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Galapagos 2017. De inhoudelijke discussie

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Omlaag ↓

[verwijderd] 14 mei 2017 20:42

Galapagos $GLGP at #ECFC17:presentation of SAPHIRA1 results, a phase 2 evaluating the CFTR potentiator GLPG1837 in G551D mutant CF patients

Bijlage:

Bijlage:

avantiavanti 15 mei 2017 12:23

En we hebben weer een nieuwe Galapagos fan!

Citi Research rapport 15 mei 2017 deel 1

At Least Three Potential Blockbuster Opportunities. BUY

-Initiate with BUY rating and EUR110 target price.
Galapagos is a unique biotech with significant opportunities in Autoimmune and Cystic Fibrosis (CF), with a proprietary R&D platform to provide continuous innovation. We believe that the market significantly underappreciates the opportunities in Crohn’s disease and CF.

-Filgotinib in Crohn’s could be worth EUR47 per share (derisked).
The differentiated profile could provide a novel, oral treatment for a disease with an unmet medical need. Current treatments eg Takeda’s Entyvio have blockbuster status despite limited efficacy and inconvenient administration.

-Market valuation of Cystic Fibrosis interest is a market anomaly – in our view. We would highlight that VRTX’s market value is approx. $30bn, based mainly on triple combination success in CF, which contrasts with an estimated <$500m (approx. 10% of current market value) for GLPG’s mid-teen percentage interest.

-Filgotinib could reach nearly $3bn peak sales in Rheumatoid Arthritis – Once the safety profile is more established, the orally delivered JAK class could become standard of care in RA, potentially with >$10bn sales. Assisted by recent baricitinib delay, filgotinib revenue opportunity could be nearly $3bn, even without a best-inclass profile – see scenario analysis and valuation impact in report.

-Valuation attractive given optionality – De-risking these projects gives a bull case scenario of >EUR200 per share, made attractive by the diversification of having several shots at creating blockbuster opportunities.

-Risks to our investment thesis – These include failure or delay to filgotinib in RA/Crohn’s and a sub-optimal safety / efficacy profile for triple combination in CF.

Bijlage:

avantiavanti 15 mei 2017 12:24

Citi Research 15 mei deel 2

Bijlage:

NielsjeB 15 mei 2017 13:11

EULAR 2017:

OP0161 THE JAK1 SELECTIVE INHIBITOR FILGOTINIB REGULATES BOTH ENTHESIS AND COLON INFLAMMATION IN A MOUSE MODEL OF PSORIATIC ARTHRITIS

THU0173 LONG TERM SAFETY AND EFFICACY OF FILGOTINIB IN A PHASE 2B OPEN LABEL EXTENSION STUDY IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS UP TO 144 WEEKS

OP0229 EFFECT OF BASELINE SERUM CRP LEVELS ON CLINICAL EFFICACY IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH FILGOTINIB: POST-HOC ANALYSIS FROM TWO PHASE 2B STUDIES

OP0180 PHARMACOLOGICAL CHARACTERIZATION OF THE ADAMTS-5 INHIBITOR GLPG1972: AN ORAL ANTI-CATABOLIC AGENT FOR THE TREATMENT OF OSTEOARTHRITIS

web.eular.org/EULAR_Production/2017_M...

Helaas nog niet de abstracts zelf, maar die verwacht ik ieder moment.

NielsjeB 15 mei 2017 21:01

Nog even de datum en tijd erbij. Het is in Madrid (14-17 juni).

Thursday 15.06.2017 10:15 - 11:45

OP0161 THE JAK1 SELECTIVE INHIBITOR FILGOTINIB REGULATES BOTH ENTHESIS AND COLON INFLAMMATION IN A MOUSE MODEL OF PSORIATIC ARTHRITIS

OP0180 PHARMACOLOGICAL CHARACTERIZATION OF THE ADAMTS-5 INHIBITOR GLPG1972: AN ORAL ANTI-CATABOLIC AGENT FOR THE TREATMENT OF OSTEOARTHRITIS

Thursday 15.06.2017 11:45 - 13:30

THU0173 LONG TERM SAFETY AND EFFICACY OF FILGOTINIB IN A PHASE 2B OPEN LABEL EXTENSION STUDY IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS UP TO 144 WEEKS

Friday 16.06.2017 10:15 - 11:45

OP0229 EFFECT OF BASELINE SERUM CRP LEVELS ON CLINICAL EFFICACY IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH FILGOTINIB: POST-HOC ANALYSIS FROM TWO PHASE 2B STUDIES

NielsjeB 15 mei 2017 22:02

Published: 22:00 CEST 15-05-2017 /GlobeNewswire /Source: Galapagos NV / : GLPG /ISIN: BE0003818359

Seven abstracts on filgotinib accepted by EULAR 2017

Mechelen, Belgium; 15 May 2017, 22.00 CET - Galapagos NV (Euronext & NASDAQ: GLPG) announces the acceptance of seven abstracts from several clinical and pre-clinical studies with the investigational agent filgotinib in rheumatoid and psoriatic arthritis, by the Annual European Congress of Rheumatology organized by the European League Against Rheumatism (EULAR) 2017, held in Madrid from 14-17 June. Following is a list of accepted abstracts:

"Long term safety and efficacy of filgotinib in a Phase 2b open label extension study in patients with rheumatoid arthritis: results up to 144 weeks"

"The JAK1-selective inhibitor filgotinib reduces multiple markers of inflammation linked to various pathologic cell types and processes in rheumatoid arthritis patients"

"Monotherapy with the JAK1-selective inhibitor filgotinib displays an anti-inflammatory biomarker profile in rheumatoid arthritis patients"

"The JAK1-selective inhibitor filgotinib regulates both enthesis and colon inflammation in a mouse model of psoriatic arthritis"

"The JAK1-selective inhibitor filgotinib inhibits inflammation pathways observed in an IL23-induced psoriatic arthritis mouse model"

"Effects of the JAK1-selective inhibitor filgotinib on multibiomarker disease activity scores in patients with active rheumatoid arthritis and an inadequate response to methotrexate"

"Effect of baseline serum CRP levels on clinical efficacy in rheumatoid arthritis patients treated with filgotinib: post-hoc analysis from two phase 2b studies"

All abstracts are available on the website of the EULAR 2017 Congress.

NielsjeB 15 mei 2017 22:13

PHARMACOLOGICAL CHARACTERIZATION OF THE ADAMTS-5 INHIBITOR GLPG1972: AN ORAL ANTI-CATABOLIC AGENT FOR THE TREATMENT OF OSTEOARTHRITIS

Bijlage:

NielsjeB 15 mei 2017 22:14

THE JAK1-SELECTIVE INHIBITOR, FILGOTINIB, INHIBITS INFLAMMATION PATHWAYS OBSERVED IN AN IL23-INDUCED PSORIATIC ARTHRITIS MOUSE MODEL

Bijlage:

NielsjeB 15 mei 2017 22:14

THE JAK1 SELECTIVE INHIBITOR FILGOTINIB REGULATES BOTH ENTHESIS AND COLON INFLAMMATION IN A MOUSE MODEL OF PSORIATIC ARTHRITIS

Bijlage:

NielsjeB 15 mei 2017 22:15

EFFECT OF BASELINE SERUM CRP LEVELS ON CLINICAL EFFICACY IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH FILGOTINIB: POST-HOC ANALYSIS FROM TWO PHASE 2B STUDIES

Bijlage:

NielsjeB 15 mei 2017 22:15

LONG TERM SAFETY AND EFFICACY OF FILGOTINIB IN A PHASE 2B OPEN LABEL EXTENSION STUDY IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS UP TO 144 WEEKS

Bijlage:

NielsjeB 15 mei 2017 22:15

MONOTHERAPY WITH THE JAK1-SELECTIVE INHIBITOR FILGOTINIB DISPLAYS AN ANTI-INFLAMMATORY BIOMARKER PROFILE IN RHEUMATOID ARTHRITIS PATIENTS

Bijlage:

NielsjeB 15 mei 2017 22:15

EFFECTS OF THE JAK1-SELECTIVE INHIBITOR FILGOTINIB ON MULTIBIOMARKER DISEASE ACTIVITY SCORES IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE

Bijlage:

NielsjeB 15 mei 2017 22:16

THE JAK1-SELECTIVE INHIBITOR FILGOTINIB REDUCES MULTIPLE MARKERS OF INFLAMMATION LINKED TO VARIOUS PATHOLOGIC CELL TYPES AND PROCESSES IN RHEUMATOID ARTHRITIS PATIENTS

Bijlage:

[verwijderd] 15 mei 2017 22:32

quote:
NielsjeB schreef op 15 mei 2017 22:15:
LONG TERM SAFETY AND EFFICACY OF FILGOTINIB IN A PHASE 2B OPEN LABEL EXTENSION STUDY IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS UP TO 144 WEEKS

Hoor graag de mening van de experts over de veiligheid. Van de 0,3 % discontinue vanwege te weinig werking en de arc20/50/70 wordt ik wel weer blij.

[verwijderd] 15 mei 2017 22:58

quote:
winx08 schreef op 15 mei 2017 22:32:
[...]

Hoor graag de mening van de experts over de veiligheid. Van de 0,3 % discontinue vanwege te weinig werking en de arc20/50/70 wordt ik wel weer blij.

Conclusions: With 1314 patientyears of exposure, the safety profile of filgotinib
appears consistent with that of previously reported doubleblind studies and the
clinical response appears durable

Galapagos zijn de experts:)

[verwijderd] 15 mei 2017 23:57

quote:
Beurskingpin schreef op 15 mei 2017 22:58:
[...]

Conclusions: With 1314 patientyears of exposure, the safety profile of filgotinib
appears consistent with that of previously reported doubleblind studies and the
clinical response appears durable

Galapagos zijn de experts:)

TB or not TB that is the question

[verwijderd] 16 mei 2017 01:35

quote:
avantiavanti schreef op 15 mei 2017 12:24:
Citi Research 15 mei

Weer leuke dingetjes, zoals deze inschatting van Citi:

Despite ABT-494 being marginally ahead in the stage of development (expected
Phase 3 results in late 2018), we note that Gilead has 3 priority review vouchers
which we would expect it to use for such a big opportunity as filgotinib. This would reduce the time to market by 4-6 months making the timeline of launch comparable.

Deze mogelijkheid hier ook al besproken.

[verwijderd] 16 mei 2017 03:56

quote:
maxen schreef op 16 mei 2017 01:35:
[...]

Weer leuke dingetjes, zoals deze inschatting van Citi:

Despite ABT-494 being marginally ahead in the stage of development (expected
Phase 3 results in late 2018), we note that Gilead has 3 priority review vouchers
which we would expect it to use for such a big opportunity as filgotinib. This would reduce the time to market by 4-6 months making the timeline of launch comparable.

Deze mogelijkheid hier ook al besproken.

Define comparable:) filgotinib pas goedkeuring in half of 2020, waarschijnlijk dus zelfs met priority voucher ongeveer een jaar later dan ABT-494

[verwijderd] 16 mei 2017 06:21

Na fase 3 resultaten en NDA heeft de FDA nog 6 tot 10 maanden om goed te keuren.

Overigens hangt het van nogal wat factoren af of en in hoeverre voorsprongen er toe doen.

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