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Savient Pharmaceuticals Reports Second Quarter 2009 Financial Results
Date:8/10/2009

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Operational Key Events:

  • Raised $31.0 million from a registered direct offering that yielded $29.0 million in cash, net of $2.0 million of offering costs

  • Elected Ginger D. Constantine, M.D. to the Company's Board of Directors

  • FDA appointed Arthritis Advisory Committee recommended marketing approval for KRYSTEXXA

  • Presented six abstracts (two oral presentations and four posters) about KRYSTEXXA at the European League Against Rheumatism (EULAR) 2009 Annual Congress addressing various aspects of treatment failure gout.

  • Received a complete response letter from the FDA on July 31, 2009 stating that the FDA cannot at this time approve the BLA for KRYSTEXXA as a treatment for chronic gout in patients refractory to conventional therapy. The complete response letter cited deficiencies with the CMC section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS). We expect to resubmit our BLA to the FDA in early 2010 to respond to the FDA's complete response letter.

  • Received notification from the FDA of a tentative meeting date scheduled for mid-September 2009 to discuss the complete response letter issued by the FDA in response to the "Type A" Meeting request filed by the Company.

Financial Results of Operations for the Three Months Ended June 30, 2009

Total revenues for the second quarter of 2009 were $0.7 million compared with $0.4 million for the second quarter of 2008, an increase of $0.3 million. The increase is primarily the result of higher product sales of oxandrolone, our authorized generic product that promotes weight gain f
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SOURCE Savient Pharmaceuticals, Inc.
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