Recently, Bristol-Myers Squibb Company (BMY) and partner Pfizer (PFE) announced encouraging data from a late-stage study (ARISTOTLE: n=18,201) which evaluated their blood thinner Eliquis (apixaban) in patients suffering from erratic heartbeat and carrying at least one additional risk factor for stroke. The cardiac rhythm disorder is referred to as atrial fibrillation (AF).
Bristol-Myers and Pfizer presented detailed data from the study at the European Society of Cardiology. Topline results were presented in June 2011. Apixaban will be marketed under the trade name Eliquis in the EU. The same trade name has been proposed in the US.
Data from the randomized, double-blind, multicenter study revealed that Eliquis was non-inferior to the standard therapy warfarin in reducing the risk of stroke or systemic embolism. Patients treated with Eliquis were 21% less likely to suffer strokes compared to those treated with warfarin.
Moreover, data from the ARISTOTLE study also demonstrated that the risks of major bleeding and death were 31% and 11% respectively lower in patients treated with Eliquis compared to those treated with warfarin.
We remind investors that in May 2011, the European Commission cleared Eliquis in the European Union for preventing venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery. This marked the first approval for Eliquis, a new oral direct factor Xa inhibitor.
We note that if Eliquis hits the market for the AF indication then it will compete primarily with Boehringer Ingelheim's Pradaxa . Moreover, Johnson & Johnson / Bayer’s (JNJ/BAYRY) Xarelto will also provide Eliquis tough competition on approval for the indication.
Bristol-Myers is looking to strengthen its product portfolio by launching new drugs to make up for the loss of revenues that is feared on the impending genericization of key drugs at Bristol-Myers, including the blockbuster blood-thinner Plavix. Plavix has been co-developed with Sanofi-Aventis (SNY).
Bristol-Myers has met with a fair amount of success this year towards achieving this objective. The approvals of key drugs in 2011, such as Yervoy, Nulojix and the subcutaneous formulation of Orencia in the US and Eliquis in the EU are major boosts for the company.
Moreover, Bristol-Myers has a robust pipeline. The pipeline, on successful development and commercialization, will boost the pharma major’s top line significantly.
Our Recommendation
We have a Neutral stance on Bristol-Myers. The stock carries a Zacks #3 Rank (Hold rating) in the short run. We are also Neutral on Pfizer which carries a Zacks #3 Rank.
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