INCY
#I think you have to put it from our needs standpoint.
I mean we have already a very large portfolio of projects in our pipeline.
I think we have a strong discovery team for small molecule.
It has been very productive over a number of years.
So our discussions were very much about what we need and we don't have, which is an organized European platform with infrastructure, with medical teams across the different countries, commercial teams and market access.
I think it just happened that it was strategically something that ARIAD was interested in discussing for the reason I was explaining.
And I think for the reasons I have also communicated this morning that they are trying to concentrate their resources in the US to be ready to not only grow Iclusig but also some of the pipeline products that may be coming soon.
That's where the discussion was centered, in fact.
I see it as a deal that has a lot of win-win qualities for both organizations and where we get really what we were looking for which is related to our European infrastructure on being able to maximize our products there.
That will be over ---+ it's Dave speaking, <UNK> ---+ it will be over the life of the patent and it will be straight line.
The patents end in 2026.
I can speak with the territory that we have organized this transaction around.
It's approved at the European Union level, so that's where the technical authority is taking place.
Then there's a reimbursement that is done country by country.
So in terms of the European Union, the reimbursement is obtained now in some of the large countries like Germany.
But it's still work in Italy which is obviously a very fast-growing country for Iclusig.
But it's still not fully obtained.
As you know, in France there is a situation where you can have an ATU.
You can basically sell the product before it is fully reimbursed but there is a claw-back that is taking place at the time of reimbursement.
It's anticipated to be happening relatively soon.
Some of the other countries are still in the process of getting reimbursement inside the EU.
And then in our agreement there are countries outside of the European Union, like Russia is one of them, where we would have to find a partner, which is probably what we would be doing to go through the entire process of approval and reimbursement.
I can take care of some of that.
In Germany the price went through the entire review, and is a price that is approved by the government.
In the UK most of the usage is funded through the cancer fund.
It's not a NICE reviewed kind of situation, it's a cancer fund.
Remember, it's a relatively rare form of CML because the product is approved for two groups of patients, the ones who are resistant to or refractory to nilotinib or Sprycel, and a group of patients with 315I mutation.
The 315I mutation is relatively rare in the first-line setting but the incidence of 315I mutations is increasing with the lines of treatment that you are receiving.
So it becomes more and more frequent on the smaller number of patients as the patients are going from first-line to second-line to third-line.
In the UK it's going through the cancer fund.
In Germany it went through the entire process.
It's ongoing in France, and we are anticipating ---+ or ARIAD is anticipating the resolution of the negotiation in France.
It's already approved and reimbursed in Italy and the other countries still in the reimbursement process now.
Yes, thank you, thank you all for your time today and for your questions.
I think it's a day today where we show that we have made three big steps.
One is you see the growth of Jakafi in the US because it's important to see that now we are a year after the launch in PV and we are still growing very dynamically, both in PV and in MF.
We spoke about the several big steps which is the progress of our pipeline.
We are planning to initiate two pivotal studies soon or over the next few months with epacadostat in first-line melanoma and with ruxolitinib in GVHD.
I think it's really important that you see the third big step was now establishing Incyte firmly as a trans-Atlantic Company with an organization in Europe.
As I said at the beginning, our goal with that organization is really to mirror the powerful and successful organizations that we have in the US we've established now five or six years ago, and be able to make sure that we maximize our launches when our products are maturing.
And also grow Iclusig, that has a lot of potential to grow, as it's still in a phase of the launch that is relatively early.
I think it was a very exciting few weeks and months for us in the beginning of the year.
I'm looking forward to sharing our progress with you later this year with the Q2 call by mid-year.
Thank you.
