20th June 2013

Fusion Portfolio Company – Diurnal announces European Medicine Agency Approval

Diurnal announces European Medicines Agency approval of Paediatric Investigation Plan

Fusion IP (AIM: FIP), the university commercialisation company that turns world-class research into business, is pleased to announce that its portfolio company, Diurnal, a spin-out from the University of Sheffield, has received approval for a Paediatric Investigation Plan from the European Medicines Agency (EMA) for a new formulation of hydrocortisone – Infacort®.

Based in Cardiff, Diurnal is developing a novel approach to drug delivery that will help patients suffering from reduced levels of the key hormone cortisol (hydrocortisone). Its lead drug Chronocort® is currently in a Phase 2 study at the National Institute of Health (US). Chronocort® has already received two related Orphan Drug designations from the European Medicines Agency, which affords ten years of market exclusivity after the grant of marketing authorisation in Europe.

Chronocort, Diurnal’s most advanced product, has been developed to be used by adults (>18yr) suffering from cortisol deficiency, whilst Infacort® will be developed for the treatment of children under 6 years old suffering a similar inability to produce cortisol.

The problem of effective hydrocortisone replacement is especially acute in this paediatric setting where no licensed therapies exist. Under the 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.

Infacort® is being developed by Diurnal and its partners under the EU collaborative research programme – “Treatment of Adrenal Insufficiency in Neonates (TAIN)”. The programme will, for the first time, create a regulatory-approved paediatric version of hydrocortisone.

Fusion owns a 43% shareholding in Diurnal.

Peter Grant, Operations Director of Fusion IP, commented:

“This is a major regulatory hurdle that has been successful overcome by Diurnal and the TAIN Consortium. Infacort® now has a clear route to obtaining market authorisation in Europe.”