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inhoudelijk LIGHT

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Pokerface
9
quote:

Woman in Chains32 schreef op 1 dec 2019 om 17:14:


@pokerface: is het een idee om nog een nieuwe topic uit te werken met alle 44 Galapagos moleculen / externe moleculen. Volgens mij heb je deze een aantal jaar geleden opgesomd en ontbraken er 1 of 2 die nagevraagd kunnen worden bij Galapagos.
...


Hierbij alvast een screenshot van m'n Excel file. Is dus nog niet up to date.
Bijlage:
Sentiment
0
Op deze vraag kregen we geen antwoord:
"Wanneer bent u van plan een aanvraag in te dienen voor de Amerikaanse NDA voor filgotinib bij reumatoïde artritis? Bespreek in het kort de belangrijkste hoogtepunten van de FINCH-proeven waarop deze NDA hoofdzakelijk is gebaseerd."
harvester
0
quote:

de tuinman schreef op 2 dec 2019 om 16:21:


[...]

Ik heb overigens aardig wat zitten meeluisteren naar de webcasts en het viel me elke keer op dat er amper aandacht is voor dit programma terwijl de omzet gigantisch kan zijn.

Het gaat veel meer over het IPF en het (veel jongere) Toledo programma.

Als een programma niet lekker loopt wordt zoiets vaak doodgezwegen. Dit heb ik vaker gezien en daarom krijg ik er een beetje negatief gevoel bij.

Maar hopelijk loopt het als in je toelichting en kan Galapagos wat pas melden als ze de data hebben bestudeerd. De rekrutering is iig voltooid.


Alle communicatie gaat in dit programma in overleg met Servier.
Servier is niet beursgenoteerd en in mijn ogen net zo gesloten als een oester. Dat helpt Galapagos niet in haar communicatie naar Galapagos aandeelhouders en andere stakeholders.
Bovendien valt er nog weinig te zeggen nu futility meting van fase 2 nog niet aan de orde is.
Woman in Chains32
1
quote:

Pokerface schreef op 4 dec 2019 om 15:29:


[...]

Hierbij alvast een screenshot van m'n Excel file. Is dus nog niet up to date.



Mooi overzicht Pokerface.
Bij een update ervan zou ik kiezen voor aparte topic.

Ik wacht je aanvullingen geduldig af.
GLPG2196 hebben we zodoende opgehelderd. Daar kan je ook meer over terugvinden:

www.fiercebiotech.com/biotech/j-j-pun...

Zo te lezen is GLPG2196 een molecuul met GPR84 target...



Later is het getest/ontwikkeld als/tot potentiator CF met mogelijke werking in chronische bronchitis, gerelateerd aan COPD:

2-4 november 2017

onlinelibrary.wiley.com/doi/10.1002/p...

Therefore, we evaluated GLPG2196 and GLPG1837, two
novel CFTR potentiators under clinical development. A YFP assay showed
GLPG2196 and GLPG1837 were potent in activating both human and ferret
WT CFTR with an EC50 of 30, 100 and 38, 113 nM, respectively.

These preliminary findings establish that GLPG2196 is
efficacious in activating wild-type CFTR in smoke-exposed ferrets and can
be used in vivo to test its ability to treat COPD-related chronic bronchitis in a ferret model of the disease.
Woman in Chains32
0

Ik heb nog niet verder gezocht, maar onderstaande status Galapagos moleculen op te helderen. Wie o wie mag het zeggen :).


GLPG03..
GLPG08..
GLPG10..
GLPG11..
GLPG13..
GLPG15..
GLPG20..
bilbo3
2
een paar weet ik:
GLPG1179 undisclosed, partner was GSK, gestopt voor fase 1
GLPG1332 werd ontwikkeld tegen OA, partner was Servier, gestopt voor fase 1
GLPG1577 undisclosed, partner was GSK, gestopt voor fase 1
voda
1
PERSBERICHT: Galapagos voltooit de rekrutering van de NOVESA studie in patiënten met systemische sclerose

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Galapagos
188,70 0,00 0,00 % Euronext Amsterdam
Galapagos NV -ADR-
$ 209,54 4,01 1,95 % NASDAQ


Mechelen, België; 5 december 2019, 22.01 CET -- Galapagos NV
(Euronext & NASDAQ: GLPG) heeft de rekrutering voor de NOVESA fase 2
klinische studie met GLPG1690 voltooid.

NOVESA is een dubbelblinde, placebo-gecontroleerde Fase 2a-studie die de
werkzaamheid, veiligheid en medicijneigenschappen van GLPG1690 evalueert
bij patiënten met diffuus cutane systemische sclerose (dcSSc). In
NOVESA zijn 33 patiënten gerekruteerd met dcSSc, een
auto-immuunziekte die een van de hoogste sterftecijfers van alle
reumatische aandoeningen heeft(1) . Eén van de meest zichtbare
symptomen is verharding van de huid. De huidverdikking tast meerdere
delen van het lichaam aan, en patiënten lopen een hoger risico op
het ontwikkelen van fibrose in verschillende inwendige organen,
waaronder de longen. Momenteel bestaan er geen medicijnen voor dcSSc.
SSc treft ongeveer 124.000(2) patiënten in de VS en Europa(3) ,
waarvan het merendeel vrouwen zijn (>80%).

Het primaire eindpunt van NOVESA is de zogenaamde modified Rodnan skin
score (mRSS) na 24 weken. mRSS meet de dikte van de huid als een marker
voor de ernst en mortaliteit van de ziekte, waarbij een toename van de
huiddikte wordt geassocieerd met de aantasting van interne organen en
verhoogde mortaliteit(4) in patiënten met dcSSc. Secundaire
eindpunten die worden gemeten omvatten veiligheid en verdraagbaarheid,
longvolume en kwaliteit van leven. De eerste resultaten van de
NOVESA-studie worden verwacht in de tweede helft van 2020.
Patiënten die de NOVESA studie afronden, krijgen de mogelijkheid om
over te stappen naar een verlenging van de studie.

"We zijn opgetogen over de snelle rekrutering van patiënten voor de
NOVESA-studie en kijken ernaar uit om meer te leren over de werkzaamheid
en veiligheid van GLPG1690 in SSc. Wij beschouwen SSc als een
belangrijke indicatie naast idiopathische longfibrose, waarvoor wij een
wereldwijd Fase 3-programma hebben lopen", aldus Dr. Walid Abi-Saab,
Chief Medical Officer bij Galapagos. "Dankzij het brede
werkingsmechanisme van GLPG1690, dat zowel ontstekingsremmend als
antifibrotisch is, heeft deze compound veel potentieel in SSc."

Over GLPG1690

GLPG1690 is een klein molecuul, een selectieve remmer van autotaxine, en
in licentie genomen door Gilead Sciences, Inc. als deel van de
samenmerking tussen Galapagos en Gilead. Autotaxine is het belangrijkste
enzym verantwoordelijk voor de productie van lysofosfatidinezuur (LPA).
LPA is een gekende pro-fibrotische en pro-inflammatoire lipide, werkend
via ten minste 6 g-proteïne gekoppelde receptoren. We hebben voor
de identificatie van autotaxine als target gebruik gemaakt van ons
target discovery platform en hebben molecuul GLPG1690 ontwikkeld als een
remmer van autotaxine. GLPG1690 wordt momenteel bestudeerd in een
wereldwijde Fase 3-programma in ideopatische longfibrose (ISABELA) en in
een Fase 2-studie in dcSSc (NOVESA).

GLPG1690 is een medicijn in ontwikkeling; de veiligheid en werkzaamheid
zijn nog niet definitief vastgesteld door enige regelgevende
authoriteit.

Voor meer informatie over GLPG1690:
www.globenewswire.com/Tracker?data=gJ...
www.glpg.com/glpg-1690.

Voor meer informatie over de studies met GLPG1690 in systemische
sclerose:
www.globenewswire.com/Tracker?data=gJ...
www.clinicaltrials.gov.
de tuinman
0
En weer wordt er in een interview geen woord gesproken over 1972..
Ik zeg het toch even..

Wel IPF en Toledo.
Rrrenderen
0
De studie naar GLPG3970 (TOLEDO) is iets uitgebreid. Van 7 naar 8 "arms" (subgroepen); enrollment target van 72 naar 80 deelnemers.

www.clinicaltrials.gov/ct2/history/NC...
Rrrenderen
1
Opvallende wijziging aan de FINCH 4 studie. De studie is uitgebreid met 2 subgroepen ("arms"), voor een open label fase:

www.clinicaltrials.gov/ct2/history/NC...
winx09
1
quote:

de tuinman schreef op 2 dec 2019 om 22:30:


En weer wordt er in een interview geen woord gesproken over 1972..
Ik zeg het toch even..

Wel IPF en Toledo.


1972 is nu in coma tot zomer 2020. Geen sites die open gaan, geen recruitering, geen info die binnen komt. Pas wanneer de trial is afgelopen (juni 2020)komt er weer leven in de brouwerij.
Op andere vlakken zoals IPF en Toledo is wel elke dag actie, dus aandacht.

Ik zou er niet teveel achter zoeken.
Wall Street Trader
1
Yesterday @OvandeStolpe gave a presentation @LivingTomorrow about The 20 Years Story of Galapagos @GLPG_Medical

Follow @GLPG_Medical on Twitter.

Medical and live congress updates from
@galapagosNV biotech and biopharma.
#ThinkBig #20YearsGalapagos

Bijlage:
Wall Street Trader
5
Interview With Galapagos CEO Onno Van De Stolpe: Partnerships, Pipeline And Potential

Dec. 2, 2019 1:19 PM ET | About: Galapagos NV (GLPG), Includes: GILD

Ashok Dutta of Avisol Capital Partners recently interviewed Onno van de Stolpe, CEO of Galapagos. This interview discusses Galapagos and its robust future and touches on the company's partnerships, pipeline and potential.
The complete interview is available to our subscribers - what follows here is a detailed excerpt.

We have a fantastic pipeline with a number of potentially blockbuster molecules moving towards the market.

~ Mr Onno van de Stolpe, CEO of Galapagos

I recently interviewed Onno van de Stolpe, CEO of Galapagos (GLPG). Mr. van de Stolpe founded Galapagos in 1999 and has been its CEO from the beginning. Before that, he had years of hands-on experience in the healthcare market across both sides of the Atlantic. Mr. van de Stolpe has sat on the board of a handful of healthcare concerns.

I have been following Galapagos for a number of years, and I have witnessed their dramatic rise from being just another European biopharma to a global R&D powerhouse. The company's principal drug asset is filgotinib, a selective JAK inhibitor that's in late stage development for a number of diseases. Galapagos has what amounts to biopharma's defining partnership of 2019 with Gilead (GILD), a multi-billion dollar synergy that has made Galapagos a $12bn behemoth with more than $6bn in cash reserves. The company has a long-tailed pipeline, and clearly we are seeing a global R&D behemoth in the making.

There also are certain potential fault lines here. The Gilead partnership itself, the risks inherent in immunomodulation, and in doing only R&D as a business model, the competition, and so on. Any good investor needs to look at a potential investment from all angles before jumping in.

So we emailed Mr. van de Stolpe a set of 10 questions, and he responded to them in detail. We began by asking what he thinks is the market's reason for this tremendous enthusiasm for what is still a clinical stage company. Here's what was said:

Dr. Ashok Dutta: Galapagos has a vast pipeline, but it's still a clinical stage company. On the other hand, with a $12bn-plus market cap, Galapagos is larger than many market stage companies. What do you think accounts for this tremendous market enthusiasm for Galapagos?

Mr. Onno van de Stolpe: Clearly filgotinib, our drug for inflammatory diseases and currently in registration for rheumatoid arthritis, is a driver for the enthusiasm. The drug is expected to be introduced on the market second half next year, and with the attractive efficacy and safety profile, the expectations for a successful launch are high. But clearly the rest of the pipeline is of great interest as well, especially our drug for IPF (idiopathic pulmonary fibrosis) that's in Ph 3 clinical testing. Add to this our discovery platform that's at the basis of all our programs, and the hallmark deal with Gilead, and it becomes clear that Galapagos has come a long way over the past couple of years.

We then discussed the terms of the partnership with Gilead. Here's what we asked:

Dr. Ashok Dutta: Your lead drug candidate is filgotinib, which many analysts consider a potential blockbuster drug. However, in 2016, you sold the rights to Filgotinib to Gilead for a 15% (22% now in 2019), $425mn stake in Galapagos, $1.35bn in milestone payments and between 20% and 30% in royalties, in all geographies and for all indications. Is my understanding of the terms of the 2016 Gilead partnership correct? What's the latest partnership terms from 2019 with Gilead? What led you to license Filgotinib to Gilead and partner with them?

The CEO discussed this at some length and clarified certain points - the details are available to our subscribers. Essentially, though, this increasingly comprehensive partnership has allowed Galapagos to leave the hassle of commercialisation to a more expert biopharma major while making very generous revenues in milestones and potential royalties. However, in my next question, I still asked him if the partnership was beneficial to Galapagos all the way. I said

Dr. Ashok Dutta: In hindsight, would you have done this differently from 2016? Would you have liked to retain the rights to filgotinib for yourself, or have made other changes to the terms? I guess what I am trying to ask is, what are some of the positives and negatives of the Gilead partnership as far as Galapagos is concerned? How are those going to affect your plans for future partnerships for the rest of your pipeline?

Mr. Onno van de Stolpe: At the time, this was the right deal with the right partner. Gilead has done an excellent job of executing phase 3 trials in rheumatoid arthritis and are exploring filgotinib in a whole range of other inflammatory diseases. In the new alliance we were able to increase our commercial footprint for Galapagos, which was something we wanted but were not able to negotiate in 2016. One learns along the way, and the many partnerships that we had over the past 15 years provides us with an excellent framework on what we want and especially what we do not want in an alliance. I believe this has all come very good together in the all-encompassing alliance with Gilead, where we struck the right balance between independence in R&D and dependence on bringing innovative products to the market.

We then moved on to filgotinib, the lead drug candidate.

Dr. Ashok Dutta: Let's discuss filgotinib. Please tell us about the molecule's nature and mechanism of action. How does its JAK1 selectivity influence filgotinib's safety and efficacy profile? In terms of biochemistry and MoA, how would you differentiate filgotinib from other selective JAK inhibitors and other pan-JAK inhibitors? How would you differentiate it from biologics in terms of MoA, efficacy, safety, convenience, and potential pricing?

Mr. Onno van de Stolpe: Filgotinib is a very selective JAK 1 inhibitor. This means that the molecule does not bind to the other JAK family members JAK 2 and 3. For the effective treatment of inflammatory diseases, only JAK 1 inhibition is necessary, and inhibiting other JAK proteins seems to be causing undesirable side effects. So what we have seen so far in clinical trials is that filgotinib has potentially an unsurpassed safety profile, which is very important for the patients, especially as this is a chronic disease.

The JAK inhibitors are a new class of drugs, with the different mode of action than the biologics (TNFa and IL6 inhibitors). The advantage of the class is the ease of use (oral versus injections), rapid onset of action and high efficacy. It will be interesting to see how fast this class will take over the biologics in treatment of inflammatory diseases.

I moved on to discuss a potential risk aspect of filgotinib and Mr. van de Stolpe clarified it for our readers.

Dr. Ashok Dutta: Recently, we have seen the FDA raising concerns about the thrombotic effects of certain JAK inhibitors like tofacitinib, baricitinib, and even AbbVie's recently-approved upadacitinib. Do you think this concern is relevant to filgotinib? Have the various trials of Filgotinib identified any thrombotic safety concerns that could potentially impact the harm-benefit analysis of the drug candidate?
Wall Street Trader
0
Mr. Onno van de Stolpe: We believe that the JAK 1 selectivity profile makes the difference here, and we have not seen thrombotic events higher than in the placebo group, to the contrary actually, the levels are lower.

I then asked the CEO about competition. Filgo is entering a rapidly diversifying market, so investors need to understand how the competition stands, and how filgo differentiates itself. So I asked:

Dr. Ashok Dutta: How would you compare filgotinib to AbbVie's upadacitinib, or RINVOQ? What are some of the other key competitors of Filgotinib, and how would you differentiate filgotinib from them?

Mr van de Stolpe responded briefly. We then discussed, in the next two questions, plans for the NDA filing, highlights of the FINCH trials, and the company's plans for the next two years. We also asked the CEO about TOLEDO, which has created a lot of interest among investors. My two questions were:

7. When do you plan to file for the US NDA for filgotinib in Rheumatoid Arthritis? Please briefly discuss the key highlights of the FINCH trials on which this NDA is principally based.

8. What are your plans for the next two years, ie, by end-2021? What label expansions will be possible by then for filgotinib? How about the rest of the pipeline - what will be some of the key milestones achievable by the end of 2021? Could you briefly tell us about Toledo.

Some of the CEO's responses are reserved for TPT subscribers. However, here's what he said about TOLEDO:

Mr. Onno van de Stolpe: Toledo is a new inflammatory program based on a target family discovered by Galapagos. We see exceptional efficacy in animal models and we now have the first 2 molecules in humans. We are planning multiple Ph2 programs with these molecules in 2020.

Let me end this article with the last two questions we asked and their responses from Mr van de Stolpe.

9. Dr. Ashok Dutta: Since your pipeline is really vast and we are limited by time constraints, let me just ask - from your entire pipeline outside of filgotinib in RA, what is the single specific drug/indication combo you are most excited about? Please give a brief overview of the drug/indication and what excites you most about it?

Mr. Onno van de Stolpe: GLPG1690 in IPF, as this is such a devastating disease and ‘1690 might make a difference to live or die for these patients. We still have to see, the Ph3 is 1/3 recruited, but I truly hope that this drug works for all these patients out there. And then Toledo of course, as this program might revolutionize the way inflammatory diseases are being treated and could potentially replace the existing therapy options. Still early though, so a lot can still go wrong, but very exciting.

10. Dr. Ashok Dutta: I have a lot more to ask. However, since I want to limit this interview to just 10 questions for the ease of readers, let me end with what I ask in all interviews - what are the three main reasons investors would be interested in Galapagos?

Mr. Onno van de Stolpe: We have a fantastic pipeline with a number of potentially blockbuster molecules moving towards the market.

The true innovation, based on a unrivaled target discovery platform, has already delivered new mode of actions into late stage clinical trials, and has the promise to address further diseases with high unmet medical needs.

The $6 billion cash pile enables us to make the right decisions for the projects, nut hindered by funding concerns. This increases the chance of further success. And that combined with the guaranteed 10-year independence as part of the Gilead deal, makes me a strong believer in the potential to grow out into one of the leading biotech companies in the world. This is just the beginning…..

Thanks to Galapagos investors for your interest, and to Mr. Onno van de Stolpe for answering my questions.

~ Dr. Ashok Dutta, Avisol Capital Partners.


Wall Street Trader
0
Galapagos wil mensen beter maken - #BeursInside

Beurs Inside bracht een bezoek aan het lab van Galapagos. Welke ontdekkingen worden daar gedaan? En hoe gaat het succesvolle biotechbedrijf precies te werk.

www.youtube.com/watch?v=iWg0u2w0fFw


Wall Street Trader
2
DIVE AWARDS 2019

Biotech of the Year: Galapagos

Staying independent can be a challenge for biotechs. But Galapagos' chief executive sees that as key to the company's success.


www.biopharmadive.com/news/galapagos-...

It's not often a biotech attracts billions of dollars from a large partner without sacrificing its independence.

But Belgian drugmaker Galapagos was able to do just that. A research deal inked in July with Gilead provides $5.1 billion in cash and equity investment as well as an uncommon guarantee its partner won't try to take it over for at least 10 years.

"I didn't want to negotiate with Gilead when there was at all the threat of an acquisition," Galapagos CEO Onno van de Stolpe told BioPharma Dive. "I didn't want to negotiate with a gun against my head."

Though van de Stolpe secured his company's autonomy — painting him as a savvy dealmaker — Galapagos now needs to show its partner's bet was well placed.

"To me, it could very well be the next Regeneron, the next Genentech," SVB Leerink's Pasha Sarraf said of Galapagos. "We just have to wait and see."

For Galapagos to join the ranks of Regeneron and Genentech, it would have to churn out at least a half dozen marketable drugs. That's challenging even for the biggest of companies, yet Galapagos and Gilead leadership seem to think it's possible.

The first real test of the biotech's R&D capabilities will be filgotinib, an inflammation drug that is under review in Japan and Europe and should, by year's end, be submitted to U.S. regulators as a treatment for rheumatoid arthritis.

Despite there being three drugs on the market that work like filgotinib, and the class as a whole raising concerns about side effects, some on Wall Street see Galapagos' offering as safer and a blockbuster in the making. Investment bank Stifel expects filgotinib to fetch $2.5 billion from rheumatoid arthritis sales at its peak. A key factor is whether Galapagos can secure a better label than rival drugs from Pfizer, Eli Lilly and AbbVie.

Galapagos can't rest on a single drug, however.

"Filgotinib is there, and that gives them some level of validation," Cowen & Co. analyst Phil Nadeau said. "But it's the other agents ... people will look at those and evaluate whether the pipeline is truly that productive."

Beyond filgotinib, at least six Galapagos drugs have moved into human testing. Perhaps the most highly anticipated of them come from a secretive program called TOLEDO, to which Galapagos has deployed half of its research organization.

So far, all investors really know is that TOLEDO is code for a new class of anti-inflammatory agents discovered by Galapagos, and that two of its drugs are in Phase 1. The company intends to reveal targets for the program next year, after Phase 2 testing begins.

"Everyone's curious as to what is the target, when are we going to know the target," Nadeau said. "People want to see proof of concept that does suggest this is as promising as management thinks it is."

In the meantime, investors appear sold on Galapagos. Its share price surged 26% around the time of the Gilead deal and has more than doubled since the start of the year. By Dec. 6, Galapagos had a market value of just over $14 billion, similar to some commercial-stage biotechs like Alnylam Pharmaceuticals and BioMarin Pharmaceutical.

Gilead, naturally, sees value as well. Linda Higgins and John Sundy, the respective heads of research external innovation and inflammation and respiratory diseases, note how it wasn't one particular asset that caught their company's attention, but rather Galapagos' chemistry, biology, and fast-paced drug development.

"That drove a lot of the structure of this deal — to preserve the things that are the real positives about Galapagos," Sundy said.

"It was clear that independence was one of their aims, and one of ours was to expand our pipeline not just in size but in diversity," Higgins said.

Once Gilead executives made it clear they weren't pursuing a takeover, van de Stolpe became more willing to enter deal talks. He said the main point of contention was the upfront payment — so much so that, by June, it looked like a deal might not go through. Gilead ultimately offered $3.95 billion for certain license and option rights outside of Europe to all current and future Galapagos drugs, as well as $1.1 billion worth of additional stock purchases.

"In the end, it's absolutely irrelevant if Gilead pays $3 billion, $4 billion or $5 billion," van de Stolpe said. "If this alliance is successful, they will get way more benefit from it than a couple billion more or less."

From his end, van de Stolpe proposes that, by maintaining Galapagos' culture, the alliance is more likely to succeed.

"I don't think [Galapagos] will fit well in any bigger organization, be it big pharma or be it even Gilead," he said. "You always see a moment where big pharma reorganizes or has a different view or different management, and decides that the research should be cut back. And the first part to cut back is innovative target discovery research."

While van de Stolpe contends that Galapagos didn't need the Gilead deal to be successful, there are upsides to having a large commercial partner — particularly with the continued controversy over drug pricing and the competition looming over filgotinib.

The deal's funding may also cushion Galapagos in the event one of its riskier programs doesn't work out. For example, Galapagos' GLPG1972 goes after osteoarthritis, which Sarraf likens to "shooting for the stars" because of how difficult it's been for drugs to show symptomatic benefits.

Still, Sarraf and other analysts remain bullish on Galapagos.

"Obviously some of the programs will fail; some of the programs will not be as exciting as one would hope. But overall, what they're doing is first rate," Sarraf said.

"What Onno is trying to do," he added, "is let this company grow without choking it, which I think is really bright."

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