Bristol-Myers Squibb Company ( BMY ) and partner Pfizer Inc. ( PFE ) recently presented encouraging data on their drug Eliquis (apixaban) from a phase III study (AMPLIFY: n=5,395). The randomized, double-blind, multicenter six-month study evaluated Eliquis as a monotherapy versus the standard of care ( Sanofi 's ( SNY ) Lovenox (enoxaparin) and warfarin) in patients suffering from acute venous thromboembolism (VTE), which includes symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Data from the study revealed the noninferiority of Eliquis to the current standard of care in the reduction of the composite endpoint of recurrent symptomatic VTE or death related to VTE. Data from the study further revealed that major bleeding was witnessed in fewer patients in the Eliquis arm compared to those treated with the standard of care. Results from the study were published in the New England Journal of Medicine (NEJM).
Bristol-Myers/Pfizer intend to seek regulatory approvals for Eliquis for the initial and long-term treatment of VTE and for extended prevention of recurrent VTE based on data from the AMPLIFY, as well as AMPLIFY-EXT studies. We note that results from the AMPLIFY-EXT study were published in the NEJM late last year.
We note that Eliquis is already approved for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in multiple countries including the US. Eliquis is also approved in the EU and some other nations for prevention of VTE events in adults, who have undergone elective hip or knee replacement surgery.
While Bristol-Myers carries a Zacks Rank #4 (Sell) reflecting short-term pressure on the stock, Pfizer carries a Zacks Rank #3 (Hold). Novo Nordisk ( NVO ) appears to be more attractive with a Zacks Rank #2 (Buy).