Alkindi® approved in Australia

Expansion of market opportunity for Diurnal’s overall adrenal insufficiency franchise

Further delivers on strategy for optimising market access outside of Europe and US

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 approved by the Australian Therapeutic Goods Administration (TGA) as a “Replacement therapy of adrenal insufficiency” (AI), with no age restriction. Diurnal anticipates the first sales in Australia will be in H2 2021 following completion of pricing and market access activities.

In Australia and New Zealand, Diurnal is partnered with Emerge Health (recently acquired by Chiesi Farmaceutici, a privately owned Italian pharmaceutical company with a broad global footprint) to pursue market and distribution efforts for Alkindi® and Chronocort® (modified release hydrocortisone), the Company’s second product in development for adults with diseases of cortisol deficiency. Together, these territories represent a significant market opportunity, with around 1,750 patients suffering from paediatric AI and the related condition Congenital Adrenal Hyperplasia (CAH), providing an estimated total market opportunity for Alkindi® and Chronocort® of approximately $10 million per annum (USD). In Australia, Alkindi® has been granted Orphan Drug Designation, thereby providing significant regulatory benefits, including waiver of application and evaluation fees. Following this approval of Alkindi® in Australia, Emerge Health will now pursue approval of Alkindi® in New Zealand.

Diurnal submitted its Marketing Authorisation Application (MAA) dossier for Chronocort® to the European Medicines Agency (EMA) in December 2019. Assuming the EMA approves Chronocort® as expected by Diurnal in Q1 2021, Emerge Health will then utilise the European dossier to submit Chronocort® for regulatory approval in Australia and New Zealand.

Martin Whitaker, CEO of Diurnal, commented:

"We are delighted to have received approval for Alkindi® in Australia, following on from our recent approval in Israel. I would like to thank Emerge Health for their efforts in obtaining this approval and we look forward to continuing to strengthen our partnership through the commercialisation of Alkindi® in Australia. The Alkindi® approval further validates the quality of our products and, in line with our vision of becoming a world-leading endocrinology company, enables us to provide Alkindi® to patients outside of our core territories of Europe and the US.”

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

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.

Alkindi® is also approved in Israel.

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 Chronocort®

Chronocort® is a modified release preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first planned indication for Chronocort® is currently under review by the EMA. Chronocort® has been extensively studied in human subjects having completed four Phase I trials, a Phase II trial in 16 CAH patients in the US in 2014, and a Phase III trial in 122 CAH patients in Europe and the US.

About Congenital Adrenal Hyperplasia

Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis.

Current therapy for CAH uses a variety of generic steroids (hydrocortisone, dexamethasone and prednisolone) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, 17,000 in the US, with over 400,000 in the rest of the world.

About Diurnal Group plc

Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing pharmaceutical 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 further information about Emerge Health, please visit www.emergehealth.com.au   

Date of Preparation: August 2020            Code: CORP-GB-0064