Eli Lilly and Company’s LLY shares tumbled 7.8% with the company announcing the termination of the development of its late-stage cholesteryl ester transfer protein (CETP) inhibitor, evacetrapib. Lilly’s decision was based on the recommendation of an independent data monitoring committee which suggested that chances of meeting the primary endpoint were low.
Evacetrapib was being evaluated in a multi-center, randomized, double-blind, placebo-controlled phase III study (ACCELERATE) in patients with high-risk atherosclerotic cardiovascular disease (ASCVD).
CETP inhibitors are designed to raise HDL-cholesterol levels or what is known as “good” cholesterol and at one point of time these experimental treatments were considered to have blockbuster potential.
However, CETP inhibitors have a checkered development history with Lilly not being the first company to face failure in this field. Back in 2006, Pfizer PFE had suspended the late-stage development of its CETP inhibitor, torceptrapib, due to safety issues. Then in 2012, Roche RHHBY discontinued the development of its CETP inhibitor, dalcetrapib, due to lack of efficacy.
While the discontinuation of the development of evacetrapib is a blow for Lilly, it comes as good news for companies like Amgen AMGN which recently launched PCSK9 inhibitors as this means one less potential competitor in the cholesterol management market.
Meanwhile, Lilly’s late-stage failure may raise doubts about the chances of success of another CETP inhibitor, anacetrapib, currently in late-stage development.
Lilly expects to take a fourth-quarter R&D charge of up to $90 million (pre-tax) or about 5 cents per share (after-tax) to reflect the development setback. While Lilly is a Zacks Rank #3 (Hold) stock, Amgen is a better-ranked stock with a Zacks Rank #1 (Strong Buy).
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