Tuesday, November 16, 2010

Merck's DEFINE Anacetrapib Safety Study AHA Presentation Materials

Here are the links (from which the image at right was derived) to all the media sets -- for the DEFINE study at AHA, and the much bally-hooed Merck Anacetrapib project, more generally:

. . . .appears safe; improves LDL levels significantly. . . .

Now, a dose of reality, here.

Assuming the 30,000 patient efficacy trial (not a substitute endpoint trial, but an actual "outcomes" trial) points to a statistically significant CV benefit in outcomes. . .

Then, according to Merck itself, there will be an FDA filing for approval "AFTER 2015".

Revenue won't begin at all until 2016; and truly large revenue will come in 2017, or later (and potentially much later).

And that is all if everything goes perfectly from here forward.

Recall that Merck's Vytorin®/Zetia® is in the midst of an 18,000 person event-driven study, called IMPROVE-IT. That's about HALF the size of the proposed Anacetrapib program study. Merck is hoping to publish IMPROVE-IT before 2014. It was started in 2006. Eight years, for half as many events (18,000).

Net, net, I'd say finding 30,000 events in under five years is. . . just a little over the top.

Look for the study to end closer to 2018 -- you heard it here first.

Still, it is potentially very good news, for the longer haul.

There are just too many in MSM who've caught the vapors over this potential 2017 event.


Anonymous said...

The size of the study and its duration must be sufficient to exclude all the adverse events seen with torcetrapib, not limited to blood pressure, etc. So, patience and time....

Anonymous said...

This will give about 5 years to digest SHARP the next and next to last "significant" study with zetia supposedly coming out this weekend.