Recently, an advisory panel of the European Medicines Agency (EMA) delivered a positive opinion regarding the European approval of Bristol-Myers’ (BMY) blood-thinner Eliquis (apixaban).
Eliquis, co-developed with Pfizer Inc. (PFE), won the backing of the advisory panel, committee for medicinal products for human use, for preventing venous thromboembolic events in adults (VTE) who have undergone elective hip or knee replacement surgery.
The advisory panel recommended the European approval of the blood-thinner on the basis of the safety and efficacy data submitted by the co-developers. The panel believed that benefits associated with Eliquis therapy outweighed the risks. We believe that if the European regulatory authorities approve Eliquis, which will primarily compete with Bayer’s (BAYRY.PK) Xarelto, then the top-line at Bristol-Myers would be boosted significantly.
We remind investors that a key target date is coming up later this month at Bristol-Myers. The US Food and Drug Administration (FDA) is scheduled to decide on the Bristol-Myers’ advanced melanoma candidate, ipilimumab, on March 26, 2011. Ipilimumab’s approval would be a major boost for the company.
Our Take & Recommendation
We currently have a ‘Neutral’ recommendation on Bristol-Myers, which is supported by a Zacks #3 Rank (short-term ‘Hold’ rating). Our biggest concern for the company is the high exposure to generic risk on many of its leading franchises.
However, the company has already taken measures like the extension of the Abilify agreement with Otsuka, the acquisition of ZymoGenetics and Medarex to combat the threat of generics hanging over it. Moreover, the company intends to launch five compounds -- apixaban, belatacept, brivanib, dapagliflozin and ipilimumab -- by 2012.
Given the present scenario, we believe the ipilimumab launch could occur before 2012. The new launches are expected to drive growth in 2013 and beyond. We expect the company to look to grow revenue through partnering deals and acquisitions.
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