Tag Archives: Bad for Schering Boceprivir Good for Vertex Telaprevir UBS Conference Hep C candidate Phase 2 Phase 3 FDA chemistry Hep C EFFICACY November 2 2009

Schering-Plough Specialty Sales Force Query, Answered

During the day today, an anonymous commenter asked the following:

. . . .Do you have any more specific info on the AASLD events? SP Specialty has been told Boceprevir has less toxicity, better SVR’s, and has passed Telapravir in the race to launch.

November 2, 2009 @ 4:29 PM. . . .

First, I have no “inside” information — and I am not in Boston this week.

That said, we must remember that this is Schering-Plough’s management making these claims. As such, a few things are fairly clear. Based on the data available thus far, most independent analysts feel Vertex’s telaprevir has shown the more promising SVR rates — both in treatment-naive populations, and null responders. So let’s call this one a Kenilworth myth.

As to less toxicity, I think it is far too early to say definitively. Not all the Phase II/III studies are complete, yet. My sense is that Vertex’s candidate is no worse, and perhaps a little better than boceprevir, the Schering candidate. So, let’s be generous, and call this one a “push“.

Finally, I cannot see a path through FDA that has Schering-Plough’s boceprevir finishing first. I do see such a path for telaprevir — but this all depends on how these studies ultimately report out. Let’s say “the jury’s still out” on this one.

Net/net: I’d say to the SP Specialty sales force — you are (mostly) being sold a load of shineola by management.

HCV Candidates “Battle Royale” — Via AASLD Press Releases, and Posters

This morning, in his round-up, Ed over at Pharmalot mentions the two leading HCV “next gen” candidates, now duking it out in Boston; this battle of the posters and press releases, at AASLD — formerly “the liver meeting” — is fascinating (at least to me).

For its part, Vertex’s telaprevir shows better than an 80% cure rate — in a small study. In larger ones, telaprevir is showing a 57% cure rate.

Schering-Plough’s boceprevir has been trying to counter the onslaught of impressive Vertex news, by touting its boceprevir data — which Kenilworth says offers a 55% response rate in “non-responders” — patients who’ve earlier failed treatment attempts.

However, Schering-Plough’s study makes much more liberal assumptions about what constitutes “prior treatment“, than Vertex’s studies do — so that the two response rates are not comparable.

If “normed” for the differing definitions, Schering’s non-responder cure rate might be closer to 28%, and on an apples to apples basis, that would compare with a 57% rate for Vertex’s telaprevir.

What do I think? “Let the games begin, in earnest!” — I think Vertex will makes its ANDA filing with FDA in late 2010 or early 2011, and draw “fast track” status. As ever, we shall see.

Here is Adam Feurstein’s latest take:

. . . .The [Vertex] study demonstrated quite convincingly that a more convenient twice-daily dose of telaprevir is just as effective and safe as the current thrice-daily dose.

The hepatitis C cure rates of greater than 80% across all four patient groups of the study are also the highest ever recorded in any telaprevir study to date and exceed the cure rates reported by any of telaprevir’s competitors. . . .

Vertex stock is up almost 10 percent in pre-market NASDAQ trading this morning — up almost $4 per share. Schering-Plough stock is essentially flat.