Replies to post #111483 on Biotech Values

[DewDiligence]

INCY—I think…050 would be unlikely to beat tasocitinib head to head, given the data reported thus far.

INCY’s drug might be able to show statsig non-inferiority, which ought to be good enough for FDA approval with a suitable SPA.

[poorgradstudent]

RA:

>Pfizer's JAK inhibitor (tasocitinib) will have been on the market for about a couple years at the time when Incyte and Lilly are working out an SPA with the FDA ... I would think Incyte would be given two options. For first line (or 2nd if Pfizer gets approved only for TNF failure patients), go head to head against tasocitinib. For 2nd line (or 3rd in the TNF failure case), show that 050 can work in tasocitinib-failure patients. <

The TNF blocking antibodies:

Humira: approved end of 2002; moderately to severely active RA

Cimzia: approved 2009; moderately to severely active RA; 4 randomized trials, all were to placebo or MTX control arm; none of the trials included patients with prior anti-TNF treatment

Simponi: approved 2009; moderately to severely active RA; 1 of the 3 trials included patients with prior TNF alpha biologic; all three trials were against placebo or MTX.

Bottom line is that I think there is definitely room for a multiple trial phase 3 program that doesn't rely on beating tasocitinib head to head or necessarily being restricted to tasocitinib failures. The Cimzia and Simponi approvals suggest that the FDA is less hard core than you are :-)

Admittedly the FDA's stance could could change.

[rkrw]

Unless I missed it, I think you guys aren't considering the relative safety profiles at all.

[biomaven0]

There could easily be a safety differentiation between the Pfizer drug and the INCY drug precisely because the INCY drug does not hit JAK3.

Inhibiting JAK3 is immunosupressive, and so there could well be fewer serious infections (like reactivating TB) in the INCY trials than in the Pfizer trials.

The INCY drug seems to promote shingles, so it has its own immunosuppressive issues. (It's not straightforward to give the shingles vaccine to this patient population because they are typically already on various immunosuppressants).

Peter