Then I come back to the history of Incyte being above average at keeping secrets.
I may not be the only one who recalls the note issue / 2 partnerships coincidence from before.
There's also the mo-mo crowd to consider. That is a substantial group of investors who were never interested in INCY.
Jacosa, I am having a hard time thinking the volume is primarily year end window dressing by funds. The new convert and some of the equity dilution that has been avoided is IMO part of the reason....BUT I am having a tough time believing that there is not some other very significang info that we are not privy to......this action really reeks of some new info to be announced publicly, soon!
I just saw that they entered a partnership with Baxter to develop Pacritinib. With good study results, the drug could reach market in 2 years or a bit less.
Interesting compound said to owe all its activity to JAK-2 inhibition (although it also inhibits FLT-3). Generally good pharmacology although the 400 mg/day dose is high enough to get you to look for off-target effects (and diarrhea is reported). Very distinct structure from most disclosed Intermune compounds suggests that some patients resistant to Jakafi may be helped.
I don't think this is a threat to Jakafi's first-line status. The drug has very little anti-JAK1 activity, and Incyte results suggest that JAK1 is important in MF morbidity (feeling sick). There is no particular reason to expect one JAK2 inhibitor to be less myelosuppressive than another, so the low myelosuppression seen in early trials suggests that the drug is being under-dosed to avoid problems. In fact, a worrisome pneumonia signal is seen in early studies.
Hi amgnjim, What calls are you buying?
Looks like this is about to make a major move up again.
Sentiment: Strong Buy
That's just silly! Institutions knew the deal was finalized was done last week! That's probably partly explains the last weeks action.
You can't be right all the time....but I am sure you are glad...... We need to keep this momentum going into the conference in early December.....
Yeah, that's roughly what I remember from the call. My best guess is that the second country should have been reported as France (which had, in fact, recently granted reimbursement). Germany would have been first. Most likely what the person on the call was thinking about for the third was The UK, where it is about time for N.I.C.E, their medical cost/value watchdog, to pronounce on the appeal of their automatic initial denial of reimbursement. Novartis had created confusion by applying to N.I.C.E. before starting the commercial rollout (That has the advantage of getting UK approval some time on the order of when other country approvals are happening.) The other theory is to go to N.I.C.E. after Germany and some smaller countries are selling, about when France is approving, to impress them with the widespread adoption of the product. Nothing works. They can sit on it as long as they like. It isn't far off the mark to say that Spain has no government. But Italy sorta functions at times.
It was not trying my attempt to say that you are misleading. Periodically, on the board discussion about overseas sales have come up. Jacosa has been the one that seems to have the most knowledge on how the sales and approvals come about in the EU. I did state in my first post that you MAY have said, or MAY implied, that the drug would have availablity in Germany first. Sorry if there is confusion. I searched the 8k and 10q then i remembered it was on the conference call. so here is the minutes, thank you seeking alpha. The big jump in eu sales is from Germany in the 3rd q then.
Novartis is also experiencing solid growth for Jakavi in Europe and rest of world. They reported third quarter sales of $48 million as compared to the $33 million sold in the second quarter. Novartis also reported reimbursement approval in a second major European country Germany in the third quarter and we continue to expect a third approval which triggers a $60 million milestone payment in the first half of 2014.
Shows the ignorance of GERN posters! An approved drug does not need breakthrough designation. The reference was for Pancreatic Cancer!
There appear to be two TJs. One is a near-clone of V, but the other one seems to be a decent numbers guy. I pay a little attention to the latter.
Anyway, I like sending people to the ITMN corporate site because it's a rare case where you get a good look at European drug regulation. [And incidentally, a VERY promising special situation, depending on how their next clinical trial comes out] Corporate positions have spooky parallels (One marketed drug; only approved treatment for a disease that kills on a 5-year time scale, 'traditional' treatment that doesn't really work (hydroxyurea vs prednisone/NAC), early stage competitive drugs aimed at same indication, clear need for a better drug eventually, "True Believer" CEOs with public speaking problems)
Jacosa FWIW....this poster, as you and I know, goes back on this board over 5 years....cannot be taken at face value....IMO is a nefarious poster.....realizes you have credibility on this board....so is trying to both get under your skin and attack your credibility....head games! waste of your time....always best not to get involved in the sex life of the ants!
I did no such thing, and if the 8K thing is true, the implication is a lie (a false statement intended to mislead) anyway.
There was some sort of incoherent statement on the last CC about which European country would be the third major market to have Jakavi; I pointed out that it didn't seem to make sense.
The graduate-level course in European drug regulations is the last couple years of news from Intermune, which has one marketed drug that is approved in Europe but not the US. Germany has a complex 'AMNOG' law, one feature of which is that any drug approved by the EMA may be introduced in Germany, at whatever price the manufacturer dictates, and it will be reimbursed. Then a sorta-private entity called IQWiG estimates cost effectiveness and reports to the government, After further discussion, usage and pricing guidelines are issued and then actual regulations are promulgated by the "states" (with much private input).
So yeah, introduction in Germany is automatic. France is slower but pretty straightforward (and the hard news that prompted the CC statement was French approval). UK is nightmarish because there is a specific [absurd] legal cost-effectiveness threshold that has to be overridden after hearings. Italy and Spain are the other 2 major markets; government functions are impaired in those countries. Most of the smaller countries permit marketing on roughly the French time scale, with Denmark having continuation-of-marketing rules on the same theme as Germany. Netherlands is in the midst of a reevaluation of drug marketing laws.
Germany had only approved the sale of jakavi,,which I believe counters what you may have stated, that being as soon as drugs get the eu approval, they are available in germany
yep, looks good to me..... Don't you think BB knows more than you or anyone on this board...