Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology ...( Phase 3 and Open Label Extension ...)

Phase 3 and Open Label Extension Results Support Efficacy and Safety of Pegloticase

EAST BRUNSWICK, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that data from its pegloticase pivotal clinical studies in treatment-failure gout (TFG) patients was presented at scientific sessions during the annual meeting of the American College of Rheumatology (ACR). Four presentations focused on results from the pegloticase double blind placebo controlled Phase 3 pivotal studies. Data from the interim results of the uncontrolled open label extension (OLE) study were included as well. The data presented at the sessions extended the positive clinical results previously reported by the Company and further demonstrated the safety and efficacy of this novel biological drug in treatment for up to one year or longer. The presentations included results and analyses in three areas not previously discussed that included the effect of pegloticase on gout tophi, gout flares, and the immune response to pegloticase in patients with long-term treatment.

The results from the OLE study were consistent with findings from the Phase 3 studies, both of which met the primary endpoint relating to the normalization of plasma uric acid, for pegloticase 8 mg intravenous infusion every 2 weeks or every 4 weeks. A substantial subset of patients who completed the Phase 3 clinical trials and enrolled in the OLE continued to show improvements in the resolution of their signs and symptoms of treatment-failure gout with continuing pegloticase treatment, extending the positive clinical results seen in Phase 3. The two clinical efficacy endpoints of most interest, gout flares and gout tophi, showed an increasing proporti
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