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FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation
Date:12/11/2007

decisions are made by the FDA. An action further to the FDA review of KYNAPID is expected on or before January 19, 2008.

KYNAPID is the proposed brand name in North America for the intravenous formulation vernakalant hydrochloride, and has been provisionally accepted by the FDA. Final approval of provisionally accepted names is granted upon approval of the investigational drug. The NDA for KYNAPID, based on a five-year clinical development program, was submitted in December 2006 and accepted for review by the FDA in February 2007.

In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize KYNAPID in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, the U.S. and Mexico. Upon approval, KYNAPID will be marketed in the United States by Astellas Pharma US, Inc., a U.S. affiliate of Astellas Pharma Inc.

About Atrial Fibrillation

AF, the most common cardiac arrhythmia, is an interruption of the normal sinus rhythm (arrhythmia) of the heart in which the atria, the two uppermost chambers of the heart, beat irregularly and at an extremely rapid rate. During AF, rapid and uncoordinated electrical discharges are generated by the heart's natural pacemaker (sinoatrial node) and other parts of the atria. This causes ineffective contractions of the atria and reduces the ability of the heart to pump blood through the body. Symptoms include dizziness, heart palpitations, weakness, shortness of breath and angina (chest pain). If AF is left undiagnosed or untreated, life-threatening complications such as stroke can occur.(1)

The number of AF patients is expected to increase dramatically over the next 50 years due to an aging population, and the increased prevalence of risk factors including hypertension, obesity, diabetes and sleep apnea.(2)

About Cardiome

Cardiome Pharma Corp. is a product-focused cardiovascular drug development company w
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SOURCE Cardiome Pharma Corp.
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