I'm thinking back on the rumor a few weeks ago that Incyte would lose patent protection on Jakafi this year. With ZZEERROO overlap between what Incyte does and what Turing does, I wonder about the work that went into connecting a response to one with a threat to the other.
If baricitinib was to replace MTX, that would be several times the market size anyone is talking about seriously (easily the largest drug market if that happened). MTX is familiar, cheap, generally well tolerated, cheap, has a specific antidote for overdose, a big step up in disease control over NSAIDs and cheap.
The official noise over why MTX will always be used first may focus on risks associated with myelosupprssion, but really, familiar and cheap are hard to beat.
The results released today are particularly important as they bolster the case for safety of baricitinib (looking mostly relative to Xeljanz...you wouldn't much want to go heads-up against Xeljanz because it would be seen s a soft target)
We've already seen protection of joint structure, which was FDA's big issue regarding Xeljanz. Non-inferiority to biologics is the last ingredient of a super-blockbuster.
You asked me once: why are you writing this?
Couple points: Incyte doesn't release data on the RA drug (baricitinib) because the trials are being run by Lilly; that's who releases the data. And compared to the real competitor that baricitinib is directed against (biologic TNF antagonists: Remicade, Humira, Cimzia, Simponi and Enbrel), methotrexate looks like candy.
Throw in investor stupidity. The issue here is drastic price increases on old, cheap-to-manufacture drugs, taken by new trademark-holders who have no research departments of their own. In Shkreli's case, he threw in some extra legal obstruction to prevent entry of competitors. The Valeant instances seem to rely on inertia and threat of undercutting any newcomers to maintain the monopoly. So far, this hasn't even spread to old drugs that actually have a natural scarcity, and have become spectacularly expensive (poster child there is ACTH, now, I think, trademarked Acthar). And while there's baseline talk about expensive newer drugs, stuff like Avastin, Provenge and Erbitux, they have only generated low-level concern.
What might change, and affect real biotech companies, is that treatments for super-orphan conditions (say, US prevalence under 100) might be pulled out of the private sector. Regular orphan conditions (say prevalence of 10,000 to 100,000) have something in common with regular illnesses, but when each individual patient is a research project, the appropriate structures are too different. Presumably the same professors will take the same time off from their usual tasks to develop super-orphan treatments, and even be well compensated, but there won't be companies formed around them.
Thinking about this some more, a possible response would be to bill the tests and interpretation of the tests as separate items. It isn't THAT different from the corporate direction of moving lab work that can be done in less-specialized labs out the door.
But the answer is still no. The company's business is to make money, on a schedule and in a way that has been communicated as well as makes sense.
There is just too strong a history of companies that got crippled trying to manage their own stock prices.
Yes, if a Democrat wins next November there will be an immediate move to change the law so Medicare negotiates drug prices as Medicaid already does. No matter which party wins, there's likely to be a move toward a systematic way of regulating the costs of medical interventions. None of this is within the usual 18-months-to-the-bottom-line investment time horizon.
or "full facial grooming?" That seems to be the issue in the CMS preliminary pricing on Vectra. CMS seems to be coming down on the former side. Basically, they're pricing based on the individual tests done to get a result, with no added price for the intellectual property that dictates which tests to perform and how to interpret the collection of results. Not an immediate issue, because Vectra is such a small contributor right now, but a huge one eventually. Several upcoming tests, including Prolaris, are based on the idea of combining several results to get an index of something that isn't directly measurable.
The target was from a report on the ipi + epac presentation at ESMO. Since this isn't the path Incyte plans to follow for registration, its immediate impact isn't great. The results were good, but not so good as to support 'breakthrough' designation for epac. And with 4 phase 2s ongoing for combinations with PD1-pathway drugs, I don't see a lot of room for MORE interest in collaborations. It's probably time to start wondering about whether epac might be helpful in intractable infections, though. That's an attractive indication because if you can offer a prospect of cure, the price per dose can be high ('cause treatment stops after cure).
When I look at the model used to generate the price target, it still looks conservative.
I think I said something about it before Suits of this sort are often filed, but don't often result in large awards. If you read old analyst reports, you can see clear signs that Incyte management was telling their favorites that the IDO drug was especially interesting, which can be used to attack the position that the wee proper trade secrets.
Still and all, in a world where the only hard evidence we have is on the effectiveness of a combination that Incyte doesn't plan to pursue, the dramatic effect attributed to the information, leak give us an extra clue that the mechanism is really exploitable.
I won't go any further now. The question is what's good and bad for Incyte. Obviously, being left alone is good for Incyte, but I'm a pretty healthy guy and drug prices are starting to be a serious drag on ME. Incyte seems to prefer confidentiality of R&D, and be more efficient than most peers in doing it, so any system that allows price leeway for shown R&D effort is bad for it. Incyte seems to have satisfied customers, so a challenge system would probably be good.
I kind of expect that we'll get an Americanized NICE, and I hope we'll get a German-like add-on (drugs can be introduced at the manufacturer's chosen price before the pricing decision is made; adjustments later).
We could get a classic sort of price controls on drugs: limits on price changes and price at introduction. You could even have some mechanism to account for R&D expenses and nominal length of exclusivity. The most obvious case where this would be horribly wrongheaded is Thalidomide, an abandoned inexpensive drug that grew new uses after a lot of low-intensity R&D and a little high-intensity work, and that has a huge post-market supervision program.
We could get a price-fairness system: anyone who thought a price was out of line could challenge it in a kind of parallel legal system. A lot of commercial stuff is handled this way, but the basic price of admission to the system makes it hard for individuals to get in...even in patent courts, when the matter can't be settled quickly there's a risk of expenses growing beyond belief.
Another possibility: a system where list price of drugs IS the price, and any discount is taxable income to somebody (along with letting Medicare bargain on prices just as the insurance companies do). This gives some very big guys an incentive to bargain hard on list prices, but it dumps too much of the dirty work on the tax system.
Lotta overheated imaginations around. We aren't going to see a federal cap of $250 on a month's supply of any drug. We probably won't even see flat regulation of drug mark-ups. I can think of a few realistic possibilities, and they're bad enough...but not as bad as what we're drifting into.
Very realistically, we might get an Americanized version of the UK's NICE--a public/private organization that reviews treatments for cost effectiveness and says "Our members will/won't pay the requested price for THAT." NICE doesn't work real well, but one huge problem is easy to avoid--a flat, legislatively set, cap on price per quality-adjusted year of life. There are some obvious special cases: HCV treatments are supposed to abolish the disease, so companies want to pay for development in a short time; in other instances, life-prolonging costly treatments are meant to be stopgaps until better and cheaper to dh eal witare available. There will have to be a way to re-open cases (like cycloserine) where cost/benefit has changed drastically, and to deal with obsolescence. The IIHC does that sort of thing for car safety features, and of course it's as huge a success as NICE (but we do get some sort of progress)
I'm gonna split here
Not really that good: Incyte has no announced JAK-3 active drugs (and for good reason--they are significantly immunosuppressive, which makes for slow approval). It would even be bad news if the problem was insufficient activity. But the Galapagos compound just wasn't selective enough. There was problematic off-target activity at effective doses. Incyte had a corresponding problem with one of its JAK-1s (just as AbbVie has a good backup candidate, Incyte has a couple of good backup candidates in the JAK-1 space). But very much to the point, baricitinib is exquisitely JAK selective, and even at the highest doses considered its on-target toxicity is also modest.
Right now, JAK 1 and 2 activity looks like the way to go, with pure JAK-1 drugs being used to tune the effects (and in situations where even bari is too myelosuppressive).
Are we deep enough into this topic to talk among ourselves? I think some (possibly a lot) of the present gern pumping is being done by bears trying to gat a worthwhile price for shorting. There IS an art, and with AT recycling news in public, it gives them a smokescreen.
The big short position is about $300MM in the hole, but staying there. Who are they, and how much pain can they stand? If the principal is Goldman itself, I'd guess something like 5 times that, which means that for stock price alone to shake them out, MYGN would have to double from here. On the other hand, if the principal is a hedge fund they are getting close to intolerable pain--say $45 might do it. Does it matter that the logic of the short has failed? Probably not in either of those cases, but perhaps in the less-likely case of rich curmudgeons (who tend to have set dates for whole-portfolio reviews). I guess a private equity pool is also possible--they tend to be pretty margined, so they're in much the same situation as a hedge fund. The mechanics of shorting make a rise in Fed-controlled interest rates a catalyst for covering, so Yellen's latest statement suggests a time limit.
There's a possibility that a market crash in response to Congressional insanity might bail them out, but frankly, I think Mr Market already has the lowest possible opinion of Congress. However, behavior bizarre enough to push a Fed rate hike beyond an investor's time horizon is imaginable. That could put off the Day of Reckoning.
Yeah, the punk is temporary, but ANGER over drug prices is real and enduring (and sometimes justified). And fear about what might be done in response to that anger is clearly a big part of what is ailing Incyte in the market. And y'know, I HAVE come across the name Jakafi in discussions of expensive drugs. So I'm just pointing out that there's a lot of space between the abuses that pretty much everyone wants slapped down and the place Incyte makes its money.
And since we're having another Geron incursion: it is vanishingly unlikely that Imetelstat can be made (direct cost of API) for less than $5,000 a dose (I'd guess a lot higher). If and when it comes to market, you can look forward to being in the bull's-eye.
Of course we're all looking at the drug pricing hoo-ha. What set it off was Turing Pharmaceuticals' increase in the US price of Daraprim from $15 a tablet to $750 a tablet (or, per Wikipedia, $833 a tablet). The price of a single dose of Jakafi is somewhere in the $75-150 range. High, but not the same range.
There's a lot going on here. Daraprim is an old drug, the development of which was paid for long ago. It is substantially cheaper to manufacture than Jakafi (the manufacturing price of which is insignificant relative to its selling price). While pyrimethamine (the API of Daraprim) is generic, and a price increase could, in principle, bring in competition, the manufacturer is using regulatory details (gotchas) to avoid that. Basically, to introduce a generic version of a trademarked drug into the US market, it needs to be compared with the incumbent. Turing Pharmaceuticals tightened distribution to make that almost impossible to do. (Incyte tries to do the same thing with Jakafi to limit head-to-head trials, but apparently regulators can intervene when a clinical trial being done) In principle, I guess, a newcomer could go the IND route with a new pyrimethamine product, but that's ridiculously expensive (even with maximum FDA cooperation, I'd guess about $25MM), and probably unethical (a clinical trial is worse for the patients than just giving them proven drugs). There are obvious legislative / regulatory ways to fix this sort of problem, but it isn't obvious whether any given route would have unintended consequences. And to make matters even messier, there are possible new uses for pyrimethamine that Turing is in no position to investigate.
Looks mostly like a temper tantrum from banks that didn't get a rate hike from The Fed. In case there was any doubt, raising rates under Fed control now would be stupid, idiotic, insane, self-defeating, suicidal and a bad idea generally. But it would be good for bankers' bonuses, so it DOES get looked at.
Tantrums only last so long. Theirs and mine.
Just curious. In the stock marker, not every short-term move needs a reason.
Obvious one is anything that decreases chance of takeover.
I'm wondering if the New York Times story about unreasonably expensive drugs might be figuring in.