EMEA Accepts Merck’s Application

We are pleased to hear that the European Medicines Agency (EMEA) has agreed to review the Marketing Authorization Application (MAA) of Merck’s (MRK - Analyst Report) vernakalant intravenous (IV). The company is seeking EMEA approval for the drug to address the unmet need for patients suffering from acute atrial fibrillation (AF, abnormal heart rhythms leading to strokes).

Along with the IV version, Merck is also developing the oral form of the drug, which is currently in phase II development.

In April 2009, Merck entered into a collaboration and licensing agreement with Cardiome Pharma Corp. in order to develop and commercialize vernakalant. While Merck retains the exclusive global rights to the oral formulation of vernakalant, its affiliate, MSD Switzerland GmbH gets the rights to the IV formulation outside the US, Canada and Mexico.

Atrial fibrillation is the most common heart rhythm abnormality in the US, accounting for one out of every three hospitalizations for irregular heart beat. The prevalence of this disease is expected to increase manifold in future primarily reflecting the growing population of elderly individuals. It increases the risk of stroke (about 15% of AF patients suffer from strokes), worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality (death). Total annual costs for the treatment of AF are estimated to be more than U.S. $6.65 billion.

In July 2009, the US Food and Drug Administration (FDA) approved Sanofi-Aventis’ (SNY - Analyst Report) Multaq, the first new drug for AF to be approved in a decade. Sanofi has yet to get approval in the European Union, which is quite crucial for the company since the European market is comparatively bigger (about 4.5 million patients) than the US (about 2.5 million). The EMEA approval for vernakalant will be a major milestone for Merck as there is significant unmet medical need for acute AF patients, especially for older adults.

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