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Merck Plans To File Regulatory Applications For Vorapaxar, Tredaptive In 2013

Healthcare giant Merck & Co., Inc. (MRK) Sunday provided an update on development programs for vorapaxar, extended release niacin/laropirprant (MK524A, Tredaptive) and anacetrapib in association with the European Society of Cardiology meeting in Munich.

Jeff Chodakewitz, senior vice president, Late Stage Development, Merck Research Laboratories stated, "The clinical outcomes studies for these three medicines have involved or will involve more than 90,000 patients around the world. All of these studies are designed to address the important question of whether, by adding these medicines to the current standard of care, we can further reduce the risk of cardiovascular events."

"Merck remains committed to research to bring forward innovations in cardiovascular disease, which remains the leading cause of death worldwide," Chodakewitz noted.

The company noted that following a review of clinical trial data and discussions with external experts, it now plans to file applications for vorapaxar, an investigational anti-thrombotic medicine in the U.S., and the European Union in 2013.

Merck plans to seek an indication for the prevention of cardiovascular events in patients with a history of heart attack and no history of transient ischemic attack or stroke.

The company confirmed that the study of extended release niacin/laropiprant (MK-524A, Tredaptive) is on track to complete later this year and plans to file in the U.S., and the European Union in 2013.

Laropiprant is used in combination with niacin to reduce blood cholesterol.

Merck also today provided information about a different method to more accurately measure low-density-lipoprotein cholesterol, or LDL-C when patients are treated with anacetrapib, an investigational CETP-inhibitor.

Based on this method, called beta-quantification, anacetrapib 100 mg daily resulted in LDL-C reductions of about 25 to 35 percent, compared to 40 percent reduction previously reported from the Determining the EFficacy and Tolerability of CETP INhibiition with AnacEtrapib, or DEFINE study and other anacetrapib studies.

According to the company, the researchers believe that these initial results indicate that the beta-quantification method provides a more accurate measure of LDL-C after treatment with anacetrapib.

MRK closed Friday's regular trading at $43.12 on the NYSE.

by RTT Staff Writer

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