DNL.L Regulatory News (DNL)

16 November 2021

Diurnal Group plc

("Diurnal" or the "Company")

Alkindi® approved by Swissmedic for use in Switzerland

Market launch by EffRx Pharmaceuticals expected during H1 2022 to address unmet need in paediatric AI

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 Swissmedic, the national authorisation and supervisory authority for drugs and medical products in Switzerland, as a replacement therapy of adrenal insufficiency (AI) for infants, children and adolescents (from birth to ® in Switzerland during H1 2022.

The MAA approval of Alkindi® in Switzerland is based on the European regulatory dossier and previously published clinical trial data. There are approximately 200 patients in Switzerland suffering from paediatric AI, providing an estimated total market opportunity for Alkindi® of approximately $1 million per annum. As previously announced, under the terms of the agreement, EffRx has the exclusive rights to market Alkindi® in Switzerland. In line with the Company's other distribution agreements, EffRx will be provided Alkindi® for sale from Diurnal's established European supply chain.

The EffRx agreement forms part of the Company's ongoing strategy for commercialisation of its lead products by optimising market access outside of key European markets through entering marketing and distribution agreements with companies focused on niche and orphan conditions. This latest approval further extends the rollout of Alkindi® across the globe, which is already approved in the UK, European Union, Israel, Australia, and the US (where it is known as Alkindi Sprinkle®). Alkindi® is the first licensed preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related condition congenital adrenal hyperplasia (CAH).

Martin Whitaker, Chief Executive Officer of Diurnal, commented: 

"We are delighted that Alkindi® has been approved for use in children and adolescents in Switzerland suffering from AI. This approval is further validation of the quality of our products and is in line with the Company's global commercial strategy to enable access to our products outside of core markets. We look forward to working with EffRx to make Alkindi® available to patients in Switzerland suffering from paediatric AI where there is a significant unmet need."

This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

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), including congenital adrenal hyperplasia (CAH). 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 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 ® is approved and known as Alkindi® Sprinkle in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel and Australia.

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

Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. 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 EffRx Pharmaceuticals

EffRx Pharmaceuticals is a commercial-stage pharmaceutical company focused on the late stage development and commercialisation of prescription medications for niche and orphan indications. The business model is centred around providing superior clinical and commercial value propositions for physicians, payers and patients. EffRx pro-actively seeks in-licensing opportunities for Europe in niche therapeutic areas, with a primary interest for rare diseases, where EffRx has received an orphan drug designation (ODD) from the FDA for a pipeline asset.

For further information about EffRx Pharmaceuticals, please visit www.effrx.com

Date of Preparation: November 2021 Code: CORP-GB-0163