Recently,
Bristol-Myers Squibb Company
(
BMY
) and
Pfizer Inc
. (
PFE
) announced that their anti-clotting drug Eliquis (apixaban) will
be reviewed on a priority basis by the US Food and Drug
Administration (FDA). A decision from the US regulatory body is
expected in the first quarter of 2012 (target date: March 28,
2012).
We note that the US regulatory authority generally reviews those
drugs on a priority basis which offer major advances in treating
diseases that do not have adequate therapy. Applications for
priority review designated drugs are reviewed by the FDA within six
months of submission as against the usual ten months.
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 atrial fibrillation (
AF
). AF refers to a cardiac rhythm disorder characterized by an
erratic heartbeat.
The FDA accepted the new drug application (NDA) for Eliquis on
the basis of positive results from two late-stage trials, ARISTOTLE
and AVERROES. The studies evaluated the efficacy and safety of the
drug for preventing stroke or systemic embolism in approximately
24,000 AF patients.
We remind investors that Eliquis was cleared in the EU earlier
in the 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 and the drug is under
review in Europe for the AF indication.
Since Eliquis offers multi-billion dollar sales potential, we
believe if the candidate is approved for the AF indication then it
would be a major boost for Bristol-Myers/Pfizer's top line.
However, Eliquis would face intense competition in the
anti-coagulant market on approval. Eliquis will have to
compete with
Bayer
/
Johnson & Johnson
'
s(
BAYRY
/
JNJ
) blood-thinner Xarelto. Moreover, the arrival of Boehringer
Ingelheim's Pradaxa has intensified competition in the market.
Our Recommendation
Currently, we have a long-term "Neutral " recommendation on
Bristol-Myers, which carries a Zacks #3 Rank (short-term "Hold"
rating).
While our long-term recommendation on Pfizer is similar, the
shares of the company carry a Zacks #2 Rank ("Buy" rating) in the
short-run. While near-term earnings growth at Pfizer will come in
the form of cost cutting and share repurchases, longer-term growth
will be dependent on the success of drug development.
BAYER A G -ADR (
BAYRY
): Free Stock Analysis Report
BRISTOL-MYERS (
BMY
): Free Stock Analysis Report
JOHNSON & JOHNS (
JNJ
): Free Stock Analysis Report
PFIZER INC (
PFE
): Free Stock Analysis Report
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