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RiapRoy
2
Antwoord t.a.v vraag over de mogelijke verandering in de perceptie van prijsstelling van medicijnen

'...
Daniel O'Day

Yes, these are unusual times for all of us, I'm sure in all of your areas of interest, as well as ours. And so what I can say is that I think people have come together in a variety of ways, and certainly that's also occurred to a certain degree in Washington. And I've spent a decent amount of time in Washington over the past several months, certainly, before the shelter in place. And I think even then, there is some change in the rhetoric. I think for highly innovative research based companies that have immediately kind of shifted their efforts to solutions on the coronavirus, it's pretty impressive actually to many of the peers in the industry, that I stay in very close touch with have spared no expense to kind of pivot and shift.

So I think at the end of the day, I think this will certainly help the industry’s reputation, I think the ability to solve a human crisis like this, because of the decades of investments and the at risk investments that's done by so many companies, people I think will -- and the general public will see that. And whether that's treatment, different types of treatments or vaccines, I think that will be the case. But certainly to your point, I think the tone is different in Washington. I think people are very appreciative and concerned about finding solutions here, and it's brought us all together, which I think is a good thing.

I'm not suggesting that, there won't continue to be focus and pressure on drug pricing. Of course, there will be. And we continue to work appropriately to make sure that, in particular the patients that are bearing the brunt sometimes of some of the pharmaceutical pricing that legislation is put into place that supports that and improve that for patients and that we lean in as an industry and as a company to give more that flows through to patients. So all of those principles I think still apply, but it's being done now in a way where we can have an appreciation for the innovation that the industry brings.

So more to come. And a lot is still to happen this year with the election coming up and with other things. But, I think from a Gilead perspective, we stay focused on innovative medicines and making sure we have access programs on leaning into legislation that supports the innovative industry and that supports reducing patient out of pocket costs, and that will be our focus accordingly, Salim. So hope that gives a little bit of a insight.
...'
abelheira
2
Vraag over IPF en OA programma van Galapagos :

Our next question comes from the line of Mohit Bansal with Citigroup.

Mohit Bansal

Great, thanks for taking my question. And I would also add my appreciation for your efforts against COVID-19. A quick one from my side, if you can help me. If you can update us on your collaboration programs with Galapagos timelines at this point, both for IPF as well as osteoarthritis, and specifically on osteoarthritis program? How important is it for Gilead to see the improvement in pain than we see the data for you to take a decision to opt in there? Thank you.

Merdad Parsey

So with the IPF program, there is a scheduled interim analysis that will be coming up

early next year and we think things will stay on track. Again, I'll put some error bars around the pandemic, but I don't think that should be impacted at least today. So, that will be something that we’ll be clearly looking forward to and will be important to how we proceed there. In terms of the osteoarthritis, it's a great question. I think while seeing structural improvement is going to be really important and interesting. Certainly, thus far the regulatory guidance has included looking at symptoms like pain for improvement. So we can push on that. Obviously, if we see special improvement and we haven't been powered for example for pain then we'll have to look at that and think about what the implications of that are and discuss it with the regulators. So, I think what we'll be looking for is directionality on all the endpoints that we will be measuring to make a smart decision in terms of moving forward with that program.
winx09
1
quote:

abelheira schreef op 1 mei 2020 09:44:


Vraag over IPF en OA programma van Galapagos :

....

Merdad Parsey

So with the IPF program, there is a scheduled interim analysis that will be coming up early next year and we think things will stay on track.
...


Andrew Dickinson melde gisteravond het volgende :
"Turning to clinical development. Like many others in our industry, we are pausing enrollment for most trials. The exception to this is studies where patient outcomes are critically impacted, such as trials of our HIV Capsid inhibitor in heavily pretreated individuals who have few other treatment options and some of our study programs that have enrolled patients with cancer who are critically ill. Enrollment in these studies is at the discretion of the investigators."


Dat de intrim analyse van Isabela doorgaat lijkt duidelijk, deze is namelijk al volledige gerecruiteerd. Echter, Gala heeft in haar antwoorden aan de VEB beklemtoond dat de recruitering van Isabela niet gepauzeerd is terwijl Gilead dat wel suggereert. @Gala, graag duidelijkheid hierover 7 0f 8 mei, wellicht valt Isabela in het rijtje "studies where patient outcomes are critically impacted".
Wall Street Trader
6
Filgotinib Marks Expansion into Inflammation with Potential for 5 Launches in Next 4 Years

(Preparing for competitive RA launch with highly experienced team)

Inflammatory Disease Pipeline

Bijlage:
pe26
10
AbbVie discontinueert ABBV-599 voor reumatische atritis
ABBV-599 = RINVOQ (JAK -inhibitor) + ABBV-105 (BTK-inhibitor)


1 mei Conference Call:


"We continue to make good progress with our early-stage immunology pipeline as well and we expect to be able to share results from the proof-of-concept study, evaluating our novel TNF steroid conjugate in RA patients very soon. We recently completed the Phase 2 proof-of-concept study evaluating ABBV-599 in RA patients, where our JAK-BTK inhibitor combination demonstrated superior efficacy compared to placebo, but the efficacy results did not prove differentiated from monotherapy with RINVOQ.

Based on these results, we are discontinuing development of ABBV-599 in rheumatoid arthritis. We plan to continue development in other autoimmune diseases where there is a greater B-cell contribution, such as lupus and systemic sclerosis in which dual JAK-BTK inhibition could provide superior benefit over current standard of care".



seekingalpha.com/article/4342124-abbv...




Binnen reumatische artritis heeft AbbVie nog 2 moleculen in de kliniek, die binnen dezelfde klasse vallen, en ook binnen dezelfde fase 2 studie worden onderzocht. Dit betreft ABBV-3373 en ABBV-154 (anti-TNF GRM steroid ADC / anti-TNF steroid conjugate).
clinicaltrials.gov/ct2/show/NCT03823391


Het is voor AbbVie te hopen dat deze studie slaagt. Want op basis van de pipeline 7 feb. 2020 zijn er niet veel RA-programma's die het gat van RINVOQ kunnen opvullen.
investors.abbvie.com/static-files/0f2...



Galapagos/Gilead hebben diverse opties om de standaard (remissie/response) voor reumatische ziekten (RA/PsA/AS/Ax Spa) te verhogen, zoals combi Filgotinib met GLPG3667?, en tevens GLPG3970 van het TOLEDO-programma voor RA/PSA etc.

pe26
7

Eerder gaf AbbVie hoog op van ABBV-599 programma. Het zou de remissie in belangrijke mate verhogen.

De BTK-inhibitor ABBV-105, met B-cel activiteit, in combi met RINVOQ (upadacitinib) heeft het niet gebracht.

Zo lukt dus ook bij AbbVie niet alles wat men veronderstelt, en dat biedt grotere kansen voor Galapagos/Gilead.
NielsjeB
5
DDW abstracts van afgelopen weekend.

ddw.apprisor.org/epsSearchDDW.cfm

Su1862 — 2020 AGA
POOLED SAFETY ANALYSES FROM PHASE 3 STUDIES OF FILGOTINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS
Bijlage:
NielsjeB
4
Tu1878 — 2020 AGA
FILGOTINIB DECREASES MOLECULAR MARKERS OF JAK1 SIGNAL TRANSDUCTION IN CROHN’S DISEASE: CONCORDANCE WITH ENDOSCOPY AND HISTOPATHOLOGY
Bijlage:
NielsjeB
4
Tu1880 — 2020 AGA
EFFECTS OF THE JANUS KINASE (JAK1)-SELECTIVE INHIBITOR FILGOTINIB (FIL) ON CIRCULATING CYTOKINES AND WHOLE-BLOOD GENES/PATHWAYS OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE (CD)
Bijlage:
NielsjeB
4
Tu1903 — 2020 AGA
EVALUATION OF POTENTIAL MECHANISMS UNDERLYING THE SAFETY OBSERVATIONS OF FILGOTINIB IN CLINICAL STUDIES IN RA
Bijlage:
Gradje 1960
2
quote:

NielsjeB schreef op 4 mei 2020 10:56:


DDW abstracts van afgelopen weekend.

ddw.apprisor.org/epsSearchDDW.cfm

Su1862 — 2020 AGA
POOLED SAFETY ANALYSES FROM PHASE 3 STUDIES OF FILGOTINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS


Nielsje, bedankt voor deze info. Helaas ben ik een leek en begrijp ik hier niets van.
Zou jij of, een andere kenner, uit kunnen leggen of dit goed of slecht nieuws is?
NielsjeB
0
Helaas niet gebaseerd op de laatste filgotinib-data volgens Bertrand, er komen vreemde DVT/PE getallen uit de bus voor filgo.

Safety of Janus Kinase Inhibitors in Patients With Inflammatory Bowel Diseases or Other Immune-mediated Diseases: A Systematic Review and Meta-Analysis

www.gastrojournal.org/article/S0016-5...
twitter.com/BertrandBio/status/125725...
MtBaker
0
Ik zie dat niet in het verhaal. Er staan 2 studies in de literatuurlijst mbt fil, maar fil wordt nauwelijks genoemd. Door dit sort artikelen worden jaks op een hoop geveegd, misschien wat gemist, ik ben geen medicus.
pe26
3
quote:

Sirlander schreef op 5 mei 2020 14:15:


www.dovepress.com/novel-therapeutic-o...

kwam dit tegen in mijn dagelijkse zoektocht... published 05/05/2020




Goed gevonden!



.....
Nevertheless, primary failure or loss of response to biologics occur in about 50% of patients treated with these drugs. Therefore, the need for new effective treatments for such patients has critically emerged as an urgent priority. With this regard, several small-molecule drugs (SMDs) targeting lymphocyte trafficking (ie, sphingosine-1-phosphate receptor modulators) and the JAK/STAT pathway (eg, tofacitinib) have been recently developed and tested in IBD. In particular, JAK inhibitors are oral compounds characterized by short half-life, low antigenicity and the ability to dampen several pro-inflammatory pathways simultaneously. Tofacitinib, a pan-JAK inhibitor, has shown good efficacy and safety in UC clinical trials and has been recently approved for the treatment of UC patients. In this review, we analyze the main evidence supporting the use of JAK inhibitors in UC and explore the unanswered questions about the use of this class of drug in UC.


.....
Cost-effectiveness analysis represents another major issue when considering the appropriate place in the therapeutic algorithm of such new molecules. Chemical synthesis of SMD (Small Molecule Drugs) is simpler than biologics' synthesis, and the oral administration avoids the need for outpatient visits and dedicated staff related to drug parenteral administration. Thus, a treatment based on SMD could be theoretically cheaper compared to biologics, even though the recent advent of biosimilars makes the difference of the costs less relevant. Studies aimed at investigating the cost-effectiveness of JAK inhibitors in UC are still lacking, and the question remains unanswered.
....


WIC32: dan een passage over bijwerkingen JAK's, voornamelijk bij JAKi's die JAK2 en JAK3 raken/blokken. Dit geldt voor tofacitinib (XELJANZ).
....
Therefore, it has been hypothesized that a more selective JAK inhibition toward a JAK1 preferential inhibition (and maybe in future a selective targeting of specific STAT molecules) could improve safety and efficacy in IBD, even though conclusive evidence is still lacking. Future studies will help address this intriguing hypothesis.


....
In conclusion, JAK inhibitors represent one of the most exciting novelties for UC management, and a positive impact for patients suffering from this condition is expected from the upcoming availability of such drugs. Safety improving and patient selection will be the hot topics for future researches.



WIC32:
Deze conclusies sluiten aan bij de zienswijze van Gilead/Galapagos: er is een grote behoefte aan de selectieve JAK1-inhibitor Filgotinib voor ziekte-indicaties Colitis Ulcerosa & Crohn's.

2 maart 2020: Cowen Webcast met Gilead.
Luister vanaf minuut 22:40 en met name vanaf minuut 24:30 > "Pay the most attention to Ulcerative Colitis. Would probably make the most impact in Ulcerative Colitis. Yes, UC".

wsw.com/webcast/cowen57/register.aspx...
Wall Street Trader
1
On Thursday 7 May, we announce our Q1 results for 2020 (22:01 CET / 16:01 EST),
followed by a conference call for investors and analysts on Friday 8 May (14:00 CET / 8:00 EST).


More details: bit.ly/2P6SlQZ


May 8, 2020 14:00 CET

Join the conference call

events.globalmeet.com/Public/ClickToJ...

Simply click the link above and enter your information to be connected.
The link becomes active 15 minutes prior to the scheduled start time.


Alternatively, TC details
Confirmation code: 6118715
Belgium: +32 (0)2 404 0659
France: +33 (0)1 76 77 22 74
Netherlands: +31 (0) 20 721 9251
UK: +44 (0)330 336 9105
United States: +1 323 794 2093

Bijlage:
Lama Daila
22
biovox.eu/onno-van-de-stolpe-talks-be...

Onno van de Stolpe talks Belgian biotech

At this year’s Innovation for Health, we sat down for a chat with Onno van de Stolpe. Winner of the Trends Manager of the Year in 2019, van de Stolpe is the driving force behind Galapagos NV, a billion-euro blockbuster and one of the Europe’s top biotech companies.
The company’s success is largely built on their lead candidate filgotinib, a small molecule drug for inflammatory diseases like rheumatoid arthritis (RA) and Crohn’s disease. We wanted to know what’s in store for Galapagos, and what van de Stolpe’s personal thoughts and predictions are for the Belgian biotech ecosystem in the coming years.
Let’s start with your company: what’s in store for Galapagos in the near future?
The approval for filgotinib is of course the most important thing for us this year. After 21 years, we are finally bringing a drug to the market. It’s such a big deal that I think it will even boost Belgium’s image as a biotech country.
We’re expecting that filgotinib’s approval for RA will rapidly be followed by other indications, like ulcerative colitis. But we also have so much more in the pipeline. We have a lot of Phase II readouts this year (5 planned), including for drugs in osteoarthritis or IPF [idiopathic pulmonary fibrosis]. We’re doing over 80 clinical trials this year, which is massive.
What are you personally most excited for?
There’s always a new thing to get excited about at Galapagos, but personally I am looking forward to seeing the results of a particular project that is coming to fruition this year. It’s a new mechanism that we found through our target discovery platform. We’ve code-named it Toledo.
“If Toledo is successful, it will work even better than current drugs… This is the biggest pharma market in the world, and we might have a new mechanism that turns everything upside down.”
Toledo is really a once-in-a-lifetime opportunity. There are some academic articles about the mechanism, but pharma hasn’t really picked up on it. We have invested massively in research over the past couple of years and the project is now ready to move into the clinic (we’ll start our first Phase II studies this year).
If Toledo is successful (and we’re all convinced that it will be), it will work even better than current drugs like the JAK inhibitors or the TNFs. This is the biggest pharma market in the world, and we might have a new mechanism that turns everything upside down. That is so exhilarating.
Do you think that biotech companies are particularly well-positioned to pursue these kinds of cutting-edge discoveries?
Yes, and I’m a strong believer in harboring that innovation in biotech. I can’t think of a single good example where a biotech was bought by a pharma company and continued innovating as it did before. We really have to cherish that culture and make sure that it is protected.
It’s why I’ve made it my life’s work to make sure that Galapagos remains independent. We’ve ended up with a beautiful deal with Gilead, where we get the best of both worlds. It’s a simple, beautiful arrangement that is far better than an acquisition.
Read this previous BioVox article for more on the Galapagos-Gilead deal.
Do you think the Galapagos success story has had a big impact on the Belgian biotech ecosystem?
Yes, I think you need companies like ours to show the way, for other CEOs, as well as for investors, banks, and the general public. The publicity Galapagos has generated helps to create awareness for the whole sector, but also pride in Belgium specifically. People start to invest more in local companies and Belgian students choose to study life sciences; it’s all part of the ecosystem. And you need every single part of it: the education; the financial side; the political support (where Flanders is particularly strong); and the role models like Galapagos, to lead the way.
“For the first time you see this whole class of European biotechs competing on the world stage. I think that will be an inspiration for others to come.”
Do you think we’re seeing more role models in Europe in general as well?
I definitely think that, with Galapagos, argenx and Genmab, we finally have three major biotech companies in Europe. Interestingly, two in Belgium. There’s also Evotec, which is very ambitious, and Morphosys which is up-and-coming. So, for the first time you see this whole class of European biotechs competing on the world stage. I think that will be an inspiration for others to come.
What are your predictions for Belgian biotech in the coming years?
I think one of the most important things will be finding ways to broaden the number of genes we can mine for novel starting points. With the regular druggable gene classes, you’re limited to about 8000 different human genes; the rest are just not accessible with small molecules.
New technologies are becoming available to address these non-druggable genes; RNA oligos, for example, and modified chemical molecules. I think types of new technologies will be vital.
So, you think new technological platforms will be key. What about the types of indications that companies are pursuing?
Clearly, orphan diseases will remain attractive to small biotechs. The commercialization, registration and development of orphan drugs are all easier. However, the pricing issue is a contentious point that is unlikely to go away. Society is just not ready for treatment costs in the hundreds or thousands of dollars. And the price of orphan drugs often ends up in that range, because otherwise you can’t recoup the cost of development and make the profit that your investors are expecting.
Read this previous BioVox article for more on drug development trends.
Drug development costs are already unsustainable; do you think they are going to get worse?
Everybody is making a lot of money in the process of drug development: the hospitals, the doctors, the CROs. And the companies are willing to pay because, from a competitive point of view, speed is of the essence. If you’re developing a treatment for a disease that’s going to sell for a billion dollars a year, then every day lost is worth 10 million. It’s simple, and it means nobody is particularly incentivized to reduce development costs.
The result is, of course, that drug development has indeed become unsustainable. Will it get worse? I don’t have the answer to that. I do have an idea for improving things though: bring the drugs to the market earlier. That could work, but you would need regulators that are open to passing a bill granting patients access to drugs with less safety data.
One way or another, something has to give.
What would your advice be to CEOs of other biotech companies? Your take-home message?
“My advice is: make sure you have a parallel path. The technology you’ve developed is a means to an end, and the end is getting the drug to the patient.”
(vervolg via link ...)
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