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Incyte Corporation Message Board

  • tjnelis tjnelis Nov 14, 2013 7:46 AM Flag

    Jasoca was looking at the lastest 8k and noticed that

    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

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    • HUH???

      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.

      • 2 Replies to jacosa
      • 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.

      • 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!

    • sorry that would be in the last q, it began

 
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