Alkindi® granted Orphan Drug Designation in Australia and grant of second Alkindi® patent in Australia
Significant opportunity to address unmet medical need in paediatric adrenal insufficiency in Australia
Highlights progress in the Group’s approach of seeking approval for Alkindi® outside core territories
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that Alkindi® (hydrocortisone granules in capsules for opening) has been granted Orphan Drug Designation in Australia by the Therapeutic Goods Administration (TGA) for the indication “replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to <18 years old)”. Orphan Drug Designation in Australia provides significant benefits, including waiver of application, evaluation and annual registration fees.
Separately, Diurnal announces the grant of its second patent for Alkindi® in Australia, No: 2014267041 entitled “Composition Comprising Hydrocortisone”, a pharmaceutical composition-of-matter patent protecting Alkindi®’s proprietary formulation as a treatment for all forms of AI, and is in addition to the already granted patent, No: 2012338583 entitled “Pharmaceutical Composition for treatment of Adrenal Insufficiency”. These patents afford in-market protection until 2034, providing a long and robust exclusivity position in Australia for Alkindi®.
Diurnal’s marketing and distribution partner in Australia and New Zealand for Alkindi® and its second product, Chronocort® (modified release hydrocortisone), Emerge Health Pty Limited, is currently pursuing registration for Alkindi® in these markets. Australia and New Zealand represent significant market opportunities for Diurnal, with around 1,750 patients in these territories suffering from paediatric AI and the genetic condition congenital adrenal hyperplasia (CAH), providing an estimated total market opportunity for Alkindi® and Chronocort® of approximately $10 million per annum (USD).
Alkindi® is already approved and marketed in Europe and is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related condition CAH.
Martin Whitaker, Chief Executive Officer of Diurnal, added:
“We are pleased to have obtained Orphan Drug Designation for Alkindi® in Australia, highlighting the importance of this product as the first specifically developed and licensed replacement therapy of paediatric adrenal insufficiency designed to address the unmet need in these young patients. This continued progress exemplifies Diurnal’s ambition to build our marketing and distribution capabilities in high value markets outside our core territories.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please visit www.diurnal.co.uk or contact:
Diurnal Group plc +44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns
Cantor Fitzgerald Europe (Joint Broker) +44 (0) 20 7894 7000
Corporate Finance: Phil Davies, Will Goode, Michael Boot
Healthcare Equity Sales: Andrew Keith
FTI Consulting +44 (0)20 3727 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Alkindi® (hydrocortisone granules in capsules for opening)
Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and congenital adrenal hyperplasia (CAH). 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 Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe.
About Paediatric Adrenal Insufficiency
Paediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone).
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
About Emerge Health
Emerge Health Pty Limited is an innovative, specialised Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. Emerge Health is dedicated to providing exceptional products and support to ensure it meets its customers and partners needs and priorities.
For more information, please visit http://www.emergehealth.com.au
Date of Preparation: April 2019 Code: Inf EU-AUS-000