Objective
Only for Children Pharmaceuticals, a French based Small and Medium-sized Enterprise (SME) developing drug for children, is the Coordinator of a multinational, multidisciplinary and complementary Consortium. This Consortium is composed of highly qualified organizations and notorious clinicians in pediatric hemato-oncology. The Consortium is an integrated team of competencies (clinicians, pædiatricians, pharmacokineticists, pharmacists, manufacturers, engineers, regulatory and ethical experts) capable of executing a pædiatric drug development from its designing to market. The Consortium will perform the non-clinical development of Methotrexate (MTX) and the non-clinical and clinical development of 6-Mercaptopurine (6MP) oral liquid formulations adapted for maintenance treatment of pediatric acute lymphoblastic leukemia with the crucial objective to make available these adapted formulation by 2012 at the latest. Methotrexate and 6-mercaptopurine are on the EMEA Priority list of off-patent medicinal products of paediatric working party of the European medicine agency - June 2007. On September 2007, EMEA’s COMP Committee has granted the orphan status to Methotrexate (oral liquid) and 6-mercaptopurine (oral liquid).
Fields of science
Topic(s)
Call for proposal
FP7-HEALTH-2007-B
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Funding Scheme
CP-FP - Small or medium-scale focused research projectCoordinator
75005 Paris
France
Participants (11)
75000 Paris
3400 Hillerod
27570 Tillières Sur Avre
40225 Dusseldorf
75008 Paris
Participation ended
Co Tipperary
Paris
69002 Lyon
24118 Kiel
44093 Nantes
59037 Lille