What;s their time frame? Do they even say? If you evaluate Incyte as a drug developer, a price in the 90s is fairly easy to justify, but Incyte is some percentage of the way to becoming a drug seller, and the valuation standard is different, largely because the time horizon is different.
In an impatient market, PV offers the fastest earnings goose. Problem is that the marketing / business case is tough there. The chance of blowing it completely isn't ignorable. Off-label use of Ruxo for PaCa would be comparably fast, but the one shot at that failed. It may generate sales before the indication goes on-label (you just have to look at the weight gain plot to make that a when rather than an if), but not before going on-label is formally justified--how does your time frame compare to the estimated Janua 1 completion in Feb 2016?
However promising '360 is, it can't generate earnings until it is approved for SOMETHING. I don't see even a hint of a roadmap. And for completeness, Bari is going to take as long as it takes. We KNOW that it's better than the approved Xeljanz, but the market has been poisoned for the whole class of drugs and Lilly NEEDS to do the thorough trial program they're doing.
At least about what's top-of-(?)mind(?). Tremendous excitement about the '360 results, but the initial move is down. The market wants earnings NOW, if not sooner.
On that theme, there may be some disappointment that only 1 patient has been enrolled in the 2 JANUS studies; I would have expected 5-10 by now.
It isn't earnings day after tomorrow. It may be leverage for favorable collaborations. Many of the exciting immune enhancers are given by injection, and may be given much longer than the immune-sensitizing treatment they enhance, so oral administration of '360 may be a plus. I'm in no position to estimate potential market size or timing, but definitely blockbuster class, and some commercial availability in say 2 1/2 years doesn't look impossible (The presentation made it sound like this was an investigator-sponsored trial 'adopted' by the company, so the roadmap to commercialization may not be sketched very fully yet).
All said positively was that one item would be seen as the biggest story. And in the IDO results, the biggest benefit wasn't really in any single item, but in the whole picture (Even the fact that the '300' group did well in the end despite unacceptable toxicity)
Wow! It just MIGHT be a miracle (but part of the history of immunotherapy is that there have been spectacular irreproducible results). The results seem to underestimate the actual drug effect. There will be no problem at all enrolling future studies, but the problem is designing the right studies to reach market with a large target population in a short time.
Two non-responders with specifically ocular melanoma suggests a way to sweeten the patient population, but perhaps you don't want to do that.
Well, they addressed why mGPS OUGHT to be regarded as a natural criterion for classifying patients. I think it was a surprise that the correlation with CRP was better than the correlation with Karnofsky score. For that matter, it was a surprise that CRP and Karnofsky score don't correlate well. This is probably going to be a few PhD theses. It seems that Incyte has a bunch of analyses stratified by other markers that will either generate leads or generate publications for years.
The weight gains were extraordinary. On the other hand, it was disappointing that patients going to hospice didn't choose to continue Rux (Q: Whikle Incyte would have continued to give them Rux, did the hospice programs perhaps forbid it?).
Too little in the Melanoma release to conclude anything...well, except that it would be criminal not to continue research. The raw result of the '50' cohort is spectacular. Now let's see n=40 rather than 4.
The justification for the subgroup in the press release on RECAP is inadequate. There isn't enough emphasis on the QoL benefits, which are only mentioned. In a way, this is encouraging. If you expect to get the indication put on-label "fairly soon" (I'd set that at 18 months or so), you don't encourage off-label use (lets you do a road-show introduction when the time comes) and vice, of course, versa. The stomatitis (mouth sores) signal may be a concern--these are very vulnerable people and this may be where the opportunistic infections some of us have long feared show up.
Unfortunately Obamacare doesn't directly or substantially limit drug company gouging of Americans. Coverage is mostly through insurance companies, which, in general, benefit from high drug prices. There will be more people covered by Medicaid, which has incentives to keep drug prices down, and which does, in fact, negotiate for lower drug prices, but that's a second-order effect.
Posted by Steve, the socialist capitalist.
Early reaction will depend a lot on spin. I don't think any advisor who likes his clients (or anyone playing serious money for himself) is going to get excited about PV prospects until the actual dollar results start coming in. One of my favorite clichés about medical research is "There are no half-miracles." Preliminary highlights on the '360 trial looked half-miraculous. Is the presentation better? The promising result might get spun into something that moves the stock, since people choose to highlight cancer immunotherapy these days (Breakthroughs have been imminent in cancer immunotherapy since 1958 to my direct personal knowledge, and notice how many have stuck). I'm most hopeful for RECAP, but it's the most sensitive to spin. What difference does Ruxo make in QoL? Can physicians get worked up about it? Can all the important parties be convinced that dividing a population by modified Glasgow prognostic score is more natural or meaningful in this context than dividing by place in the alphabet?
And of course, any surprises in the third-party experiments?
Your world is more exciting than the one most of us live in. Best case for your position is that INCY jumps on meeting news and then doesn't do much for the next year or two.
It is just possible that the '360 results might cause a pop. There remains too much business uncertainty for PV results to cause an actual pop. I'm very hopeful about RECAP, but with p3s started, any large move is likely to happen later. If Jakafi for PV is a business success, it will be evident in about a year. Basically, the most likely scenario is modest movement early (not enough to make your June 55 or 60 calls profitable), followed by some sort of continuing up move against which your sale of 55 or 60 calls looks burdensome.
There are a lot of balls in the air. One will probably become the dominant news story. I don't think the PV presentation is a candidate for that. I think the IDO release is the best candidate because the news may be in topline results. If the QoL benefit in RECAP is spectacular, that might become the lead story. But really, for all programs, look closely at the safety/tolerability measures.
I personally have never believed in immunotherapy for cancer, but yeah, everyone seems to want a chance with '360.
I think pretty exactly the opposite. I don't think they "fumbled the ball in 2010." They came pretty close to approval with a data collection that technically met the requirements, but didn't hit FDA's usual standard (YES two pivotal trials, but NO both of them didn't hit primary endpoint). They came out of it with a pretty clear roadmap to approval, which they have followed. They couldn't have gotten a SPA because it would re-open the issue of whether a pivotal trial had to have survival as a primary endpoint. Maybe you could blame management for not going with stricter enrollment criteria in the CAPACITYs, but I think enrollment was difficult 8 years ago when the IFN failure was fresher and the side effects looked worse.
And whether FDA is tougher on big pharma players or not, I observe that the big guys make MUCH fatter submissions. Intermune WILL get approval, and probably fairly quickly; a big player might get run around the bush.
It's just that I think The Esbriet Company could go for about $60 organically, so a suitor would have to offer a\decent premium. As always, the difficulty of a deal depends a lot on how uncertain the value of longer-term assets is.
Healthcare is good in a generally punk economy, but I use DIOD as a leading indicator, and their results predict something like prosperity. Might look to other sectors.
Mr Welch does not have the sort of personality that fits the program. I mean, I don't think you could get him to jump up and down with "The Miracle on Ice" on the monitor and hot peppers in his shorts. Cramer: "Would you agree that Intermune will soon have all the money in the world?" Welch: "Thank you for a very good question. I am not prepared to speculate on events that far into the future. I might be safe to say that we have funding to continue our marketing efforts for the next two quarters." The video may go viral.
A week before ASCO. with much moaning about the ill-defined survival benefit shown in RECAP, recall that the business goal in doing the trial was not to show survival, but to show palliation. It would have been difficult to run a study that didn't offer SOME hope of showing a survival benefit, so that's how it was done. We still haven't seen the key results. And there is most likely a survival benefit too.