October 12, 2015
By Alex Keown, BioSpace.com Breaking News Staff
INDIANAPOLIS -- Eli Lilly and Company ’s stock fell more than 10 percent in pre-market this morning after the company announced it was discontinuing development of its late stage cardiovascular drug evacetrapib due to insufficient efficacy.
Indiana-based Eli Lilly said it was accepting the recommendation of an independent data monitoring committee to terminate the Phase III Accelerate trial studying the efficacy of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease. The independent committee said there was a “low probability the study would achieve its primary endpoint based on results to date,” Eli Lilly said in a statement. In July, this same committee recommended the company continue the Phase III trial based on data from an interim futility analysis.
The discontinuation of the clinical trial is expected to cost the company a $90 million pre-tax charge. Eli Lilly said it will include the charge in its 2015 economic guidance when it releases its third-quarter statements on Oct. 27.
Evacetrapib was being studied for its impact on cholesterol in a Phase III clinical trial with 12,095 patients with high-risk atherosclerotic cardiovascular disease in 37 countries. Evacetrapib was being developed as a selective inhibitor of cholesteryl ester transfer protein. In earlier clinical trials, the drug had shown effects on high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and cholesterol efflux.
The loss is a financial blow to Eli Lilly as the drug was expected to generate $632.7 million in annual sales in 2020, according to an average of seven analysts’ predictions compiled by Bloomberg.
The failure of Evacetrapib is also serving as a warning to other drugmakers working on anti-cholesterol developers. In a Monday morning note, Joel Beatty, an investment analysts with Citi Group, said that Lilly’s decision could negatively impact Esperion Therapeutics’ development of ETC-1002. Beatty speculated Lilly’s decision could increase the likelihood the FDA will require outcomes trial results for LDL-lowering drugs before approval, In his note, Beatty said evacetrapib’s effectiveness at lowering LDL is at about the same rate as Esperion’s experimental drug.
Lilly’s decision to pull evacetrapib leaves Merck’s anacetrapib as the sole CETP inhibitor in phase III development, Beatty said. Beatty said Esperion’s ETC-1002 could be an attractive target for acquisition.
David Ricks, president of Lilly Bio-Medicines said the outcome was disappointing as the company hoped the experimental evacetrapib would be able to advance treatment methods for cardiovascular disease. Ricks said that Lilly will work with the drug’s investigators to “appropriately conclude these trials.”
Although evacetrapib will not be moving forward, at least as of now, Ricks said the company remains positive in its pipeline and is preparing launches in “other therapeutics areas with significant unmet needs.”
“This unfortunate outcome for evacetrapib does not change our ability to generate long-term growth,” Derica Rice, Lilly’s chief financial officer said in a statement. “Our recent string of positive data-readouts and our strong pipeline position us to grow revenue and expand margins through the remainder of this decade.”
Although Eli Lilly is halting studies of evacetrapib, a Lilly diabetes drug, Jardiance, has shown to be highly effective at reducing the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care, in patients with type 2 diabetes. Lilly is co-developing Jardiance with Germany-based Boehringer Ingelheim. In trials, the drug has shown a 38 percent reduction in cardiovascular deaths, the companies said in September.
While this trial is ceasing, Lilly has been expanding in other areas. In September, the company announced it was taking 6,000 square feet of additional space in the crowded Kendall Square area of Cambridge, Mass. The additional space gives Eli Lilly a total of about 23,000 square feet of space in an area packed with colleagues and competitors. Earlier this year, John Lechleiter, president and chief executive officer of Lilly, said in a statement that being in the Cambridge area provides access to “a concentration of high-caliber academic institutions, cutting-edge life science and technology companies, and some of the world’s leading talent.”
Both Amgen and Sanofi had anti-cholesterol drugs approved earlier this year, Repatha and Praluent, respectively. Stocks for Amgen and Sanofi were both up this morning following Lilly’s announcement.
