Recently, Bristol-Myers Squibb Company (BMY) and partner Pfizer (PFE) announced encouraging top line data from a late-stage study (ARISTOTLE: n=18,201) which evaluated their blood thinner apixaban in patients suffering from an erratic heartbeat. This cardiac rhythm disorder is referred to as atrial fibrillation (AF).
Apixaban will be marketed under the trade name Eliquis in the EU. The same trade name has been proposed in the US and other countries.
Top-line results from the double-blind, multicenter study revealed that Eliquis was non-inferior to the standard therapy warfarin with respect to the combined outcome of stroke and systemic embolism. Data further revealed that Eliquis was superior to warfarin with respect to effectiveness and major bleeding.
Bristol-Myers and Pfizer intend to seek approval from the US Food and Drug Administration (FDA) and also from the European Commission (EC) in the second half of this year for the AF indication. The co-developers intend to present detailed data from the study at the European Society of Cardiology in August this year.
If Eliquis manages to clear the regulatory hurdles then it will compete primarily with Boehringer Ingelheim’s Pradaxa (approved in October, 2010) in the AF market. Moreover, Johnson & Johnson / Bayer’s (JNJ/BAYRY) Xarelto will also provide Eliquis tough competition on approval for the indication.
We remind investors that in May 2011, the EC cleared Eliquis in the European Union (EU) 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.
Bristol-Myers is looking to strengthen its product portfolio by launching new drugs to make up for the loss of revenues due to 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 key products approved this year include Eliquis in the EU (referred to above), Yervoy in the US (skin-cancer) and Nulojix in the US (kidney transplant).
Moreover, Bristol-Myers has two key action dates coming up this year. The FDA is scheduled to decide by August 4, 2011, on a subcutaneous formulation of Orencia for treating adults suffering from moderate-to-severe rheumatoid arthritis.
Furthermore, the US regulatory body is expected to decide on dapagliflozin, co-developed with AstraZeneca (AZN), for treating adults suffering from type II diabetes by October 28, 2011. Positive news from the FDA regarding the candidates coupled with the new launches mentioned above should drive growth in the coming years.
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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