Merck's plans to file its cholesterol-lowering drug Tredaptive in the US have come to a halt. The company announced Thursday that its extended-release niacin and laropiprant combination failed to meet its Phase III study targets. The company said in a statement that the study also found a "statistically significant increase" in non-fatal, but serious adverse events among participants who received the drug.
Merck said it was releasing the results of this Phase III study to other regulators and healthcare providers and is recommending that physicians avoid starting patients on the drug. The firm estimates that the drug is sold in around 40 countries, and is approved in about 70.
In financial terms, the loss isn't a huge one—Bernstein analyst Tim Anderson said in a research note that sales were around $50 million a year. However, the company's findings that the drug failed to reduce the risk of non-fatal heart attacks, strokes or coronary deaths any more effectively than statins darkens prospects for the CETP category, which aims to reduce coronary incidents by elevating “good” cholesterol levels.
The HDL-boosting approach has already logged several failures, including Roche's decision in May to stop development of its then-Phase III drug dalcetrapib after a Data and Safety Monitoring Board review said the experimental drug didn't show any clinically meaningful effect. This disappointment was preceded by a Pfizer flop in the same vein, when safety issues caused the drug maker to stop development of torcetrapib back in 2006.
This latest failure doesn't mean Merck is clear of CETP tests. The company still has anacetrapib lurking in its pipeline, with an estimated Phase III date of 2017. Eli Lilly is also waiting on CETP news. Anderson wrote that Phase III results of its contender, evacetrapib, are scheduled for the end of 2015.
Anderson said the Tredaptive news could sideswipe AbbVie's Niaspan, noting that the $900 million-a-year drug has already been hurt by results of a recent trial, and wrote that Merck's news could end up amplifying the deleterious effect of those findings.
Jefferies analyst Thomas Wei said in his Thursday research note that the news could prop up Amarin's Vascepa, which the FDA approved in July as therapy to lower triglyceride levels. Amarin is currently trying to determine whether lowering triglycerides can promote better cardiovascular outcomes, an impact Tredaptive studies also hoped to define. Wei wrote Thursday that a successful Amarin study could change the focus from using treatments containing niacin to drive down triglycerides to ones that contain omega-3s. Amarin's Reduce-It study is still enrolling patients. Wei also noted that the Tredaptive results could still sour doctors on leveraging triglyceride levels to reduce cardiovascular risks.