Vancouver, Canada, October 19, 2005 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. today announced the initiation of an open-label safety study of intravenous RSD1235 for the acute treatment of atrial fibrillation. The study, called ACT 4 (Atrial arrhythmia Conversion Trial 4) will evaluate the safety of intravenous RSD1235 in approximately 120 atrial fibrillation patients. There is no placebo or active control group in the study, which is being conducted by Astellas and carried out across approximately 30 centers in the U.S., Canada, and Europe. ACT 4 is primarily a safety study and it is anticipated that the added safety data will supplement the pivotal ACT 1 and ACT 3 trial results.
“Results from our ACT 1 and ACT 3 trials have established a promising efficacy and safety profile for RSD1235 IV,” stated Bob Rieder, President and CEO of Cardiome. “Our objective for this additional study is to ensure that we submit the most robust NDA possible within our stated timeline. With this study, we can enlarge our safety database and accomplish that goal efficiently.”
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with three clinical drug programs, two of which focus on atrial arrhythmia (intravenous and oral dosing) and one directed at congestive heart failure.
RSD1235 IV is the intravenous formulation of an investigational drug being evaluated for the acute treatment of recent-onset atrial fibrillation (AF). Positive top-line results from two Phase 3 trials for RSD1235 IV, called ACT 1 and ACT 3, were released in December 2004 and September 2005. The ACT 2 study, evaluating patients with post-operative atrial arrhythmia, is ongoing. RSD1235 also has a potential application as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF.
Cardiome recently completed a Phase 2 clinical trial evaluating the safety and effectiveness of oxypurinol, a xanthine oxidase inhibitor, for the treatment of congestive heart failure (CHF). Top-line results from this trial were negative. Cardiome is in the process of analyzing the entire data package from the trial prior to making any decision regarding the program.
Cardiome recently announced that it has executed a letter of intent to acquire Artesian Therapeutics Inc., a privately held U.S. biopharmaceutical company developing bi-functional small-molecule drugs for the treatment of cardiovascular disease.
Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.
Astellas Pharma US, Inc., a US subsidiary of Tokyo-based Astellas Pharma Inc., is a research based pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Established on April 1, 2005, the company was formed through a merger that combined the outstanding research, development and marketing capabilities of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. Astellas ranks among the top 20 pharmaceutical companies in the world and will continue to grow as a competitive company in the world pharmaceutical market.
For more information on Astellas Pharma US, Inc., go to www.astellas.com/us.
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