Eben Tessari

Wyeth and Elan Take Hits on Bad Trials

Biotechbull,
I don't totally disagree with your statement about evaluating programs based on NPV but you made one crucial error... why do you assume that all programs have a 67% success rate in phase III?

Just because that is the industry average doesn't mean that it is the
best number to use for bapineuzumab. You have to take other things into account: novel therapeutic target, missing phase II endpoints etc...

Using 67% is mathematically lazy.

Furthermore, your assumption that "all this drug has to do is not kill anyone" is completely off base. The FDA has been tighting like crazy, this is not the agency of four years ago when your comment would have made sense.

Finally, given that:
1.) the drug failed multiple endpoints (and no drug targeting any tau related protein has ever worked in the clinic)
2.) has a pretty nasty dose-dependent AE of vasogenic edema
3.) at best works in 30% of AD patients

I'm all about disagreement but to hand wave using "average" statistics and make wildly off base judgment calls about the FDA approving anything that doesn't kill AD patients is not an argument that impresses me. Especially in the face of the three critical issues laid out above.

Tesa,
I'd totally agree that combination therapy holds the greatest promise.


FrankieCooper
For the record... I have never had a position in Wyeth or Elan. Though I now wish I had pulled the trigger on those shorts.

Also, i fucked up the link in my blog... it's been fixed there and the link here:
www.pharmababble.com/b.../