Monday, November 15, 2010

Merck's DEFINE CV Safety Trial Results: Anacetrapib Program News, But Not Before Wednesday

The 2010 American Heart Scientific Sessions in Chicago are well-underway this morning. Much chatter is being generated about Merck's 2016 or 2017 CETP candidate, Anacetrapib (our background coverage is here), after safety setbacks in Pfizer's similar class CETP candidate, two years ago.

Even with a clear "green" safety light, on Wednesday -- Merck itself doesn't expect to file for FDA approval until "after 2015". That is the company's most aggressive estimate, given that additional studies are needed, just to be in a position to submit an New Drug Application to FDA. Accordingly, the chatter is likely flak-generated, not market generated, in my estimation. Why? Well, there simply cannot be any significant new revenue -- in any of Merck's models, before 2016 or 2017 -- just to dampen all these caught-vapors, here.

From the AHA's previously-published press event/media guide, then:

. . . .Wednesday, Nov. 17, (10:45 a.m.-12:13 p.m.). . . .

Primary Results of the DEFINE trial: Determining the Efficacy and Tolerability of CETP Inhibition with Anacetrapib - Efficacy and safety of cholesteryl ester transfer protein inhibition using anacetrapib in CHD. . . .

We will let you know how it turns out, right here. Stay-tuned. But expect nothing before Wednesday morning, November 17th.

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