Recently, Bristol-Myers Squibb Company (BMY) and partner Pfizer Inc. (PFE) announced encouraging data from a phase III study (AMPLIFY-EXT: n=2,486), which evaluated their anti-clotting drug Eliquis (apixaban) for the prevention of recurrent venous thromboembolism (VTE). The randomized, double-blind, multicenter study evaluated the drug across two doses - 2.5 mg and 5 mg versus placebo in patients, who had been previously treated for VTE. VTE includes deep vein thrombosis (DVT) and pulmonary embolism (PE).
We note that thrombosis refers to the formation of a blood clot inside a blood vessel, thereby blocking a vein (venous thrombosis) or artery (arterial thrombosis). DVT refers to a condition in which blood clots are formed in one of the large, deep veins, usually in the legs. PE is a condition, where a blood clot blocks one or more vessels in the lungs
Data from the year-long phase III study, published in the New England Journal of Medicine, revealed that treatment with Eliquis significantly reduced the recurrence of VTE and death from any cause compared to those treated with placebo. The rate of recurrence or death in the placebo arm was observed to be 11.6% as opposed to 3.8% for patients treated with Eliquis (2.5 mg) and 4.2% for those treated with 5 mg of Eliquis. Moreover, data from the study also revealed that the rate of major bleeding was comparable across all cohorts.
We remind investors that Eliquis was cleared in the EU last year for preventing VTE in adults, who have undergone elective hip or knee replacement surgery. Last month, Eliquis was approved in the EU for preventing strokes and systemic embolism in adults suffering from nonvalvular atrial fibrillation (NVAF) along with one or more risk factors for stroke. Atrial fibrillation refers to a cardiac rhythm disorder characterized by an erratic heartbeat.
We note that the US approval process of Eliquis for the NVAF indication is on track. The US Food and Drug Administration (FDA) is expected to decide on whether to approve Eliquis for the indication by March 17, 2013. Positive news from the FDA would boost the sales potential of the drug.
Neutral on Bristol-Myers/Pfizer
Currently, we have a long-term Neutral recommendation on Bristol-Myers. The stock carries a Zacks #3 Rank (Hold rating) in the short run. We have a similar stance on Pfizer.
Today, at 11:20 AM PT: Get the Market Movements in Advance; Williams Edge Webinar for July 29th, 2014 | John Ransom
Today, at 11:20 AM PT: Get the Market Movements in Advance; Williams Edge Webinar for July 28th, 2014 | John Ransom