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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."

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 Sole Broker)	+44 (0)20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: James Stearns
FTI Consulting (Media and Investor Relations)	+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.