Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRY...(0. We hope to have more clarity on the e...),Health

Date:8/2/2009

0. We hope to have more clarity on the expected timeline after we meet with the FDA to discuss the complete response letter," stated Paul Hamelin, President of Savient Pharmaceuticals. "While we believe we have made substantial progress toward the potential final approval of KRYSTEXXA, we also have more work to do with the FDA to resolve these open issues. We are committed to work diligently to address these issues with a goal of obtaining final approval for KRYSTEXXA so we can provide this therapy to those chronic gout patients who are suffering from this crippling, debilitating disease and have no other treatment options."

The Company believes that its resubmission will respond to all of the deficiencies cited in the compete response letter and would lead to a new Prescription Drug User Fee Act expected action date of either two or six months after the date of the Company's resubmission, depending on the FDA's classification of the resubmission.

ABOUT KRYSTEXXA(TM)

KRYSTEXXA(TM) (pegloticase) is a PEGylated uricase enzyme intended for the treatment of chronic gout in patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Conference Call Information

Savient will host a live webcast to discuss the approval of KRYSTEXXA on August 3, 2009 at 8:00 a.m. Eastern Time. Both the live and archived webcast can be accessed from the Investor Relations page of Savient's Website at http://www.savient.com. A digital recording of the webcast will be available within one hour following the conclusion of the c
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SOURCE Savient Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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