Novel targets, better treatments - Jefferies Healthcare Conference London| November 2019
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Novel targets, better treatments Jefferies Healthcare Conference London| November 2019
Disclaimer This presentation contains forward-looking statements, including (without limitation) statements concerning the progress of our clinical pipeline, the statements regarding the global R&D collaboration with Gilead, the amount and timing of potential future milestone, opt-in and/or royalty payments by Gilead, the slides captioned “’4059 in diabetic monkeys” “Dual activity confirmed in colon tissue” “Efficacy in arthritis models with ‘3970” “Activity across generations & indications” “Broad indication exploration with ‘3970” “Expand our target & drug workplace” “Novel targets: next step” “Drug modalities – current and future” “Additional targets to be explored” “Filgotinib program” “Global inflammation market $65B by 2027” “ISABELA timeline” “In full launch mode with filgotinib” two slides titled “Growing geographic footprint” “Bringing our innovation to patients” “Looking forward to a newsflow rich 2020” “Pioneering for patients,” all slides pertaining to the collaboration with Gilead announced on 14 July 2019, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in RA, IBD, and other potential indications (ii) with GLPG1690 and GLPG1205 in IPF and Ssc, (iii) with the Toledo program, (iv) with GLPG1972 in OA, and expectations regarding the commercial potential of our product candidates. When used in this presentation, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “will,” “plan,” “potential,” “possible,” “predict,” “objective,” “should,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements (including that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons), reliance on third parties (including Galapagos’ collaboration partners Gilead, Servier, MorphoSys, and Novartis) and estimating the commercial potential of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Galapagos’ Securities and Exchange Commission (“SEC”) filing and reports, including Galapagos’ most recent Form 20-F and subsequent filings with the SEC. Given these uncertainties, you are advised not to place any undue reliance on such forward-looking statements. All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any statement in this document to reflect any change in future development with respect thereto, any future results, or any change in events, conditions and/or circumstances, on which any statement is based, unless specifically required by law or regulation. Under no circumstances may any copy of this presentation, if obtained, be retained, copied, or transmitted.
Galapagos in a nutshell
FAST FACTS SITES DIVERSITY
Founded
in 1999 910 EMPLOYEES
Headquarters
Mechelen, Belgium
Galapagos R&D R&D
750
Belgium, The Netherlands, 41% 59%
France, Switzerland, USA
Service Operation Fidelta
Zagreb, Croatia
Note: All values as per 30-06-2019
Historic strategic alliance deal
Gilead-Galapagos collaboration
Unique deal in life sciences, with independence anchored
10 Year $3.95 B $1.5 B 20+%
Collaboration upfront equity investment Royalties
& standstill plus opt-in fees Galapagos retains full
& milestones European rightsReady for the future • Independence anchored • ~6 billion cash in the bank • Full European rights* • Ex-Europe royalties 20+% * Except for GLPG1972
We discover novel targets
balanced unbalancedProlific late stage pipeline
Area Preclinical Phase 1 Phase 2 Phase 3
Filgotinib Programs in filing, Ph3 and Ph2
IPF/Fibrosis In Ph3 and Ph2
OA In Ph2b
Inflammation >20
Fibrosis programs
>40 clinical trials planned in 2019Filgotinib Pipeline in a product opportunity
Filgotinib program
MAA filed
NDA H2 ‘19 Ph3
topline
Q2 ‘20 Ph3
recruiting
Ph3
Phase 3 initiating
Ph3
preparing
Phase 2
RA UC CD PsA AS OtherGlobal inflammation market $65B by 2027
estimated market size, $B
UC AS
~8 ~6
PsA
~9
CD
~16
RA
~26
Indications beyond RA 60% of future market
Source: Galapagos estimates, Decision Resources GroupPh3 in RA: FINCH summary up to W24
Dose-dependent efficacy data on clinically meaningful endpoints
• ACR50/70
• DAS remission
• radiographic progression
Safety data
• very low rates of serious infection, DVT/PE, MACE, death
• normalizing of abnormalities associated with RA (Hb, platelets)
• higher % change in HDL vs LDL
No dose-dependent difference on safety data
Supports best-in-class potential in RA
Note: Filgotinib is a compound in development by Gilead and Galapagos. The summary above was derived from the filgotinib FINCH trial data up to week 24 (Gilead and
Galapagos press releases dated 29 March 2019). Data from the FINCH 1 and FINCH 3 trials will be presented at EULAR 2019.Filgotinib’s JAK1 inhibition is sufficient to
address inflammation
Active in MTX- Treatment Clinical
naïve to effect of benefits seen
bDMARD-IR 200mg early
patients maintained
(156 wks)…without liabilities of off-target effects
FINCH program
up to wk24
adalimumab filgotinib
PBO/MTX
40mg EOW total
No. (%)
N=1039 N=325 N=2088
serious
infection
10 (1.0) 8 (2.5) 29 (1.4)
herpes
zoster
4 (0.4) 2 (0.6) 12 (0.6)
DVT/PE 3 (0.3) 0 (0) 1 (EU5: JAKi’s growing in RA
3%
JAKi’s EU5
16%
97% biologics 84%
Q3 ‘17 Q1 ‘19
Source: Gilead and Galapagos analysis on IPSOS data, share of prescriptionsEU5: JAK patients from biologic naïve
EU5
Bio-naïve Bio-IR
Q1 ’18 44% 56%
Q1 ’19 57% 43%
Source: Therapy watch Q1’19GLPG1690 For idiopathic pulmonary fibrosis (IPF) Progressive lung fibrosis leading to death • 200k cases in US & EU • 75k new cases every year • Median survival 2-5 years
We are building a fibrosis portfolio
program discovery preclinical Ph1 Ph2 Ph3
‘1690 (autotaxin) ISABELA IPF
‘1205 (GPR84) PINTA IPF
New IPF programs
Status end ‘18 • Opportunity to combine
Status end ’19 (projected) • Several fibrosis programs in discoveryPositive ‘1690 data in patients Flora
Placebo ‘1690 600mg QD
*= pISABELA participating countries * As on Nov 8, 2019
ISABELA
Timeline
Nov 2019 Q1 2021
500 patients futility topline
randomized outcome data
2019 2020 2021 2022 2023ISABELA, innovative program in IPF
Controlled data on
Largest IPF
medically-relevant, hard
program thus far
endpoints like changes in FVC,
mortality rates, respiratory-
related hospitalizations and PROs
Assesses efficacy & safety
in real world setting Large safety dataset
in 1500 patients
over 52 weeks or longerToledo in inflammation • novel, undisclosed target • dual action on inflammation • IBD models show strong activity • Ph1 started with ‘3312 & ‘3970
Promising preclinical results with ‘3312
DSS model T-cell transfer model MDR1 model
disease activity index
(AUC)
*** *
***
*** ***
*** *** ***
***
diseased Toledo diseased Toledo diseased Toledo
healthy int. control healthy IL-12p40 Ab healthy abatacept
*p < 0.05; ***p < 0.001
Impressive activity of Toledo in 3 IBD models with different mechanismsEfficacy in arthritis models with ‘3970
CIA model PsA model
clinical score AUC (D32-D47)
IL-23-induced
clinical score AUC (D7-D44)
*** ***
***p < 0.001 ***p < 0.001
diseased ‘3970 diseased ‘3970
Robust efficacy demonstrated across preclinical models of arthritis with 2nd gen Toledo
Source: internal data on fileTOLEDO’s expanding family
Different selectivity profiles
TOL1
• ‘3312 pan-TOL
• ‘3970 TOL2 & TOL3 selective
TOL2 ‘3312
Third candidate nominated
• ‘4399 TOL3 selective
‘3970 TOL3 ‘4399Activity across generations & indications
IBD RA Pso PsA SLE OA OP Fib
PanTOL ‘3312
TOL2/3 ‘3970 2020
TOL3 ‘4399 2020 2020 2020
4th gen LO 2020
5th gen LO 2020
• On track to develop multiple candidates across different selectivity profiles
• Robust activity in broad panel of in vivo disease models
• Plan multiple PoC’s with ‘3970 in patients in 2020
Green: activity; Salmon: insufficient activityOutlook
Going forward Build commercial infrastructure EU • Big5 + Benelux for filgotinib • Whole of Europe for others Progress pipeline Expand organization • Double R&D • Grow support departments • Expand facilities
Growing geographic footprint
Building out a European commercial presence
2020-2021
• Benelux
• France, Italy, Spain
• UK, Germany UK
GermanyGrowing geographic footprint
Building out a European commercial presence
2020-2021
• Benelux
• France, Italy, Spain
• UK, Germany
Europe
2022-2023
• Roll out in rest of Europe
• Future productsPioneering for patients We are pioneering for patients. Exploring new frontiers to improve people’s lives. We discover. We dare. We care.
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