Poor Jeff Kindler.
Just two days ago, the new Pfizer Chief Executive had told hundreds of analysts at a research meeting that Pfizer could seek approval for their great HDL cholesterol hope as early as next year if clinical data supported it.
Pfizer planned to pair torcetrapib with its Lipitor, the world's best-selling drug that cuts bad cholesterol, to maintain sales once Lipitor loses U.S. patent protection in 2011. The company was planning to spend about $800 million in developing it.
Then along comes "totally unexpected and disapointing" data from the ILLUMINATE study!
More here at Reuters
2 comments:
I must admit there's something about this trial that seem off to me. First of all, it was a 15,000 patient pre-marketing trial. That's huge, considering that for new molecular entities most drug companies are trying to redefine "months" just so they can meet exposure requirements of 1500 for a month, etc. So safety doesn't require that. Second, it seems hugely overpowered. By my estimate, they powered the trial to detect a difference of about 0.7 g/dL HDL. What's the point? Efficacy doesn't require 15,000.
And then there's this issue of the October DSMB meeting not showing this difference in mortality. All of a sudden, (i.e. within the space of a month), there's a separation of 30 more subjects in mortality in the A/T group?
Definitely a lot more here than meets the eye.
Bad Cholesterol (Lipitor) is good for Pfizer while Good Cholesterol (Torcetrapib) is bad.
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