Merck & Co., Inc. MRK announced that it is not going ahead with filing the regulatory applications seeking approval for anacetrapib, a cholesteryl ester transfer protein (CETP) inhibitor that it had developed for cholesterol management.
The stock was down more than 1% on Wednesday. Merck's shares have risen 8.3% this year so far compared with an 18.3% increase for the industry .
Detailed data from a large phase III cardiovascular outcomes study (REVEAL) announced in August showed that anacetrapib and a statin reduced the risk of major coronary events (composite of coronary death, myocardial infarction and coronary revascularization) by 9% relative to placebo in patients with atherosclerotic vascular disease who are already receiving an effective cholesterol treatment.
While anacetrapib reduced the risk to 10.8%, the same was 11.8% for patients on a placebo and a statin. However, no significant benefit was observed in reducing the risk of ischemic stroke.
Top-line data from the study was announced in June 2017 wherein the company said that the study had met the primary endpoint. It was also said that anacetrapib's safety profile was in line with that observed in previous studies with the most significant side effect being the accumulation of anacetrapib in adipose or fat tissue for years after taking the drug.
Merck had clearly said then that it was not sure whether the data was strong enough to seek approval. Merck said it will consider whether to file regulatory applications with the FDA and other agencies after reviewing the results with external experts. It was apprehended by investors that the accumulation of anacetrapib in fat tissues could get in the way of regulatory approval.
Following a thorough evaluation of data and discussions with external experts, Merck decided not to seek approval for anacetrapib as its clinical profile did not support regulatory filings.
We remind investors that three previous experimental CETP inhibitors had failed in their respective studies. CETP inhibitors are designed to raise HDL-cholesterol levels or what is known as "good" cholesterol.
In 2015, Eli Lilly LLY terminated the development of its late-stage CETP inhibitor, evacetrapib based on the recommendation of an independent data monitoring committee, which suggested that chances of meeting the primary endpoint were low. Back in 2006, Pfizer PFE suspended the late-stage development of its CETP inhibitor, torceptrapib, due to safety issues. In 2012, Roche RHHBY discontinued the development of its CETP inhibitor, dalcetrapib, due to lack of efficacy.
Merck carries a Zacks Rank #4 (Sell).
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