Bristol-Myers Squibb Company
) and partner
) 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)
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
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
The Medicines Company
). Both companies sport a Zacks Rank #1 (Strong Buy).
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