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Eli Lilly Halts Work on Cholesterol-Lowering Drug After Poor Performance in Phase-3 Trial

Filed October 15th, 2015 F.A. Kelley

On Monday, Eli Lilly & Co. announced that it had halted work on a new heart drug, after the drug, evacetrapib, failed to perform well in a clinical study.

Lilly is discontinuing development of evacetrapib, which was designed to prevent heart attacks and other cardiovascular problems by reducing cholesterol levels, the Wall Street Journal reports.

Interim results from a large clinical trial showed that evacetrapib was not likely to significantly reduce cardiovascular risk versus a placebo, despite having the desired effect on cholesterol levels. According to the WSJ, Lilly said the decision is not based on safety findings.

Evacetrapib is the latest in a new class of drugs—cholesterol esterase transfer protein (CETP) inhibitors. These drugs lower LDL (“bad”) cholesterol, but thus far, CETP inhibitors have had a disappointing record, according to Medscape. Torcetrapib and dalcetrapib, two earlier drugs in this class, were both pulled before reaching the market. In a large trial, torcetrapib showed an increased risk of mortality and cardiovascular events and dalcetrapib failed to demonstrate a benefit.

Evacetrapib was being evaluated in ACCELERATE, a phase-3 randomized trial, which enrolled 12,095 patients in 37 countries. (A phase-3 trial is the third of four phases in Food and Drug Administration (FDA) drug approval.) The study subjects had diabetes, a history of acute coronary syndrome, statin-resistant dyslipidemia, and other high-risk features. The study was following them for the composite end point of CV death, heart attack, stroke, revascularization (stent or angioplasty), or hospitalization for unstable angina. The trial was scheduled to continue for another year, but the data safety monitoring board recommended the trial be stopped based on a data review that “suggested there was a low probability the study would achieve its primary end point based on results to date,” Lilly said, according to Medscape.

The WSJ reported that Lilly stock plummeted after Monday’s announcement. Lilly had been attempting to come back from revenue losses due to a series of patent expirations that slashed sales of older blockbuster medicines like Zyprexa and Cymbalta for mental illnesses. Once the patent has expired, other drug makers can enter the market with a generic version of the drug, bringing down the price of the brand name drug.

Since early 2014, Lilly has won regulatory approval to market three new drugs, and several experimental treatments in development look promising. This helped to raise Lilly’s shares to a 10-year high last month. But the announcement about evacetrapib resulted in 7.8 percent drop in Lilly’s shares. Lilly is awaiting regulatory decisions on potential new drugs for lung cancer and psoriasis, and is running late-stage studies of drugs for arthritis and breast cancer.

Lilly has avoided the megamergers other drug makers have undertaken, leaving it smaller than its rivals in sales and market value. The failure of even one drug can have a major impact on Lilly’s financial outlook. John Lechleiter, Lilly’s chief executive, feels large-scale mergers in the industry have disrupted drug research efforts. But, as the WSJ notes, bigger companies enjoy a cushion Lilly does not have when difficulties arise in drug development.

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