the drug to drop out of the study.

Savient shares, which rose as much as 55% in premarket trading, were lately trading up $3.46, or 24%, at $17.92.

Gout is a condition that develops from a buildup of uric acid in the bloodstream, which results in the formation of uric acid crystals on the joints, tendons and surrounding tissues, causing inflammatory reactions in those areas. Puricase works by controlling the buildup of uric acid in the blood stream. The drug also saw success in reducing gout tophi, nodular masses of uric-acid buildup in body tissues.

Savient plans to file a biologics licenses application with the Food and Drug Administration in 2008 based on the results from the trials. If the treatment gets regulatory approval, it will be the only treatment for unsuccessfully-treated patients.

Gout patients who've found other treatments unsuccessful experience frequent, crippling gout flares and a high rate of co-morbidities such as hypertension and cardiovascular disease, among others, according to Savient. Lazard analyst Megan Murphy estimates that about 38,000 patients would be treated with Puricase at its peak, not including other uses for nongout patients.