The Ghost Of Torcetrapib Doesn’t Scare Merck
Make a commentBy Ed Silverman // December 11th, 2007 // 10:17 am
The drugmaker, which is briefing analysts and fund managers today on its product pipeline, is pushing ahead with plans to develop the same type of cholesterol drug that caused Pfizer a great deal of trouble. Known as a CETP-inhibitor, the Merck drug would raise HDL, or so-called good cholesterol and, so far, Merck officials say they haven’t seen the kind of side effect problems that tanked Pfizer’s torcetrapib a year ago.
“The safety and tolerability profile of anacetrapib was comparable to placebo in clinical studies conducted to date,” says Peter Kim, Merck’s chief scientist, in a statement (yes, that’s him in the photo). “In 2008, we plan to initiate a sequenced Phase III program to obtain additional clinical experience in patients before initiating an outcomes study.”
You may recall that the big issue with Pfizer’s torcetrapib was increased blood pressure, which may have caused an increased number of deaths that ultimately ended further development of the drug, dashing Pfizer’s chances of rebuilding its thinning pipeline. Morevoer, the episode raised serious questions about the entire class of CETP drugs (Roche has one in the oven, too), and data released at the recent American Heart Association meeting didn’t really clear up the mystery.
In his remarks this morning, however, Kim stressed that Merck’s anacetrapib - or MK-859 - not only lowered LDL, or bad cholesterol, and raised HDL, but also produced blood pressure levels that were simliar to placebo. And there were apparently no issues with production of a chemical called aldosterone, which is known to cause heart attacks. And so Merck now plans to conduct a cardiovascular outcomes study starting in early 2009.
UPDATE: Kim tells the crowd that Merck is still working the Phase III testing, but if anacetrapib isn’t safe and effective at the highest dose tested, there’s no point continuing it.