Posted on Tuesday, 20/Dec/2016 Posted by michelle

European market authorisation anticipated in late 2017

First market authorisation submission by Diurnal

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the submission of a Paediatric Use Marketing Authorisation (PUMA) application for Infacort®to the European Medicines Agency (EMA). This application has completed the validation period and has been accepted for review by the EMA.

This submission follows the highly statistically significant data previously reported from the Company’s pivotal Phase III study for Infacort® in Europe for paediatric Adrenal Insufficiency (AI). The EMA has already approved a Paediatric Investigation Plan (PIP) for Infacort®, setting out the regulatory pathway to market authorisation via the PUMA route. If approved, Infacort® has the potential to be the first licensed treatment in Europe for AI (including the related condition Congenital Adrenal Hyperplasia (CAH)) specifically designed for use in children. As previously communicated, Diurnal anticipates market authorisation in late 2017, with product revenues expected from early 2018. The company estimates that the total market for paediatric AI and CAH in Europe is approximately $28 million per year. 

Dr Martin Whitaker, CEO of Diurnal, commented:

“I am delighted to report that our recently filed dossier with the EMA, seeking regulatory approval for Infacort®,has been validated and accepted for review by the EMA. This signals the commencement of their formal review cycle and we continue to anticipate Market Authorisation in late 2017. This is our first product candidate to be submitted for regulatory approval and marks another important milestone towards building a proprietary endocrinology franchise. If approved, Infacort® will be a major breakthrough in the treatment of paediatric adrenal insufficiency, a condition of high unmet medical need with no currently licensed products specifically for young children.”

For further information, please visit www.diurnal.co.uk or contact: 

Diurnal Group plc     
Martin Whitaker, CEO    
Ian Ardill, CFO    
Tel: +44 (0)20 3727 1000

Numis Securities Ltd (Nominated Adviser)    
Nominated Adviser: Michael Meade, Freddie Barnfield,  Paul Gillam    
Corporate Broking: James Black    
Tel: +44 (0)20 7260 1000    

FTI Consulting     
Simon Conway    
Victoria Foster Mitchell
Tel: +44 (0)20 3727 1000   

Notes to Editors

About Adrenal Insufficiency
Adrenal Insufficiency (AI) is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress.  AI has been identified as a rare disease in Europe where there are estimated to be approximately 4,000 sufferers younger than the age of six.  Currently there are no licensed hydrocortisone preparations in Europe specifically designed to treat these young patients.  These children are often administered compounded adult tablets or other unlicensed products.  Poor control of disease can result in precocious puberty in young children, virilisation in girls and chronic fatigue leading to a poor quality of life in adulthood resulting in increased morbidity and mortality.

About Infacort®
Infacort® represents the first preparation of hydrocortisone specifically designed for use in children suffering from AI. It is a patented, immediate-release, oral, paediatric formulation of hydrocortisone that allows for age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than six year of age suffering from diseases due to cortisol deficiency including adrenal insufficiency and congenital adrenal hyperplasia. AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives. The European Medicines Agency has already approved a Paediatric Investigation Plan (EMEA-001283-PIP01-12) for Infacort®, which sets out the regulatory pathway to market authorisation via the Paediatric Use Marketing Authorisation (PUMA) route.

About Diurnal Group plc
Founded in 2004, Diurnal is a UK-based specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including Congenital Adrenal Hyperplasia and Adrenal Insufficiency. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.

For further information about Diurnal, please visit www.diurnal.co.uk