Bristol comes out swinging at Lilly clot drug

By Ransdell Pierson

NEW YORK (Reuters) - Bristol-Myers Squibb Co, which sells leading blood clot preventer Plavix, on Thursday dismissed Eli Lilly and Co's rival Effient drug as a "niche" product that has harmed or failed to help three groups of patients in a big study.

Effient, which is awaiting approval by U.S. regulators, has been widely touted as a medicine that could supplant the $5 billion-a-year Plavix as the standard treatment to prevent heart attacks among heart patients, including those receiving stents.

"The way I see it, if and when it is approved, it will be a niche product," Lamberto Andreotti, chief operating officer of Bristol-Myers, told analysts on a conference call related to the drugmaker's second-quarter earnings report. Andreotti is in charge of Bristol-Myers' global pharmaceuticals operations.

Lilly officials did not have any immediate comment.

"There are three important subgroups of patients that seem to derive either net harm or no clinical advantages" from Effient, Andreotti said.

He was referring to findings from a study of 13,600 patients, called Triton, involving patients with acute coronary syndrome -- an umbrella term covering symptoms ranging from severe chest pain to heart attacks.

Patients enrolled in the trial received the anti-clotting drugs after receiving stents, tiny scaffold-like devices used to prop open coronary arteries that have been cleared of plaque.

Effient, also known as prasugrel, was 19 percent more effective in preventing heart attacks than Plavix among patients in the closely watched study, according to researchers with the Lilly-sponsored trial.

But Effient, being co-developed with Daiichi Sankyo Co Ltd, caused a 32 percent higher incidence of major bleeding than Plavix and was deemed especially risky for patients over 75 years old, who had an earlier stroke or weighed less than 60 kilograms (132 pounds).

Some analysts believe that because of Effient's potency it will be approved as soon as Sept, 26, while others predict U.S. regulators will demand another time-consuming safety trial because of the bleeding trend and risk to the three subgroups of patients in the Triton study.

"Their application is focused only on a small acute coronary syndrome population that represents approximately 15 percent of our Plavix" patient base, Andreotti said Thursday.

Moreover, he said, Plavix has a more convenient dosing schedule than Effient.

(Reporting by Ransdell Pierson; Editing by Andre Grenon/Jeffrey Benkoe)