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[verwijderd] 28 juli 2020 19:52

4

quote:
Toert schreef op 28 juli 2020 18:46:
Iemand wat uitleg, please ?

Helaas betekent dit in dit geval nog niet dat de gehoopte 854 patiënten zijn gevonden en een behandeling is gestart.
In de beschrijving staat namelijk de volgende zin:
"Detailed Description: 28April2020: The study recruitment is currently on pause due to the coronavirus disease (COVID-19) pandemic. The overall status will be updated when the study begins recruiting again.”

Clinical Trails kent niet echt een status als "on pause" dus hebben ze het maar op "Active, Not recruiting" gezet.
Pas als bij Enrollment het woordje "Anticipated" wordt aangepast naar "Actual" kan je de weken van Primair ofwel Secondair aftellen.

[verwijderd] 28 juli 2020 20:12

0

Aha, dank, lmr.

[verwijderd] 30 juli 2020 17:09

6

De afgelopen dagen het nog eens op me in laten werken.
Goedkeurend adviesoordeel CHMP/EMA voor de 100mg en 200mg Filgotinib dosis.
Prachtige vooruitzichten Filgotinib franchise. Deze redenen vaak weergegeven, en daar zelf ook grote Long-positie voor ingenomen. Maar koers blijft maar duikelen.

Verder gekeken op FDA pagina, en onder advisory committee trof ik daar het volgende aan:

** Industry Representative, (non-voting)

**Marek J. Honczarenko, MD, PhD
Expertise: Immunology, Rheumatology
Term: 11/1/2019 – 10/31/2023
Vice President
Global Immunology Development
Pharmaceutical Research and Development
AbbVie Inc.
1 North Waukegan Road
North Chicago, Illinois 60064

www.fda.gov/advisory-committees/arthr...

Deze meneer heeft een zeer hoge positie binnen AbbVie, en heeft een bepaalde invloed binnen adviescommittee. Deze invloed zal neem ik aan beperkt zijn tot interne adviesaangelegenheden.
Daarbij heeft hij geen stem in advesoordelen (non-voting).

Ik heb een Galapagos positie wegens de kwaliteit van Filgotinib data, en andere programma's, maar zou toch weer bedroevend zijn als dit deksele AbbVie een oude kwestie weet uit te buiten in haar voordeel. Zie ook UBS-rapport over MANTA.
Welke tussentijdse data komt er voort uit de open label arms van MANTA, waar de FDA over zal beschikken.

> Participants will receive open-label filgotinib for up to 13 weeks.

clinicaltrials.gov/ct2/show/NCT03201445

Pacino 30 juli 2020 17:32

4

De regelgeving tav deze adviescommissies is heel strak. Dit lid zal zich verre (moeten) houden van het beoordelingsproces van een kandidaat medicijn waarbij directe concurrenten van AbbVie betrokken zijn. Dat geldt evenzo tav Manta onderzoek naar mijn mening.

[verwijderd] 30 juli 2020 17:48

0

Heeft hij er dan wel voor gezorgd dat Abbvie een Class label heeft ontvangen voor RINVOQ in plaats van een specifieke BBW voor alleen RINVOQ?

[verwijderd] 30 juli 2020 22:18

1

quote:
lmr schreef op 30 juli 2020 17:48:
Heeft hij er dan wel voor gezorgd dat Abbvie een Class label heeft ontvangen voor RINVOQ in plaats van een specifieke BBW voor alleen RINVOQ?

Nee, hij is per 1 november 2019 aangesteld. En dank Pacino voor jou inbreng.

[verwijderd] 30 juli 2020 22:27

2

Beide Manta studies zijn enrollment Completed volgens de Q2 2020 slides van Gilead. Dat houdt in dat ze, na het gesprek met de FDA, geen extra patiënten meer te hoeven werven om aanvullende informatie over de impact op sperma inzichtelijk te maken.

Lama Daila 31 juli 2020 08:11

4

“ So you are right in some regards Matthew, the patients are all enrolled.”

seekingalpha.com/article/4362693-gile...

Matthew Harrison

Great, good evening. Thanks for taking the question. I just want to ask a little bit more about filgotinib and MANTA. So it sounds like you've finished enrollment, I think, it's either about three months when you take the primary end point there. So I'm just wondering how the timing of getting the data from MANTA, which it sounds like it could come towards the end of this year versus the approval timeline for filgotinib. How those two work and your ability to get that data to the FDA or how that influences the application? Thanks.

Daniel O'Day

Hey thanks Matt we'll turn it right over to Merdad.

Merdad Parsey

Hi Matthew its Merdad. I hope everybody can hear me. Sorry I got disconnected earlier. So you are right in some regards Matthew, the patients are all enrolled. I don't – we don't anticipate that the three months is going to be the duration necessarily that will be sufficient for the regulators, in terms of looking at both onset and recovery. So while that first three months is a critical period, we think that's the blinded period, there's probably longer to be that's necessary. So we're looking at probably late in this year, early next year for us to have the data and then for us to submit it to the agency in the first half of next year. Those are the kinds of timelines we're looking at.

Pacino 31 juli 2020 08:52

1

Voor zover ik kan overzien zal dit niet tot vertraging van het goedkeuringsproces door de FDA leiden. Rekening houdend met de priority voucher kan goedkeuring worden verwacht rond 19 augustus. De FDA kent na een goedkeuring (al dan niet met Black Box warning) ook een zgn post -market surveillance. Mocht tijdens gebruik van het medicijn danwel uit nader onderzoek blijken dat er een aanvullend label dient te komen dan gebeurt dat achteraf. Zo'n revision label zou dus indien er aanleiding toe bestaat na de uitkomsten van de Manta studie (eerste H 21) kunnen worden toegepast.

Lama Daila 31 juli 2020 08:53

0

quote:
Pacino schreef op 31 juli 2020 08:52:
Voor zover ik kan overzien zal dit niet tot vertraging van het goedkeuringsproces door de FDA leiden. Rekening houdend met de priority voucher kan goedkeuring worden verwacht rond 19 augustus. De FDA kent na een goedkeuring (al dan niet met Black Box warning) ook een zgn post -market surveillance. Mocht tijdens gebruik van het medicijn danwel uit nader onderzoek blijken dat er een aanvullend label dient te komen dan gebeurt dat achteraf. Zo'n revision label zou dus indien er aanleiding toe bestaat na de uitkomsten van de Manta studie (eerste H 21) kunnen worden toegepast.

“We continue to have ongoing dialogue with the FDA. We've been informed that there will be an Advisory Committee meeting and the PDUFA date remains unchanged“

Pacino 31 juli 2020 08:59

2

Zelfs een zgn accelerated approval behoort nog tot de mogelijkheden.

winx09 31 juli 2020 09:24

8

quote:
Lama Daila schreef op 31 juli 2020 08:53:
[...]

“We continue to have ongoing dialogue with the FDA. We've been informed that there will be an Advisory Committee meeting and the PDUFA date remains unchanged“

zie inhoudelijke light. "there will NOT be an Advisory Committee meeting"

Lama Daila 31 juli 2020 09:41

2

quote:
winx09 schreef op 31 juli 2020 09:24:
[...]

zie inhoudelijke light. "there will NOT be an Advisory Committee meeting"

Thx, ik had het al gezien en met jouw credits op Twitter gezet: twitter.com/lama_daila/status/1289094...

Crees 31 juli 2020 09:44

1

quote:
Lama Daila schreef op 31 juli 2020 09:41:
[...]
Thx, ik had het al gezien en met jouw credits op Twitter gezet: twitter.com/lama_daila/status/1289094...

Help me even, geen committee & no changed PDUFA date dus approval is 100% zeker?

Wall Street Trader 31 juli 2020 11:40

4

Moving on to filgotinib, we continue to believe that this selective JAK inhibitor has the potential to provide a new option for patients suffering from a variety of inflammatory diseases. I’d like to update you on recent discussions with regulators on rheumatoid arthritis. In Europe, we are pleased to see the positive CHMP opinion for the treatment of adults with moderate to severe rheumatoid arthritis. The opinion includes both the 100 and 200 milligram doses and indicates use is appropriate as monotherapy and in combination with methotrexate. As a reminder, this opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe. We continue to have ongoing dialog with the FDA. We’ve been informed that there will not be an advisory committee meeting, and the PDUFA date remains unchanged.

Brian Abrahams — RBC Capital Markets — Analyst

Hi, there. Thanks very much for taking my question. Question on filgotinib. With the PDUFA upcoming and the current state of the pandemic, I’m curious, your latest thoughts on launch approach and potential for differentiation through the label or otherwise, how that shapes your commercial strategy. And then I’m also wondering if there’s any reason that why the CHMP recommendations on dosing and indication. Wouldn’t necessarily be illustrative of global positioning for the product? Do you think FDA and EMA are still looking at the JAK benefit risk profiles differently? Thanks.

Johanna Mercier — Chief Commercial Officer

Okay. Thanks Brian for the question. So yeah, so obviously, pleased with the recent positive CHMP opinion, and we are working — we’ve been working diligently with the teams around the world to prepare for launch with filgotinib. We are looking at the COVID situation. And in assessing the situation, to be honest with you, maybe a couple of months back, we were thinking virtual, not virtual. But I think in light of kind of what — where we’re seeing the dynamics of the market, I think virtual is the way to go. And so we’re looking at how we do this and the best approach. So more to come on that front, a lot of work going on to make sure that we do this as competitively as possible. From a differentiation standpoint, it’s in line with what we’ve talked about before. We believe in the profile of filgotinib and the differentiation that it offers. And so therefore that that’s really an opportunity medically to make sure that to our medical teams, that conversation, that education happens with physicians. Merdad, do you want to comment on the regulatory piece?

Daniel O’Day — Chairman and Chief Executive Officer

I think Merdad is having a bit of an audio issue, so I’ll feed in here Brian. I think it’s kind of premature to anticipate exactly what’s going to happen in different regulatory authorities around the world. We continue to have discussions with all regulatory authorities, obviously, Europe was the first one out of the gate. We’re pleased with that. And as soon as we have some additional information, we’ll let you know, but difficult to speculate. Thanks.

Matthew Harrison — Morgan Stanley — Analyst

Hi. Great. Good evening. Thanks for taking my question. I just want to ask a little bit more about filgotinib and MANTA. So it sounds like you’ve finished enrollment, and I think it’s either about three months when you take the primary endpoint there. So I’m just wondering how the timing of getting the data for MANTA, which it sounds like could come towards the end of this year versus the the approval timeline for filgotinib, how those two work and your ability to get that data to the FDA or how that influences the application? Thanks.

Merdad Parsey — Chief Medical Officer

HI, Matthew; it’s Merdad. I hope everybody can hear me. Sorry, I got disconnected earlier. So, you’re right in some regards, Matthew, that the patients are all enrolled. I don’t — we don’t anticipate that the three months is going to be the duration necessarily that would be sufficient for the regulators. In terms of looking at both on-site and recovery. So, while that first two months is a critical period, we think that’s the blinded period, there is probably longer to be that’s necessary. So, we’re looking at probably late in this year or early next year for us to have the data, and then for us to submit it to the agency in the first half of next year. Those are the kind of timelines we’re looking at.

Gilead Sciences Inc. (GILD) Q2 2020 Earnings Call Transcript

GILD Earnings Call - Final Transcript

www.youtube.com/watch?v=HDXFniF3230

news.alphastreet.com/gilead-sciences-...

rakara 31 juli 2020 14:07

1

Abbvie:
Second-Quarter Global Net Revenues From the Immunology Portfolio Were $5.316 Billion, an Increase of 8.1 Percent on a Reported Basis, or 8.6 percent on an Operational Basis; U.S. Humira Net Revenues Were $3.974 Billion, an Increase of 4.8 Percent; Internationally, Humira Net Revenues Were $863 Million, a Decrease of 19.9 Percent on a Reported Basis, or 17.4 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $330 Million; Global Rinvoq Net Revenues Were $149 Million

--> 43 - 86 - 149 is hun rijtje van kwartaalomzetten Rinvoq

[verwijderd] 31 juli 2020 15:24

0

Dan heeft de uptake van Rinvoq weinig impact ondervonden van Covid19. Als dat zo doorgaat gaan ze ruim boven de $500m uitkomen full year 2020. Als de lijn zich doortrekt gaat het richting de miljard. 1,75 als vermenigvuldigingsfactor genomen. Goed of slecht nieuws voor Jyseleca? Van welk(e) medicijn(en) snoept Rinvoq nu sales af?

Q4 2019: $43m

Q1 2020: $86m
Q2 2020: $149m

Q3 2020: $263m (?)
Q4 2020: $460m (?)

[verwijderd] 2 augustus 2020 15:23

5

quote:
Pacino schreef op 31 juli 2020 08:52:
Voor zover ik kan overzien zal dit niet tot vertraging van het goedkeuringsproces door de FDA leiden. Rekening houdend met de priority voucher kan goedkeuring worden verwacht rond 19 augustus. De FDA kent na een goedkeuring (al dan niet met Black Box warning) ook een zgn post -market surveillance. Mocht tijdens gebruik van het medicijn danwel uit nader onderzoek blijken dat er een aanvullend label dient te komen dan gebeurt dat achteraf. Zo'n revision label zou dus indien er aanleiding toe bestaat na de uitkomsten van de Manta studie (eerste H 21) kunnen worden toegepast.

Lijkt me ook meest logische uitkomst Pacino.

Veronderstelling (vraag) met betrekking tot de (twee) Manta’s:
FDA zal ondertussen de reeds gerecruteerde en actieve “patiënten” hun data te zien krijgen om te helpen bij hun oordeel, toch? Lijkt me enerzijds toch logisch (en noodzakelijk)? Na 13 weken wordt het bij manta ray open label en er zullen toch al patiënten zijn die ondertussen in die fase van het onderzoek zitten? Correcte aanname? (Indien niet krijgen ze blinded data te zien die in principe niet zo fel mag afwijken van elkaar (pbo vs filgotinib).)

Zo interpreteer ik het uit Merdad (CMO) haar antwoord uit de confcall. Driemaandelijks vermoed ze dat niet voldoende zal zijn, volledige dataset (26 weeks) einde dit jaar of begin volgend jaar.

Aangezien het een long term extension is tot 156 weken (manta RAy) lijkt post market surveillance dus plausibel, logisch en uiteraard OK.

Kan iemand hier zijn mening over geven? Bedankt!

MtBaker 3 augustus 2020 08:45

0

quote:
Bosebox schreef op 31 juli 2020 15:24:
Dan heeft de uptake van Rinvoq weinig impact ondervonden van Covid19. Als dat zo doorgaat gaan ze ruim boven de $500m uitkomen full year 2020. Als de lijn zich doortrekt gaat het richting de miljard. 1,75 als vermenigvuldigingsfactor genomen. Goed of slecht nieuws voor Jyseleca? Van welk(e) medicijn(en) snoept Rinvoq nu sales af?

Q4 2019: $43m

Q1 2020: $86m
Q2 2020: $149m

Q3 2020: $263m (?)
Q4 2020: $460m (?)

Q3 2020: $225
Q4 2020: $340
De lijn is 100% 70% 40% etc. en dan nieuw product dat beter is. Je kan dit soort data alle kanten op interpreteren , maar van belang is dat de groei flink is zoals ook voor het betere produkt te verwachten is.

avantiavanti 4 augustus 2020 11:23

5

Ook maar even hier de update van Morgan Stanley van gisteren mbt Manta.

Catalyst Driven Idea: Filgotinib Regulatory Outcomes

North America

Industry View In-Line

Matthew Harrison, Connor Meehan, Thomas F Lavery, J.D.

August 3, 2020

We expect FDA to rule on Gilead/Galapagos' filgotinib filing in RA by late August. What dose level is approved and the scope of warnings on the label are key drivers of both stocks. We expect both dose levels to be approved with similar warnings to other JAK inhibitors in our base case.

What and when is the catalyst?

US Regulatory response for filgotinib in RA due by late August: Galapagos and Gilead are jointly developing filgotinib, a selective JAK1 inhibitor, for a number of inflammatory indications. Rheumatoid Arthritis (RA) is the first commercial indication with new drug applications submitted for the U.S., EU, and Japan. Europe's CHMP recently suggested approval at both dose levels (100mg/200mg), while we are awaiting responses in the US and Japan. In the US, regulators have been particularly concerned with risk/benefit for JAK inhibitors in RA patients and have tended to be more risk averse than their global peers. Approval at the highest dose (200mg) is viewed as important for the long-term commercial success of filgotinib given only the 200mg dose induced remission in the induction phase of treatment in patients with Ulcerative Colitis (UC). The PhIII program was called FINCH.

FINCH1 evaluated patients in four separate cohorts: filgotinib 200mg + methotrexate (MTX), filgotinib 100mg + MTX, adalimumab (Humira) + MTX, and placebo + MTX. The responses observed in the 200mg filgotinib arm were superior to those observed in the adalimumab arm. Filgotinib 100mg demonstrated superiority to adalimumab in some measures of efficacy, such as ACR50 and ACR70.

FINCH3 included MTX-naive patients in four cohorts: patients treated with filgotinib 200mg + MTX, filgotinib 100mg + MTX, filgotinib 200mg monotherapy, and patients treated with MTX alone. Patients included in all three filgotinib arms (including monotherapy) had greater reductions in their ACR20/50/70 scores versus those treated with MTX only. Full data here. Original note here.
FINCH2 was another component of the FINCH program, data from which was released prior to FINCH1/3 in September 2018. The trial included RA patients that had not responded to prior treatment with biologics (a more severe population than FINCH1/3). Data from the FINCH2 trial demonstrated efficacy that was in line with other JAK inhibitors in RA, and both dose levels met the primary endpoint of ACR20.

Do lower events reduce risk of class labeling?

Safety is a major focus as the FDA has approved other JAK inhibitors with black box warnings, but filgotinib has lower rates of those key adverse events, potentially suggesting it may not have to carry similar warnings. In 2019, the FDA approved upadacitinib (Rinvoq) with a boxed warning for the risk of thrombotic events and serious infections. Thrombotic events include deep vein thrombosis (DVT) and/or pulmonary embolism (PE), both of which relate to the formation of arterial blood clots, and can be fatal if left untreated. A similar black box warning (including both DVT/PE and serious infections) was assigned to baricitinib (Olumiant). tofacitinib (Xeljanz) has a black box warning for the risk of developing serious infections. JAK inhibitors work by moderating a patient's overactive immune system, and as a result, the risk of developing serious infections is thought to be a class effect. Thus, filgotinib could be approved with a black box for infections, thrombotic events, both or neither.

Can both levels be approved?

An additional consideration is the possibility of regulators approving filgotinib at only the 100mg dose level. In the FINCH trials, dose dependency was observed with regard to efficacy, but not safety. However, a preclinical finding around the potential for male reproductive toxicity required management to run two PhIII studies (MANTA and MANTA-RAy) to evaluate that risk in humans. Gilead management recently clarified that the MANTA data will not be available until 1H21, well after the current regulatory action date. Despite encouraging safety to date, the possibility of the FDA rejecting the 200mg dose level is a key concern for investors.

What are the potential outcomes for this event?

Scenario 1: Filgotinib is approved in RA with a clean label (no black box) at both dose levels: FDA determines there is a significant positive risk-benefit for filgotinib in RA at both 100mg and 200mg dose levels, based on the FINCH program, interim data from MANTA and long-term safety data. Infrequent cases of DVT/PE, serious infections, and MACE justify the drug's approval without black box, and no class label.

Scenario 2: Filgotinib is approved in RA with a class label (warning for serious infections) at both dose levels: FDA determines there is a positive risk-benefit for filgotinib in RA at both 100mg and 200mg dose levels, based on the FINCH program and long-term safety data. Despite differentiation data on safety, FDA sees the risk as a class effect. The scenario may include a warning about male toxicity pending full readout of the MANTA data.

Scenario 3: Filgotinib is approved in RA with a class label at 100mg only: FDA sees positive risk-benefit for filgotinib in RA at 100mg only, rejects 200mg dose level pending the full outcome of the MANTA study, and approval includes a class label warning for serious infections. Rejection of high dose filgotinib is based on the lack of data from the MANTA and MANTA-RAy trials.
Scenario 4: FDA issues a Complete Response Letter (CRL): Due to lack of clarity on testicular toxicity, FDA issues a CRL and thereby rejects the application for filgotinib at both 100mg and 200mg dose levels. We would expect management to need to refile in 1H21, likely delaying the launch by 1-1.5 years.

What are the potential stock implications from these outcomes?

Scenario 1: We see GLPG up 10-15%+ and GILD up 3-5%+ on a clean label with both doses approved.
Scenario 2: We see approval of both doses with a class label as the most likely scenario. In this case, GLPG may rise ~5%, and GILD may rise by ~2-3%.
Scenario 3: We see GLPG flat to down ~5% and GILD flat to down ~2-3% on rejection of the high dose and approval of the low dose with a class label.
Scenario 4: We see GLPG down 15-20%+ and GILD down 3-5% in the event of a Complete Response Letter (rejection requiring the company to provide more information and then resubmit for approval again) from the FDA.

What is our base case expectation for this event?
Our base case expectation is class labeling with approval of both doses, including a potential warning about male reproductive toxicity pending the results of the MANTA studies:

Enclosed table: Filgotinib Key Safety Data Comparison vs. Competitive JAKis

Bijlage:

Vertraagd	19 apr 2024 17:35
Koers	27,180
Verschil	-0,200 (-0,73%)
Hoog	27,280
Laag	26,860
Volume	62.640
Volume gemiddeld	80.149
Volume gisteren	135.801

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