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Fusion IP PLC (FIP)

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Thursday 20 June, 2013

Fusion IP PLC

Diurnal: Approval of Paediatric Investigation Plan

RNS Number : 4377H
Fusion IP PLC
20 June 2013

20 June 2013



("Fusion" or the "Company")

Fusion portfolio company, 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."







For further information please contact:

Fusion IP

     +44 (0) 114 275 5555

David Baynes, CEO

Stuart Gall, Press Relations



Cenkos Securities plc                                                                                                     +44 (0) 20 7397 8900

Elizabeth Bowman, Bobbie Hilliam (Corporate Finance)

Julian Morse (Sales)      


Media enquiries:


Allerton Communications                                                                                              +44 (0) 20 3137 2500


Peter Curtain



About Fusion IP

Fusion IP plc (Fusion) was established in 2002 to commercialise university-generated intellectual property. It has long-term exclusive agreements with two of the UK's leading research-intensive universities, the University of Sheffield and Cardiff University, giving it exclusive access to all the IP generated by their research departments. These exclusive agreements enable Fusion to identify world class IP and turn it into a commercial opportunity, either through the creation of a start-up company or a licence.

Fusion IP currently owns shareholdings in over 20 portfolio companies, including significant shareholdings in Seren, Magnomatics, Phase Focus, MedaPhor, Asalus and Diurnal.

In 2012 Fusion IP announced its first major exit, when it sold its portfolio company Simcyp, a research-based business providing a modelling and simulation platform for predicting the fate of drugs in virtual populations, to US based Certara LP for $32 million, a 200-fold return on its original investment.

In March 2013 Fusion announced that it had raised £20 million through a Placing to existing and new institutional shareholders. Fusion also announced that it had signed agreements with two additional universities - the University of Nottingham and Swansea University.

For more information, visit


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: 


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