* Analysts: good chance for speedy FDA review of clot drug
* Priority review could suggest unique drug attributes
* FDA, Bristol-Myers, Pfizer decline comment
By Ransdell Pierson
Nov 16 Eliquis, a promising blood clot
preventer from Bristol-Myers Squibb and Pfizer, has a decent
chance at getting an accelerated review by U.S. health
regulators in coming months, industry analysts said.
Bristol-Myers and Pfizer plan to submit
their application to the U.S. Food and Drug Administration by
The experimental pill was shown in clinical trials to be
safer and more effective than warfarin, a widely used oral
anticoagulant, in preventing strokes among patients with an
irregular heartbeat called atrial fibrillation.
The FDA typically takes 10 months or longer to review new
drug applications, but could render a decision on Eliquis
within six months under an expedited review.
"That would be a major coup for the drug, from a Wall
Street perspective," said Barclays Capital analyst Tony Butler,
who predicted shares of both Bristol-Myers and Pfizer could
each rise as much as $1 on news of a so-called "priority
review" of the drug.
"The assumption would be that there's something unique
about this product, compared to drugs that are currently
available in the marketplace" Butler said.
Two other new blood-clot drugs, Boehringer Ingelheim's
Pradaxa, and Xarelto from Bayer and Johnson &
Johnson , were recently approved in standard FDA
They have shown benefits over warfarin but are not deemed
safer in terms of overall bleeding risk. Neither of them has
reduced overall risk of death as Eliquis has demonstrated.
"Bristol-Myers and Pfizer will go for an expedited review
if they can; I don't think the other companies' data were
strong enough to even ask for one," said Atlantic Equities
analyst Richard Purkiss.
The FDA, Bristol-Myers and Pfizer all declined to comment
on the prospects of a priority review.
Purkiss said a quicker review might elevate Eliquis in the
minds of some cardiologists. But he cautioned that the FDA
might be hard-pressed to complete its review so quickly given
the volume of data from various clinical trials.
Michael Liss, portfolio manager of American Century
Investments, said he thinks there is a 50/50 chance the FDA
will grant an expedited review. "It's a flip of the coin."
Bristol-Myers and Pfizer shares would get a small bump --
of maybe one percent -- in the event of an expedited review
because the shares have outperformed this year, he said.
Bristol Myers shares, now trading in the $31 range, have
jumped 17 percent this year, bolstered by high hopes for
Eliquis and other new drugs, including its Yervoy treatment for
melanoma. Pfizer shares, now in the $20 range, have risen 12
percent, compared with an overall average gain of about 3
percent for large U.S. and European drugmakers.
The FDA in late 2010 approved Pradaxa, which works by
directly blocking thrombin, a protein involved in the clotting
process. The agency earlier this month approved Xarelto which,
like Eliquis, blocks a protein called Factor Xa.
Wall Street is expecting the three new drugs to capture
combined sales of more than $10 billion in coming years, a boon
for an industry suffering from generic competition and efforts
by insurers to keep a lid on drug prices.
Dr. Jeffrey Berger, who heads treatment and prevention of
cardiovascular blood clots at New York University Langone
Medical Center, said the data for Eliquis are "compelling."
But he said Eliquis cannot yet be considered the superior
drug for preventing strokes because no trials have been done to
compare it, Xarelto and Pradaxa with each other.
"All three drugs have significant advantages compared with
warfarin," he said, arguing that the FDA should take its time
on the Eliquis review if it needs to.
"We have to tread a little slowly because it's important
for regulatory agencies to adequately understand the benefit
and risks and to help educate the public on the different
mechanisms and different effects of different drugs," Berger
More than 2 million Americans have atrial fibrillation, an
irregular heartbeat that causes blood to pool in the heart and
form clots that can cause strokes.
Many patients are unwilling or unable to take warfarin
because of dietary requirements, bleeding risk, conflicts with
other medicines and the need for regular testing to assure the
right concentrations of warfarin are in their bloodstream.