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Savient Pharmaceuticals Reports Third Quarter 2009 Financial Results
Date:11/4/2009

EAST BRUNSWICK, N.J., Nov. 4 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today reported financial results for the three and nine months ended September 30, 2009, ending the quarter with $67.5 million in cash and short-term investments, a reduction of $11.1 million from December 31, 2008. In October 2009, we raised $60.9 million in cash, net of $4.8 million of offering costs from an underwritten public offering of 4,945,000 shares of our common stock. The effect of combining the offering with our existing cash brings Savient to approximately $128.4 million in cash and short-term investments as of September 30, 2009, on a pro forma basis.

"Our strengthened cash position will support future important initiatives in addition to our focused efforts for the resubmission of our Biologics License Application for KRYSTEXXA(TM) to the U.S. Food and Drug Administration for the treatment of chronic gout in patients refractory to conventional treatment, which we expect will be submitted in early 2010," stated Paul Hamelin, President of Savient.

Operational Key Events:

  • During July 2009, we completed the dosing phase of our open label extension (OLE) study for KRYSTEXXA. This study is currently in an observation only stage.
  • In July 2009, we received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) stating that the FDA at that time could not approve our Biologics License Application (BLA) for KRYSTEXXA. The complete response letter cited deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided a draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS).
  • Our requested Type A meeting with the FDA occurred on
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SOURCE Savient Pharmaceuticals, Inc.
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