Diurnal Limited is pleased to announce that it is a major partner in the collaborative research program - Treatment of Adrenal Insufficiency in Neonates (TAIN) - that for the first time will create a regulatory approved paediatric version of hydrocortisone specifically for neonates and infants who suffer from the rare disease adrenal insufficiency. Children who suffer from adrenal insufficiency cannot produce adequate amounts of the essential stress hormone cortisol and need to administer hydrocortisone as a replacement. The problem of effective hydrocortisone replacement is especially acute in this paediatric setting where no licensed therapies exist.
TAIN is a collaborative project that involves European leaders in drug development, neonatology and paediatric pharmacology who will work together to create, develop and trial a new formulation of hydrocortisone - Infacort®. This grouping of partners has a strong SME focus enabling these innovative organisations to rapidly bring new pharmaceutical products to market in niche therapeutic areas. Under a Paediatric Investigation Plan, clinical trials will be carried out to provide sufficient evidence of safety and efficacy for Infacort® to allow submission of a Paediatric Use Medicines Authorisation (PUMA) to the European Medicines Agency by the end of 2015 and its subsequent use in patients.
Melanie Goward, Finance Wales stated
"We are delighted that Diurnal and its partners, with support from the Welsh Assembly Government, have been awarded this important grant that will complement and build on Diurnal's expertise in the adult hydrocortisone replacement field"
Peter Grant, Fusion IP added
"This is a prestigious award for Diurnal who will be taking a leading role in this project. With potentially over €1.6M in EU contribution being allocated to Diurnal over the timeframe of the project, successful completion of the TAIN project will highlight Diurnal's capabilities in orphan drug development"
About the TAIN project
The TAIN Project is funded by the Seventh Framework Programme (CORDIS FP7) of the European Commission, HEALTH
Call Identifier: FP7-HEALTH-2011-Single Stage-4.2-1
Project Identifier: 281654
Start date: 01/12/2011
End date: 31/11/2015
Project cost: €5.56 million
EU contribution: €4.20 million
Coordinator: Dr Martin Whitaker (The University of Sheffield, UK)
Diurnal Limited, United Kingdom
SimCyp Limited, United Kingdom
The University of Sheffield, United Kingdom
Glatt GmbH, Germany
ADD Advanced Drug Delivery Technologies, Switzerland
Charité, Universitätsmedizin Berlin, Germany
For further information and contact details see: www.tain-project.org