Tuesday, January 14, 2014

Contra To Some Goofy MSM Stories -- ZontivityTM (Vorapaxar) Doesn't Appear Before ANY Advisory Committee -- For Formal Vote -- Until TOMORROW

As the politically incorrect Philly-based sports guys used to say. . . "the fat lady isn't even clearing her throat, yet." [Click the link, if Kate Smith was before your time. And to be fair, an alternate operatic derivation/reference here.]

Either way, it will be immaterial to Merck, so this is another Fast Fred & Crew "mind over matter" story (i.e., I don't mind, because they no longer. . . matter!) -- but the idea that some so-called journalists, and members of the financial press (slightly more understandably -- as numbers, not WORDS people!) can't figure out the meaning of the cover page of the materials they derive breathless stories from. . . is stultifying. Okay -- from the background, here -- then:

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 tomorrow.

On balance though, I suspect the Advisory Committee may now 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.

Please people -- reading is a skill! -- from the Cover Page of the FDA staff's packet, assembled for tomorrow's meeting:

. . . .The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought the vorapaxar New Drug Application (NDA) to this Advisory Committee in order to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the advisory committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting.. . .

And, as we've previously written -- whether voted up, or down, at the close of the FDA Advisory Committee session tomorrow, and then, whether voted up or down by the full Commission, at FDA -- this drug is likely only ever going to be a very modest seller for Whitehouse Station. So, either way, this will be immaterial to Merck. Will somebody tar and feather Fred, Carrie, Tom, Brent and Tom, already though? Seriously. (Not.}. . . Sheesh.

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