FDA delays decision on Pfizer, Bristol-Myers drug

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Associated Press

Posted on June 25, 2012 at 4:01 PM

Updated Tuesday, Jun 26 at 3:00 AM

TRENTON, N.J. (AP) — Shares of Pfizer Inc. and Bristol-Myers Squibb Co. fell Monday after federal regulators unexpectedly delayed for a second time a decision on whether to approve the companies' highly touted experimental anticlotting drug Eliquis.

Some analysts see Eliquis as better than two new clot-preventing pills that beat it to market, but the latest delay means a U.S. launch of Eliquis likely won't happen until next year.

The Food and Drug Administration said it wants more information on "data management and verification" from a huge international study called ARISTOTLE that examined how well Eliquis prevented strokes in patients with an irregular heartbeat called atrial fibrillation, the drugmakers said Monday.

The companies said the FDA did not ask for new studies, and they plan to work quickly to address outstanding questions. Even so, a spokeswoman for New York-based Bristol-Myers said the agency could take up to six months to review their response.

"We are already working with the agency, and we are hopeful that the review of our submission can be completed within a shorter timeframe," said spokeswoman Laura Hortas.

Analyst Erik Gordon, a professor at University of Michigan's Ross School of Business, said the FDA requiring more information on data management and verification indicates "someone either flubbed the application by not making the data management process clear or flubbed the actual data process."

"It's a giant botch-up to, at best, lose a year on one of your much-needed blockbusters," Gordon added.

Bristol-Myers shares dropped $1.23, or 3.5 percent, to close at $34.13, and Pfizer shares fell 26 cents, or 1.1 perccent, to $22.47.

The news has a bigger impact on Bristol-Myers, because it is much smaller than Pfizer, the world's biggest drugmaker. Also, the FDA in January delayed a decision on another crucial experimental drug from Bristol, diabetes treatment Forxiga, known chemically as dapagliflozin. The agency said it needed more data, including data from an ongoing study and possibly new studies, to assess Forxiga's benefits and risks.

Eliquis, known chemically as apixaban, is one of a handful of new drugs meant to prevent heart attacks and strokes better than warfarin — long the standard treatment despite how tricky it is to use. Eliquis, Boehringer Ingelheim GmbH's Pradaxa and Xarelto from Johnson & Johnson and Bayer HealthCare all are expected to grow into much-needed blockbusters for their makers, with annual sales topping $1 billion.

"All of this is surprising given the widespread perception that Eliquis is a best-in-class product relative to already-approved" Pradaxa and Xarelto, BernsteinResearch analyst Dr. Tim Anderson wrote of the new delay.

It could benefit Xarelto and Pradaxa, and possibly a fourth stroke-preventing pill in late-stage testing by Daiichi Sankyo, called edoxaban, Barclays analyst C. Anthony Butler wrote to investors.

"The longer time window is significant in a market that appears to be less open to switches (from warfarin) than previously assumed," Butler wrote.

He added that if Bristol-Myers and Pfizer give the FDA the new information by September, the agency could make a decision next March. That would be a year after the FDA's original target date for a decision on Eliquis. At the end of March, the FDA pushed back its original deadline until June 28, saying it needed more time to review additional information the companies submitted after applying for approval late last year.

Both men noted analysts may revise their sales forecasts for Eliquis, which Anderson had pegged at $2.3 billion in 2015 and $3.5 billion in 2020.

Doctors and millions of patients have long wanted a better alternative to warfarin, an inexpensive generic drug also sold under brand names such as Coumadin. Getting the dose of warfarin correct is so tricky that patients must have frequent blood tests to ensure they're getting enough to prevent clots but not enough to cause internal bleeding. Some foods interact with warfarin, compounding the difficulty.

Bristol-Myers discovered Eliquis and since 2007 has been testing it in partnership with New York-based Pfizer. The European Union approved it in May for preventing blood clots in patients getting hip or knee replacement surgery, and the companies are considering whether to seek approval for that use in the U.S., Hortas said. The drug also is in late-stage testing for treating patients with clots in major blood vessels.

Pradaxa, also known as dabigatran, was first to market, getting approved in October 2010 for patients with atrial fibrillation. Xarelto has since been approved for patients with atrial fibrillation and for preventing blood clots after hip or knee replacement surgery. But J&J said last week the FDA denied its request to expand approval of Xarelto to prevent life-threatening blood clots in patients with acute coronary artery disease, and it expects to work with them to address the questions as quickly as possible.

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AP Business Writer Tom Murphy in Indianapolis contributed to this story.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

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