Monday, August 4, 2008

Next Generation Hep C Drugs -- Vertex v. Schering -- Who's Ahead? And, whose drug sports "the most rashes"?


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.

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(Graphic, above right, derived from a thumb-nail CGI model made available by RKM.COM.AU).

5 comments:

Anonymous said...

You're a freaking douche bag that has a hard on against SP for some reason and you need to get professional help. Seriously, it is not normal to do what you are doing. You are screwed up psychologically.

Condor said...

Thanks so much for your input, here. You wrote:

". . . .Seriously, it is not normal to do what you are doing. You are screwed up psychologically. . . ."

Is believing everything CEO Fred Hassan publishes about Schering your idea of "normal"?

Is that any less "screwed-up", in your estimation?

Do tell.

Next. . . .

Anonymous said...

I read with interest the SP boceprevir press release from the Phase 2 SPRINT trial. The release reported a 74% SVR12 with 48 weeks of treatment in naive genotype 1 patients. For certain this is a significant improvement over current standard therapy with typical SVR for a similar patient population of 40-50% with 48 weeks treatment.

This race to market becomes more interesting when examining telaprevir data released by Vertex from their PROVE 2 trial reported at EASL in April which showed a 68% SVR in a similar patient population.

On the surface, 74% would seem superior to 68%, however of significant importance is that the boceprevir trial used a 48 WEEK treatment regimen compared to a 24 WEEK treatment regimen in the telaprevir trial (48 week results for telaprevir I believe are still pending).

Now what could this potentially mean down the road should these therapies be successfully commercialized?

We know the cost of a 48 week regimen of SPs Pegintron+rebetol is approx. $25K ($12.5K for 24 weeks). If one assumes (for the sake of argument) that the add on of a protease inhibitor to current therapy will double the weekly cost (a big assumption but arguably not an unreasonable one), the cost of a 48 week boceprevir regimen would become $50K (double the current standard) compared to $25K with a 24 week telaprevir regimen (no increase in cost of current standard of care).

In an era of socialized medicine and cost containment in many parts of the world, it begs the question: Would payers especially governments be willing to pay double for a therapy that might deliver an extra 6% response (depending on Phase 3 trial results) especially with the additional side effects that would be expected to come with a regimen that is twice the duration??. This analysis suggests that SP would have to price boceprevir significantly below telaprevir in order to be competitive. I guess we will have to wait and see what happens in Phase 3 and beyond.

An interesting (and largely unnoticed) footnote to the SPRINT results was the lacklustre performance of the PegIntron + ribavirin control arm (SPs current marketed therapy) reported at 38% SVR which is lower than the expected 45-50% that has been reported with Pegasys + ribavirin in G1 patients.

I have no financial relationship/interest in Vertex or SP but am only sharing my personal observations and opinion as one with an interest in virology and the reporting of clinical trial results.

Wolf

Anonymous said...

Check out the recent posts on the Yahoo VRTX board for some insights on Schering's questionable use of data in the boceprevir reporting

Anonymous said...

Thanks for the link. I find it quite amusing that SP would choose to release this important Phase 2 data via press release rather than by way of scientific meeting and/or publication where the data would be subject to the scrutiny of the medical and scientific community. The urgency of this press release reeks of desperation and a need to have some good news in the market.

Wolf