A little under three and a half years ago, this candidate, one of Schering-Plough ex-CEO Fred Hassan’s five stars, clanked — and clanked loudly — on a pivotal Phase II/IIb study. That forced Whitehouse Station to take a $1.7 billion write-off on the research, to that point, in early 2011.
In July 2013, with additional data showing a modest on-target effect, Merck submitted the candidate for standard FDA review, on a full New Drug Application (the slowest US path to approvability).
However, the off-target effects include brain bleeds. Remember, this was Fast Fred’s star new drug candidate, in early 2009 to late 2010. It is possible the Committee will vote against approval on 01.15.2014.
On balance though, I suspect the Advisory Committee will vote to recommend that the full FDA approve vorapaxar sulfate — proposed to be branded by Whitehouse Station as ZontivityTM. Even if the full FDA approves the Zontivity application, it will likely never sell over $100 million a year — at peak sales. That’s my (experienced, educated) bet. Read the backgrounder here, from almost two years ago — to learn why I’ve so long held this opinion.
From the just posted FDA Advisory Committee meeting agendas, and calendar pages, then:
. . . .The committee will discuss new drug application (NDA) 204886, vorapaxar sulfate, proposed trade name ZONTIVITY, 2.5 milligram tablets, submitted by Merck Sharp & Dohme Corp., Inc., for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI). . . .
I get it — Merck needs to try to salvage something from the nearly $2 billion investment in vorapaxar — to this point. That’s understandable. As I said above, Merck was forced to write off $1.7 billion of that, leaving only $300 million or so on the books, at this point.
I just don’t see the drug, even if approved, reaching the top tier of reimbursement in the US formularies. I don’t see Caremark/CVS, Express Scripts or Catamaran, just to name a few PBMs, suggesting that Zontivity should supplant the much cheaper (and many would argue, less risky) generics — in the space. Especially not so, post the full-rollout of Obamacare; not by a long shot.
[H/T to Daily Finance, for reminding me about vorapaxar’s upcoming meeting date.]