Bristol-Myers Squibb Company
) and partner,
) received some encouraging news with the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) recommending the approval of their anti-clotting drug
The European Commission (EC) will take the final decision on
Eliquis' approval after reviewing the CHMP's opinion. The EC's
decision will be binding on the 27 member states of the EU in
addition to Iceland and Norway.
We note that Bristol-Myers and Pfizer intend to get the blood
thinner approved in the EU for preventing strokes and systemic
embolism in patients suffering from nonvalvular atrial fibrillation
(NVAF) in addition to one or more risk factors for stroke. Atrial
fibrillation refers to a cardiac rhythm disorder characterized by
an erratic heartbeat.
The positive opinion of the CHMP was based on data from two phase
III studies, ARISTOTLE and AVERROES. The studies evaluated
approximately 24,000 patients suffering from NVAF.
We expect a hiccup-free approval for Eliquis for the NVAF
indication in the EU unlike in the US. In June 2012, the US Food
and Drug Administration (FDA) declined to approve Eliquis on the
basis of the submitted data.
The US regulatory body issued a complete response letter (CRL)
to the companies after reviewing the new drug application for
Eliquis submitted last year. While issuing the CRL, the FDA asked
for additional information on data management and verification from
the ARISTOTLE study.
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Even if Eliquis manages to gain approval, it would face intense
competition in the anti-coagulant market on approval. Eliquis will
have to compete with
Johnson & Johnson'
) blood-thinner Xarelto. Moreover, the arrival of Boehringer
Ingelheim's Pradaxa has intensified competition in the market.
We remind investors that Eliquis was cleared in the EU last year
for preventing venous thromboembolic events (VTE) in adults, who
have undergone elective hip or knee replacement surgery. However,
the atrial fibrillation market is more lucrative.
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.