It was frustrating when N.I.C.E. gave the narrowest justifiable approval to sale of Jakavi. But with a couple years of limited English sales as a result of that, it partially insulates Incyte from Brexit (and I DO believe Britain is headed for the big exit--Scottish devolution soon, possibly with a less-than-friendly border; Northern Ireland next.) (Welsh participation in The UK has always been something you see if you look one way, and don't see if you look another)
N.I.C.E. is going to have to change substantially to replace the overall approval function of EMA. Probably going to be delays for everything. Unfortunately, bari has very much the profile of a drug most likely to be hurt by the changeover (The case for it is SO strong that EMA might even beat FDA to approval; cost effectiveness likely to get it through N.I.C.E's existing functions quickly--even if it's the first thing English FDA approves, that's likely to be a few months of delay).
I heard a noise from the Midwet about the rarity of GVHD. With about 5000 new cases a year and miserable prognosis, the market is comparable to active MF. Effective treatment could easily double the market size. The present mainstay of GVHD management is steroids. Since ruxo and steroids don't play well together (even alternated), if ruxo is adopted at all, it will likely be used first.
I could be Sleepy, too.
This may save a meaningful amount of money as Incyte brings GVHD on-label for ruxo. I don't know the reimbursement landscape for off-label use, but that ought to improve also. I think a large fraction of the sales possible for this indication are not waiting for the label expansion, though, so The direct benefit of accelerated approval is modest.
The second-order benefits are unpredictable, and may be larger. It'll take at least until the p3 finishes for those to show clearly, because they are likely to involve more cautious oncologists. With improved prognosis for GVHD, more procedures that carry a risk of causing it will be done (particularly mixed autologous / heterologous stem cell transplants--I've said why I'm an avid spectator of myeloma developments, and mixed transplants have a large AVERAGE benefit there, but are limited because the worst case outcome is so bad). Other procedures that have a risk of causing marrow failure will look more attractive as rescue by transplant becomes less desperate.
Interesting MarketWatch article dated 6/20. Looks like drug pricing is going to figure in the Presidential election no matter what, because Trump thinks it can broaden his appeal, and frankly, Hillary is a bit scared to touch it after the reaction to her Turing tweet.
ANYway, there's a suggestion in the article which might get us most of the benefit of UK's N.I.C.E. without the rigidity (which would hurt worse in the US than it does Over There, 'cause we don't have such a tradition of changing laws on-the-fly). A government agency might require cost::effectiveness reviews of selected already-approved [classes of?] drugs. It offers a hope of stopping the present trend for newest drugs to explore unheard-of price territory without intolerably disrupting markets.
Something MUST give. The politics of hepatitis C could get unlimitedly bad (many, maybe most cases were a result of treatment of war wounds but VA can't afford CURATIVE drugs for all; by limiting number of cases cured, an outbreak that could be ended in a year or two can be stretched for decades).
Trump's said to favor allowing re-importation of drugs sold overseas, and to want to free Mdiacare to negotiate drug prices any way they choose. Hillary is thought to favor something much closer to N.I.C.E. (Whose main tool is "You can't sell it for that price. Come back cheaper and we'll reconsider--from the beginning).
Most likely extended report on phase 1/2 of epac + pembo vs multiple tumor types. What we've heard about is longer follow-up on the same subjects from last SITC. I'm guessing a journal publication. "Other" PD-axis drugs + epac probably not until this year SITC.
Trial of a combination of ruxo with low dose interferon could come any time. I don't know the politics here, but on a purely med-sci basis, this would have happened months ago.
Also in the investing time frame, there may be an announcement related to that S,N oligonucleotide. A planned safety/tolerability review has perhaps 1 chance in 3 of causing the dosages being tested to be changed. Change would be announced; no change won't be.
$5 grand in MDT at the right time and I AM retired now (MCI, Immunex .and Intermune helped. Lotus, Intel and HP, not so much.) And incidentally, Medtronic starting around 1999 was a PRIME example of a company where for over a decade, the important things were going right but there were occasional embarrassing headlines and the stock languished.
I expect that this will be just as frustrating a wait as the bari trials, but it's GOING. We can rule out early catastrophic toxicity, so the next news ought to be full enrollment. Be REAL nice to see that by the Feb. CC.
From the quarterly report
» Vectra DA volumes were up 18 percent year-over-year and 11 percent sequentially in the fiscal third-quarter
with approximately 42,500 tests performed.
» Expanded the successful practice integration pilot program to the national phase with our entire rheumatology
sales team in the fiscal-third quarter.
» Signed two private insurance contracts totaling 2 million additional covered lives for Vectra DA.
» Prolaris sample volume was up 90 percent year-over-year and 21 percent sequentially with approximately
4,300 tests ordered.
» Signed multiple additional private insurance contracts bringing our total covered private lives to 28 million.
Meanwhile, the Zack's writer and TMF Ultralong (and a fair number of supposedly more reputable individuals who get paid for their advice) think BRACANalysis is still the bulk of Myriad's business.
The 18% YoY on Vectra represents about 1 Q of active selling, and is consistent with the 11% QoQ. So in August, we can anticipate something over 20% YoY Vectra growth. [severe RA market about 250,000]
The 90% YoY on Prolaris reflects MANY physicians unable to use the test until CMS blessed it. QoQ above 15% in August would be MOST encouraging [Pr CA market about 180,000].
Sometimes you just have to make the money before enough people believe you.
Two more quarters to get a read on how Vectra is REALLY doing. Probably same for Prolaris. Like to see movement toward kit commercialization by Jan. Like to see at least 1 more drug requiring a companion diagnostic.
TMF UltraLong is definitely below par. Here, he makes the common mistake of saying that BRACAnalysis is still Myriad's bread and butter. But he DOES catch that the future is companion diagnostics.
The EULAR posters on Vectra were sort of mixed. Does pretty well with decisions on adding treatments, but only modestly better than clinical judgment on subtracting treatments. A lot of demand is going to depend on pricing of the upcoming major DMARD baricitinib (if it is very costly, even though it is safer than the anti-TNFs, insurers may want to limit use) (If you haven't seen the phase 3 results on baricitinib, consider checking them--all 4 reported in 2015)
My best guess is that someone read that MBC story and saw doom, for a big chunk of money. It IS a warning, but the time scale is long, other kinds of products are coming along fast enough (Vectra, Prolaris, MyPath, EndoPredict, companion diagnostics--none germ-line sequence based), and the database isn't the only barrier to competitors.
They tell me that there are at least 15MM people US/Eur who objectively have RA but aren't affected greatly enough to show up in this argument so far. I don't think it changes anything. It's amusing that the price range of INCY seems to reflect belief in an approval that will generate roughly the level of revenues guessed at here, at a time now [just] within investing horizons, but the sell-siders are hardly talking about it.
It appears to be a small shop. They have one reasonably bright guy on staff ("Good TJ") and a perhaps 3 posting typers (I think DRIP may represent a new writer. 15...14...13 may be gone or may be on another project). The temporary friendliness to Incyte may have been pique at being left out of last Fall's bear raid. I suspect that Yahoo has done something to inhibit 20 posts in 10 minutes.
But these guys aren't class. To support a bear raid you buy recognized sources and take floor traders to lunch. These guys just function to keep real information (which for Incyte is generally favorable) moving to the back of the book in the message board. Bickering with them, even in non-replies, does their job too. To see the height of information concealment, look at the Geron board (much more traffic with much less information)
If you haven't read it yet, look up the old Seeking Alpha article "Inside the Boiler Room," although that covers a larger operation (and focused on a pump rather than a bash).
It bothered me that Novartis said they had initiated further phase 2 studies, but nothing showed in clinicaltrials. I had thought that anyone doing business in the US had to post on clinicaltrials for all drugs and most medical devices before treating the first subject in a trial. Turns out, it's a lot more complicated. I'd welcome informed comments. After about 1 1/2 hours of poking around by this non-lawyer, it appears that a trial on a not-yet-approved drug, receiving no federal funding, and not enrolling subjects in the US can comply with the relevant law by posting to clinicaltrials promptly after study completion.
Fittingly, HH gave a longer term look than RH. Central message was that Incyte should do just fine with ruxo and bari for as long as necessary, but the mid-maturity pipeline (something like '110, capmatinib, epac, the delta candidate and maybe the EGFR candidate ought to generate a flurry of approvals in the '19-'22 span. Apparently, the ones useful only in combinations may need separate approval for each combination. Cross-modal combinations (say an infusion and a tablet) where neither agent has a good case for approval without the other are unfamiliar regulatory ground, and there may be some of those.
I admit amusement that HH characterized PV rather than MF as the largest Jakafi opportunity (with GVHD trailing and nothing serious about hair growth yet). You could look it up: I was saying that in '424 days The other half of that is that Jakafi is priced too high to take maximum advantage of the PV market. So sooner or later, expect a price drop or at least some skipped price hikes. Every reason to time and promote these for maximum political benefit.
More of me rather than HH talking--he DID say that Lilly are telling him bari approval in '17. The more I think about it, the more I expect an advisory panel first. It stands to reason that with the supporting data, Lilly would be proposing a label that displaces MTX entirely, and maybe more. A positive recommendation (even with less than the requested breadth) would make a fine Christmas present (approval in late Q1).
A few quick observations:
For epac, not only did the melanoma trial start first, the disease is more homogeneous than most of the others being studied and the baseline response to the underlying immunotherapy is better-characterized. So that's part of why other results are slow appearing.
Not explicit, but the answer to a question about the Comfort follow-up suggests considerable resistance to use of Jakafi in intermediate-risk MF. Potential for a lot more market penetration.
Comment about interest in non-oncology treatments brings bari back in from the cold. and suggests that maybe the inflammation-directed JAK 1 program might be returning.
First justification I've heard for the FGFR drug program: aiming at higher selectivity than existing agents.
Clock on Myriad's database is ticking pretty loudly. The social-media-savvy Metastatic Breast Cancer (MBC) project is collecting everything they can get, including full genetic sequences from saliva and tumor specimens, from "metsers." (metastatic breast cancer patients). Doesn't really change the expected time before non-Myriad databases become clinically useful (still probably 2019), but gives a visible example of a project collecting the information needed to do such a thing, working now, and with resources to finish the job. Probably take longer for "free information" based tests to become competitive on prognosis or treatment selection because those depend on following patients aggressively; voluntary participation is unlikely to be able to overcome "missing data" prolems.
Presented at ASCO.