The FDA picks on the big guys too...

Pfizer Inc. (PFE) (PFE) and Bristol-Myers Squibb Co. (BMY) (BMY) failed to gain approval of their top experimental drug, the blood thinner Eliquis, from U.S. regulators who said they needed more data on the treatment.

The Food and Drug Administration wants clarification of information from already completed trials, and isn’t seeking new studies, the companies said in a statement. The drug, aimed at patients with heart arrhythmia, would have $2.5 billion a year in sales by 2015 if approved, according to Tim Anderson, a Sanford C. Bernstein & Co. analyst in New York.

Eliquis is among experimental products the two New York-based companies were depending on to replace sales from best-selling drugs that have lost patent protection in the last year. An FDA response could take six months after the requested data is supplied, said Laura Hortas, a Bristol-Myers spokeswoman.

“We are already working with the agency, and we are hopeful that the review of our submission can be completed within a shorter time frame,” Hortas said in an e-mailed response to questions. The FDA’s response “does not alter our confidence in the therapeutic profile of Eliquis.”

Pfizer shares (PFE) fell 1.1 percent to $22.47 at 4 p.m. New York time. Bristol-Myers shares (BMY) dropped 3.5 percent to $34.13.

Competing Products

Johnson & Johnson (JNJ) (JNJ), of New Brunswick, New Jersey, and Leverkusen, Germany-based Bayer AG have a competing pill, Xarelto, as does Boehringer Ingelheim GmbH, of Ingelheim, Germany. Bayer rose less than 1 percent to 52.97 euros in Frankfurt.

Both Pfizer’s cholesterol pill Lipitor, with $12.9 billion in peak yearly sales, and Bristol’s blood-thinner Plavix, with $7.09 billion in revenue, lost patent protection.

“It’s a delay but it shouldn’t impact the longer term profile of the product,” said Marshall Gordon, an investor with Clearbridge Advisors in New York, in a telephone interview.“It’ll still have a best-in class profile.” His fund owns shares of both companies.

Mark Schoenebaum, an analyst with ISI Group, said the FDA was likely looking to make sure data in one of the clinical trials was accurate about how many strokes and bleeding episodes patients on the drugs had.

“Although this is a material time delay, we don’t see an impact to our conclusion that Eliquis will eventually dominate the blood thinner space,” he said in a note to clients.

The companies had been planning to launch promotion of the pill after what had been an expected approval this month, Hortas said. A six month delay would push that launch into 2013.

Eliquis is one of three drugs Pfizer had been expecting to help replace revenue lost from Lipitor. The company is awaiting FDA approval of its arthritis pill tofacitinib, which won the backing of U.S. regulatory advisers last month. Pfizer plans to release data on its experimental Alzheimer’s treatment bapineuzumab at a medical meeting in October.

http://www.businessweek.com/news/2012-06-25/pfizer-bristol-myers-eliquis-drug-fails-to-win-fda-approval