There will be no CETP heart drug miracle in the works at Merck.
The pharma giant looked over a set of positive but troublesome Phase III data for its drug anacetrapib and concluded today that they will relegate it to the same graveyard that has greeted every other CETP heart drug so far.
The decision underscores a tidal shift in drug developer’s standards for launching a big new drug into a major market, where the data has to point to a compelling market opportunity. Failing that, marginal drugs don’t stand a chance, even if they might pass muster at the FDA.
“Unfortunately, after comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings,” said Roger Perlmutter, president of Merck Research Laboratories. “During the past half-century, Merck has made numerous, important contributions to the treatment of cardiovascular disease. Our work in cardiovascular research continues.”
Once upon a time, CETP offered a bright prospect for some of the world’s biggest developers, driving massive late-stage studies in search of huge markets that would run for years and gobble hundreds of millions of dollars. Then rivals at Roche, Pfizer and Eli Lilly all fell by the wayside with poor outcomes.
Eventually, Merck was left to carry on to the end. But when it announced stunningly positive data earlier this year, the pharma giant carefully refrained from any victory celebrations. The data underscored the reasons for their low-key review.
Across the study population of more than 30,000 patients, the drug arm demonstrated a 9% reduction in the risk of a composite of major coronary events: coronary death, myocardial infarction or coronary re-vascularization. That translates into a lean and hard-to-market 1-point difference — a significant but so-so 10.8% compared to 11.8% — in the rate of events. And it was a consistent result across the sub-groups that the researchers wanted to follow.
After a bit more than 4 years of treatment on average, non-HDL cholesterol level declined by 17 mg/dL; good HDL levels rose by 43 mg/dL.
The bad news:
Dragging behind on expected rates of presumed ischemic stroke, researchers concluded that the drug missed the key secondary endpoint of their composite of major atherosclerotic events: myocardial infarction, coronary death or presumed ischemic stroke.
These days, that spells a drug that can get approved but never find a market. And that’s not good enough for the likes of Merck.
R.I.P. "HDL Hypothesis." It's now all about LDL and non-HDL cholesterol, just like the genetics always told us so. https://t.co/kMV7J80IZG
— John Maraganore (@JMaraganore) October 11, 2017
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