Link to Merck the webcast here. . . . See my quick transcript below, too.
No 2011 or 2012 FDA NDA filing -- one study -- TRACER (at Duke) discontinued; looks to be a safety issue with patients with a prior stroke -- per the Bloomberg breaking newspiece:
. . . .Studies of Merck & Co.’s anti-clotting drug vorapaxar, a product analysts said may generate $5 billion in sales, were halted for patients with a previous stroke, potentially limiting its use.
Interim study results suggest the experimental medication, which uses a novel method to prevent platelets within blood from clumping together, isn’t appropriate for people who suffered a stroke, researchers at Brigham and Women’s Hospital and the Duke Clinical Research Institute said in a statement today. The trial was stopped by an overview board, the institutes said.
The drug was expected to generate peak sales of $5 billion or more a year for Whitehouse Station, New Jersey Merck, if the treatment is proved safe and effective, said Robert Hazlett, an analyst at BMO Capital Markets in New York. . . .
Ouch.
LIVE-BLOG:
▲ Q: Tim Anderson (Sanford Bernstein) -- "Was bleeding the issue?; sure sounds like it. . ."▲ A: Peter Kim -- That was not stated by the DSMB (reviewing safety panel).
▲ Q: David Risinger (Morgan Stanley) "Timing?"
▲ A: Peter Kim -- That is not yet known. . .
▲ Q: Barbara Ryan (Deutsche Bank) -- Was futility the issue? What do you think?
▲ A: Peter Kim -- That is unknown.
▲ Q: Catherine Arnold (Credit Suisse): How was the study powered; is this ambiguous?
▲ A: Peter Kim -- These studies are highly powered, but we need to evaluate our data -- we will have a future disclosure.
▲ Q: Seamus Fernandez (Leerink Swann) -- "Wasn't this a safety study, primarily? So, what was the value proposition?"
▲ A: Peter Kim -- We don't have a view as to why (other than what we have stated).
▲ Q: Steve Scala (Cowen & Co.) -- "Was it stopped for overwhelming efficacy?"
▲A: Peter Kim -- We don't have a view as to why (other than what we have stated).
▲ [Editor: Call ended at 10:22 AM EST.]
For what it's worth, it would be nearly impossible to imagine a discontinuation in one study -- and the instruction not to medicate prior stroke victims -- if it was safe and effective. The DMSB would likely only act if patient safety were in issue -- and that clearly seems to be the case with prior stroke sufferers.
This is unfortunate in the extreme -- as the Vorapaxar program was a bright hope for many cardiac patients -- let us hope that the data is not as bad as the DMSB has assumed.
Remember, the DMSB is charged first with "do no harm" -- so it might have erred on the side of protecting stroke patients. I admit that seems unlikely, as well -- to my experienced eye.
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