ymi mention in this incy report
Incyte Corp. (INCY: Buy; $25 Target Price) - YM Back In The Saddle But Still Incyte’s Game For A Few Years Investment Summary
Brean Murray Jonathan Aschoff
Phase 2 data presented by YM at ASH shows that competition for Jakafi could be, in our estimation, about 3.5 years away, as we project U.S. approval for YM’s CYT387 in mid-2015. YM, in our view, appears to have a real drug, but we have identified some caveats in equating CYT387 and Jakafi or viewing CYT387 as better. YM claims an anemia benefit, and clearly shows one especially with the 300mg QD dose, but there is no graph depicting hemoglobin levels over time, and reticulocyte data is also absent, both of which would have made a far stronger case. We also would appreciate seeing complete adverse event data, rather than only what was deemed to be drug related. Also, the 90 non-Mayo patients evaluable for spleen size had to have experienced less than 31% benefit in order for the 142 total patients to result in 31% benefit, given how much higher the benefit was in the 52 Mayo patients at ASCO. Regardless, the drug looks interesting and we expect a European trial to be conducted, as Jakafi being available in the U.S. would in one way or another likely compromise YM''s ability to run as clean a trial. A European Phase 3 program should suffice for U.S. approval.
YM completed the enrollment of 166 patients in total in the expanded Phase 1/2 trial. YM dosed 52 patients with 150mg QD of CYT387, 60 patients with 300mg QD, and 42 patients with 150mg BID. We note that dose titration (5mg at a time) with Jakafi may enable doctors to better arrive at a more appropriate patient dosage, as myelofibrosis is a strikingly heterogeneous disease with respect to symptoms and hematological parameters. We believe the greater flexibility with Jakafi dosing is a significant advantage.
It also appears that Jakafi may maintain the advantage of achieving a greater spleen reduction, as the Phase 2 data for Jakafi showed 49% of patients achieving a =50% decrease in palpable spleen length, but CYT387 yields a 33% rate of patients are achieving this overall and in the 300mg QD dose group which YM appears to be favoring for the Phase 3 trial dose. The 300mg QD dose group had the greatest transfusion independence rate of 65%, and YM likely views this as the differentiating factor necessary to market CYT387 against Jakafi. In the Phase 3 COMFORT-I trial, Jakafi achieved a 41% transfusion independence rate using the IWG criteria, so that relative anemia benefit still needs to hold up in a larger trial.
Jakafi is also beginning to show a statistically significant survival advantage, which we expect to continue to improve over time. On an ITT basis, COMFORT-I patients have a hazard ratio (HR) of 0.50 with a p-value=0.04 after 76 weeks. Additionally, after 51 weeks of median follow up there were only 13 (8.4%) deaths in the Jakafi arm versus 24 (15.7%) deaths in the placebo arm. We note that there is a survival improvement across all subgroups rather than the benefit being driven by a select few. The full overall survival analysis is shown in Exhibit 3, which details the relevant subgroups.
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