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Savient Resubmits Biologics License Application for KRYSTEXXA(TM) (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy
Date:3/15/2010

e," "estimate," "expect," "intend," "plan," "will" and other similar expressions identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the results of Savient's actions and efforts in support of its resubmission of the KRYSTEXXA™ (pegloticase)  BLA, the results of the reversion to and revalidation of the Phase 3 manufacturing process, whether the Company's third party contract manufacturing organization will successfully address the deficiencies and observations cited by the FDA at their facility, whether our BLA resubmission, combined with the submissions made and planned by our third party contract manufacturer, fully addresses the deficiencies and observations raised and provides the additional materials requested in the Complete Response Letter that we received from the FDA on July 31, 2009, which were further clarified in our meeting with the FDA on September 14, 2009, the timing of FDA action with respect to the resubmission, the efficacy and safety of KRYSTEXXA, potential FDA marketing approval for KRYSTEXXA and whether any further clinical trials will be required are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, our Phase 3 clinical data, our current understanding of the complete response letter and on current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, the possibility that the FDA may raise further issues regarding the BLA for KRYSTEXXA or require that we conduct additional cl
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SOURCE Savient Pharmaceuticals, Inc.
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