It is hard to read Schering-Plough’s press release of this morning as anything but a “Me, too!” faux-clarion-call. “How so?”, you might ask. Well. . . . the Schering presser must be read, side-by-side, with the Vertex second quarter press release, of last week — to discern where the two stand, in relation to one-another.
While Vertex previously-indicated it had already begun enrolling various sub-sets of its Phase III trial subjects for Teleprevir, Schering-Plough said just this morning it “expects” to begin enrolling Phase III subjects “this summer“. [Confidential Note to Schering-Plough: It is August 4. There is not much time left in the “summer” to make that statement true. And, as regular-reader “Wolf” very cogently pointed-out, last time we visited this topic, Schering may be having trouble getting its scale-up chemistry on-line and operating, in commercial batch-sizes. But let’s move on, shall we?]
Yes, let’s — let’s take just a second, to look at adverse events, as reported thus far, by each company. Vertex reports that about 7 percent of its Phase II subjects discontinued treatment due to side effects (primarily rashes).
Schering? 17 percent to 23 percent — for “severe adverse events“. In context, then, see this:
. . . .In the PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in the INTRON A/ REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL. . . .
Seems Vertex holds a rather-commanding lead, no? Both on a lower-incidence-rate of Phase II side-effects — and on getting to, and through, FDA-mandated Phase III trials. Just to keep it fair, here.
(Graphic, above right, derived from a thumb-nail CGI model made available by RKM.COM.AU).