7 October 2022

Diurnal Group plc

("Diurnal" or the "Company")

AWMSG recommends Efmody^® as treatment option for adolescents and adults with congenital adrenal hyperplasia in Wales

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the All Wales Medicines Strategy Group (AWMSG) has recommended Efmody^® (hydrocortisone modified-release hard capsules) as an option for restricted use to treat adolescents and adults with congenital adrenal hyperplasia (CAH) within NHS Wales.

The AWMSG's recommendation means that Efmody^® is available for use as a second-line treatment option in adolescents with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone; and as a third-line treatment in adults with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone and/or prednisolone. Diurnal will commercially roll-out Efmody^® in Wales using its existing sales and marketing infrastructure and supply chain.

Efmody^® has been available for the treatment of CAH in the UK since launch in October 2021. Efmody^® is licensed for the treatment of congenital adrenal hyperplasia in adolescents aged 12 years and older and in adults in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA).

Richard Bungay, Interim Chief Executive Officer of Diurnal commented:

"We are delighted that, after a rigorous review, the AWMSG has recognised the potential for Efmody^® to address important unmet needs in patients suffering with CAH. Diurnal believes the use of this medicine will improve the lives of adults and adolescents in Wales living with this rare disease."

Notes to Editors

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.com

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 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.

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 5 years. Summary of Product Characteristics (SmPC) for UK including Northern Ireland) can be found here.

Date of Preparation: October 2022                     Code: CH EU-GLO-0011