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

ged an experienced independent panel of clinical experts, headed by Dr. William B. White, Professor of Medicine, Calhoun Cardiology Center, University of Connecticut School of Medicine, to perform a formal blinded and unblinded post-hoc adjudication of all cardiovascular events included in reports of Serious Adverse Events, Infusion Reactions and Severe Infusion Reactions from the Phase 3 pegloticase trials. The primary event evaluation was predicated on the Anti-Platelet Trialist Collaborative (APTC) assessment criteria. This is a standardized approach that the FDA has widely accepted as a method of evaluating cardiovascular risk. APTC cardiovascular events include deaths, nonfatal myocardial infarction or nonfatal stroke. Dr. White and his panel concluded that:

  • As a result of the post-hoc blinded adjudication and unblinded review of the Serious Infusion reactions of the Phase 3 trials, there were 3 APTC cardiovascular events in the pegloticase treatment arms and 0 in the comparator placebo treatment arm. Furthermore, the panel found that there were 10 non-APTC cardiovascular events in the treatment arms and 0 non-APTC cardiovascular events in the comparator placebo treatment arm.

  • The panel also performed an un-blinded adjudication of the Company's Open Label Extension study employing the same criteria used for the Phase 3 trials with the exception that there were no patients on placebo during the Open Label Extension study. The panel found 2 APTC cardiovascular events and 7 non-APTC cardiovascular events. The data cut off date of this analysis was through August 29, 2008.

In addition to the work of Dr. White and his team, a separate external panel of experts performed an additional analysis by reviewing "all cause" mortality in the Phase 3 trials and Open Label Extension study. It is important to note that in the P
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SOURCE Savient Pharmaceuticals, Inc.
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