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Biotech / Medical : Incyte (INCY) -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (2649)5/3/2011 3:54:20 PM
From: former_pgs1 Recommendation  Respond to of 3202
 
pcrutch isn't taking my bait ;-)

But if we assume (despite the perils) that INCY will be on the market within 12 months, then what does YMI do? If YMI goes for an SPA, then I think it is reasonable for the FDA to make them deal with the reality that INCY's drug is on the market. At that point, I see two possibilities:

1) They run a trial in INCY failures.

2) They run a trial in the same setting as INCY and go head to head or noninferiority.

For scenario #1, all the talk of anemia won't matter any since they won't be able to make a comparison with a drug in an upstream setting.

For scenario #2, a noninferiority trial is not feasible (cost, etc...). Going head to head would be a massive risk because there will likely be an endpoint that depends on splenomegaly either directly or as a composite, and INCY's 42% is not easily surmounted.

So I think this is all posturing by YMI in order to drum up some excitement about their drug and its supposed difference from INCY. But they still don't have the hard numbers to back up their talk.



To: tuck who wrote (2649)5/4/2011 2:15:00 PM
From: Biotech Jim  Read Replies (2) | Respond to of 3202
 
<Some feel the better affect on anemia from the YMI drug is important. What does the board think? Management's position is physicians in this filed are "used to dealing with anemia." Meaning, I suppose, giving patients EPO if needed.>

My view FWIW is that it is very curious that different drug candidates in the class have different effects on rbcs. Is it a difference in activity of the respective compounds against Jak1 vs Jak2? The preclinical data that I have looked at do not support that contention. Further, ruxo is much more potent in vitro (and I believe) in vivo than CYT387, and we need much more data on CYT387 to understand its activity. Though anemia alleviation of CYT387 is useful, it is easy to give epo and of course the docs are used to this. So what is the reason for the apparent differential activity?

Since ruxo is 3 or so years ahead of CYT387, it should be entrenched in the market by then and will be difficult to displace.

<Does being first to market by a year or so trump this issue?>

Absolutely in the general sense. An equally important issue here will be dosing frequency, QD vs BID, despite what was stated in the INCY CC, though INCY does have a sustained release formulation in the works though not much detail on that has been provided.

I am continuing to bet on INCY, though YMI has been a good trader lately.