At Phase 3

Savient Pharmaceuticals, Inc. announced that it has reached its Phase 3 enrollment target of 200 patients total, in the two replicate placebo-controlled six-month clinical trials. The trials assess the safety and efficacy of Puricase in patients with treatment-failure gout, under the auspices of a Special Protocol Assessment from the U.S. Food and Drug Administration. Completion of the in-life portion of the Phase 3 trials is expected during the fourth quarter of this year, with release of top line results by year-end. "We are extremely pleased with the progress of the clinical development program for Puricase and now, having successfully reached our Phase 3 enrollment timeline, we remain on target for a Biologics License Application filing in early 2008," commented Christopher Clement, President and Chief Executive Officer of Savient. "We believe Puricase represents an important innovation in the care of gout patients, potentially delivering the first and only effective therapy for patients with treatment-failure gout." Puricase, a pegylated recombinant porcine urate oxidase, is being developed to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The Phase 3 study design designates the normalization of uric acid during months 3 and 6 of the six-month trials as the primary endpoint. Secondary efficacy endpoints that define clinical outcomes such as the reduction in the burden of gout tophi, the occurrence of gout flares, and the reduction in the count of tender and swollen joints will be analyzed in a data set pooled from the two replicate studies numbers. "The Phase 3 program is progressing with a high degree of commitment shown by study participants and our clinical investigators," stated Zeb Horowitz, MD, Senior Vice President and Chief Medical Officer of Savient. "Up to this point, the tolerability of intravenous dosing has been good, with a low rate of infusion reactions across all placebo and Puricase infusions. Even more importantly, physicians appear to be highly successful in treating through infusion reactions when they do occur, just as in clinical practice with other infused biologicals. Patients and physicians continue to demonstrate satisfaction and confidence in the treatment, as evidenced by their participation in our Open Label Extension protocol in which patients can choose to receive Puricase or go on observation only after completion of their Phase 3 participation. Thus far, 100% of completed patients have chosen to enroll in the Open Label Extension protocol in order to receive Puricase treatment for 12 months beyond the six-month core Phase 3 trials." The company intends to allow patients currently in the screening process at the clinical sites to complete the screening and enroll in the Phase 3 clinical trials if they qualify, going somewhat beyond the 200 patient target of randomization. "The patients currently in screening have no alternative therapeutic option and should not be turned away," said Dr. Horowitz. "Allowing them to complete the screening process will translate into an extension of patient randomization for about two additional weeks, but it should not jeopardize subsequent key milestone dates. These patients and their physicians are truly anxious for a new therapy."