The stopping of Zytiga's trial based upon the fact it met one of its primary end points, progression free survival while stating it did not meet the end point for overall survival, may be a death blow to this cancer drug. I see few patients being interested in pain free survival without any life extension benifit. This is an effort by Johnson and Johnson to minimize the costs of the trial process while saving as much face as is possible. The news release yesterday by its proponents was another example of how Wall Street attempts to spin news to meet their own goals.
I won't bother you with boring true stories of PC patients living 3 years after taking Provenge (I have an idea you already are familair with those). And I won't bother explaining what "median" means because I also think you know this too. But a 8-month regimen of Zytiga (who knows if patients will live long enough to benefit from the drug if the side-effects and age don't kill them first) but again I think the thinking person would choose 3 office visits in a month's time over an 8-month regimen.
I 100% agree. Wallstreet is playing this to let the shorts cover and to let invest co's build long positions. there is massive accumulation at these levels or the stock would already be at 4 bucks or less.
this was actually a defensive move by JNJ.
twice as many PC patients in the pre-chemo stage and JNJ was losing this market to Provenge. the sole purpose of the trial was to get approval for pre-chemo use and stop the market share losses. once Provenge gets entrenched as the standard of care with UROLOGISTS, it would be hard for Zytiga to survive. when MDV3100 gets approved for post-chemo, Zytiga essentially loses that market.
so read between the lines... JNJ is merely trying to keep Zytiga in play as a treatment option and make some money before MDV3100 gets approved for pre-chemo stage as well, which could be 2015. after that point, nobody would use Zytiga at any stage. Zytiga has a potential life of 6-12 months for post-chemo and a life now of 12-24 months in pre-chemo. that's all... then Zytiga is history. so naturally, there was an emergency need to cut short the trial and get to pre-chemo marketplace ASAP.
Great analysis, Peso.
Another underappreciated factor in the Zytiga push is that the cancer market is desperate for a magic, easy-to-use pill (Zytiga) rather than what some consider a messy series of blood transfusions. They will do anything to see that the pill prevails. Hey, if my life was on the line, I'd want something that actually WORKS, even if it involves transfusions rather than pills.
well said and I totally agree
from all the side effects of both drugs prednisone and Zytiga- only an idiot would subject themselves to this course of treatment without promise of a cure or long term remission- neither of which have even been hinted at in the results from the study.
Remember date 18.10.11:
Deutsch Bank Bio - DNDN (Buy) - **Zytiga read-thru from JNJ call for Provenge**
>From JNJ call this morning, we're highlighting comments on Zytiga which could have a read-thru to DNDN's Provenge
*Not counting on interim look in Q4 but waiting on overall survival data. So JNJ is guiding to filing on overall survival
*This should bode well for DNDN b/c overall survival endpoint will take longer giving them more lead time for 1L in US and EU
*Zytiga contributed 1.5 points of growth to pharmaceutical business compared to same quarter last year.
The fact that they have spun this as a positive will not convince th FDA to appove label expansion in my opinion... The adverse events associated with prednisone cotherapy along with no statistical overall survival advantage over placebo is all the FDA needs to not only disallow the expansion of label but they may actually call for new review of existi ng label for zytiga... See you on the otherside of the gap, $35.84...