As Ed, over at Pharmalot forcefully points out, Whitehouse Station buried the two immaterial non-approvable letters from FDA, on page 54 of its SEC Form 10-Q. That is, of course, a perfectly lawful practice. It is sort of against the grain for a company claiming transparency as a new mantra, though. A press release would have been far more typical -- in addition to the page 54 mention in the Form 10-Q.
But on Wall and Broad this morning, all is forgotten, as Merck gaps up -- due to a dividend hike of 10.5 percent, per slide 29 of the slide deck (of 229, in total!) just filed with the SEC this morning, and this press report:
. . . .Merck & Co. Inc. said Thursday it will increase it quarterly dividend by 10.5% to 42 cents a share from 38 cents a share. The pharmaceutical company said shareholders of record as of Dec. 15 will be paid the dividend on Jan. 9, 2012. . . .
These two were pretty clearly immaterial programs — still, the common practice is to press release complete response letters from FDA, even on immaterial projects. Why?
Because a company’s trend line, on non-approvals and follow-up data requests, is important. One should hope that this doesn’t foretell a more skeptical eye — at FDA — as to Whitehouse Station’s submissions, more generally.
Oh, and not-entirely-coincidentally, here -- Merck has just announced (at the R&D Day, SEC-filed slide 31) the goal of resubmitting to FDA the legacy Schering-Plough Bridion® (sugammadex) O.R. drug product, dinged by FDA in August of 2008, on a similar complete response/non-approvable letter. . . . that's a complete re-submission (do-over, with additional data needed) almost four years after Ex-CEO Fred Hassan declared it an expected FDA-approved breakthrough product, and one of his "five stars".
In any event, we will be able to track how FDA reacts to the resubmission, here -- as sugammadex is a material program at Merck (already approved in Japan and the EU) -- thus, it will be press-released. And, to be sure, a second bad outcome at FDA after 2012, would be ominous for continued approval in the EU and Japan, in my estimation.
So it goes.
2 comments:
R&D day was delightful today. Nice overall presentations and well informed (exposed) analysts had many pertinent questions. All answered very well by the Merck crew; Frazier, Kim, Kellogg etc.. Exciting pipeline I will say.
I agree -- if Merck executes on every platitude (and prospect) it mentioned -- it will be among the top three pharma companies once again. Between now and 2016, though, it is likely to fall to number 7 or 8, worldwide.
Time will tell if Merck can stay disciplined enough to pull the plug on candidates that turn out not to be "best in class", as opposed to just first in class. Thanks for visiting -- and do stop back.
Namaste
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