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Daiichi, Lilly Say Heart Drug Effient Fails To Meet Goal In A Phase III Trial

Daiichi Sankyo Co., Ltd. (DSKYF, DSNKY) and Eli Lilly and Co. (LLY) Sunday announced that their new heart drug Effient (prasugrel) failed to beat the older product Plavix (clopidogrel). The study named TRILOGY ACS did not meet primary objective of demonstrating prasugrel superiority over clopidogrel.

Daiichi Sankyo and Eli Lilly co-developed Effient, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd.

"While this is not the outcome we anticipated, we believe this study contributes to the knowledge base about ACS patients who are medically managed," said Glenn Gormley, Global Head of Research & Development and Senior Executive Officer, Daiichi Sankyo.

Sanofi SA's (SNY, SNYNF.PK) blood thinner Plavix lost its exclusivity in the U.S. on May 17, 2012.

The companies announced data from TRILOGY ACS study, a phase III trial comparing prasugrel plus aspirin to clopidogrel plus aspirin in patients with unstable angina or non-ST elevation myocardial infarction, who were managed medically without an artery-opening procedure.

The study was conducted by Daiichi Sankyo and Eli Lilly in conjunction with Duke Clinical Research Institute. Approved by the U.S. Food and Drug Administration in July 2009, Effient is indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome, or ACS.

TRILOGY ACS was a multi-center, double-blind, randomized, controlled trial to evaluate the safety and efficacy in a type of chest pain called unstable angina, or UA/NSTEMI patients who were to be medically managed without revascularization.

At 30 months, 13.9 percent of prasugrel patients compared to 16 percent of clopidogrel patients experienced combined primary endpoint of heart attack, stroke or cardiovascular death in patients under 75 years of age.

From a safety perspective, the study showed that rates of TIMI major bleeding events, including life-threatening or fatal bleeds, did not differ significantly between the prasugrel plus aspirin and clopidogrel plus aspirin treatment groups in patients less than 75 years of age or in the overall study population.

Serious allergic reactions can happen with Effient, or if the patient has had a serious allergic reaction to the medicines Plavix or ticlopidine, the companies added.

Anthony Ware, M.D., Group Vice President and Cardiovascular/Acute Care Platform Leader, Eli Lilly, stated, "We look forward to presenting additional data from the platelet function sub-study, analyses of the elderly population data, as well as genomics information in future peer-reviewed forums."

Daiichi and Eli Lilly said the results of this study were published in the New England Journal of Medicine and also presented during a late-breaking session at the European Society of Cardiology, or ESC, Congress 2012 in Munich, Germany.

LLY closed Friday's regular trading at $43.86 on the NYSE

DSKYF ended on Friday at $17.28 on the OTC markets, while DSNKY finished at $17.25.

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