Posted on Wednesday, 01/Apr/2020 Posted by michelle

European regulatory recommendation for approval targeted for Q1 2021

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the Marketing Authorisation Application (MAA) for Chronocort® (modified release hydrocortisone) as a treatment for the rare condition congenital adrenal hyperplasia (CAH) in Europe has passed validation with the European Medicines Agency (EMA). The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

CAH is an orphan genetic condition caused by a block in cortisol production, an essential adrenal steroid hormone required for healthy life. A lack of cortisol in turn causes the over-production of male steroid hormones (androgens). Cortisol deficiency and over-production of androgens can lead to increased mortality, infertility and issues during sexual development, including ambiguous genitalia, precocious puberty and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. The condition is estimated to affect a total of approximately 41,000 adult patients in Europe, with over 400,000 in the rest of the world.

The MAA for Chronocort® was submitted in December 2019 subsequent to a positive meeting with the EMA in March 2019 and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chronocort® as a treatment for patients with CAH.

Martin Whitaker, CEO of Diurnal, commented:

“We are pleased to announce that our MAA for Chronocort® has been validated and we look forward to working with the EMA during the review process. This is another important step towards the targeted recommendation for approval of our second product in Q1 2021. There is a significant need for new therapies to improve outcomes for adult and adolescent patients with CAH, which still results in increased morbidity and mortality. Following the recent US licensing agreement with Eton Pharmaceuticals for Alkindi® Sprinkle and £11.2 million placing, Diurnal now has a strong cash position to progress through to and past the anticipated approval date for Chronocort®.”

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

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 Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns

Cantor Fitzgerald Europe (Joint Broker) +44 (0) 20 7894 7000
Corporate Finance: Phil Davies, Will Goode, Michael Boot
Healthcare Equity Sales: Andrew Keith

FTI Consulting +44 (0)20 3727 1000
Simon Conway 
Victoria Foster Mitchell

Notes to Editors

About Chronocort®
Chronocort® is a modified release preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (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 planned indication for Chronocort® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents. Chronocort® has been extensively studied in human subjects having completed four Phase I trials, a Phase II trial in 16 CAH patients in the US in 2014, and a Phase III trial in 122 CAH patients in Europe and the US.

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 steroids (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, with over 400,000 in the rest of the world.

About Diurnal Group plc
Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing pharmaceutical products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia and adrenal insufficiency. 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:  April 2020            Code: CORP-GB-0053