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Additional Clinical Trial to be Conducted for KYNAPID Under FDA Special Protocol Agreement
Date:8/10/2009 

    NASDAQ: CRME   TSX: COM

VANCOUVER and DEERFIELD, IL, Aug. 10 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") announced today that Astellas will undertake a single confirmatory additional Phase 3 clinical trial of KYNAPID(TM) (vernakalant hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus rhythm. The trial, to be called ACT 5, is expected to begin enrolling patients by the end of 2009, with completion expected in the first half of 2011.

The decision to conduct another trial was reached following extended discussions with the FDA to define the best regulatory path forward for KYNAPID. Under the Special Protocol Assessment (SPA) process, the FDA has agreed that the design and planned analysis of the study adequately address objectives in support of the KYNAPID New Drug Application (NDA). The prospectively-defined trial will enroll recent-onset atrial fibrillation patients without a history of heart failure. Cardiome and Astellas believe that this study, coupled with the overall clinical development program, should in principle meet the FDA standards for approval.

"In addition to receiving a positive recommendation for approval from the FDA Cardiovascular and Renal Drugs Advisory Committee, KYNAPID has demonstrated consistent results across all of the four completed Phase 3 clinical trials," said William E. Fitzsimmons, PharmD, Senior Vice President, Development at Astellas. "We are confident that the ACT 5 trial will confirm these prior results and further demonstrate the therapeutic value of this exciting drug candidate."

"We support the decision to conduct the ACT 5 trial, and we will assist our partner Astellas in every way to expedite the launch and successful completion of this study," said Doug Janzen, President and Chief Executive Officer of Cardiome. "We estimate that Cardiome's alloca
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SOURCE Cardiome Pharma Corp.
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