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Prijzengala 25 oktober 2019 23:26

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quote:
Guuster schreef op 25 oktober 2019 23:17:
[...]
Ik vermoed van wel. Geeft in mijn ogen nog meer vertrouwen aan. Als ik iets als positief zie dan neemt de koers meestal eerst een duikvlucht: inslaan. Om daarna te stijgen. Waarom eerst die duikvlucht begrijp ik niet. Maar ik probeer er wel gebruik van te maken. Met wisselend succes

Dat gaat bij meestal ook zo.
Vandaag ging het gelukkig eens zoals ik had gehoopt.
Maandag mag het van van omhoog dan verzilver ik waarschijnlijk een aantal opties.
Mocht het onverhoopt toch dalen dan ga ik weer stevig inkopen doen; aandelen dus, en die hou ik dan wel vast tot na november.
Want half november schijnt er nieuws bekendgemaakt te worden volgens eerdere berichten hier op het forum, en ja dan wil je wel aandelen bezitten.

Guuster 25 oktober 2019 23:30

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quote:
Prijzengala schreef op 25 oktober 2019 23:26:
[...]

Dat gaat bij meestal ook zo.
Vandaag ging het gelukkig eens zoals ik had gehoopt.
Maandag mag het van van omhoog dan verzilver ik waarschijnlijk een aantal opties.
Mocht het onverhoopt toch dalen dan ga ik weer stevig inkopen doen; aandelen dus, en die hou ik dan wel vast tot na november.
Want half november schijnt er nieuws bekendgemaakt te worden volgens eerdere berichten hier op het forum, en ja dan wil je wel aandelen bezitten.

Ja dat wordt denk ik ook mijn modus operandi. Zij het dat die opties bij mij turbo’s zijn

Lingus 26 oktober 2019 01:49

1

Earnings Call Transcript: seekingalpha.com/article/4299307-gala...

Lingus 26 oktober 2019 01:55

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Walid Abi-Saab

This is Walid. I’ll take the first question. So, good morning, good afternoon, everybody. So, regarding the class labeling for the JAKs regarding thrombosis is what you mean. I think this will at the end be a issue. However, you have to look at the data that we have currently with filgotinib. The FDA will look at the totality of the data and they judge based on the frequency of the events in your program, but also they will judge based on the background rates of these events.

We’ve always said that we believe in the selectivity of our JAK1 inhibition with filgotinib. And this will translate in a very favorable safety profile. And the data that we have to-date support this point. Particularly if you think about, not just on preclinical data, but if you look at the clinical data with filgotinib and use the changes in hemoglobin and its platelets as a way to gauge whether treating of the underlying condition with filgotinib is interfering with the natural ability of the body to recover by increasing hemoglobin and reducing platelets, you see that hemoglobin does not interfere with that. Actually you can look at it side by side with medication like maybe adalimumab that do not interfere at all with JAK signaling, and you see that we behave in the same way. So, these are clear evidence in the clinic that tells you that filgotinib actually does not affect the JAK2 pathway, does not interfere with the EPO signaling, or TPO signaling, for the platelets.

And with that we think this is why we have such a lower rate of thromboembolic event. We’ve been communicating on this, as you know, on a regular basis. And when we continue to update the data and show you, we still see the same variable rates of these events. So, we believe that when we present the totality of the data to the FDA, we have a very strong case to make to support our hypothesis, not just pre-clinic, but we have very solid clinical data and also the rates of these thromboembolic events. But in the end, it would be a review issue that -- with the agency, and we look forward to have that scientific discussion with them around this point.

Lingus 26 oktober 2019 01:56

3

Piet Wigerinck

Thanks, Walid. Good morning for the people in the U.S. Good afternoon for the people in Europe. Thanks for asking the question on the Toledo program. As you all know, we’re extremely excited about this program. Up to now, we have selected three different molecules of different profiles for development. So, 3312 is the first is we’re advancing in multiple ascending dose in Phase 1 healthy volunteers now and will move early next year into the first patient study. And so, that patient study will for sure gives us a good indication on the level of efficacy we can obtain. This will be short study. Whether this will be sufficient to completely get an idea on the differentiation profile versus other treatments, that is a bit early, I think. But, least we hope to confirming that first patient study the impressive efficacy we have seen in the animal studies.

So, 3970 has started Phase 1, it’s in the early steps of a single ascending dose and will move next year into multiple proof of concept that we will announce at that moment. So, we don’t have any plans on the short term to disclose what the target is. So, you’re all welcome to the R&D update in New York on November 14th, but don’t expect that we’re going to disclose the target there. I can tell you that upfront. And so, there is a third and more compounds are flowing.

Lingus 26 oktober 2019 01:58

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Bart Filius

Hi, Brian. It’s Bart speaking. Let me answer that first one. Look, at the end of the day, what we’ll be doing first is to look at the filgotinib profile. And we think that the filgotinib profile has shown great results in the clinic, both in terms of efficacy and in terms of safety. And we feel that the data that we have is differentiated from other JAKs there. So, that’s going to be the key angle. Then, we’re going to see what as Walid was just pointing out what the label will eventually bring and that will determine obviously overall our commercial strategy. So, it’s not that much based on what the others are doing currently in the market as more on the strength of on our molecule.

Lingus 26 oktober 2019 01:59

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And then, on the development side, can you talk about maybe the type of evidence of activity that you saw from the Phase 2 lupus and Sjögren's study? Perhaps reasons why those might not have hit their primary endpoints? And what you and Gilead will be looking at to potentially move forward in those indications? Any sub-populations for instance, and how those results might shape how you guys think about future indications? I’ll hop back in the queue. Thanks.

Walid Abi-Saab

Thanks, Brian, for this question. Yes. So, I think, you kind of answered partially some of the question yourself. But, so the bottom line, I maybe just frame it a little bit. So, these studies were exploratory in nature. So, just if you take the lupus, the way Gilead tackled this is that we went after cutaneous lupus, where we also have other ongoing study in membranous arthritis linked to lupus. And, this was our first foray in there. So, these studies were designed to essentially inform the next step in Phase 2 development.

And while the primary endpoint was not met, I can tell you for filgotinib, when you look at patients who have markers of more active disease or markers of inflammation or right out systemic lupus, you clearly see a signal of activity. And when I say single of activity, I’m talking about the typical endpoint that we use for lupus but also for Sjögren’s. So, this is not just the changes in certain biomarkers specifically.

So, I can tell you, I’m personally excited about these results. I think, these support taking the next step and further evaluating Phase 2 and probably, as you say, sort of sub-population. What we need to do now, which is what we are doing, with Gilead is to fully analyze the data set and look at which patients will benefit both from it and design the next studies that we will be doing. And this is something that’s ongoing between us and Gilead. And then, I will close by saying that we will share these results more fully in an upcoming scientific meeting coming up soon.

Lingus 26 oktober 2019 02:01

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Walid Abi-Saab

All right. So, I think, we have one more study in membranous arthritis and lupus, as I mentioned before. And there’s an ongoing study in uveitis. Those are the ongoing studies. There are still a couple of studies in adjacent areas in Crohn’s, fistulizing Crohn’s and related, a small bowel I believe, Crohn’s. So these are the studies that are currently ongoing with filgotinib.

Regarding the studies with lupus, I think, it’s what we talked about. I don’t have any further details. We need to really dig into the data to see where we need to go. But again, I think, what we have seen with filgotinib would be very encouraging to be able to take the next steps. But, we need to figure out in which patient population, how to best select. Particularly in lupus, if you think about it, this has been an area that’s been very challenging in drug research, and we have to be very careful as we evaluate things to choose the right population, so we make sure that we are able to detect a signal if one exists, so that we can bring the drug for patients. I mean, so that’s why we’re being careful in the way we look at this and way we plan our next steps, but we’re actively doing that.

Lingus 26 oktober 2019 02:05

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Walid Abi-Saab

Sure, yes. I mean, I think, I’ve said before. I think it’s very difficult to predict what the position the FDA will take. All we can do is share the data that we have, which, as you guys know, continues to be very favorable. And we can articulate scientifically why we believe that we do have a differentiated profile when it comes to safety and also the low rates of the thromboembolic events. Beyond that, I think we need to make sure that the data are adequately shared with the community, with the prescribing community as well. And then, that’s where we go from there. I think, the data will speak for themselves.

And so far, I think, you have seen that the safety profile for filgotinib, including but not just limited to thromboembolic event, has been very favorable. And we think that’s due to our selectivity for JAK1.

So, maybe, I can take on -- move on to the IPF. So, yes, it’s good point. I think, what we’re are currently doing, as you know, is we are running another program, which is the 1205 program, GPR84 antagonist in -- which is currently in Phase 2. So, depending on the outcome of these results, if they turn out to be good, I would imagine that we would expect to run a study that will evaluate the combination of 1205 with 1690. The shape of the program, right now I think it’s a little bit early to describe. But, I think that would for us the trigger to start evaluating whether there is benefit of combining the two compounds to treat IPF. As you know, this is a disease with high unmet medical need. And as a result, whatever we can use to try and stop the progress of the disease towards deaths in these patients, this would be our goal. So, combination therapy is the way to go, as you know.

Lingus 26 oktober 2019 02:06

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Walid Abi-Saab

Okay. This is Walid again. So I’ll start with the 1690 because it’s easier. So, we will be talking -- giving more details on this on our R&D Day on November 14th, where we will give more color on how well things are going in terms of recruitment and when do we expect to get the futility analysis. The fact that this compound is now a joint development between us and Gilead, this will be a joint decision between us and them regarding communication. So, it’s not in Gilead’s control or in our control. This is a joint discussion or decision and communication that will come from both of us.

Going to the AdCom on filgotinib, I think this is nothing that would be in our control. We cannot influence. This would be -- the AdCom mechanics is that during the review process, the division will decide whether or not they have certain questions that a specialized advisory committee will help them answer. And what specific questions, advisory committees are not open ended. There are specific questions that the review division will have for the Advisory Committee, and based on that they will convene it with the right composition to be able to answer those questions.

So, that’s what I can say. Whether or not this will mean that if there is no advisory committee that means that the authorize [ph] class labeling, I don’t think that would be the case. It depends really to what degree the agency has a question, and that’s what they use the AdCom for. If it’s clear in their mind that there should be more class labeling, they will not be an AdCom. If it’s clear for them that should be class labeling, there will be no AdCom. If they have questions, then they would have an AdCom. But they could also have an AdCom for other reasons as well. And that will only be apparent after they start their review. Thanks.

Lingus 26 oktober 2019 02:08

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Piet Wigerinck

Yes. This is Piet here. Thank you for the question on the Chinese company we work with. So, over the past years, we’ve been working hard to expand our drug discovery platform, mainly planning, but also setting first steps to split our wings. In AdCom, the R&D update will give you clear view on where we’re going to, what elements we want to incorporate. And this contract with the Chinese company is a very small step in the much, much broader effort where we as well try to broaden our chemistry access, so we have internally compound library of couple of hundred compounds. And by accessing and a compound library of couple of billions we clearly expand our chances of finding starting point for the drug discovery efforts. So, this is a quite small step into a much, much broader efforts, for which I am very happy to update you in New York on the 14th of November. Thank you.

Lingus 26 oktober 2019 02:09

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Walid Abi-Saab

Okay. So, I’ll take the 1690 question. So, yes, we’ll be updating the recruitment at the November 14th meeting and will -- what I will do is provide you with a bit more detailed timeline. That’s why I didn’t want to provide any specific date because I still am working with the team to see when we will get these data, because there is so much to be done to be able to clean the data to do the interim analysis. So, it’s not enough to have recruited the people and having them passed through the checkpoint that we needed to pass through to be able to have enough data. We also need to make sure that the data are clean and the way to be analyzed. So, forgive me. I’m not going to confirm. But, I don’t think -- we’ve been telling you that we’re going to be doing it around the time where we have about 25% to 30% of the patient recruited, and they would have passed a full year in the trial. In addition, we need about 70% of the information available on the trial. Those are two fundamental pieces that drive the analysis. And recruitment has been going well. We’re very happy with it. The study is progressing very well actually. And with that, I’m -- we will provide you with a bit more details on the timeline on at the November 14th.

Regarding sub-type analysis and so on so forth, that is not really what has been included in the futility. And frankly, we will not have enough power at that point for the futility to be able to drill into sub-type analyses. The futility will be able to essentially advise us to start the trial in the event that we don’t see any meaningful effect that will translate into a significant at the end of the trial. And if that chance is low, then it’s really not ethical to continue the trial, and that’s the purpose of the futility analysis. And that’s as much that we can ask of it with the number of subjects included in the trial. Otherwise, we would be unable to make those success. Thanks.

Lingus 26 oktober 2019 02:11

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Walid Abi-Saab

Okay. Thanks, Bart. So, yes, I mean, the ROCCELLA study has been designed and powered to evaluate the cartilage thickness over a period of one year, but in addition, we’ll be looking at a number of other endpoints around pain and around function using the traditional way of looking at things like the WOMAC score in addition to others patient reported outcomes. We will also look at X-ray and joint space narrowing. So we will have a lot of data to come through. I certainly would hope that we will not have a problem with meeting the cartilage thickness, but I don’t think -- it would be very really very difficult to be able to speculate what we would do. It really depends on the data. If there is a clear signal on other endpoints such as functioning and pain, I think that there is a clear path forward there. So, you guys have to be patient with us, and by the end of next year, we should be in a better place to give much more clarity on the next steps with the compound.

Lingus 26 oktober 2019 02:12

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Is some of the ongoing evaluation for cutaneous lupus relate to the possibility of maybe using a topical formulation for filgotinib?

Walid Abi-Saab

I don’t think, that it’s ruled out, but I don’t think that is currently in the natural next step. I think, as I mentioned, the data that we’ve seen in this study, particularly in the subset of patients with more severe disease or with actually lupus itself, systemic lupus, would suggest that in certain group of patients, filgotinib orally as it’s given -- as it was given in that trial, would be the way to go.

Lingus 26 oktober 2019 02:14

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Obviously, in two weeks, we’re going to have the American College of Rheumatology coming up, which is obviously probably one of the biggest years for you guys ahead of the launch of filgotinib in RA. Could you just maybe give us what your team’s focused on for the presentations that are going to be at the conference, and also what you’re trying to accomplish on -- maybe the bridging into the commercial side now? Thank you.

Walid Abi-Saab

I think, it’s a question for maybe both of us, Bart. I don’t know how you want to tackle it. But, I think this is -- for the commercial part, maybe I’ll leave it to Bart and discussions with Gilead. I mean, for us, it would be continuing to present data that would characterize essentially the mechanization of filgotinib, the data that we have in the clinic, and continue to show the evidence of efficacy with this compound and also in terms of -- efficacy in certain sub-population, and so on so forth. You could see that from the abstracts, maybe in -- we have some assets in older population and so on so forth. But, it would continue to disseminate the data that is stemming from analysis of the trials that we’ve conducted, particularly I believe Finch 2 is mostly -- it’s being analyzed in some additional sub-population. And, Bart. I don’t know if you want to tackle the other piece regarding...

Bart Filius

Yes. Look, what I can add is that these congresses are terribly important because it’s really the place where we have a chance to really display the clinical results and we make a start with the commercial position, even though we’re not yet in an approved phase. But, this is an important congress for us, like the European equivalents of these congresses. And there’s going to be a significant presence of both, the Gilead and the Galapagos teams, including both CEOs that will be attending the Congress. So, yes, ACR is a big event for us and we will be hoping to display the characteristics of the molecule there in full force.

Lingus 26 oktober 2019 02:21

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Heel veel om blij van te worden. Aan de voorkant van het proces het stuk van Piet over de enorme uitbreiding in de drug discovery. Stelt de toekomst veilig. Alle andere stukken (ik heb me beperkt tot de trialstukken) roepen het beeld op van een aanzwellende voortdenderende blockbustermachine. Ik ga nu maar eerste even slapen.

Hans Igor 26 oktober 2019 06:28

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quote:
Lingus schreef op 26 oktober 2019 02:21:
Heel veel om blij van te worden. Aan de voorkant van het proces het stuk van Piet over de enorme uitbreiding in de drug discovery. Stelt de toekomst veilig. Alle andere stukken (ik heb me beperkt tot de trialstukken) roepen het beeld op van een aanzwellende voortdenderende blockbustermachine. Ik ga nu maar eerste even slapen.

Grote dank voor dit duidelijke en uitgebreide verslag. Allemaal zeer hoopgevend. We kijken uit naar de 14e november.

[verwijderd] 26 oktober 2019 07:51

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Hoe kan het dat nu al bekend is, dat er 14 november een kers op de kaart komt? Nieuws moet toch gedeeld worden? Wat mij betreft is het een grote kers.

Wittesneeuw 26 oktober 2019 08:41

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www.tijd.be/ondernemen/durfkapitaal/G...

Jaja, wat zal november toch een bewogen maand zijn.

Ikkedike 26 oktober 2019 08:48

2

quote:
Wittesneeuw schreef op 26 oktober 2019 08:41:
www.tijd.be/ondernemen/durfkapitaal/G...

De meesten die geen abonnement hebben op de tijd zullen dit niet kunnen lezen.
oplossing:
In chrome : je kopieert de link , je gaat naar de 3verticale puntjes (helemaal rechts)
nieuw incognitovenster
plak de link

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