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.
7 comments:
That's gotta sting:
http://www.reuters.com/article/rbssHealthcareNews/idUSN3043005220091030
FDA says 'no' to Pegintron.
A double whammy today:
http://finance.yahoo.com/news/FDA-wont-accept-Mercks-apf-1423990880.html?x=0&.v=4
FDA declines to accept a combo of Zetia and Lipitor.
Interesting.....very interesting....
But, at least, those grass tablets are working. Maybe they take them with that French Sea Water?!
http://phx.corporate-ir.net/phoenix.zhtml?c=89839&p=irol-newsArticle&ID=1349395&highlight=
link for the success of the grass tablets
http://phx.corporate-ir.net/phoenix.zhtml?c=89839&p=irol-newsArticle&ID=1349395&highlight=
link for the success of the grass tablets
Condor,
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.
Regarding comment No. 2. The WSJ also has an online article.
http://blogs.wsj.com/health/2009/11/02/zetia-plus-lipitor-for-now-fda-wont-consider-it/
The article states that Merck stated in an SEC filing:
"… 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."
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 facia 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 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 refuse to file. In fact what they 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
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