INCY CC Notes:
- Early comments were focused on Jakafi sales. Salient facts for me were that the use of 5 and 10 mg doses are increasing, suggesting that their education efforts in starting patients off at low doses are being adhered to.
- They note that 1/3 of prescriptions now are from docs who are new to prescribing, a number that is falling. That suggests that the MF market for jakafi is maturing and most that are prescribing have had a history of using the drug with their patients.
- They have updated the authorities on the survival data from Comfort I and II and are expecting to hear back in regarding to having survival information added to the jakafi label in 3Q14.
- Sales projection of around 320 million next year. The guidance is available in the PR.
Upcoming Trials and Data:
- They're working to develop the Jak1 inhibitor 39110 in 2 double blind trials in nonsmall cell lung cancer using two different regimen backbones
- From the P2 pancreatic cancer RECAP study, the subgroup information will be released at ASCO. It is being termed as a marker that is reflective of "tumour induced inflammation"
- For this indication, two phase 3 trials will be running (Janus 1 and 2). The first trial is under an SPA with the FDA and will enroll only the pancreatic cancer subgroup that was identified for benefit in the RECAP study. The SPA does not require validation of a companion diagnostic for the subgroup marker.
- Although the first pancreatic P3 trial has an SPA, they are running a second trial to both increase their change of regulatory approval, and because the second trial has more symptomatic benefit endpoints that they had not had time to incorporate into the first trial.
- Both trials will enroll ~300 patients and have overall survival as the primary endpoint
My take regarding this program is that they are not confident in relying on the SPA for approval based on one trial and are therefore running a second nearly identical trial to improve the package. Still lots of speculation on the marker that defines the subgroup, but these trials will address its validity.
- based on the RECAP subgroup, they are running trials of jakafi in breast, nonsmall cell and colon cancer. All three are enrolling based on the RECAP subgroup, but the colon cancer trial is enrolling in 2 groups, one that meets the subgroup requirements from RECAP and one that does not. They noted that the breast and nonsmall cell trials will not be sufficient for approval, but noted that the trial in advanced colon cancer may have an outside shot if the data are unequivocal.
Jakafi in polycythemia vera:
- I thought this was the most important part of the CC. They expect the phase 3 trial to provide top-line results in March / April and, if positive, an sNDA in June
- they note that the addressable population in PV breaks down as such: 100K patients are diagnosed and treated, mostly with hydroxyurea and 25% of those are resistant / intolerant or progress from hydroxyurea and are the targeted population for the PV trial
- they noted that sales in PV are not part of 2014’s sales guidance
My note from this is that the previous PV phase 2 data for jakafi was very encouraging, and I think the soon-to-be-released P3 data have a high chance of being positive. If the data are available promptly and they’re able to execute on the sNDA filing expeditiously, there is a possibility of sales contributing to the bottom line this year. More importantly, sales for 2015 could rise significantly from 2014 if PV is approved. I think this indication provides a good chance for improving INCY’s performance over the next 18 months.
Amusing note: the new CEO, Herve Hoppenot, sounded very much like the stereotypical Frenchman speaking English in Monty Python’s Quest for the Holy Grail. Unless I missed it, no one on the CC was taunted ey se-cond tay-mah.
