Biotech Values

[DewDiligence]

MRK’s Anacetrapib CVOT hits primary endpoint, but…

https://finance.yahoo.com/news/merck-provides-reveal-outcomes-study-105500151.html

Merck…today announced that the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events (defined as the composite of coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen.

The safety profile of anacetrapib in the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue, as has been previously reported.

Merck plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The results of the REVEAL study will be presented at the European Society of Cardiology meeting on Aug. 29, 2017.

If MRK isn’t yet sure whether it will even submit an NDA/MAA, the overall results for efficacy and safety must be tepid at best.

MRK is trading down marginally today.