TRACER Study (Vorapaxar): Failed Primary Endpoint; Tripled Bleeding Risk

Back in January 2011, the data motitoring safety board on the study had halted enrollment, strongly suggesting that vorapaxar wasn’t helping more than it was hurting.

Thus, all Wall Street analysts had revisied their 2015 to 2020 models for Merck, removing vorapaxar — and its potential for generating $3 billion in annual sales, in the latter half of the decade. In taking the vorapaxar program impairment charge, Merck wrote off another four percent of the total price it paid for legacy Schering-Plough. [Thanks again, Fred — suggesting that his five stars turned out to be about 1 for 10, in commercial potentials.]

This news today is nearly the final nail in vorapaxar’s coffin — per Reuters, at the late-breaking clinical trials session at the American Heart Association 2011 Scientific Sessions, published concurrently online in the New England Journal of Medicine — do go read it all:

. . . .An experimental anti-clotting drug from Merck failed to meet the main goal of of improving a host of cardiovascular problems in a large study and tripled the risk of bleeding in the brain, researchers said on Sunday. . . .

“There is a signal of efficacy with vorapaxar driven primarily by” a reduction in heart attacks, said Dr Kenneth Mahaffey, one of the study’s lead investigators. He called the reduction intriguing, “but when you balance it with the bleeding then it becomes a little less impressive. . . .”

That’s an exceptional understatement, from the PI (study-affiliated researcher) Mahaffey.

In any event, Merck has said it will wait for the final results of the TRA-2P study, a companion, before making a final decision, but it would seem likely that this candidate will never be submitted to FDA for review. So it goes, in high stakes drug development, after $1.7 billion in research and development outlays, over a decade or more. Yikes.


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