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.

Salmon Rises — On the FDA Refusal To Accept Merck’s Combo-NDA

While tied up with clients all day, I just knew Salmon would eventually surface — and grace us with some expert insight on the Merck “NDA bounced by FDA” news [when I saw the story scroll through my iPhone WSJ app, as I sat locked (helplessly) in a meeting/conference room]. Here is the operative language, from page 46 of Merck’s Form 10-Q, this afternoon:

. . . .the FDA recently refused to file the application. The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA’s response in order to determine a new timetable for filing. . . .

And now, while noting that Larry Husten, over at Cardiobrief had also written earlier today, on the same topic (H/T Marilyn Mann!), I’ll turn it over to Salmon, thus:

. . . .The only reason to not file an application is that it’s not complete on its face. In other words, there’s not even enough information included to review it. Even if prima facie, the studies were negative (or that the sponsor had been told that biomarkers just wouldn’t cut it) and the FDA knew the drug had to be turned down eventually they would still file it, and do a review.

It’s almost unheard of for a big company to not include even adequate information to allow review — so that it results in a refusal to file. In fact what companies will often do is get the FDA to agree to a submission of the additional data during the review cycle. Of course if it doesn’t come in when it was promised the review of this additional info may have to be done in a short time frame and veeeery superficially.

Since the refusal-to-file criteria is a policy that effects the public it should be publicly available somewhere. I’m just too lazy to look for it right now.

Veeery Interesting.

Salmon

November 2, 2009 @ 7:42 PM

Thanks again, Salmon! I’ll go look for it now, Salmon — but it may be that FDA agreed to wait to make this decision public, until Merck could make an SEC filing on the topic, since it is an arguably material development – in SEC parlance. I will report back.

In the meantime, here is the December 9, 2008 slide on the combo pill, from Whitehouse Station — and my post on it, from that day:

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.