) and partner,
), suffered a setback when the US Food and Drug Administration
(FDA) declined to approve their anti-clotting drug Eliquis
(apixaban) on the basis of the submitted data. The news had a
negative impact on the companies' shares.
We note that Bristol-Myers and Pfizer are looking to get the
blood thinner approved in the US for preventing strokes and
systemic embolism in patients suffering from nonvalvular atrial
fibrillation (AF). AF refers to a cardiac rhythm disorder
characterized by an erratic heartbeat.
The US regulatory body issued a complete response letter (CRL)
to the companies after reviewing the new drug application (NDA) for
Eliquis submitted last year. The NDA included data from two phase
III studies, ARISTOTLE and AVERROES.
While issuing the CRL, the FDA asked for additional information
on data management and verification from the ARISTOTLE study.
However, the US regulatory body did not ask the companies to
conduct additional studies with Eliquis. The requirement of
additional trials would have pushed up their research and
In February 2012, the FDA pushed back its originally assigned
target date of March 28, 2012 by three months to June 28. However,
the FDA came to a conclusion and issued a CRL to the companies a
few days ahead of the newly assigned target date. Bristol-Myers and
Pfizer intend to work closely with the FDA regarding the future of
Eliquis. Eliquis is under review for the AF indication in ex-US
markets such as the EU and Japan.
Even if Eliquis ultimately manages to gain FDA 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 AF market is more lucrative.
Neutral on Bristol-Myers/Pfizer
Currently, we have long-term Neutral recommendations on both
Bristol-Myers and Pfizer. However, the companies carry different
ranks in the short-term. While Bristol-Myers carries a Zacks #4
Rank (Sell rating), Pfizer carries a Zacks #3 Rank (Hold
BAYER A G -ADR (BAYRY): Free Stock Analysis
BRISTOL-MYERS (BMY): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
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