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Savient Provides Update on KRYSTEXXA(TM) BLA Resubmission Activities
Date:1/8/2010

EAST BRUNSWICK, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today provided an update on its activities directed toward the resubmission of its Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy and reaffirmed its belief that it continues to be on track for the filing of the BLA resubmission for KRYSTEXXA in the first quarter of 2010.

The Company announced that:

  • It has completed the reversion to the manufacturing processes used to manufacture its pegloticase active pharmaceutical ingredient (API) drug substance for the pivotal Phase 3 clinical trials which the Company had committed to pursue during the September 2009 Type "A" meeting as its plan to address the concerns raised by the Food and Drug Administration (FDA) in the July 31, 2009 complete response letter. Three consecutive batches of pegloticase API drug substance were manufactured in late October 2009 at the Company's third party contract manufacturer (CMO) and were then manufactured into final KRYSTEXXA drug product in November 2009. All batches were placed on stability testing by early December 2009. This manufacturing process reversion included the successful return to the PEGylation concentration utilized in the manufacture of pegloticase API for the pivotal replicate Phase 3 clinical trials.
  • The Company has received from its third party testing laboratories the majority of the in-process and final release analytical test results performed on the three consecutive batches of pegloticase API drug substance and final drug product. These analytical tests are necessary to validate these batches as being comparable to the drug product used in the Phase 3 clinical trials to establish the safety and effic
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SOURCE Savient Pharmaceuticals, Inc.
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