UPDATE 1-Savient says gout drug reaches main goal, shares jump
(Adds details, share movement)
Dec 13 (Reuters) - Savient Pharmaceuticals Inc (SVNT.O) said its gout drug, Puricase (pegloticase), reached its main goal in late-stage trials, sending shares up as much as 27 percent to a new year-high.
The company said the drug achieved statistically significant positive results in the late-stage trial in treatment-failure gout patients, which was conducted under a special protocol assessment with the U.S. Food and Drug Administration.
Gout is a painful joint disorder caused by a buildup of uric acid in the blood. The treatment-failure gout population is characterized by very severe gout symptoms such as frequent crippling gout flares, including a high probability of hypertension, cardiovascular disease and diabetes.
Puricase 8 mg administered by a two-hour intravenous infusion every two weeks or every four weeks met the main efficacy goal in each of two replicate, six-month late-stage clinical trials.
The main efficacy goal specified under the special protocol assessment was normalization of plasma uric acid during the third and sixth month of the clinical trials, the company said in a statement.
Savient said three deaths occurred in the treatment phase but none of them appeared to be related to the pegloticase treatment, as judged by clinical investigators.
The company's stock rose more than 23 percent, or $3.37, to $17.83 in morning trade making it the second biggest percentage gainer on the Nasdaq. The shares touched their year-high of $18.36 earlier in the session. (Reporting by Shamik Paul in Bangalore; Editing by Amitha Rajan)










