* 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 (Reuters) - 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 year’s end.
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 reviews.
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 said.
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.