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Bristol-Myers/Pfizer Commence Phase IV Study on Eliquis

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Bristol-Myers Squibb Company (BMY - Free Report) and partner Pfizer Inc. (PFE - Free Report) announced the initiation of enrollment in a phase IV study (EMANATE: n~1,500) on their blood thinner Eliquis. The study is designed to evaluate the safety and efficacy of the drug in patients suffering from nonvalvular atrial fibrillation (NVAF) undergoing cardioversion.

The patients in this randomized, open-label study will be enrolled from the U.S., Canada, Europe and Asia. They will be randomized 1:1 to Eliquis or the standard of care, administered for up to 30 days following early cardioversion or 90 days after randomization if cardioversion is not done within the timeframe. The occurrence of acute stroke, systemic embolism and all-cause death are the primary efficacy endpoints of the study. Primary safety objectives of the trial are major bleeding and clinically relevant non-major bleeding.

We note that Eliquis is already marketed in a number of countries across the globe to reduce the risk of stroke and systemic embolism in NVAF patients. The companies are looking to expand Eliquis’ label to include the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE (U.S. target date: Aug 25, 2014, under review in the EU). Successful label expansion would boost the sales potential of the drug, which recorded modest sales of $106 million in the first quarter of 2014.

Bristol-Myers carries a Zacks Rank #3 (Hold). Pfizer is a Zacks Ranked #2 (Buy) stock. Better ranked stocks in the health care space include Actelion and The Medicines Company (MDCO - Free Report) . Both companies sport a Zacks Rank #1 (Strong Buy).

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