Healthcare Industry News:  vernakalant 

Biopharmaceuticals Cardiology Regulatory

 News Release - August 26, 2009

Marketing Application for Vernakalant Intravenous (IV) Filed in Europe for the Treatment of Atrial Fibrillation

WHITEHOUSE STATION, N.J., U.S.A.--(HSMN NewsFeed)--Merck & Co., Inc., Whitehouse Station, NJ, USA, which operates in many countries as Merck Sharp & Dohme Limited, announced today that the European Medicines Agency (EMEA) accepted for review the Company’s Marketing Authorisation Application (MAA) for regulatory approval of vernakalant intravenous (IV).

The proposed indication for vernakalant IV is for the treatment of acute atrial fibrillation, which is the most common cardiac arrhythmia (abnormal heart rhythm). Atrial fibrillation is the term used to describe an erratic and often rapid heart rate where the electrical activity of the heart's two small upper chambers (atria) is not coordinated, resulting in inefficient pumping of blood and an increased risk of developing a blood clot in the heart, which could lead to stroke.

"Acute atrial fibrillation represents a significant unmet medical need, particularly for older adults," said Stefan Oschmann, president, Europe, Middle East, Africa and Canada, Merck Global Human Health. “The decision by EMEA to review vernakalant IV represents an important milestone in our long history of developing novel therapeutics for cardiovascular disease.”

About vernakalant

vernakalant is an investigational compound being developed in two formulations, oral and IV, to address multiple unmet needs in the management of atrial fibrillation. vernakalant IV is being developed for rapid-acting cardioversion, or restoration of normal heart rhythm, of patients suffering from acute atrial fibrillation. vernakalant oral is being developed for daily maintenance of normal heart rhythm in patients with atrial fibrillation to prevent reoccurrence of atrial fibrillation. Oral vernakalant is currently in Phase II development.

Merck & Co., Inc. announced a collaboration and licensing agreement with Cardiome Pharma Corp. in April for the development and commercialization of vernakalant. The agreement provides Merck & Co., Inc. with exclusive global rights to the oral formulation of vernakalant, and provides the Merck affiliate, MSD Switzerland GmbH, exclusive rights to the I.V. formulation outside of the United States, Canada and Mexico.

About Atrial Fibrillation

Atrial fibrillation (AF) commonly leads to symptoms of fast heart rate or beat, palpitations, shortness of breath and weakness, and an increased risk of developing a blood clot in the heart. If a blood clot in the atria leaves the heart and becomes lodged in an artery in the brain, a stroke may result. About 15 percent of strokes occur in people with AF.

The risk of AF increases with age. The lifetime risk of developing AF at age 55 has been estimated at 24 percent in men and 22 percent in women. In addition, during the past 20 years, there has been a 60% increase in hospital admissions for AF independent of changes in known risk factors.

About Merck & Co., Inc.

Merck & Co., Inc. (Whitehouse Station, N.J., U.S.A.), which operates in many countries as Merck Sharp & Dohme or MSD, is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-looking statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.


Source: Merck

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