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Galapagos 200 euro per aandeel

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[verwijderd] 24 februari 2018 10:53

inderdaad: het wordt een draadje Galapagos 300€ :)

[verwijderd] 24 februari 2018 11:09

If you first look at filgotinib, Gilead and us, initiated Phase 2 trials in 8 new indications on top of the 3 that were already ongoing. We also showed very nice DARWIN 3 results which is the long-term expansion study from the DARWIN 1 and DARWIN 2 trials that confirmed the profile with respect to activity and safety profile in rheumatoid arthritis. As we initiated the building of the commercial organization that Galapagos – that will prepare Galapagos for the launch of filgotinib in 8 European countries, so a good start in that side and that activity and that will accelerate in 2018 clearly.

In IPF, idiopathic pulmonary fibrosis, we saw very nice data in a 12-week study, where we halted the disease progression in these patients, which gave us a lot of confidence that we have some very interesting molecule that will move into late stage trials in 2018. And on top of that, we announced that we have two other mechanism of actions that will move forward in IPF, so that enables us to build a franchise here of three independent molecules moving forward that on its own or in combination maybe good treatment for this deadly disease. In cystic fibrosis, we saw good results with our corrector 1 in-patient study in the ALBATROSS and FLAMINGO studies and we are now preparing to launch our first triple combination study that is our potentiator corrector 1 and corrector 2 in triple patients called FALCON, which is on track to start this quarter and we are looking forward to that dataset later in the year. But clearly, Galapagos is more than these three indications, we see in continuously expanding pipeline, very nice data in our collaboration with MorphoSys, MOR106, our IL-17C antibody, where we showed promising data in atopic dermatitis patients and we showed very strong data with regard to a biomarker in osteoarthritis patients with our molecule 1972. These are just some of the clinical highlights, we also had a lot of them new developments in our preclinical pipeline that hopefully will get to the clinic shortly.
If we can go to the next slide you see our track to get to the market with our molecule and with our organization where last year showed us our second and third proof of concept with novel target in patients. This year and next year we will continue to show data in the pivotal trials for filgotinib and also expansion of the latest stage pipeline. And that would lead in 2020, 2022 to the introduction of multiple products on the market starting with filgotinib that followed with other products from our pipeline. And hopefully we will see a number of programs the early stage programs moving forward to late stage development. So a lot is ongoing and it can be expected.

If we step back and look at filgotinib on the next slide, you will see that that is in a massive franchise now, where we started with rheumatoid arthritis that is expanded in Phase 3 trials in Crohn’s and UC and then all wings of Phase 2 trials that were initiated by Galapagos and by Gilead. And so filgotinib is being tested in this whole range of autoimmune inflammatory diseases and hopefully will lead to a number of indications where this can reach the market. To give you more detail on that, I would love to hand it over to Walid to discuss

[verwijderd] 24 februari 2018 11:13

We have on the next slide please – we have great ambitions for the filgotinib’s profile based on the data generated so far in the Phase 2 studies in rheumatoid arthritis and in Crohn’s disease. We are very excited by filgotinib’s safety and tolerability profile which promises to be best in class. We believe this is due to a high selectivity for JAK1. With data from more than 2,000 patient year exposure to-date, we have been consistently impressed by the favorable safety and adverse event profile. We expect to present long-term data with up to 2 years of treatment from the DARWIN 3 open label study in rheumatoid arthritis patients at the upcoming ACR meeting this year.

[verwijderd] 24 februari 2018 11:15

quote:
inspirator schreef op 24 februari 2018 11:13:
We have on the next slide please – we have great ambitions for the filgotinib’s profile based on the data generated so far in the Phase 2 studies in rheumatoid arthritis and in Crohn’s disease. We are very excited by filgotinib’s safety and tolerability profile which promises to be best in class. We believe this is due to a high selectivity for JAK1. With data from more than 2,000 patient year exposure to-date, we have been consistently impressed by the favorable safety and adverse event profile. We expect to present long-term data with up to 2 years of treatment from the DARWIN 3 open label study in rheumatoid arthritis patients at the upcoming ACR meeting this year.

Save the date for the 2018 ACR/ARHP Annual Meeting, October 19 - 24 in Chicago, Illinois.

[verwijderd] 24 februari 2018 11:16

quote:
inspirator schreef op 24 februari 2018 11:15:
[...]

Save the date for the 2018 ACR/ARHP Annual Meeting, October 19 - 24 in Chicago, Illinois.

Looking beyond tolerability, the efficacy we observed in the Phase 2 studies in both RA and Crohn’s disease were robust and showed the rapid onset of action and sustained activity over time. As the Phase 3 program is progressing and reading out 0308 over this year and next, we expect that these initial findings will be confirmed and demonstrates filgotinib as a convenient oral once-a-day monotherapy agent with an excellent safety, efficacy and tolerability attributes.

[verwijderd] 24 februari 2018 11:18

over the past year we have made great progress in the FINCH program in RA. This is a robust Phase 3 program in more than 3,000 patients, three large studies were both the 100 milligrams and 200 milligrams doses are fully being evaluated in methotrexate incomplete responder, methotrexate naive patient and in biologic incomplete responders. Results from the Phase 2 study in biological incomplete responders are expected in the second half of this year. In addition recruitment in the FINCH 1 study will be completed in the second quarter and the case of FINCH 3 in the third quarter of this year.

[verwijderd] 24 februari 2018 11:19

our Phase 3 program in inflammatory bowel diseases, both UC and CD which is equally robust with approximately 2,600 patients in total. We expect the results of the interim futility analysis in the Phase 2/3 selection study in UC to be available in the first half of this year. We also expect the recruitment to be complete in the Crohn’s Phase 3 program in the second half of the year – of next year.

[verwijderd] 24 februari 2018 11:20

here we see the EQUATOR study. This is a study that we started last year. It’s a proof of concept study in patients with moderate-to-severe psoriatic arthritis. This is an ongoing study where patients are randomized one-to-one to either filgotinib 200 milligram daily or placebo for 16 weeks. We have approximately 60 patients per arm in this study, where the primary endpoint is the ACR20. EQUATOR is being conducted in 8 European countries. It is fully recruited and we expect top line results in the second quarter of this year.

[verwijderd] 24 februari 2018 11:21

this is the second Phase 2 study we conducted, but in this case, it’s in moderate and severe patients with ankylosing spondylitis. The study which is called TORTUGA is also conducted in 8 European countries. Approximately, 100 patients per arm will be randomized in a one-to-one ratio to filgotinib 200 milligrams daily or to placebo and treated for a total of 12 weeks. The primary endpoint in this study is the anklyosing spondylitis disease activity score, ASDAS. The study is fully recruited and we expect top line results in the second half of the year.

[verwijderd] 24 februari 2018 11:22

so moving on to idiopathic pulmonary fibrosis, a lot has happened this past year as you have heard initially from Onno in the introduction. Back in the summer, we announced the exciting results from the FLORA study, which showed that GLPG1690, an autotaxin inhibitor managed to start disease progression as evidenced by virtually no change in forced vital capacity after 12 weeks of treatment, whereas patients who are randomized to placebo lost approximately 19 mls as would be expected in this population over that period of time. These exciting data coupled with a very encouraging safety and tolerability profile led us to embark on a registrational program, which we are currently discussing with the FDA and EMA. I am happy to share that we had a very positive meeting with the FDA a couple of weeks ago. In the next 2 weeks, we will be meeting with the EMA. I am quite confident we will be finalizing our program soon after that at which time we will share with you the details of the design of the study. You should expect that in March or April timeframe.

[verwijderd] 24 februari 2018 11:23

Capitalizing on the promise of 1690 in addition to two other fully proprietary compounds with novel mechanism of action, we decided to build an IPF franchise and develop these compounds and ultimately commercialize them on our own. So in addition to 1690, we have 1205 which is a GPR84 antagonist. This compound, which is currently in Phase 2, will be evaluated in a proof-of-concept study in IPF later this year. Our third compound is 3499, which is currently in the IND preparation phase getting ready to enter Phase 1 later in the year. Having three compounds with distinct and novel mechanism of action will allow us for combination therapy – will allow for combination therapy in this very serious and lethal disease where the high unmet medical need still exist.

[verwijderd] 24 februari 2018 11:23

And last but not least for my part of the discussion today is 1972, this is an ADAMTS-5 inhibitor, which is being developed in osteoarthritis in the area of large and ever increasing unmet medical need where no disease modifying agent exists today. We are showing data here from a recently completed study in osteoarthritis patients. In this study, we treated OA patients with three different doses of 1972 or placebo over a 4-week period. Similar to what we have seen in healthy subjects and reported before, here we show robust reductions in our levels in the blood. You see a gradual decrease in ARGS over a period of 2 weeks, a plateauing then recovery after treatment is stopped on Day 29. You can also appreciate on this slide a good dose response curve with the highest dose showing a maximum of approximately 55% reduction from baseline in ARGS levels. These data are relevant, because ARGS are a byproduct of collagen breakdown suggesting that treatment with 1972 could reduce the loss of collagens and have disease modifying properties in osteoarthritis. In order to evaluate this, we are going to conduct a large dose finding Phase 2b study in collaboration with our partner, Servier. If positive, this robust study will enable us to move into Phase 3 development.

[verwijderd] 24 februari 2018 11:34

Let me start with MOR106. So earlier this week, at the dermatology conference in San Diego, we presented the Phase 1 data consisting of both an SAD in healthy volunteers and multiple ascending dose in patients. So, let me remind you IL-17C is a cytokine that is expressed mainly in the epithelia and shows very low systemic levels. So, we see it as a local amplifier of ongoing processes and as a target it holds the promise to show full efficacy with very low propensity of systemic side effects. So with Phase 1 data which we will show in the slide as well impressed both ourselves, partner MorphoSys and many people in external world. So with weekly intervals dosed the patients for 4x the atopic dermatitis patients first time and we saw a very nice efficacy both in terms of magnitude of efficacies, in terms of number of patients that responded to therapy. And most of all in terms of the length with which efficacy was maintained after which we stopped dosing. So we are quite impressed and working extremely hard to now initiate quite soon a large Phase 2 IV dose range of study which will kick off over the coming weeks. We hope to recruit almost 200 patients into that atopic dermatitis and the results will become available somewhere next year.

In parallel to this large IV dose range of study, we will bring as well as the subcu form into healthy volunteers first and patients later this year and hope that we can bridge them at a moment when we have the IV data towards in a subcu program which will then be – which can then move into Phase 3. So on this slide, we have given the insight, which is one of the disease course which is frequently used in the disease of atopic dermatitis and I am not sure we can say that the compound shows efficacy which are at par with the ones of dupilumab [ph] which have been recently approved for this disease.

[verwijderd] 24 februari 2018 11:35

So let’s now move to CF, where we have been working for many years in the CF field, have setup a large drug discovery program. We discovered our own internal series of both of potentiators C1s and C2s progress to cystic candidates, backup candidates all to Phase 1. And so 2018 is sort of the year of the series work where we will have will initiate multiple triple studies with different combos. So our experience up to now is being validating and we have reported a number of those data during 2017 where we in smaller studies validated the single components in CF patients. And as I said this year we will initiate multiple triple studies and will have to as well readout of a couple of those studies. With over these recent years, we have build out a nice network, global network about five countries and included more than 100 patients in our study. So we feel confident as well that we will be finding the patients and the centers and to execute the plan as we have laid out before.

So for the first study that we will readout is the PELICAN study, I will come back to that study later. But so the second triple study which was started in fact the 2451, 22, 2737 study. So we have also named the PELICAN study. We did receive MHRA approval and as well approval of the clinical - of the CF clinical trial network for this triple combo. And as soon as we now have ethical committee approval we can start dosing patients in this study, so this will be first fully owned triple study which will kick off. Portfolio as well we have complete dosing in healthy volunteers of our second triple consisting of 3067, 2222 and 2737 and we are preparing a large global Phase 2 dose range program that will include both homozygous and [indiscernible] patients. So that program will kick off around mid of the year and will be running on a global basis.

Let me now go to the PELICAN study which is going to be the first study which will be leading us. So in PELICAN we have included the homozygous Delta 508 patients which were on the stable regimen of Orkambi and stayed on the Orkambi regimen. The study was quickly fully recruited. We only opened study in Germany that could easily find sufficient patience as sort of patients will be on therapy or either in placebo controlled study for four weeks. So top lines will include a disease as well if you dose on top of Orkambi and a lot of plasma PK measurements and we will report on those. So we expect to report of this study during Q2 of this year and this will be the first time that we can then see the efficacy of 2737 of the C2. And then the next study reading out somewhat later will be the FALCON study with 2451, 2222 and 2737, but that’s it for the CF.

[verwijderd] 24 februari 2018 11:39

Well, this cash burn is increased over 2017, but as you can see on this slide, we are expecting a lot of return for the money being spent. We will be initiating trials in a number of diseases in IPF, the late stage 1690 trial. We also start a Phase 2 trial in IPF with 1205, then we got the triple trials for cystic fibrosis, the osteoarthritis trial with 1972, which we are conducting together with Servier, but we are responsible for the U.S. part of that trial and we are initiating a full Phase 2 on MOR106 in atopic dermatitis together with MorphoSys. We will also see POC data of filgotinib in psoriatic arthritis and ankylosing spondylitis. And we will see the data, the proof of concept data in the – of the PELICAN and the FALCON trials, so a lot of data on proof of concept. And even more important the pivotal data that we are expecting on filgotinib in the FINCH 2 trial and the decision to move filgotinib in Ulcerative colitis to a full Phase 3 the go, no go decision that will take place this year. And also as already announced by Walid we have – we are expecting full completion of recruitment for the FINCH 1 and FINCH 3 trials.

[verwijderd] 24 februari 2018 11:39

So a lot of activity there and you can expect as an investor the news flow regarding these trials in the month to come.

[verwijderd] 25 februari 2018 16:43

quote:
inspirator schreef op 24 februari 2018 11:39:
So a lot of activity there and you can expect as an investor the news flow regarding these trials in the month to come.

De dagen naderen van al die mooie Galapagos aankondigingen in 2018.

[verwijderd] 25 februari 2018 17:18

quote:
inspirator schreef op 25 februari 2018 16:43:
[...]

De dagen naderen van al die mooie Galapagos aankondigingen in 2018.

Ik hoop het......vrijdag ingestap!

[verwijderd] 25 februari 2018 17:50

quote:
Cancel schreef op 25 februari 2018 17:18:
[...]

Ik hoop het......vrijdag ingestap!

Goede zet Cancel.
Koersdoel voor 2018 is 180 euro.
Er komt zoveel omzetverhogend nieuws de komende weken, maanden aangaande Galapagos.

[verwijderd] 26 februari 2018 09:49

quote:
inspirator schreef op 25 februari 2018 17:50:
[...]

Goede zet Cancel.
Koersdoel voor 2018 is 180 euro.
Er komt zoveel omzetverhogend nieuws de komende weken, maanden aangaande Galapagos.

Jaarrapportage was zuiver, met veel omzetverhogende introducties die Galapagos te wachten staan.

Koersdoel Galapagos inmiddels 180 euro.

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