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pcrutch

10/14/11 10:26 AM

#128437 RE: biomaven0 #128436

if INCY gets approved, could come early. High unmet need, niche indications has seen 4 early approvals thus far in 2011

turtlepower

10/14/11 10:31 AM

#128438 RE: biomaven0 #128436

INCY - Is approval priced in, in your opinion? The EV is more 1.8 B when the convertible is taken into account.

mcbio

10/14/11 10:39 AM

#128439 RE: biomaven0 #128436

I've now seen some analyst reports defending INCY, and they make some reasonable points.

Key seems to be that this trial had a wide dosage variation - some doses that were too low and some that were too high. So you would get discontinuations for both efficacy and for tox. Those discontinuations in turn would drive no improvement in OS. Also, the rebound effects claimed here do not seem to have been repeated in other trials for whatever reason.

So I'm starting to wonder if the weakness was an overreaction
.

To add on to turtle's question, what are sales projections for the MF drug, if approved? Also, INCY has all U.S. rights to the drug, while NVS has ex-U.S. rights, correct? What are the economics due INCY from NVS ex-U.S.? And does INCY have the full capabilities to market the drug on their own in the U.S.? (That's obviously a big deal having full U.S. rights to the drug, assuming it is projected to potentially be a big seller.)

And I do think there is nice potential for the RA drug partnered with LLY. Curious about the economics due INCY on that drug as well as I don't recall off-hand.

jq1234

10/14/11 11:08 AM

#128441 RE: biomaven0 #128436

Key seems to be that this trial had a wide dosage variation - some doses that were too low and some that were too high. So you would get discontinuations for both efficacy and for tox. Those discontinuations in turn would drive no improvement in OS. Also, the rebound effects claimed here do not seem to have been repeated in other trials for whatever reason.



Exactly. The article just mentioned it was subset of phase 1/2, didn't give any background on the trial, and possible explanations for the issues the article raised, then just drew conclusion from 51 patients out of single arm phase 1/2 without mentioning anything of the more than 500 patients phase 3 randomized, placebo/best available therapy controlled trials.