CS: RIGL, PFE, LLY - Positive Data of of INCB28050 Reported
5/7/10
! The Interim Efficacy Data of INCB28050 Appear Promising. Incyte announced three-month interim top-line results from an
ongoing six-month, dose-ranging Phase II trial of INCB28050, an oral JAK1/JAK2 inhibitor, in patients with rheumatoid
arthritis. ACR 20, 50, and 70 scores at 12 weeks of treatment of the INCB28050 arms were up to 60%, 36%, and 16%
respectively. All three doses were equally efficacious. It was shown to be effective in biologics-naïve patients as well as in
patients who were previously treated with biologics and did not achieve adequate response. No cases of thrombocytopenia
were reported. Anemia was observed in only the highest dose group treated with 10 mg QD.
! Implication for RIGL: The INCB28050 data is promising but also very early in development. Efficacy is similar to that of
R788, RIGL's oral SYK inhibitor partnered with AstraZeneca, and PFE's CP-690550. We believe a lower dose of
INCB28050 needs to be evaluated in the Phase IIb trial given the lack of a clear dose response in the Phase IIa trial. With
very limited safety data available, we think it is premature to assess the competitive strength of INCB28050 among the oral
treatments for rheumatoid arthritis (RA). In our view, R788 remains a viable RA therapy with considerable amount of safety
and efficacy data behind it. Further, we remind investors that the size of this market allows more than just one winner as
evidenced by the existence of multiple blockbusters in the anti-TNF space.
! Implication for LLY: 6th May's data suggests that LLY's partnership with INCY is at least heading in the right direction,
despite the limited data disclosure. Given that INCB28050 is still in Phase II, the product will not benefit LLY as it makes its
way through its patent cliff years (2011-2014), but it may be a positive contributor in 2015 and beyond. Along with seeing
the final results of this study, the ACR Annual Meeting in November will provide us with the next look at LLY's internal
approaches to RA, as data from two Phase II studies of their BAFF antibody will be released at the meeting. Additional
Phase IIb data for their IL-17 antibody is expected next year.
! Implication for PFE: PFE remains in the lead amongst the companies with novel oral RA agents. We expect Phase III data
for their JAK3 inhibitor tasocitinib (CP-690,550) will also be released at ACR in November, making that a critical meeting to
understand the evolving dynamics of the space. We currently forecast a regulatory filing of tasocitinib in 2011 and global
sales in 2015 of $700 MM. We estimate the compound contributes an NPV of $0.17/share to PFE, based on a 50%
probability of success. |
