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Savient Provides Update on Meeting with U.S. Food and Drug Administration for KRYSTEXXA(TM)
Date:9/16/2009

EAST BRUNSWICK, N.J. Sept. 16 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that on September 14, 2009, the Company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) received by Savient on July 31, 2009 regarding the Company's Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.

Based on the results of this meeting with the FDA, Savient believes that the FDA supports its approach to resolve all issues cited in the CRL. The meeting also confirmed that the FDA does not expect further clinical trials to be required as a result of Savient's reversion to the original manufacturing process to produce the Phase 3 clinical trial material for KRYSTEXXA, provided that no significant differences are observed between the material produced with the validated Phase 3 process and the Phase 3 clinical trial material. Savient, therefore, continues to believe that it can meet its previously discussed timeline of filing the resubmission in response to the CRL in early 2010.

"We are encouraged by the FDA's continuing collegial and collaborative dialogue in providing guidance to assist us in establishing the path forward to our resubmission for KRYSTEXXA," stated Paul Hamelin, President of Savient Pharmaceuticals. "We are grateful to the FDA for granting us this meeting so quickly and appreciate the considerable time and effort devoted by the FDA reviewers in evaluating our pre-meeting package and in providing very valuable feedback and guidance."

In response to the CRL, Savient requested and was granted the Type A meeting with the FDA to disc
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SOURCE Savient Pharmaceuticals, Inc.
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