Company Announcements

20 April 2022

Diurnal Group plc

("Diurnal" or the "Company")

Distribution agreement signed with Er-Kim for Greece, Cyprus and Malta targeting a market opportunity of approximately €7m

Deepens existing distribution relationship with Er-Kim covering Alkindi^® and Efmody^®

In line with Company's strategy to commercialise products outside of key markets; Alkindi^® and Efmody^® now being commercialised in 20 countries in the European Union

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has extended its distribution agreement with Er-Kim to include the distribution and marketing of Alkindi^® (hydrocortisone granules in capsules for opening) and Efmody^® (hydrocortisone modified-release hard capsules) in Greece, Cyprus and Malta.

Under the terms of the agreement, Er-Kim will receive the exclusive rights to distribute and market Alkindi^® and Efmody^® in Greece, Cyprus and Malta. The Company estimates the combined market opportunity for these three countries to be approximately €7m in paediatric adrenal insufficiency (AI) and adult congenital adrenal hyperplasia (CAH). This latest agreement deepens the Company's existing relationship with Er-Kim, who also hold the rights to distribute and market Alkindi^® and Efmody^® in Turkey, Romania and Bulgaria.

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 CAH. This distribution agreement further extends the global rollout of Alkindi^®, which is already approved in the UK, the European Economic Area, Israel, Australia, Switzerland and the US (where it is known as Alkindi Sprinkle^®).

Efmody^® is a modified-release preparation of hydrocortisone that has been specifically designed for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes. In May 2021, Efmody^® was granted marketing authorisation in the European Union and was launched by the Company in Germany, Austria and the UK in September 2021.

In line with the Company's commercialisation strategy and other global distribution agreements, Diurnal will provide Alkindi^® and Efmody^® from its established European supply chain for sale by Er-Kim.

Richard Bungay, Interim Chief Executive Officer and Chief Financial Officer of Diurnal, commented:

"We are excited to strengthen our partnership with Er-Kim to now include Greece, Cyprus and Malta. Following this latest agreement with Er-Kim, we are pleased that the Company's commercial footprint now reaches 70% of the European Union population."

Cem Zorlular, Chairman and Chief Executive Officer of Er-Kim, commented:

"We are pleased to expand our collaboration with Diurnal after a year of working relentlessly to execute on our shared vision of addressing unmet rare endocrine conditions in Turkey, Romania and Bulgaria. We are very excited to have the opportunity to now provide market access to much needed paediatric and adult cortisol deficiency treatments in Greece, Malta, Cyprus."

This is a business press release and Regulatory News Service (RNS) announcement 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 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 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 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 approved and known as Alkindi Sprinkle^® in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi^® is also approved in Israel, Australia and Switzerland.

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 glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone, prednisolone and prednisone in the US, 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 16,000 patients in the US, with over 400,000 in the rest of the world.

About Efmody^® (hydrocortisone modified-release hard capsules)

Efmody^® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered 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 indication for Efmody^® is congenital adrenal hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody^® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US.

The MHRA and European Commission marketing authorisation approval of Efmody^® was based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including sites in Great Britain, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody^® over an extended period, with a number of patients on this trial having been treated for over five years. Summary of Product Characteristics (SmPC) for UK (Northern Ireland) can be found here.

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 Er-Kim

ER-Kim has been serving as the regional affiliate for the world's most important pharmaceutical and biotechnology companies since 1981. Today, ER-Kim remains one of the oldest and largest companies delivering novel treatments to patients in Central and Eastern Europe (CEE), the Mediterranean and Turkey.

For further information about Er-Kim, please visit www.er-kim.com 

Date of Preparation: April 2022              Code: CORP-EU-0033