Development of 6-mercaptopurine and Methotrexate oral liquid formulations for the maintenance treatment of Acute Lymphoblastic Leukæmia in children

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).

Field of science

• /medical and health sciences/clinical medicine/oncology/leukemia

Programme(s)

• FP7-HEALTH - Specific Programme "Cooperation": Health

Topic(s)

• HEALTH-2007-4.2-1 - Adapting off-patent medicines to the specific needs of paediatric populations

Call for proposal

FP7-HEALTH-2007-B
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Funding Scheme

Coordinator

Participants (11)