UPDATE — REWRITE: Continuing Noxafil® (S-P) Chronicles: Suddenly, KaloBios Moves To “On-Topic” — For This Merck-Focused Blog…

UPDATED 09.02.2016 | 10:30 AM EDT: A clearly well-versed anonymous commenter has quite correctly shown me a major error of mine, below. Here it is:

. . .The thesis of this article is incorrect. A PRV would be awarded for each new Active Pharmaceutical Ingredient (API) that treats Chagas disease. There is nothing in the Tropical Disease PRV legislation that would prevent multiple PRVs for the same indication (i.e. Chagas) as long as each newly approved drug does not contain an API that was previously approved in any form or for any other indication. Merck and KaloBios would both be eligible for PRVs under current legislation. . . . [Entirely new rewrite follows — see strike-throughs, and green text as the updated copy. END UPDATE]

I had no idea. Truly. I either did not notice (or entirely forgot) that in 2015, Merck was conducting a study to investigate whether one of the legacy Schering-Plough existing and approved small molecule drugs might be active against chronic (but perhaps not acute) Chagas. But as New KaloBios catches up on its ’34 Act periodic reports — delayed during its bankruptcy — we read last night that Kenilworth is affirmatively in the mix — perhaps also hunting for that coveted PRV. And to be clear, only one will be awarded — to the first finisher with an approved Chagas treatment.

Seeing an as well-heeled, and substantially-progressed (late Phase II) competitor in the water — circling lil’ KaloBios may be moderately bad news for KaloBios, at least as to sales revenue potential worldwide, once approved for Chagas — as between the two now would-be competitors. As irony would have it though, even the possibility of Merck picking up a $350 million first to market Chagas PRV certainly merits a mention, as “in the middle of the fairway” of this blog (and an offset to the coming odanacatib shut down charge, as well). We shall have to wait and see. From pages 16 and 17 of the KaloBios SEC Form 10-K, filed last night, then:

. . . .Other compounds that have undergone or are undergoing preclinical studies or clinical trials for Chagas disease include posaconazole, ravuconazole, Eisai Co. Ltd.’s E1224, and VNI, which has been studied at Vanderbilt University. In 2015, Merck Sharp & Dohme completed a Phase 2 proof-of-activity study of Noxafil® (posaconazole) in the treatment of asymptomatic chronic Chagas disease.

Recent trials led by Eisai failed to show a benefit of E1224 (fosravuconazole) over benznidazole either in monotherapy or in combination with benznidazole. Eisai has also conducted research with the Broad Institute to discover and develop new therapeutic agents for Chagas disease, including a compound known as ML341. Eisai, Shionogi & Co. Ltd., Takeda Pharmaceutical Ltd. and AstraZeneca plc are members of the Neglected Tropical Diseases Drug Discovery booster program, which aims in part to accelerate early stage drug discovery for Chagas disease.

Other than Merck’s trial, most of these programs are in the pre-clinical or early clinical stages of development and we believe will take many years to reach the market, if at all. . . .

All of which is to say — Merck is a very real global sales revenue threat to KaloBios’ Benznidazole PRV plans. More metaphysically, it will be forever fascinating to me, that any two things separated, and yet carefully observed. . . eventually often seem to be drawn together — perhaps even simply by the act of being carefully observed. Or maybe it is just a small (pharma) world, afterall. Smile. [No excuses here, but at 1:30 in the morning this morning, I didn’t go back and reread the Federal Register, on PRVs for NTDs. . . Thanks, Anon. — Truly!]



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