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Circulation Publishes Data Showing KYNAPID(TM) (Vernakalant Hydrochloride) Injection Rapidly Converted Short-Duration Atrial Fibrillation to Sinus Rhythm
Date:3/25/2008

DEERFIELD, Ill. and VANCOUVER, British Columbia, March 25 /PRNewswire-FirstCall/ -- Astellas Pharma US, Inc. and its co-development partner Cardiome Pharma Corp. (Nasdaq: CRME; TSX: COM) announced the first pivotal Phase III study evaluating the investigational agent KYNAPID(TM) (vernakalant hydrochloride) Injection was published today in Circulation, the official journal of the American Heart Association.

In the study, known as the Atrial arrhythmia Conversion Trial (ACT I), the primary efficacy analysis showed that 75 of the 145 (51.7%) KYNAPID patients in the short-duration atrial fibrillation (AF) group (3 hours to 7 days) converted to sinus rhythm within 90 minutes compared with 3 of the 75 (4.0%) placebo patients. Patients with AF lasting 3 to 48 hours who received KYNAPID demonstrated the highest conversion rate (62.1%) compared with 4.9% with placebo. The median time to conversion to sinus rhythm for the 75 patients receiving KYNAPID who converted was 11 minutes. Only 1 of the 75 KYNAPID-treated patients who converted to sinus rhythm relapsed to AF at 24 hours.

"Due to the importance of treating AF quickly, we're pleased that KYNAPID displayed such a rapid conversion of AF to sinus rhythm," said Edward Pritchett, MD, Consulting Professor of Medicine, Divisions of Cardiology and Clinical Pharmacology, Duke University Medical Center and consultant for Astellas Pharma US.

About ACT I

The Phase III study, referred to as ACT I, was a prospective, randomized, double-blind, placebo-controlled trial of hemodynamically stable patients with symptomatic AF or nontypical atrial flutter, conducted at 44 sites in Canada, the United States and Scandinavia. The study assessed the safety and efficacy of KYNAPID for the
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SOURCE Astellas Pharma US, Inc.
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