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Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
Date:10/27/2008

on of patients with favorable response over time. The results of the pivotal Phase 3 studies and the interim data set from the OLE with 101 patients with at least 12 months of continuous pegloticase treatment, will be included in the Biologics License Application (BLA) that the Company plans to file with the Food Drug Administration (FDA) by the end of the month.

"The results from these studies represent hope for treatment-failure gout patients, as defined by our clinical program," said Dr. Zeb Horowitz, Chief Medical Officer for Savient. "Many of these patients have suffered from debilitating, sometimes crippling gout symptoms for many years along with serious co-morbidities and are considered to be difficult to treat. Currently, there are no alternative treatment options available for these patients. The information presented this week from our pegloticase studies further demonstrate a compelling treatment effect not only for the control of uric acid, but more importantly for the amelioration of the signs and symptoms of disease. If approved, pegloticase would be an important new therapy for patients living with the debilitating effects of treatment-failure gout."

"Based on the positive results that were reported from our Phase 3 studies along with the continued clinical improvement and high rate of patient participation in our OLE program, we believe this is indicative of the need for a new treatment option," stated Christopher Clement, President and CEO of Savient. "We are optimistic about the potential opportunity ahead and we are honored that the American College of Rheumatology chose to feature these exciting results in a plenary session."

The two pegloticase Phase 3 studies are known as the GOUT 1 and GOUT 2 studies (Gout Outcomes and Uric Acid Treatment) and the OLE Study is known as GOUT 3. Four ACR presentations focused on the results of the GOUT 1, GOUT 2 and GOUT 3 studies. A fifth presentation defined TFG as a unique medical cond
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SOURCE Savient Pharmaceuticals, Inc.
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