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Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strategic Advisor
Date:3/17/2008

NASDAQ: CRME TSX: COM

VANCOUVER, March 17 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) today announced positive interim clinical results from its 90-day Phase 2b study of vernakalant (oral). The interim analysis demonstrated statistically significant efficacy for the patient group receiving 500mg b.i.d. of vernakalant (oral) as compared to placebo. The safety data from the interim analysis also suggests that vernakalant (oral) was well-tolerated in the atrial fibrillation population studied during the dosing period under analysis.

A Kaplan-Meier analysis of the 446 patients included in the interim dataset demonstrated a significant efficacy benefit for the 500mg dosing group as compared to placebo (two-sided, p<0.05). Median time to recurrence of atrial fibrillation was greater than 90 days for the 500mg dosing group, compared to 39 days for the placebo group. 52% of patients in the 500mg dosing group (n=110) completed the study in normal heart rhythm compared to 39% of patients receiving placebo (n=118). The interim efficacy analysis for the 150mg (n=110) and 300mg (n=108) dosing groups had not achieved statistical significance at the interim timepoint.

"This larger-scale, longer-term study of vernakalant (oral) was designed to find the appropriate dose to take into Phase 3, and to confirm our assumptions regarding safety," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "While the study is ongoing and we must await the final data before drawing conclusions, these statistically significant and clinically significant efficacy results as well as the attractive safety profile observed in this interim analysis strongly support our belief in the exciting potential of vernakalant (oral) as a therapy for atrial fibrillation."

The safety data for all dosing groups suggests that vernakalant (oral) was well-tolerated within the interim safety populatio
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SOURCE Cardiome Pharma Corp.
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