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Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Programs Update
Date:11/6/2008

SAN DIEGO, Nov. 6 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today reported financial results for the third quarter and nine months ended September 30, 2008.

The company also provided an update on the clinical development programs for its two Phase III product candidates -- Acetavance(TM), an intravenous formulation of acetaminophen for the treatment of acute pain and fever, and Omigard(TM), a topical antimicrobial gel for the prevention of catheter-related infections.

"During the third quarter of 2008, and as previously announced, the Food and Drug Administration (FDA) accepted our revised clinical development plan for Acetavance," stated Ted Schroeder, President and Chief Executive Officer of Cadence. "The FDA indicated that two previously completed clinical efficacy trials, the Sinatra Study in patients with moderate-to-severe post-operative pain and Study 302 in adult fever, will be sufficient to meet the pivotal clinical trial requirements for submission of a New Drug Application (NDA) for Acetavance. Consequently, during the remainder of the third quarter, we focused on advancing key clinical, regulatory and manufacturing activities towards our goal of filing the Acetavance NDA in the second quarter of 2009."

"We are pleased to report that during the third quarter of 2008, we completed patient enrollment in two of the three clinical trials remaining to complete our clinical development program for Acetavance -- Study 351, an adult safety trial, and Study 102, a pediatric pharmacokinetic trial," stated James Breitmeyer, M.D., P
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SOURCE Cadence Pharmaceuticals, Inc.
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