Merck Encounters FDA Delay On Its C. Diff. BLA — But Stool Capsules Are Likely Already Eating Into Would-Be Market Share…

While this offering will, in part, serve as a complement to the Cubist acquisition offerings, it will certainly sell on its own — if and when it garners approval. However, the reality may be that the biologic will be overpriced compared to the purified stool capsules (or alternatively, implants) which have gained increasing favor, as payers look for more economical methods for tackling this otherwise rather common and widely-dispersed infection problem. We shall have to wait and see how it all unfolds, but I expect that Merck has trimmed its peak annual sales expectations for the candidate, given intervening developments on other C. diff. fronts.

Chief among these is the notion that, as I had originally noted — as early as December 2012 — Clostridium difficile biologics franchises may face the reality that purified stool implants (or more recently, carefully insulated oral capsules!) solve the same problem, at a fraction of the biologics’ costs. And some of that filtered through at the earlier FDA Advisory Committee meeting — but here is FierceBiotech on it all, as of this morning:

. . . .Trials for the drug, which is not a traditional antibiotic but designed as a mAb to prevent the recurrence of C. difficile infection by binding to and neutralizing the C. difficile toxin B, have already been chided by an FDA expert panel.


Last month the regulator’s advisory group questioned the Big Pharma giant for its small trial size despite the patient population being huge, with others seeing shortcomings in the data. The panel did vote 10-5 (with one abstention) for a recommendation, but most seemed to harbor differing levels of reservation. . . .

So now the earlierst this BLA will be cleared will be late October, 2016. Now you know — and onward, to a perfect — if smokin’ hot summer weekend — all grins here! I refuse to allow the re-emergence of the name of David Duke — into national politics dialogues, bend the arc of my joy — at all. Next Star Trek movie installment in the offing, as well!

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