Biotech Values

[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.