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

uss, clarify and reach alignment on a resubmission plan to fully address all deficiencies and issues identified in the CRL. The FDA indicated that, in its view, Savient's plan to revert to and validate the original manufacturing process used to produce the Phase 3 clinical trials material, together with the inclusion of additional 0.22 micron filters in the manufacturing process, is a reasonable approach that the FDA expects will produce drug substance that is representative of that used in the pivotal Phase 3 clinical trials. The FDA stated that it also expects that the comparability between material produced with the validated Phase 3 process and the Phase 3 clinical trial material used in the replicate clinical trials to establish safety and efficacy can be sufficiently established by quality criteria alone without the need to conduct additional clinical studies, provided no significant differences between products are observed.

The FDA also agreed at this meeting with the methods and criteria proposed by Savient to tighten manufacturing analytical methods and acceptance criteria for all manufacturing steps in the final commercial production process. However, some of these final analytical methods and acceptance criteria are subject to being set based upon the data from historical manufacturing and validation batches that will be included in the resubmission. The meeting outcomes confirm Savient's belief that it is on track to meet its previously discussed timeline of filing the resubmission in response to the CRL in early 2010.

The FDA also provided additional clarity relating to the steps necessary for Savient's drug substance manufacturer, Bio-Technology General (Israel) Ltd (BTG), a subsidiary of Ferring Pharmaceuticals, to satisfactorily correct the observations cited by the FDA during its pre-approval inspection of the BTG manufacturing facility. Savient believes that BTG's remediation of these observations can be
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SOURCE Savient Pharmaceuticals, Inc.
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