I haven't swept clinicaltrials, but I think all the trials that might have reported before June are gone. Next news items are likely to be the journal publication of the follow-up of the MF phase 3s, and the clinical plans dump in April. Neither one likely to generate price movement. "Other" epac phase 2s could come out any time, but we've been gently urged to expect them on a roughly 4-12 month time scale. Announcement of the plan for epac/pembro phase 3 also any time (but I'd guess April). For some reason, I don't expect it to generate much enthusiasm. Application to have N.I.C.E. reconsider Jakavi for MF should follow closely on publication of follow-up, but again, until it's in the can (June?) it's probably a yawn (I guess they could reject again, which would be a negative)
Anyone know the problem with low dose interferon in the US? Yeah, it's a possible competitor in MPNs by itself, but the combination with Jakavi looked miraculous.
Janssen going 100% for MDSs with IM maybe? Makes too much sense.
So maybe I care too much about corporate communication. During my second listen to the CC I tried to pick up any mention of how long it will remain available on the Incyte web site (I see no need for quarterly calls to go away EVER, and really, they stay useful for at least 13 months) (plenty of time to compare this year with last year). Transcripts are nice too, but slide decks just don't cut it.
Did you participate in the rumor campaign last Fall about ruxo patents expiring? That was disgusting.
If you want to understand this topic, look at other post around the same vintage
Take a moment Compare to previous CCs and those from other companies. What might have been there but wasn't? I don't recall anything but a chart appearance for the cMet inhibitor. No commentary around the 4% Jakafi price increase. I kind of expected a question about corporate communication policy. I was happy not to hear any new buzzwords.
Oh, in addition to the gorilla, there
s a feisty chimp in the room: the cMet inhibitor. I think Incyte is only in for teens royalties, but apparently it keeps chugging along toward market.
Ok, the actual sales numbers are super (they did warn that revenues reported in May are unlikely to grow quite as strongly).
Baricitinib is the 800-lb gorilla that everyone is ignoring. I can't see it having ultimate RA sales less than 1/3 of the anti-TNF market, and the non-failure of Xeljanz will make sell-in easier (they don't really compete with each other; both compete against anti-TNFs)
Epac remains the go-to companion IDO-1 inhibitor in immunotherapy combinations, but nothing else is as far along as the melanoma combo. But in melanoma, things look extremely promising. It sounds like Incyte is pre-recruiting locations to get the promised phase 3 a fast start. With success, there could be approval in 2017 (but commercial handling of epac is still a bit mysterious)
PI3K-delta is a validated target that has been shrouded by drug tolerability problems. Incyte's new entry looks like an important advance, and could go phase 3 in a year or so.
And just because Incyte is letting Novartis pull the plow on ruxo for GVHD, that won't prevent there being meaningful sales (say starting late Fall). It really is a condition where '110 would be preferable if it can be used at all, so it's reasonable for Incyte to put their trial effort there. A badly under-met need, with prevalence in the MPN range. I have a sad joke about one of the principal existing GVHD treatments: "watchful dying."
The 'broken pencils' chatter was edifying. What was left out was the fact that most analysts had already dropped their valuation of the ruxo in solid tumors program to zero (accompanying the CRC cohort discontinuation move), so instead of the stock paying for the discontinuation 3 times, it's paid 4 times. New specificity on bari participation-low end of the tiered range is 20% with an expected average of 25%. HH was clearly torn on whether to answer a question that amounted to whether bari will eventually sell over $6 Bln annually; I think he came down closer to yes than to no. (With the evident non-failure of Xeljanz, the vulnerability of RA biologics is clearer).
Since your mother has come up in this discussion, I'll ask whether she named you "reality_check_I" If not, you're at least as much a pseudo as I am. I say at least, because jacosa is pretty much my only online identity everywhere.
With all the communication problems, the candidate change vs PIK3-delta has been handled successfully. And the clarification of their hope for the program was helpful.
Unusually clear answer on further research collabs with Lilly. Getting to nitty-gritty on diabetic nephropathy. Earlier stage on atopic dermatitis. But neither decision made.
Clarification on what has been discontinued an why: all studies based on systemic (and regional) inflammation activity of ruxo combined with other agents gone. Local inflammation based studies continue. Not all of the discontinued studies had actually failed, but were considered unpromising. Available results will be published.
Epac remains the item that you can't assign a value to. But yeah, the solid tumor programs were a big part of the "You say trial costs, I say multi-billion dollar market" takeover defense.
I've noticed a trend toward buzzwordification in recent presentations. Jus a cloud like a man's hand, but a downpour might follow, and it might imaginably split the company (You can reconstruct from how analysts react after meetings with management that there are favorite and "stepchild" programs, and an opportunity to stay with a favorite-enriched piece might be tempting). Dr Paul ADORES epac. I think HH likes biologics, and would like to bring in more.
They didn't announce the discontinuation last month, only discontinuation of one cohort of one [never-optimistically-regarded] study. At the JPM conference, HH was upbeat about Janus-1.
On the other hand, at least the BoA/ML analyst put his estimate of the ruxo market for solid tumors at zero after the high-CRP CRC discontinuation, and few other analysts had imputed much value to the program in the first place.
WOW. Huge in both directions. And in cash items, too. I guess the high-range YoY growth of Jakafi sales is probably the biggest one. But Janus-1 was the best hope for a new income stream before next Winter, and while the various studies in the ruxo combinations vs solid tumors collection were pretty unglamorous, the ultimate [always acknowledged low probability] market opportunities were enormous. But I keep saying "Year of cash." These were expensive studies, and they won't need to be paid for going forward. Some analysts imputed substantial value to the chance of at least one success in this set of programs. I hope we'll get some publications about paraneoplastic syndromes out of this failure. While the "inflammatory regional environment favors tumor survival" story was the most public one, the "Cytokine storm causes fever, wasting, weakness, etc. and mixed JAK inhibition blocks those effects" story seemed pretty solid. Are micrometastases the real culprit in toxic cancers?
Nothing in the release about participation in Lilly's study against diabetic nephropathy. If nothing is volunteered, that ought to draw a question.
This is an incredibly odd time to announce failure of Janus-1. I can't get away from that. The normal "preplanned interim analysis" would have been done long ago. With data collection due to end in April for a study that began last January, patients are not being spared a whole lot of futile treatment.