Eli Lilly said Monday that it was halting development of a drug for cardiovascular disease because the drug was not likely to be found effective in preventing heart attacks and strokes.
The move is a blow for Lilly because the drug, evacetrapib, was in the final stages of clinical trials and was expected to have been a blockbuster had it reached the market.
It is also the latest disappointment for this class of drugs, known as CETP inhibitors, which can raise the levels of so-called good cholesterol while lowering the levels of bad cholesterol.
Pfizer halted a late-stage study of its CETP inhibitor, torcetrapib, in late 2006, when the drug, despite raising good cholesterol levels as intended, was found to increase the risk of death and heart problems in a clinical trial. Roche gave up on its candidate, dalcetrapib, in 2012, after a trial suggested the drug was not effective.
Merck is continuing to study a similar drug, anacetrapib, which is in late-stage trials.
Lilly said in a news release on Monday that a safety monitoring committee that was reviewing interim results of its phase 3 trial had recommended the trial be stopped because the drug was unlikely to be shown to be effective in reducing the risk of heart problems, including heart attack, stroke and death from cardiovascular causes. Lilly said the trial, which had 12,095 patients in 37 countries, was not halted for safety reasons.
“We’re obviously disappointed in this outcome, as we hoped that evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease,” David Ricks, senior vice president of Lilly and president of its bio-medicines division, said in a statement. “We remain confident in our pipeline as we prepare for launches in other therapeutic areas with significant unmet needs.”
Lilly said the decision to abandon evacetrapib would result in a fourth-quarter charge of up to $90 million pretax, or about 5 cents a share. Lilly’s stock was down about 7 percent at 10:30 a.m. in New York trading.
While statins like Lipitor are the mainstay drugs for lowering bad cholesterol, doctors say additional types of drugs are needed to further prevent heart attacks and strokes. This summer, two new drugs that can sharply lower LDL, or bad cholesterol, won approval from the Food and Drug Administration. They are Repatha from Amgen, and Praluent from Sanofi and Regeneron Pharmaceuticals.
But it is not clear yet whether those drugs, known as PCSK9 inhibitors, reduce the risks of heart attacks and strokes. Also, those drugs are given by injection, which could make them unattractive for some people with high cholesterol.
By contrast, the CETP inhibitors like evacetrapib are taken orally. CETP stands for cholesteryl ester transfer protein.
With evacetrapib out of the picture, investors might focus even more on solanezumab, Lilly’s late-stage drug for Alzheimer’s disease, which is also considered a risky gamble but potential blockbuster.
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