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Savient Provides Update on Pegloticase BLA
Date:2/12/2009

Company Files Amendments to Strengthen and Clarify BLA Data

FDA Extends PDUFA Action Date to July 30, 2009

Company to Host Conference Call

EAST BRUNSWICK, N.J., Feb. 12 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the Company filed amendments to strengthen and clarify the data included in the previously submitted pegloticase Biologics License Application (BLA), which was granted priority review. The amendments focus on topics identified by the BLA Oversight Committee (the "Committee") of the Board of Directors as a result of its review of the BLA filing and also address review-related questions from the Food and Drug Administration (FDA).

Since its formation on November 19, 2008, the Committee, Chaired by Board Member Dr. Lee S. Simon, M.D., a former Director of the Analgesic, Anti-Inflammatory, Ophthalmologic Drug Products Division of the FDA and a Board Certified Rheumatologist with 25 years of clinical practice experience, has assumed oversight of all Company activities related to the FDA's BLA review process. The Committee has conducted a comprehensive review of the BLA filing with the assistance of external experts. In late January 2009, the Board of Directors also formally retained Dr. Simon as a consultant to assume day-to-day supervision of the BLA and Advisory Panel preparation.

"We believe the steps we have taken further clarify the favorable risk to benefit profile of pegloticase. Securing FDA approval remains our number one priority and we believe making these amendments is an important step toward achieving that goal. We look forward to continuing to work with the FDA as we move through the regulatory process. The Committee, our retained external experts, along with the management team, continue to belie
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SOURCE Savient Pharmaceuticals, Inc.
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