Comments on: Pharmalot… Pharmalittle… Good Morning http://www.pharmalot.com/2009/11/pharmalot-pharmalittle-good-morning-140/ News, Comment and Conversation Fri, 19 Mar 2010 03:11:01 +0000 http://wordpress.org/?v=2.6.2 By: Condor http://www.pharmalot.com/2009/11/pharmalot-pharmalittle-good-morning-140/#comment-443126 Condor Mon, 02 Nov 2009 13:26:31 +0000 http://www.pharmalot.com/?p=19509#comment-443126 Ed mentions the two HCV candidates, now duking it out in Boston -- this battle of the press releases at AASLD -- is interesting, at least to me. For its part, Vertex's telaprevir shows 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 "<i>non-responders</i>" -- patients who've earlier failed treatment attempts. However, Schering-Plough's study makes much more liberal assumptions about what constitutes "<i>prior treatment</i>", than Vertex's studies do -- so that the two response rates are not comparable. If "<i>normed</i>" 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? "<i>Let the games begin, in earnest!</i>" -- I think Vertex will makes its ANDA filing with FDA in late 2010 or early 2011, and draw "<i>fast track</i>" status. As ever, we shall see. Namaste Ed mentions the two HCV candidates, now duking it out in Boston — this battle of the press releases at AASLD — is interesting, at least to me.

For its part, Vertex’s telaprevir shows 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.

Namaste

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