In Brief: Side effects of Merck's experimental blood thinner could stall approval; Bristol-Myers Squibb may have …

A study of an experimental blood thinner from Merck showed that while the drug helped thwart heart attacks it raised the risk of brain bleeding, a side effect that could stymie its approval.

The three-year study of 26,449 patients who had heart attack, stroke or leg artery disease, found those who got Mercks vorapaxar along with standard therapy were 13 percent less likely to have another heart attack or die from cardiovascular causes than those on standard treatment. More patients on the drug also had serious bleeding, according to data reported yesterday at the American College of Cardiology meeting in Chicago.

The findings are unlikely to be good enough to get U.S. marketing approval, said Steven Nissen, a cardiologist at the Cleveland Clinic who wasnt involved in the study. New studies are needed to prove vorapaxar can be used in some patients without excess bleeding, he said.

"The results are disappointing," Nissen said. "The bottom line is it is extremely difficult to make the case that the benefits exceed the risks here."

In January 2011, Merck narrowed the scope of the trial to stop testing the drug in stroke patients and halted another vorapaxar trial entirely after doctors monitoring the results found an increased risk of brain hemorrhage in those patients. Merck, based in Whitehouse Station, New Jersey, later took a $1.7 billion charge to write down the value of the drug. Bloomberg

Amylin Pharmaceuticals, maker of the diabetes drug Bydureon, may draw bids from other suitors after rejecting a $3.5 billion unsolicited takeover offer from Bristol-Myers Squibb earlier this year.

Drugmakers from AstraZeneca to Sanofi may be better equipped than Bristol-Myers to sell Amylins medicines and could make higher offers, said Joshua Schimmer of Leerink Swann.

Bristol-Myers proposed an acquisition at $22 a share, which Amylins board turned down last month, according to two people with knowledge of the matter who declined to be identified because the approach was private.

Amylin may be worth as much as $31 a share, said Robyn Karnauskas, an analyst with Deutsche Bank.

The San Diego-based company received regulatory approval for Bydureon, a once-weekly formulation of the earlier diabetes drug Byetta, in January and the therapy may draw $1.5 billion in peak annual sales in the U.S., Karnauskas said.

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In Brief: Side effects of Merck's experimental blood thinner could stall approval; Bristol-Myers Squibb may have ...