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[verwijderd] 27 juli 2017 09:57

0

quote:
NielsjeB schreef op 26 juli 2017 22:47:
Zie bijlage: Gilead Pipeline Milestones Anticipated in 2017 - 2018.

Filgotinib
Q2 18 - Initiate Phase 2 study with GS-9876 in RA
1H 18 - Interim analysis from Phase 3 study in UC
Q2 18 - Complete Phase 2 study in ankylosing spondylitis
Q2 18 - Complete Phase 2 study in psoriatic arthritis

Gilead Second Quarter 2017 Earnings Slides:
phx.corporate-ir.net/External.File?it...

Enige verwarring over UC interim zoals hierboven vermeld. Wel in de slides, niet bekend bij Bischofberger of liever niet bekend ?
Uit de seeking Alpha transcript:

Michael J. Yee - Jefferies LLC

Hey. Good afternoon. Thanks. I have two R&D questions. One is on filgotinib, where you mentioned there was an interim analysis in UC in the first half of 2018. Can you just remind us a bit on that and what the importance is of that in terms of that interim ......

Norbert W. Bischofberger - Gilead Sciences, Inc.

Yeah, thank you, Michael. No, the interim analysis was not on filgotinib, it was on the MMP9 antibody andecaliximab. And that interim analysis is an analysis when we will have reached 30% of the endpoints, ......

Michael J. Yee - Jefferies LLC

Maybe I'm just reading it wrong on slide 51, and so I'll follow up with you. On the top there it says filgotinib, Phase 3 UC interim. But we'll keep going.

Norbert W. Bischofberger - Gilead Sciences, Inc.

Okay. Yes, we'll follow up with you afterwards. I don't have slide 51.

[verwijderd] 27 juli 2017 12:50

3

quote:
winx08 schreef op 27 juli 2017 09:57:
[...]

Enige verwarring over UC interim zoals hierboven vermeld. Wel in de slides, niet bekend bij Bischofberger of liever niet bekend ?
Uit de seeking Alpha transcript:

Michael J. Yee - Jefferies LLC

Hey. Good afternoon. Thanks. I have two R&D questions. One is on filgotinib, where you mentioned there was an interim analysis in UC in the first half of 2018. Can you just remind us a bit on that and what the importance is of that in terms of that interim ......

Norbert W. Bischofberger - Gilead Sciences, Inc.

Yeah, thank you, Michael. No, the interim analysis was not on filgotinib, it was on the MMP9 antibody andecaliximab. And that interim analysis is an analysis when we will have reached 30% of the endpoints, ......

Michael J. Yee - Jefferies LLC

Maybe I'm just reading it wrong on slide 51, and so I'll follow up with you. On the top there it says filgotinib, Phase 3 UC interim. But we'll keep going.

Norbert W. Bischofberger - Gilead Sciences, Inc.

Okay. Yes, we'll follow up with you afterwards. I don't have slide 51.

Vreemd dat Norbert daar geen antwoord op geeft. Of die dat bewust doet, geen idee.
Galapagos zal de Fase2b scores (10-weeks induction period) toch zeker wel rapporteren, zodat daarna direct fase 3 traject ingaat (maintenance van week 11 - week 58).

Gilead/Galapagos zijn zeer overtuigd van werkzaamheid Filgotinib in chronische darmontstekingsziekten.

Filgotinib in Crohn en Colitis Ulcerosa wordt een succes.

NielsjeB 27 juli 2017 16:11

0

quote:
pe26 schreef op 27 juli 2017 12:50:
[...]

Vreemd dat Norbert daar geen antwoord op geeft. Of die dat bewust doet, geen idee.
Galapagos zal de Fase2b scores (10-weeks induction period) toch zeker wel rapporteren, zodat daarna direct fase 3 traject ingaat (maintenance van week 11 - week 58).

Gilead/Galapagos zijn zeer overtuigd van werkzaamheid Filgotinib in chronische darmontstekingsziekten.

Filgotinib in Crohn en Colitis Ulcerosa wordt een succes.

Was mij ook opgevallen. Ik vermoed geen kwade opzet. Die slides worden echt wel 100x bekeken voordat ze worden gepubliceerd, zeker bij een bedrijf als Gilead.

De tijdlijn van GS-9876 en de combo met filgotinib vond ik ook interessant, maar werd niet echt heel lang bij stilgestaan.

Misschien een poging waard om Gilead of Galapagos een mailtje te sturen over UC. Of wie weet komt het vanavond of morgenmiddag aan bod.

jodu 27 juli 2017 21:03

0

There was one positive bit of information on the pipeline that helped tip me to like GILD stock more. This is on filgotinib, from Galapagos (GLPG), a Janus kinase, or JAK, inhibitor.
Filgotinib may be looking better

This was a deal I liked from the start, a derisked, truly Phase 3-ready molecule that ABBV let go to focus on a similar drug that it had developed internally. The whole field was thrown into some turmoil when a major pipeline product for Lilly (LLY), baricitinib, developed by Incyte (INCY), was not approved by the FDA. Apparently, the grounds for non-approval revolved around dosage and side effect issues.

GILD's filgotinib was suggested by Dr. Bischofberger in the conference call to have a better chance of success for two reasons. One was that the company was using two doses as suggested by the FDA. The other was that baricitinib had blood clotting as a side effect. However, that drug raised platelet levels in the blood, while filgotinib lowers platelets.

That's a bit of encouraging news. Filgotinib has some strong pharmacologic characteristics. It is in Phase 3 for three major autoimmune diseases, rheumatoid arthritis and both major inflammatory bowel diseases. It is also in Phase 2 for two other autoimmune diseases. There will be an interim analysis by mid-year next year in the ulcerative colitis study.

While GILD shares revenues with GLPG, GILD also owns some equity in GLPG, which has appreciated since the deal was struck.

This is the sort of deal that I like and would like to see more of, but I agree with GILD that until it knows where it is going with filgotinib, in NASH and its other, less-promising R&D ventures (my opinion), it just does not make sense to pay today's high prices for pharma assets. Rather, GILD's stock is a good enough investment based on current trends.

seekingalpha.com/article/4091399-gile...

voda 27 juli 2017 22:04

2

Servier licenses GLPG1972 in osteoarthritis from Galapagos

22:00
Galapagos press release

Published: 22:00 CEST 27-07-2017 /GlobeNewswire /Source: Galapagos NV / : GLPG /ISIN: BE0003818359
Servier licenses GLPG1972 in osteoarthritis from Galapagos

Mechelen, Belgium; Suresnes Cedex, France; 27 July 2017, 22.00 CET, regulated information - As a result of their research collaboration, Servier announces today that it has exercised its option to develop novel osteoarthritis molecule GLPG1972/S201086 from Galapagos NV (Euronext/NASDAQ: GLPG), thus obtaining global commercial rights outside the U.S.

Osteoarthritis (OA) is a highly prevalent and disabling pathology, considered as a priority by the World Health Organization. So far, no treatment is available to counteract disease progression, patients being left with only symptomatic treatments. OA represents an important unmet medical need. Since June 2010, Servier and Galapagos have been joining their expertise to tackle this problem, leading to the development of GLPG1972/S201086, a first-in-class and potentially disease-modifying molecule.

The mechanism of action of GLPG1972/S201086, which targets a cartilage degrading enzyme called ADAMTS-5, has been confirmed in two animal models. The phase 1 trial run by Galapagos met all its safety and pharmacokinetic targets. Phase 1 in healthy volunteers also demonstrated that GLPG1972/S201086 reduced ARGS neoepitope, an important cartilage breakdown biomarker, by more than 50% within two weeks. Galapagos is currently exploring safety and pharmacokinetics of G1972/S201086 in a phase 1b trial in OA patients in the US. A Phase 2 program is currently being prepared with this drug candidate.

"We strongly believe that the combination of our knowledge of osteoarthritis with Galapagos' recognized expertise in discovery of small molecules with novel modes of potentially increases chances to deliver life-changing treatments to patients", said Dr. Patricia Belissa-Mathiot, Director of the Research and development in immune-inflammatory disease for Servier.

"We look forward to exploring together how GLPG1972/S201086 might meet OA patients' urgent needs. Servier's commitment in OA fits really well with our drive to deliver a first disease-modifying drug in this debilitating disease," said Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.

Galapagos will receive a €6 million license fee from Servier and is eligible to a total of €290 million in success-based milestones from the collaboration. Servier and Galapagos will make joint decisions on the development through a joint steering committee. Galapagos has full US commercial rights to GLPG1972/S201086 and is entitled to receive royalties on commercial sales outside the US.

About Servier
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier's constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric disease, oncology and diabetes, as well as by its activities in high-quality generic drugs.
Becoming a key player in the fight against immune-inflammatory disease is part of Servier's long-term strategy. Servier wishes to bring innovative therapeutic solutions to patients suffering from these often highly debilitating pathologies. Its research focuses on lupus, Gougerot-Sjögren syndrome and scleroderma, for which no cure exists. This goal will be reached by establishing partnerships all over the world, in order to accelerate the marketing of innovative drugs with high added value for patients.
More information: www.servier.com

About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises a pipeline of Phase 3, Phase 2, Phase 1, pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 550 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.

Contact Servier
Karine Bousseau
Servier External Communications
Tel: +33 1 5572 4021 /+33 6.49.92.16.05
media@servier.com

aston.martin 27 juli 2017 22:11

2

Galapagos kondigt de benoeming aan van Michele Manto, voorheen Global Marketing General Manager Rheumatology bij AbbVie, waar hij verantwoordelijk was voor Humira en de voorbereidingen voor de wereldwijde lancering van ABT-494. Daarvoor vervulde Michele bij AbbVie vanaf 2004 verschillende commerciële rollen, meest recent als General Manager van de Nederlandse activiteiten en Business Unit Director Immunology bij de Duitse en Zwitserse activiteiten. Als SVP Commercial Operations zal Michele vanaf 1 september verantwoordelijk zijn voor het ontwikkelen en uitvoeren van de commerciële strategie van Galapagos. Michele zal de operationele taak hebben om de commerciële organisatie voor het bedrijf op te bouwen, het juiste talent te werven in Europa en leiding te geven aan deze commerciële teams binnen onze alliantie met Gilead voor filgotinib.

voda 27 juli 2017 22:14

0

Solid financials support R&D progress
E-mail van Galapagos press release: Solid financials support R&D progress

22:01
Galapagos press release

Published: 22:01 CEST 27-07-2017 /GlobeNewswire /Source: Galapagos NV / : GLPG /ISIN: BE0003818359
Solid financials support R&D progress

First half-year financial results:

Revenues €73.0 M, an increase of €24.3 M compared to H1 2016
Operating loss €32.9 M, an increase of €8.6 M compared to H1 2016
Cash on 30 June 2017 of €1,263.2 M
Raised €363.9 M gross proceeds in the U.S. public equity offering
Substantial progress in R&D
Consistent filgotinib profile in RA in DARWIN 3 interim readout
Expansion of filgotinib Ph2 patient trials
Ph1 evaluation completed for individual components of first triple combo in CF
Initiation of Ph1b trial in U.S. with GLPG1972 in osteoarthritis patients
FDA orphan status for GLPG1690 in IPF
Nomination of fully proprietary pre-clinical candidates in inflammation, fibrosis, and other indications
Appointment of Michele Manto as Senior Vice President Commercial Operations
In-licensing of GLPG1972 by Servier triggers €6 million license fee

Webcast presentation tomorrow, 28 July 2017, at 14.00 CET/8 AM ET, www.glpg.com, +32 2 403 7297, code 4659682

Mechelen, Belgium; 27 July 2017, 22.01 CET; regulated information - Galapagos NV (Euronext & NASDAQ: GLPG) announces its unaudited first half-year results, which are further detailed in its H1 2017 report available on the Galapagos website, www.glpg.com.

"I am pleased with the results over the first six months, both financially and in our R&D," said Onno van de Stolpe, CEO. "We note the consistency of the DARWIN 3 results and are excited to see Gilead's rapid rollout of inflammation studies with filgotinib. We expect more Phase 2 study starts with filgotinib. In cystic fibrosis we are making progress towards initiating patient evaluations of our first triple combo therapy. Most exciting for us is that we expect two patient study readouts from novel mechanism of action candidates this coming half year: the GLPG1690 FLORA study in IPF and the MOR106 study in atopic dermatitis."

"In the first half of 2017 Galapagos continued to invest in its R&D pipeline to produce substantial progress. The U.S. public equity offering in April confirmed shareholders' confidence in the future of our company and in our ability to execute," said Bart Filius, CFO. "With a cash position of close to €1.3 billion, we are well positioned to advance our wide range of R&D programs. We confirm our cash burn guidance for the full year within the range of €135 - 155 million."

Key figures first half-year report 2017 (unaudited)
(€ millions, except basic & diluted income/loss per share)

30 June 2017 group total
30 June 2016 group total
Revenues
73.0
48.8
R&D expenditure
(92.9)
(62.4)
G&A and S&M expenses
(13.0)
(10.7)
Operating loss
(32.9)
(24.3)
Non-cash adjustment on short term financial asset1

57.5
Other net financial result
(16.2)
(0.9)
Taxes
(0.1)
-
Net result for the period
(49.2)
32.2
Basic income/loss (-) per share (€)
(1.03)
0.71
Diluted income/loss (-) per share (€)
(1.03)
0.69
Cash, cash equivalents and restricted cash
1,263.2
968.5

Notes:
1) reflects non-cash financial asset adjustment resulting from the Gilead subscription agreement

Appointment of SVP Commercial Operations
Galapagos announces the hire of Michele Manto, formerly Rheumatology Global Marketing General Manager at AbbVie, where he was responsible for Humira and preparation of the launch strategy of ABT-494. Prior to that Michele held several commercial roles at AbbVie starting in 2004, most recently General Manager of the Netherlands operations and Business Unit Director Immunology at AbbVie's German and Swiss operations. Joining on 1 September as SVP Commercial Operations at Galapagos, Michele will be responsible for envisioning, scoping and operationalizing the commercial strategy for the organization. Michele will have the operational task of building the commercial organization for the company, recruiting the right talent across Europe and leading these commercial teams in our alliance with Gilead for filgotinib.

"We welcome Michele to the Galapagos team. Michele brings valuable commercial experience and is the right person to spearhead build-up of our new commercial operations. The new SVP Commercial Operations will be a critical addition to the senior team and a key contributor to Galapagos' transition to a fully integrated biotech company," commented Onno van de Stolpe.

First half-year report 2017
Galapagos' financial report for the first half-year ended 30 June 2017 can be accessed via www.glpg.com/financial-reports.

Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow, 28 July 2017 at 14:00 CET / 8 AM ET, which will also be webcast. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

CODE: 4659682

USA:
+1 719 325 2213
UK:
+44 330 336 9411
Netherlands:
+31 20 703 8261
France:
+33 1 76 77 22 57
Belgium:
+32 2 400 6926

A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

Financial calendar
26 October 2017 Third quarter 2017 results (webcast 27 October 2017)
22 February 2018 Full year 2017 results (webcast 23 February 2018)

About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, Phase 2, Phase 1, pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 550 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.

de tuinman 27 juli 2017 22:14

1

Heeft dat filmpje toch geholpen.;)

Piet2010 27 juli 2017 22:28

0

Ik had toch wat meer verwacht van 1672. Is toch een gigamarkt waar volgens mij geen echt middel beschikbaar is. Maar misschien kunnen de experts dit beter verklaren.

aston.martin 27 juli 2017 22:32

0

Ander en naar mijn gevoel heel belangrijk feit is de verdere samenwerking met Servier op vlak van atritis:

Servier en Galapagos zullen gemeenschappelijke beslissingen over de verdere ontwikkeling nemen in een gezamenlijke stuurgroep.

aston.martin 27 juli 2017 22:37

0

quote:
Piet2010 schreef op 27 juli 2017 22:28:
Ik had toch wat meer verwacht van 1672. Is toch een gigamarkt waar volgens mij geen echt middel beschikbaar is. Maar misschien kunnen de experts dit beter verklaren.

Bedoel je het bedrag van 6 miljoen euro voor de licentie?

De grootte van de milestones lagen waarschijnlijk al vast van in 2010 toen Servier en Galapagos een deal sloten voor het ontwikkelen van een therapie tegen artrose.

MrMarket 27 juli 2017 22:37

0

quote:
Piet2010 schreef op 27 juli 2017 22:28:
Ik had toch wat meer verwacht van 1672. Is toch een gigamarkt waar volgens mij geen echt middel beschikbaar is. Maar misschien kunnen de experts dit beter verklaren.

GLP houdt rechten VS en ontvangt royalties over verkopen elders. Staat ook dat Servier 'de optie heeft uitgeoefend'. Als het niet werkte had Servier dit niet gedaan en had GLP er ook niets meer aan denk ik

[verwijderd] 27 juli 2017 22:49

1

quote:
Piet2010 schreef op 27 juli 2017 22:28:
Ik had toch wat meer verwacht van 1672. Is toch een gigamarkt waar volgens mij geen echt middel beschikbaar is. Maar misschien kunnen de experts dit beter verklaren.

Royalties en milestones inbegrepen bij de deal.

Zeer positief dat signaal dat Servier in-licentie neemt.

Ook CCO aangesteld. Het gaat voor de wind met Galapagos.

pardon 27 juli 2017 22:50

1

Als het kraakbeen 50% herstelt werkt 1672 echt wel,andere medicamenten blijken alleen wat af te remmen maar geven geen herstel.
Amerika is ook hier een grote markt en is makkelijker te bereiken en goedkoper dan dat je over de hele wereld moet zien te verkopen.
En de royalties zullen veel goedmaken.

aston.martin 28 juli 2017 10:00

3

Samenwerking met Calchan (overeenkomst uit 2014) levert een preklinische kandidaat, GLPG3535

www.glpg.com/docs/view/8829eb2f-nl

www.glpg.com/docs/view/597a4c405465f-en

aston.martin 28 juli 2017 10:33

2

Nog 2 andere nieuwe preklinische kandidaten:

GLPG3312 - ontsteking/inflammatie

GLPG3499 - IPF vervangt GLPG2938 zoals tijdens de R&D update al aangekondigd werd

Het volledig overzicht blz. 35-36:

www.glpg.com/docs/view/597a4c405465f-en

Lingus 28 juli 2017 12:13

0

quote:
aston.martin schreef op 28 juli 2017 10:00:
Samenwerking met Calchan (overeenkomst uit 2014) levert een preklinische kandidaat, GLPG3535

www.glpg.com/docs/view/8829eb2f-nl

www.glpg.com/docs/view/597a4c405465f-en

Daaruit: Onno van de Stolpe, Chief Executive Officer van Galapagos: "De vraag naar medicijnen voor artrosepijn blijft hoog. Deze alliantie met Calchan is gebaseerd op de expertise van Galapagos in drug discovery, en is een aanvulling op ons langdurig artroseonderzoek. Ondersteund door de Biomedical Catalyst Early Stage Round 2 subsidie, kijken we uit naar de samenwerking met Calchan om een nieuwe klasse van artrose pijnmedicatie naar de kliniek te brengen."

Bij succes gaat hier weer een flinke markt aangeboord worden.

[verwijderd] 28 juli 2017 12:24

0

Zowel onderzoek op gebied van kraakbeenherstel (GLPG1972) als pijnbestrijding (GlPG3535).

Galapagos benadert beide onderzoeksmethoden aangaande Artrose-behandeling.

The R&D machine van Galapagos = garantie op succes.

Lingus 28 juli 2017 12:35

0

Artrose is de meest voorkomende chronische gewrichtsziekte. 1,1 miljoen mensen in Nederland hebben er last van.
Bron: www.reumafonds.nl/informatie-voor-doe...

1,1 miljoen, alleen al in Nederland. Stel je eens voor dat daar een goede pijnmedicatie voor komt. En dat de leverancier Galapagos heet.

Endless 28 juli 2017 12:44

1

quote:
Guus Gelijk schreef op 28 juli 2017 12:35:
Artrose is de meest voorkomende chronische gewrichtsziekte. 1,1 miljoen mensen in Nederland hebben er last van.
Bron: www.reumafonds.nl/informatie-voor-doe...

1,1 miljoen, alleen al in Nederland. Stel je eens voor dat daar een goede pijnmedicatie voor komt. En dat de leverancier Galapagos heet.

Klopt en denk dat de markt nog groter is ik en in mijn omgeving hebben artrose en dat staat nergens gesignaleerd dus ik denk dat deze markt veel groter is. behalve pijnstilling in mijn geval paracetamol is er niets wat goed werkt. De enigste optie voor mij en velen is operatie maar daar ben ik te jong voor om dat een alternatief te vinden .
Mocht er dus een goed medicijn cq pijnstiller of wat dan ook ben ik de eerste klant die dit wil innemen want de pijn verziekt je leven behoorlijk

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