Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Progr...(h.D. Executive Vice President Developmen...),Health

Date:11/6/2008

h.D., Executive Vice President, Development and Chief Medical Officer of Cadence. "We continue to anticipate completing patient enrollment in the final clinical trial required to complete our Acetavance clinical development program, Study 352 evaluating pediatric safety, by the end of the year."

In addition, during the third quarter of 2008 Cadence completed patient enrollment in its clinical trial of Acetavance in patients undergoing abdominal laparoscopic surgery (Study 304). Although this trial is not required as part of the Acetavance NDA, the company continues to expect to report topline results from Study 304 in the fourth quarter of 2008.

During the third quarter of 2008, and as previously announced, Cadence also revised the expected timing of its announcement of results from the CLIRS trial, the company's Phase III clinical trial of Omigard, from the fourth quarter of 2008 to the first quarter of 2009. The revised timeline was prompted by ongoing discussions with the FDA regarding the statistical analysis plan for the CLIRS trial. These discussions, which are being conducted under a Special Protocol Assessment (SPA), must be completed prior to unblinding the data from the trial. If the trial is successful, Cadence plans to file an NDA for Omigard in the second quarter of 2009.

Financial Results

For the third quarter of 2008, Cadence reported a net loss of $13.7 million, or $0.36 per share, compared to a net loss of $13.0 million, or $0.45 per share, for the third quarter of 2007. For the nine months ended September 30, 2008, the company reported a net loss of $43.1 million, or $1.18 per share, compared to a net loss of $37.5 million, or $1.31 per share, for the nine months ended September 30, 2007.

As of September 30, 2008, Cadence held cash and cash equivalents of $61.1 million, which includes the net proceeds from a registered direct offering completed in the first quarter of 2008. As of September 30, 2008, the company's
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SOURCE Cadence Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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