Pharmalot… Pharmalittle… Good Morning
1 CommentBy Ed Silverman // November 2nd, 2009 // 7:21 am
Welcome back. We hope your weekend was fun. After all, there was Halloween and the World Series for baseball fans. And there was plenty of opportunity to get some exercise raking leaves, at least for those who live in the US Northeast. Now, though, another week beckons. And so as you prepare for those meetings and deadlines, here are a few items to help you along. Have a nice day everyone…
Will Pfizer Buy Protalix? (Globes)
Amylin And Takeda To Develop Obesity Drugs (Reuters)
Dendreon Seeks FDA Approval For Provenge Vaccine (Reuters)
Human Genome Sciences’ Lupus Drug Cuts Symptoms (Bloomberg)
Schering-Plough Reports Hepatitis C Drug Results (Associated Press)
Vertex Pitches Its Hepatitis C Drug (The Boston Globe)
Condor
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