Cadence Pharmaceuticals Finalizes Agreement with FDA on Special Protocol Assessment for Confirmatory Phase III Trial of CPI-226 for Catheter-Related Infections.

SAN DIEGO -- Cadence Pharmaceuticals, Inc., a hospital-focused specialty pharmaceutical company, announced today that the company and the U.S. Food and Drug Administration (FDA) have reached written agreement on a protocol for a clinical trial of CPI-226 (omiganan 1% gel) which, if successful, would support the approval of CPI-226 for the prevention of catheter-related infections. This agreement was reached under the FDA's special protocol assessment (SPA) process.

"We are delighted to have reached agreement with the FDA for a single confirmatory phase III study required for approval, which we expect to initiate in the third quarter," said Ted Schroeder, President and Chief Executive Officer of Cadence Pharmaceuticals.

The confirmatory Phase III trial will be a multi-national, randomized, Evaluation Committee-blinded study to evaluate the effectiveness of CPI-226 vs. 10% povidone-iodine for the prevention of catheter-related infections in approximately 1,250 hospitalized patients with central venous catheters. The primary efficacy endpoint of the study will be the incidence of local catheter site infections. Other objectives of this study include gathering additional safety data on CPI-226 and assessing the effectiveness of CPI-226 on the prevention of catheter colonization.

"Catheter-related infections -- a leading cause of hospital-acquired infections -- are associated with significant morbidity, mortality, and cost burden on the healthcare system. CPI-226 is being developed to address this significant unmet medical need," noted Kenneth Heilbrunn, M.D., Chief Medical Officer of Cadence Pharmaceuticals.

The SPA creates a written agreement between the FDA and sponsoring company regarding clinical trial design, endpoints, study conduct, data analysis, and other elements of the study protocol. It is intended to provide agreement that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, the SPA is considered binding on both the FDA and the study sponsor.

About Cadence Pharmaceuticals, Inc.

Cadence Pharmaceuticals, Inc. is a San Diego-based specialty pharmaceutical company focused on the development and commercialization of therapeutics utilized primarily in the hospital setting. The business of Cadence is driven by in-licensing and acquisition of late-stage development compounds and commercial-stage drugs. Cadence is backed by a syndicate of leading healthcare-focused venture capital firms, including Domain Associates, ProQuest Investments, and Windamere Venture Partners.

For more information, contact Ted Schroeder, President and CEO, at 858-436-1410, or visit our website at www.cadencepharm.com.

Cadence cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Cadence that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Cadence's business, including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing, and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement and Cadence undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.