DNL.L Regulatory News (DNL)

07 March 2022

Diurnal Group plc

("Diurnal" or the "Company")

Scottish Medicines Consortium Update

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, provides an update on the status of reimbursement of Efmody® (modified-release hydrocortisone) for NHS Scotland.

The Company notes that, while Efmody® remains available to prescribe in Scotland, the Scottish Medicines Consortium (SMC) has today announced that Efmody® has not been recommended for automatic reimbursement within NHS Scotland as a treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Diurnal will generate further clinical and health-economic data to support a re-submission to the SMC at the earliest possible opportunity.

Diurnal will continue to make Efmody available to patients in Scotland and is committed to patient access through a number of means including support for clinicians wishing to utilise Efmody® in their clinics.

As a result of the SMC decision, Diurnal's Efmody® sales forecasts for the UK will be impacted reflecting the reliance of a number of healthcare clinical commissioning groups on the SMC assessment. However, the Board still expects strong sales growth in total product sales in excess of 100% for the 12-month period ended 30 June 2022 compared to the prior period as the commercial roll out of Alkindi® and Efmody® continues across Europe.

Martin Whitaker, Chief Executive Officer of Diurnal, commented: 

"Diurnal remains firmly committed to making Efmody® available to Scottish patients and the Company will work with clinicians and patient groups to achieve this goal. Further data to support Efmody®'s clinical benefit are being generated from ongoing clinical trials with Efmody® and Diurnal will work to make this available to the SMC via a resubmission as soon as possible."

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Notes to Editors

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 5 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

Date of Preparation: March 2022 Code: CORP-EU-0030