DeBeurs.nl

Lama Daila 25 maart 2021 21:50

4

Ik heb even de compounds in de glossary van het jaarverslag 2020 vergeleken met die van 2019:

5 nieuwe:
Glpg4876: new Toledo Sik2/3
Glpg4716: oatd-01
Glpg4605: new Toledo sik2/3
GLPG4586: FIB656
Glpg4399: Toledo

3 verwijderd:
Glpg4124: novel MOA for fibrosis
Glpg4259: backup for inflammation
Glpg4471: backup for inflammation

Wall Street Trader 25 maart 2021 22:31

3

Annual Report 2020

reports.glpg.com/annual-report-2020/n...

PDF NL

reports.glpg.com/annual-report-2020/n...

PDF ENGLISH

reports.glpg.com/annual-report-2020/e...

Onze klinische pijplijn

Bijlage:

Lama Daila 29 maart 2021 09:59

4

Op de laatste pagina van het jaarverslag kan je zien dat Sandra Cauwenberghs, ex-biotech-analiste van KBC Securities het IR-team van Galapagos heeft versterkt als “Director of Investor Relations”. Volgens haar LinkedIn heeft ze de overstap gemaakt in nov20. Sofie Van Gijsel heeft sinds jun20 de promotie gemaakt naar “Senior Director of Investor Relations“.

Ornito 29 maart 2021 21:02

4

Is deze hier al gepasseerd?

twitter.com/CrohnsColitisUK/status/13...

Het lijkt wel een gesponsord artikel; al zie ik er niet meteen een referentie naar in het DailyMail artikel.

Lama Daila 29 maart 2021 21:33

0

quote:
Ornito schreef op 29 maart 2021 21:02:
Is deze hier al gepasseerd?

twitter.com/CrohnsColitisUK/status/13...

Het lijkt wel een gesponsord artikel; al zie ik er niet meteen een referentie naar in het DailyMail artikel.

Ook Nederlandse versie:
whatsnew2day.com/nieuwe-dageraad-in-d...

K. Wiebes 30 maart 2021 08:42

0

Lijkt toch verdácht veel op dat "spontane" tripje van "De Tijd" naar Moldavië.
www.iex.nl/Leden/1766397/Ornito.aspx
Brrr...

Ornito 30 maart 2021 09:00

0

Wat is je (inhoudelijk) punt?

K. Wiebes 30 maart 2021 12:12

0

Wat is jóuw punt?

Moeten jullie hier extra 'n account aanmaken om te melden dat de behandeling
met Filgo in minstens één patiënt is aangeslagen?

Steek je moeite liever in heldere communicatie en zorg ervoor dat 't spul bij de
autoriteiten 't juiste stempeltje meekrijgt.

Ornito 30 maart 2021 12:26

1

Fout.

Gebruik de zoekfunctie op dit forum. Dan kan je zien dat dit niet mijn eerste bijdrage was.

En nu graag opnieuw inhoudelijk.

Wall Street Trader 5 april 2021 17:58

5

AbbVie has pegged multibillion-dollar hopes on Rinvoq to fill the revenue gap when immunology superstar Humira loses U.S. market exclusivity. But that plan, dependent on multiple label expansions, has hit its second regulatory setback in weeks.

by Angus Liu | Apr 5, 2021 10:45am

The FDA has pushed back a decision on an application for Rinvoq in moderate to severe atopic dermatitis by three months, as the agency—which has concerns about the safety of meds in the JAK inhibitor class—needs more time to review additional information the company submitted at its request, AbbVie said Friday. The verdict is now expected early in the third quarter.

The news didn’t come as a surprise. It followed another three-month delay for Rinvoq’s filing in psoriatic arthritis, which the Illinois pharma unveiled mid-March. At the time, AbbVie disclosed that the FDA had requested additional information on the benefit-risk profile for the JAK inhibitor in eczema, too.

In eczema, AbbVie has predicted peak sales of Rinvoq to hit around $2 billion in 2025. The internal estimate came from an investor update in December, when management dialed up its combined peak projection for Rinvoq and fellow immunology rising star Skyrizi to $15 billion after a series of clinical wins for the two meds.

Rinvoq topped Sanofi and Regeneron eczema big shot Dupixent in a phase 3b head-to-head trial. The AbbVie drug helped more patients achieve 75% improvement on an eczema severity scale after 16 weeks, and it also hit several secondary endpoints evaluating its ability to clear skin and reduce itch.

At the time, industry watchers said they expected Rinvoq to be used after Dupixent in practice because of the AbbVie drug’s relatively weaker safety profile, most notably an increased risk of infection. But the FDA’s concern is not about the infection, but about potential heart problems that have been haunting the entire JAK inhibitor drug class.

The FDA’s requests for more data on Rinvoq in eczema and psoriatic arthritis are “essentially identical and are focused solely on the long-term safety data that Pfizer released for Xeljanz in late January,” Mizuho analyst Vamil Divan wrote in a note after talking to AbbVie when the first delay was announced.

Xeljanz, also a JAK inhibitor, was linked to higher risk of cardiovascular events and cancers compared with traditional TNF inhibitors—such as Humira—in a post-marketing rheumatoid arthritis trial required by the FDA. The study was carried out in a group of high-risk patients. Before that, the FDA first noted problems with a high dose of Xeljanz in 2019 and immediately slapped a restriction on that use.

The agency is now weighing whether to take further action against the Pfizer drug, given the final analysis showed risks for both doses tested. And as Divan views it, the agency might be looking at the Xeljanz issues as a potential class effect.

Before the Xeljanz debacle, the agency had already rejected Gilead Sciences’ JAK inhibitor filgotinib in rheumatoid arthritis, though mainly on the drug’s sperm toxicity. Eli Lilly’s JAK drug Olumiant carries a black box warning covering serious infections, lymphoma and other malignances, and blood clots.

Rinvoq, in its currently approved rheumatoid arthritis indication, also bears a boxed warning about those same safety problems mentioned on Olumiant's label—and that’s for a 15-mg once-daily dose. For eczema, AbbVie is seeking a green light for a 30-mg dose, and the drug’s recent clinical win in ulcerative colitis features a 45-mg version.

The fact that AbbVie’s only pegging $2 billion in peak sales for Rinvoq in an eczema market worth more than $10 billion is evidence that AbbVie expects challenges advancing the higher 30-mg dose, SVB Leerink analyst Geoffrey Porges said in a note in December.

In a separate report in December, Porges noted that results for 15-mg Rinvoq weren’t shared in the top-line eczema trial announcement despite the drug showing fairly robust efficacy in two earlier pivotal trials. “If the 15-mg dose failed to match Dupixent’s efficacy it will be a liability for AbbVie should the FDA impose their usual restrictions on higher doses of JAK inhibitors,” he said at the time.

www.fiercepharma.com/marketing/abbvie...

de tuinman 5 april 2021 19:41

1

Maar voor reuma is het wel Ok?

Wall Street Trader 12 april 2021 16:35

4

Galapagos Momentum/Summary of where we stand today and Key Takeaways 2021

What’s next for Gilead?

It still has a right to opt-in if any new interesting drug emerges from Galapagos’s pipeline.

Galapagos funds and leads all discovery and development autonomously until the end of Phase 2. After the completion of a qualifying Phase 2 study, Gilead will have the option to acquire a license to the compound outside Europe. If the option is exercised, Galapagos and Gilead will co-develop the compound and share costs equally. Gilead will maintain option rights to the programs through the 10-year term of the collaboration and for up to an additional three years thereafter for those programs that have entered clinical development prior to the end of the collaboration term. For all other programs resulting from the collaboration, Gilead will make a $150 million opt-in payment per program and will owe no subsequent milestones. Galapagos will receive tiered royalties ranging from 20-24% on net sales of all products licensed by Gilead in all countries outside Europe as part of the agreement.

In August 2019, Gilead and Galapagos entered into a 10-year global transformative research and development collaboration, giving Gilead access to Galapagos’ innovative portfolio of compounds and drug discovery platform. As part of the transaction, Gilead made a $1.1B equity investment, increasing Gilead’s stake in Galapagos from approximately 12.3% to 22% of the issued and outstanding shares in Galapagos. In addition, Galapagos issued two warrants, allowing Gilead to further increase its ownership of Galapagos to up to 29.9% of the company’s issued and outstanding shares. Through the exercise of a first warrant, Gilead’s shareholding further increased to 25.1%. The most recent transparency notice received by Galapagos from Gilead indicates a 25.5% ownership position.

The amendment announced the full lock-up is extended: Gilead is now committed to a full lock-up of 5 years, retaining all of its 16,707,477 shares (currently 25.5%) until 22 August 2024. Previously, there was a full lock-up of 2 years, followed by a 3-year period during which the company would have held a minimum of 20% of outstanding shares. The lock-up restrictions are subject to certain exceptions as provided in the share subscription agreement.

Commenting on the amendment, Gilead CFO Andrew Dickinson said, “We remain strongly committed to our long-term collaboration. We continue to see significant value in Galapagos’ unique target discovery approach, and we support Galapagos, as the company works to deliver on this potential.”

Jyseleca (Filgotinib) UPDATE.

Gilead decided not to pursue FDA approval of filgotinib for RA. While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead concluded that this dose was required to be competitive in RA in the U.S. and that the 200 mg dose is unlikely to achieve approval for RA in the U.S. without conducting substantial additional clinical studies.

Both companies continue to pursue the inflammatory bowel disease (IBD) opportunity with filgotinib and the Phase 3 DIVERSITY program in Crohn’s disease (CD) continues to recruit patients.

The filgotinib launch in Japan and Europe is currently underway for rheumatoid arthritis (RA), and an EMA decision on ulcerative colitis (UC) is expected in 2H21 (CHMP in 1H21). With the DIVERSITY study reading out in 1H22, there may be potential for a Crohn's disease (CD) filing in 2H22.

Through a phased transition period, the majority of activities supporting and commercializing filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Filgotinib is now on the market in Germany, Italy, and The Netherlands, with other European territories scheduled to follow in the course of 2021.

www.ema.europa.eu/en/documents/produc...

What about the US?

In the US, Gilead has terminated development for filgotinib in all indications besides inflammatory bowel disease (IBD).

The next step on this front is the MANTA safety study. MANTA is required for approval in UC, and following the Type A meeting, the FDA requested an increased 52-week follow-up from the 26-week primary endpoint for any patients who display >50% decrease in semen parameters and do not recover at 26 weeks. The data will remain blinded, except to a specific team responsible for reviewing the data and conducting discussions with regulators. While it is possible that the company will be able to file before the 52-week endpoint (no signals on hormone levels have been detected across trials, which should correlate with semen parameter), semen parameters can be highly variable, so filing will likely have to wait until the full data is available.

Gilead will only move forward in the US market for IBD indications if they believe there is a best-in-class profile.

Based on results from the FINCH trials, Gilead believes that a 200mg dose is required to be competitive in rheumatoid arthritis (RA) in the US. As such, it is not clear yet if a low dose would be compelling for the US market. Gilead expects to have additional discussions with the FDA following the MANTA and MANTA-RAy data readouts.

Wall Street Trader 12 april 2021 16:39

6

IPF

Two more shots on goal in the IPF pipeline.

Galapagos still has several opportunities over the longer term. In particular, GLPG1205 demonstrated positive Phase2 data and has become the lead asset in IPF.
Galapagos now has two mid-stage assets in its IPF franchise - GLPG1205, which will enter a Phase2b in 2021 and GLPG4716, which is expected to enter a Phase2b in 4Q21/1Q22.
As GLPG1205 and GLPG4716 have different MOAs analysts don't see an immediate readthrough.
Top-line data from these two assets is expected in 2023-2024. For GLPG4716, we can assume US, EU and Japan launch in 2030/2031/2031 respectively. Analysts forecast peak risk unadjusted sales of ~ €1.3bn in 2035.

What about acquisitions?

Galapagos Management plans to fill the gap in the pipeline left by ziri with in-licensing or acquisitions of anti-fibrotic/inflammatory assets, with a focus on novel targets and MoAs.

With the purchase of the European sales rights for a drug from an American company, Galapagos could close the gap to the start of sales of new drugs from the Toledo program. They are also considering an acquisition of a biotech company or the licensing of a drug that is in the third research phase and can therefore be marketed within a few years. They mainly look at drugs that are closest to their research programs. They will only make really large acquisitions, worth say € 1 billion, together with their American partner Gilead.

License deals with:

Fibrocor Therapeutics (Targets; 1st target moved to PCC), OncoArendi (Phase 2 ready chitinase program), Scipher Medicine (Targets) and Ryvu Therapeutic (Lead optimization) strengthen the internal pipeline.

Where does Galapagos go from here?

Within their broader inflammation portfolio, they expect to report topline results from several trials, including a Phase 1b trial with TYK2 inhibitor GLPG3667 in psoriasis, a Phase 1b trial with JAK1 inhibitor GLPG0555 via intra-articular injection in OA. GLPG555 economics: partnership with GSK was terminated, so now fully owned by GLPG.

Three Proof of Concept studies with lead Toledo candidate SIK2/3 inhibitor GLPG3970 in psoriasis, UC, and RA.

The Toledo program is early stage but promising, and data readouts are expected over 2021.
Galapagos is running a number of proof-of-concept studies for the Toledo program, notably for GLPG3970 in psoriasis, RA, and ulcerative colitis (CALOSOMA, LADYBUG, and SEA TURTLE, respectively).

See Key newsflow TOLEDO below:

www.iex.nl/Forum/Upload/2021/13283541...

It is important to remember that Gilead paid Galapagos $3.95B (+ a $1.1B equity investment) to maintain the option to in-license the ex-European commercial rights to each of the Toledo molecules following completion of Phase 2 Trials. Gilead will be able to opt in to each molecule and split development costs going forward in Phase 3.

In addition, filgotinib is also not out of the picture, but the European markets and irritable bowel syndrome in the US are likely to drive more modest sales compared to other inflammatory drugs. Jyseleca peak sales guidance of €0.5bn, which assumes 8-12% market share. EU5 inflammation market is estimated at €5.7bn (RA: €3.2bn, UC: €0.8bn, CD: €1.7bn). Patent exclusivity until 2035. Jyseleca in RA is differentiated by its fast onset of action, ability to use as monotherapy, lasting activity, and safety profile.

The company still has ~ $6B in cash and has the time to develop its earlier stage pipeline, but most analysts need to see more data emerge from these programs and gain clarity if/when value drivers emerge. As such, most analysts are stepping to the sidelines, downgrading the shares to Hold, from Buy and removing their price targets.

YE'21 cash position estimate is ~ € 73 a share.

The next potentially meaningful catalysts are the results from phase 2a with GLPG3970 (SIK2/3 inhibitor, also known as TOLEDO) in psoriasis, RA, and Ulcerative Colitis expected in the summer/mid'21.

These potential catalysts could boost the share price, pharma alliances or deals could provide further upside.

Wall Street Trader 15 april 2021 12:48

4

Barbet01: "Afgelopen weekend stuurde ik een heel opportunistisch mailtje naar IR van Gilead. Reden waarom ik mailde is enerzijds mijn ongeduld tot duidelijkheid m.b.t US en anderzijds de signalen die Gilead tijdens conference calls zelf gaf. Hierbij de vragen en hun antwoorden."

Investor questions and the reply from Gilead Investor Relations.

Is Gilead still interested in gaining US market approval for Filgotinib in IBD indications?

Yes, we are still exploring filgotinib in IBD indications. Of note, we will only move forward in the US market for IBD indications if we believe there is a best-in-class profile.

Manta outcome: is Gilead able to file for Ulcerative Colitis soon?

Pending additional MANTA and MANTA-Ray data readouts, we look forward to discussions with the FDA to help determine the best path in the US.

Isn’t there an option for Gilead to sell US rights for RA low dose to another firm (like Pfizer or so)?

Based on results from the FINCH trials, we believe that a 200mg dose is required to be competitive in rheumatoid arthritis (RA) in the US. As such, it is not clear yet if a low dose would be compelling for the US market.

“Best in class profile”; could that also be best in class safety profile? Given FDAs current view in JAK class?

To determine whether a therapy is best-in-class, we take into consideration both safety and efficacy as well as an assessment of how that would compare to other treatments for that specific indication. While there has been some recent safety concern emerging from a JAK study, FDA hasn’t issued any recent communication on the class and we’ll continue to monitor for regulatory updates here.

So there will be future discussions with FDA regarding the 52week follow up demand?

Yes, we expect to have additional discussions with the FDA following the MANTA and MANTA-RAy data readouts.

What do you mean with “not clear yet”? Could Gilead still proceed with the low dose in RA if other indications with the high dose would be approved? Or what is not clear yet? That other firms would be interested?

For RA in the US, we have decided not to pursue a filing and Galapagos will assume responsibility for this program. As such, we would refer you to the Galapagos team on their go-forward plans for any dose in the US for the treatment of RA. However, we would add that given the level of competition in the US, the 200mg high-dose is required to be competitive in RA. If the other doses are successful in other indications, there would not be a direct read-through to RA given the differences in the disease and market.

Was thinking only EU rights were for GLPG?

Correct, we returned rights to Europe to Galapagos and in the US, Galapagos assumes responsibility for ongoing clinical trials evaluating filgotinib in RA.

So they can go to the market in US for RA by themselves?

Gilead retains commercial rights in the US, however, Gilead has concluded that it does not see a viable path forward for RA in the US. Gilead believes a 200mg dose is required to be competitive in the US RA market, but given the FDA’s feedback, it is unlikely that a 200mg dose for RA will receive approval in the US without conducting substantial additional clinical studies. As noted in Q1, Galapagos assumes responsibility for ongoing clinical trials evaluating filgotinib in RA.

Or they may find a partner other than Gilead to do so for them with only the low dose? And what if Gilead is going to US market in IBD indications? I heard that it would be a problem (it was said in an interview) if two different firms would sell the same product?

Gilead believes that to be competitive in RA, we would need to have the 200 mg dose. As we do not see a path forward, we will not pursue FDA approval of filgotinib in RA. For IBD, Gilead and Galapagos continue to investigate the potential role of filgotinib in UC and Crohn’s disease, and will assess its clinical and commercial viability in the US pending data. As a reminder, last year, Galapagos filed for approval in Europe for UC.

When will investors know more about Manta and outcome with FDA?

We anticipate additional MANTA and MANTA-RAy data in Q221, and will engage in discussions with FDA once the full readout is available.

investors.gilead.com/investor-resourc...

vankuipie 15 april 2021 12:54

0

Hoezo niet de 100 mg op de markt brengen en mensen kunnen dan zelf alsnog extra slikken? Of is dat onethisch.

Wall Street Trader 15 april 2021 19:49

2

Galapagos treedt toe tot de Business Club Rijksmuseum Boerhaave.

Op maandag 12 april jl. trad Galapagos toe tot de Business Club Rijksmuseum
Boerhaave. CEO en oprichter van Galapagos, Onno van de Stolpe, kwam persoonlijk
naar het museum voor de start van het lidmaatschap.

Hij liet zich fotograferen voor de wand met röntgenfoto's in één van de museumzalen. "Deze
ontdekking zorgde voor een revolutie in de medische technologie. Het is inspirerend dat
Wilhelm Röntgen maar liefst 125 jaar geleden een ontdekking deed die wij vandaag de dag
nog steeds op allerlei manieren gebruiken in de geneeskunde." Dit is een van de vele
inspirerende verhalen in het museum over hoe de ontdekkingen van wetenschappers van
onschatbare waarde zijn voor ons eigen leven.

rijksmuseumboerhaave.nl/documents/397...

Bijlage:

Lama Daila 20 april 2021 16:12

1

www.bloomberg.com/press-releases/2021...

Global Kinase Inhibitors in Autoimmune Diseases Market to Continue on Growth Trajectory with 19.17% CAGR During the Study Period (2018-2030), Asserts DelveInsight

Pfizer, Eli Lilly, AbbVie, Gilead Sciences, Astellas Pharma, Japan Tobacco
and Torii Pharmaceutical, Reistone Biopharma, Bristol Myers Squibb,
Galapagos NV, Aclaris Therapeutics, Taiho Pharma, Oncostellae, Novartis
Pharmaceuticals, Aclaris Therapeutics, Theravance Biopharma and Janssen
(Johnson & Johnson), Kadmon Pharmaceuticals, Incyte Corporation, and
others are the major players working in Global Kinase Inhibitor in
Autoimmune Diseases Market regimen.

Besides the JAK inhibitors, compounds that target other kinase inhibitors
such as SYK, SRC- family kinases, TYK2 or BTK inhibitors are expected to
emerge as new therapy for autoimmune diseases hopes for TYK2 inhibition.

Global Kinase Inhibitor in Autoimmune Diseases Emerging Therapies Along with
Key Players

* Ritlecitinib: Pfizer
* PF-06650833/Tofacitinib: Pfizer
* SHR0302: Reistone Biopharma
* Abrocitinib: Pfizer
* Ruxolitinib: Incyte Corporation
* Branebrutinib: Bristol Myers Squibb
* GLPG3970: Galapagos NV
* ATI-450: Aclaris Therapeutics
* TAS5315: Taiho Pharma
* OST-122: Oncostellae
* Remibrutinib: Novartis Pharmaceuticals
* ATI-1777: Aclaris Therapeutics
* Izencitinib: Theravance Biopharma and Janssen (Johnson & Johnson)
* PF-06826647: Pfizer
* Deucravacitinib (BMS-986165): BMS
* PF-06700841 (Brepocitinib): Pfizer
* Belumosudil: Kadmon Pharmaceuticals
* Elsubrutinib: AbbVie

de tuinman 20 april 2021 17:34

2

www.abivax.com/events/

Abivax heeft een webinar geplaatst dat draait om hun medicijn tegen IBD, waarbij ook andere medicijnen, zoals JAKi, voorbij komen.

Ik wist niet zeker waar ik deze moest plaatsen, maar het is in ieder geval wel zware kost.

voda 23 april 2021 06:23

2

PERSBERICHT: Gilead Sciences dient goedkeuringsaanvraag in Japan in voor filgotinib voor de behandeling van colitis ulcerosa bij patiënten met onvoldoende respons op conventionele behandelingen

Aanvraag is gebaseerd op fase 2b/3 SELECTION-studieresultaten bij
patiënten met matige tot ernstige actieve colitis ulcerosa

Mechelen, België; 23 april 2021; 06.01 CET; -- Galapagos NV
(Euronext & Nasdaq: GLPG) meldt vandaag dat haar samenwerkingspartner
Gilead Sciences K.K. (hierna genoemd "Gilead") en Eisai Co., Ltd.
("Eisai") vandaag bekend hebben gemaakt dat Gilead een aanvraag heeft
ingediend bij het Japanse Pharmaceuticals and Medical Devices Agency
(PMDA) voor de goedkeuring van filgotinib voor een bijkomende indicatie
voor de behandeling van patiënten met matige tot ernstige actieve
colitis ulcerosa (CU). Filgotinib is een nieuwe orale Janus kinase
(JAK)-remmer die in september 2020 in Japan werd goedgekeurd voor de
behandeling van reumatoïde artritis.

Deze meest recente indiening bij de regelgevende instanties is gebaseerd
op resultaten uit de gerandomiseerde, dubbelblinde,
placebogecontroleerde fase 2b/3 SELECTION-studie. Deze studie werd
opgezet om de werkzaamheid en veiligheid van filgotinib te beoordelen
bij de aanzet en behoud van remissie bij patiënten met matige tot
ernstige actieve CU die onvoldoende respons toonden, respons verloren,
of intolerant waren voor conventionele behandelingen of biologische
middelen. Deze studie toonde aan dat, vergeleken met placebo, een
significant hoger percentage patiënten behandeld met eenmaal daags
filgotinib 200mg klinische remissie bereikte in week 10, en in remissie
bleven tot en met week 58; er werden geen nieuwe veiligheidsrisico's
vastgesteld.

CU is een chronische ziekte die gekenmerkt wordt door ontsteking van de
slijmvlieswand van de dikke darm en endeldarm. De laatste jaren komt CU
steeds vaker voor. De ziekte heeft een aanzienlijke impact op de
levenskwaliteit van meer dan 2 miljoen mensen wereldwijd. Zelfs bij
patiënten die worden behandeld, komen ontlastingsdrang en
incontinentie, terugkerende bloederige diarree, frequente stoelgang,
buikpijn, slapeloosheid en vermoeidheid nog veel voor. CU kreeg de
status van intractable disease(1) toegekend door het Japanse Ministerie
van Volksgezondheid, Werk en Welzijn. Volgens een nationaal onderzoek
bedroeg het geschatte aantal patiënten met CU in 2014 in Japan
219.685, met een gerapporteerde jaarlijkse prevalentie van 100.000 vs.
172,9 (192,3 voor mannen; 154,5 voor vrouwen).(2)

Over filgotinib

Filgotinib is goedgekeurd en wordt op de markt gebracht als Jyseleca
(200mg en 100mg tabletten) in Europa, het VK en Japan voor de
behandeling van volwassenen met matige tot ernstige actieve RA die
eerder onvoldoende hebben gereageerd op of intolerant zijn voor
één of meerdere ziekte-modificerende anti-reumatische
geneesmiddelen (disease modifying anti-rheumatic drugs; DMARDs).
Filgotinib kan worden gebruikt als monotherapie of in combinatie met
methotrexaat (MTX). De Europese samenvatting van de productkenmerken
(Full European Summary of Product Characteristics) van filgotinib, die
contra-indicaties en speciale waarschuwingen en voorzorgsmaatregelen
bevat, is beschikbaar op www.ema.europa.eu. Het beoordelingsformulier
van het Japanse Ministerie voor Gezondheid, Werk en Welzijn (Japanese
Ministry of Health, Labour and Welfare, MHLW) is beschikbaar op
www.info.pmda.go.jp. De samenvatting van productkenmerken (Great Britain
Summary of Product Characteristics) van filgotinib voor het Verenigd
Koninkrijk is beschikbaar op www.medicines.org.uk/emc. Aanvragen zijn
ingediend bij de Europese Commissie, het MHRA en het PMDA voor een
aanvullende indicatie voor de behandeling van volwassenen met matig tot
ernstig actieve CU die een onvoldoende respons hebben gehad op, een niet
langer reageren op, of intolerant waren voor een conventionele therapie
of een biologisch middel. Deze aanvragen worden momenteel
geëvalueerd. Filgotinib is in geen enkel ander rechtsgebied
goedgekeurd.

Over de samenwerking rond filgotinib

Gilead en Galapagos NV zijn samenwerkingspartners voor de wereldwijde
ontwikkeling en commercialisering van filgotinib. Galapagos zal
verantwoordelijk zijn voor de commercialisering van filgotinib in Europa
(transitie verwacht om eind 2021 afgerond te zijn), terwijl Gilead
verantwoordelijk is voor filgotinib buiten Europa, ook in Japan, waar
filgotinib samen met Eisai op de markt wordt gebracht. Filgotinib is in
Europa ingediend voor CU en er loopt een wereldwijd fase 3-programma
voor de ziekte van Crohn. Meer informatie over de klinische studies is
te vinden op
www.globenewswire.com/Tracker?data=Wb...

Over Galapagos

Galapagos NV ontdekt en ontwikkelt geneesmiddelen met nieuwe
werkingsmechanismen. Sommige geneesmiddelen leverden al veelbelovende
resultaten op bij patiënten, en bevinden zich momenteel in een
vergevorderd onderzoeksstadium in verschillende ziektes. Onze pijplijn
bestaat uit onderzoeksprogramma's tot en met fase 3-studies op het
gebied van ontstekingsziekten, fibrose en andere indicaties. Onze
ambitie is om uit te groeien tot een toonaangevend internationaal
biofarmaceutisch bedrijf, gericht op het ontdekken, de ontwikkeling en
het op de markt brengen van innovatieve geneesmiddelen. Meer informatie
op
www.globenewswire.com/Tracker?data=Wb...

Contactpersonen

Investeerders:

Elizabeth Goodwin

VP Investor Relations

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Sofie Van Gijsel

Senior Director Investor Relations

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Carmen Vroonen

Global Head of Communications & Public Affairs

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Anna Gibbins

Senior Director Therapeutic Areas Communications

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[verwijderd] 23 april 2021 12:57

0

jobs.sciencecareers.org/job/543913/as...

Gilead zoekt een Associate director global value and access heor inflammation pipeline.

Heor = Health economics and outcomes research (HEOR) is a discipline that is used to complement traditional clinical development information (ie, efficacy, safety, quality) to guide decision makers regarding patient access to specific drugs and services.

Key Responsibilities zijn best boeiend.
Wil allemaal niets zeggen natuurlijk... maar feit dat ze hier (nog steeds) voor aanwerven, want hun eigen inflammatory pipe is vrij beperkt en early stage.
Zie ze toch graag verschijnen, zulke vacatures.

Vertraagd	18 apr 2024 17:35
Koers	27,380
Verschil	0,000 (0,00%)
Hoog	27,380
Laag	26,940
Volume	135.801
Volume gemiddeld	81.069
Volume gisteren	104.556

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