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Liver Investigation: Testing Marker Utility in Steatohepatitis

Objective

Strongly associated with the epidemics of obesity and type 2 diabetes that are testing healthcare systems worldwide, Non-Alcoholic Fatty Liver Disease (NAFLD) is an increasingly common cause of advanced liver disease that is characterized by substantial inter-patient variability in severity and rate of progression. It is currently assessed by liver biopsy, an invasive, costly and risky procedure. The lack of noninvasive biomarkers has hampered patient care and impeded drug development by complicating conduct of clinical trials.The overarching aim of LITMUS is to develop, robustly validate and advance towards regulatory qualification biomarkers that diagnose, risk stratify and/or monitor NAFLD/NASH progression and fibrosis stage. This will be achieved through a goal-oriented, tri-partite collaboration delivering a definitive and impartial evaluation platform for biomarkers, bringing together: (i) End-users of biomarker technologies (clinicians with expertise in NAFLD and the pharmaceutical industry)? (ii) Independent academics with expertise in the evaluation of medical test/biomarker performance? and (iii) Biomarker researchers and developers (academic or commercial).

LITMUS has the demonstrable capability to fulfil the IMI call remit. Built upon foundations laid by the EU-funded FLIP/EPoS projects and long-established, successful scientific collaborations amongst many of Europe’s leading clinical-academic centres, LITMUS is at a unique advantage due to its existing large-scale patient cohorts, bioresources and multi-omics datasets. Consortium members are internationally recognised experts with substantial relevant expertise supporting the program’s clear focus on biomarker identification, validation and accelerating EMA/FDA qualification. Thus, LITMUS is powered to provide clarity on biomarker validity for NAFLD at scale and pace: supporting drug development and the targeting of medical care and limited healthcare resources to those at greatest need.

Coordinator

UNIVERSITY OF NEWCASTLE UPON TYNE
Net EU contribution
€ 2 990 166,39
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne
United Kingdom

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Region
North East (England) Northumberland and Tyne and Wear Tyneside
Activity type
Higher or Secondary Education Establishments
Other funding
€ 4 507 351,12

Participants (59)

ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
Net EU contribution
€ 1 180 910,00
Address
Meibergdreef 15
1105AZ Amsterdam

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Region
West-Nederland Noord-Holland Groot-Amsterdam
Activity type
Higher or Secondary Education Establishments
Other funding
€ 275 500,00
INST CARDIOMETABOLISME NUTRITION ICAN
France
Net EU contribution
€ 536 718,75
Address
Boulevard De L'hopital 47-83
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 100 000,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

SORBONNE UNIVERSITE
France
Net EU contribution
€ 85 031,25
Address
21 Rue De L'ecole De Medecine
75006 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 323 000,00
Address
55 Boulevard Diderot
75012 Paris

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Region
Ile-de-France Ile-de-France Val-de-Marne
Activity type
Research Organisations
Other funding
€ 0,00
UNIVERSITAETSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITAET MAINZ
Germany
Net EU contribution
€ 1 073 015,00
Address
Langenbeckstrasse 1
55131 Mainz

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Region
Rheinland-Pfalz Rheinhessen-Pfalz Mainz, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 450 000,00
THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE
United Kingdom
Net EU contribution
€ 598 005,00
Address
Trinity Lane The Old Schools
CB2 1TN Cambridge

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Region
East of England East Anglia Cambridgeshire CC
Activity type
Higher or Secondary Education Establishments
Other funding
€ 275 000,00
OREBRO UNIVERSITY
Sweden
Net EU contribution
€ 312 500,00
Address
Fakultetsgatan 1
70182 Orebro

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Region
Östra Sverige Östra Mellansverige Örebro län
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ASOCIACION CENTRO DE INVESTIGACION COOPERATIVA EN BIOCIENCIAS
Spain
Net EU contribution
€ 403 017,50
Address
Parque Tecnologico Edificio 801 A
48160 Derio Vizcaya

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Region
Noreste País Vasco Bizkaia
Activity type
Research Organisations
Other funding
€ 0,00
UNIVERSITAET BERN
Switzerland
Net EU contribution
€ 435 000,00
Address
Hochschulstrasse 6
3012 Bern

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Region
Schweiz/Suisse/Svizzera Espace Mittelland Bern / Berne
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Net EU contribution
€ 1 811 250,00
Address
Wellington Square University Offices
OX1 2JD Oxford

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Other funding
€ 170 000,00
PERSPECTUM LTD
United Kingdom
Net EU contribution
€ 257 500,00
Address
Gemini One, 5520 John Smith Drive Oxford Business Park South
OX4 2LL Oxford

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
SERVICIO ANDALUZ DE SALUD
Spain
Net EU contribution
€ 601 250,00
Address
Avenida De La Constitucion 18
41071 Sevilla

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Region
Andalucía Sevilla
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 56 000,00
NORDIC BIOSCIENCE A/S
Denmark
Net EU contribution
€ 1 427 093,00
Address
Herlev Hovedgade 205-207
2730 Herlev

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Danmark Hovedstaden Københavns omegn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 113 295,75
LUXEMBOURG INSTITUTE OF HEALTH
Luxembourg
Net EU contribution
€ 540 033,75
Address
1a Rue Rue Thomas Edison
1445 Strassen

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Region
Luxembourg Luxembourg Luxembourg
Activity type
Research Organisations
Other funding
€ 627 500,00
UNIVERSITA DEGLI STUDI DI TORINO
Italy
Net EU contribution
€ 330 239,50
Address
Via Giuseppe Verdi 8
10124 Torino

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Region
Nord-Ovest Piemonte Torino
Activity type
Higher or Secondary Education Establishments
Other funding
€ 205 000,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITA DEGLI STUDI DI FIRENZE
Italy
Net EU contribution
€ 13 882,50
Address
Piazza San Marco 4
50121 Florence

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Region
Centro (IT) Toscana Firenze
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

CONSIGLIO NAZIONALE DELLE RICERCHE
Italy
Net EU contribution
€ 21 038,75
Address
Piazzale Aldo Moro 7
00185 Roma

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Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Other funding
€ 10 000,00
UNIVERSITE D'ANGERS
France
Net EU contribution
€ 122 500,00
Address
Rue De Rennes 40
49035 Angers Cedex 01

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Region
Pays de la Loire Pays de la Loire Maine-et-Loire
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAIR ZIEKENHUIS ANTWERPEN
Belgium
Net EU contribution
€ 167 100,00
Address
Drie Eikenstraat 655
2650 Edegem

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Region
Vlaams Gewest Prov. Antwerpen Arr. Antwerpen
Activity type
Research Organisations
Other funding
€ 0,00
LINKOPINGS UNIVERSITET
Sweden
Net EU contribution
€ 99 600,00
Address
Campus Valla
581 83 Linkoping

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Region
Östra Sverige Östra Mellansverige Östergötlands län
Activity type
Higher or Secondary Education Establishments
Other funding
€ 56 000,00
HELSINGIN YLIOPISTO
Finland
Net EU contribution
€ 202 500,00
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto

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Region
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
Net EU contribution
€ 273 328,75
Address
Heidelberglaan 100
3584 CX Utrecht

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
Net EU contribution
€ 118 350,00
Address
6 Christou Lada Str
10561 Athina

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Region
Κεντρικός Τομέας Αθηνών Aττική Αττική
Activity type
Higher or Secondary Education Establishments
Other funding
€ 20 000,00
FACULDADE DE MEDICINA DA UNIVERSIDADE DE LISBOA
Portugal
Net EU contribution
€ 78 487,50
Address
Avenida Professor Egas Moniz, Edificio Hospital Santa Maria
1649-028 Lisboa

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Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITA DEGLI STUDI DI MILANO
Italy
Net EU contribution
€ 80 722,50
Address
Via Festa Del Perdono 7
20122 Milano

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Region
Nord-Ovest Lombardia Milano
Activity type
Higher or Secondary Education Establishments
Other funding
€ 10 000,00
UNIVERSITA DEGLI STUDI DI PALERMO
Italy
Net EU contribution
€ 105 081,25
Address
Piazza Marina 61
90133 Palermo

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Region
Isole Sicilia Palermo
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITA CATTOLICA DEL SACRO CUORE
Italy
Net EU contribution
€ 80 653,75
Address
Largo Gemelli 1
20123 Milano

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Region
Nord-Ovest Lombardia Milano
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT
Germany
Net EU contribution
€ 406 206,25
Address
Josef-schneider-strasse 2
97080 Wurzburg

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Region
Bayern Unterfranken Würzburg, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAETSKLINIKUM AACHEN
Germany
Net EU contribution
€ 248 076,25
Address
Pauwelsstrasse 30
52074 Aachen

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Region
Nordrhein-Westfalen Köln Städteregion Aachen
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
THE UNIVERSITY OF NOTTINGHAM
United Kingdom
Net EU contribution
€ 118 115,00
Address
University Park
NG7 2RD Nottingham

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Region
East Midlands (England) Derbyshire and Nottinghamshire Nottingham
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
MEDIZINISCHE UNIVERSITAET WIEN

Participation ended

Austria
Net EU contribution
€ 1 944,86
Address
Spitalgasse 23
1090 Wien
Region
Wien Wien
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ANTAROS MEDICAL AB
Sweden
Net EU contribution
€ 231 275,00
Address
Bioventure Hub Pepparedsleden 1
431 83 Molndal

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Södra Sverige Västsverige Västra Götalands län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 207 975,00
THE UNIVERSITY OF BIRMINGHAM
United Kingdom
Net EU contribution
€ 61 263,75
Address
Edgbaston
B15 2TT Birmingham

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Region
West Midlands (England) West Midlands Birmingham
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
IXSCIENT LIMITED
United Kingdom
Net EU contribution
€ 344 375,00
Address
Popes Grove 76
TW1 4JX Twickenham Middlesex

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
London Outer London — West and North West Hounslow and Richmond upon Thames
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 222 000,01
Faculdade de Farmácia da Universidade de Lisboa
Portugal
Net EU contribution
€ 56 968,75
Address
Av. Prof. Gama Pinto
1649-003 Lisboa

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Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER
Switzerland
Net EU contribution
€ 61 680,00
Address
Rue Daubin 7
1203 Geneve

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Region
Schweiz/Suisse/Svizzera Région lémanique Genève
Activity type
Other
Other funding
€ 0,00
GENFIT
France
Net EU contribution
€ 0,00
Address
885 Avenue Eugene Avinee Parc Eurosante
59120 Loos

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Hauts-de-France Nord-Pas de Calais Nord
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 450 000,00
INTERCEPT PHARMA EUROPE LTD
United Kingdom
Net EU contribution
€ 0,00
Address
One, Glass Wharf
BS2 0ZX Bristol

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Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Bristol, City of
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 426 000,00
ONE WAY LIVER SL
Spain
Net EU contribution
€ 1,00
Address
Parque Tecnologico De Bizkaia Edif 502
48160 Derio Bizkaia

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Noreste País Vasco Bizkaia
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 302 552,75
EXALENZ BIOSCIENCE LTD

Participation ended

Israel
Net EU contribution
€ 0,00
Address
4 Ha'maayan Str
7177872 Modiin
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 2 500,00
ELI LILLY AND COMPANY LTD
United Kingdom
Net EU contribution
€ 0,00
Address
Lilly House Basingview
RG21 4FA Basingstoke

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Region
South East (England) Hampshire and Isle of Wight North Hampshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 925 000,00
PFIZER LIMITED
United Kingdom
Net EU contribution
€ 0,00
Address
Ramsgate Road
CT13 9NJ Sandwich

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Region
South East (England) Kent East Kent
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 100 000,00
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
Net EU contribution
€ 0,00
Address
Binger Strasse
55218 Ingelheim

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 500 000,00
SOMALOGIC INC
United States
Net EU contribution
€ 0,00
Address
Wilderness Place 2945
80301 Boulder Colorado

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 600 000,00
NOVO NORDISK A/S
Denmark
Net EU contribution
€ 0,00
Address
Novo Alle 1
2880 Bagsvaerd

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Region
Danmark Hovedstaden Københavns omegn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 485 000,00
SANOFI-AVENTIS DEUTSCHLAND GMBH

Participation ended

Germany
Net EU contribution
€ 0,00
Address
Bruningstrasse 50
65929 Frankfurt Am Main
Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 013 000,00
ELLEGAARD GOTTINGEN MINIPIGS AS
Denmark
Net EU contribution
€ 0,00
Address
Soro Landevej 302 Hove
4261 Dalmose

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Danmark Sjælland Vest- og Sydsjælland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 996 213,00
NOVARTIS PHARMA AG
Switzerland
Net EU contribution
€ 0,00
Address
Lichtstrasse 35
4056 Basel

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 360 000,00
TAKEDA DEVELOPMENT CENTRE EUROPE LTD

Participation ended

United Kingdom
Net EU contribution
€ 0,00
Address
Aldwych 61
WC2B 4AE London
Region
London Inner London — West Westminster
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 96 841,83
ASTRAZENECA AB
Sweden
Net EU contribution
€ 0,00
Address
Vastra Maelarhamnen
151 85 Sodertaelje

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 5 976 150,00
ECHOSENS
France
Net EU contribution
€ 0,00
Address
Rue Ferrus 6
75014 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 2 474 625,00
RESOUNDANT, INC.
United States
Net EU contribution
€ 0,00
Address
421 1st Avenue Sw Ste 204w
55902 Rochester

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 787 500,00
BRISTOL-MYERS SQUIBB COMPANY CORP
United States
Net EU contribution
€ 0,00
Address
Park Avenue 345
10154 New York

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 600 000,00
HISTOINDEX PTE LTD
Singapore
Net EU contribution
€ 0,00
Address
79 Ayer Rajah Crescent 04-05 Jtc Launchpad
139955 Singapore

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 157 500,00
ALLERGAN LIMITED

Participation ended

United Kingdom
Net EU contribution
€ 0,00
Address
1st Floor Marlow International The Parkway
Marlow
Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Buckinghamshire CC
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 8 300,00
GILEAD SCIENCES INC
United States
Net EU contribution
€ 0,00
Address
Lakeside Drive 333
94404 Foster City Ca

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 246 875,00
RESEARCH TRIANGLE INSTITUTE
United States
Net EU contribution
€ 0,00
Other funding
€ 280 688,00
TAKEDA PHARMACEUTICALS INTERNATIONAL AG
Switzerland
Net EU contribution
€ 0,00
Address
Thurgauerstrasse 130
8152 Glattpark

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Region
Schweiz/Suisse/Svizzera Zürich Zürich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 364 158,17
ABBVIE INC
United States
Net EU contribution
€ 0,00
Address
North Waukegan Road 1
60064 North Chicago Il

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 25 000,00