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Development of an innovative paediatric formulation of an antiepileptic agent for the treatment of absence epilepsy in children

Objectif

The KIEKIDS project is dedicated to the development of an innovative paediatric formulation of an antiepileptic agent for a safe alternative treatment of absence epilepsy in children.

Development of such an age-appropriate formulation is regarded by The European Medicines Agency (EMA) to be amongst one of highest priorities for the treatment of absence seizures, using a drug with identified and documented efficacy in the target population.

The KIEKIDS project has gathered a very strong consortium of well trained and qualified partners from industry, academy, and hospital with extensive experience in drug development in clinical, pharmacological, data analysis and regulatory areas. The proposed strategy for KIEKIDS implies to develop a dedicated paediatric formulation with sustained delivery and to conduct a clinical programme, which will be endorsed by approval of the Paediatric Investigation Plan (PIP).

The consortium is coordinated by the Unit 663 of INSERM (INSERM U663), a French public organisation of research devoted to the paediatric epilepsies and brain plasticity. This consortium rallies all the competencies required to manage a paediatric drug development from the designing of an adapted formulation up to market. With its solid track record of clinical success in pharmaceutical and biotech companies, and its huge expertise in absence epilepsy, this consortium will be able to avoid the pitfalls of pharmaceutical drug development and is in a strong position to guarantee the success of the programme.

The ultimate goal of KIEKIDS is to submit in 2015 this novel age-adapted paediatric formulation as a Paediatric-Use Marketing Authorisation, a PUMA, the tool identified by the EMA to bridge the gap for off-patent drugs.

Appel à propositions

FP7-HEALTH-2011-single-stage
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Coordinateur

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Adresse
Rue De Tolbiac 101
75654 Paris
France
Type d’activité
Research Organisations
Contribution de l’UE
€ 451 705
Contact administratif
Nicolas Jeanjean (Mr.)

Participants (3)

ADVICENNE SA
France
Contribution de l’UE
€ 1 127 100
Adresse
Rue Georges Besse 155
30000 Nimes Cedex 01
Type d’activité
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contact administratif
Caroline Roussel-Maupetit (Ms.)
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS
Suisse
Contribution de l’UE
€ 279 946
Adresse
Rue Du Bugnon 21
1011 Lausanne
Type d’activité
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Contact administratif
Thierry Buclin (Dr.)
CLINBAY SPRL
Belgique
Contribution de l’UE
€ 298 320
Adresse
Rue Bon Air 30
1470 Genappe
Type d’activité
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contact administratif
François Vandenhende (Dr.)