Wednesday, November 10, 2010

Merck's Anacetrapib Cholesterol Candidate: An FDA Filing "After 2015"

Michelle Fay Cortez and Tom Randle, writing for Bloomberg, put out a Merck "pipeline highlights" story overnight -- and the key takeaway (besides how fraught with pitfalls this area of research has become) is that Merck's Anacetrapib program is still a half-decade away from an FDA New Drug Application filing. Do go read it all, but here is a snippet:

. . . .Merck paused its own research after Pfizer’s torcetrapib setback to scour ongoing studies for signals of hypertension and design a new safety trial, called Define. Merck’s anacetrapib is now in the third and final stage of tests generally needed for U.S. approval.

“With torcetrapib and the toxicity that was observed, the bar is raised in terms of having to really demonstrate a benefit,” said Yale Mitchel, Merck’s vice president of cardiovascular disease research, in a telephone interview.

Results next week are from the Define trial, which followed 1,800 people for 18 months to examine safety and ability to alter cholesterol levels. Based on this trial, Merck began planning its final study, and may seek U.S. approval after 2015. . . .

I wouldn't look for this to be any kind of a near-term NYSE catalyst for Merck's flagging share prices.

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