Posted on Thursday, 03/Sep/2020 Posted by michelle

Accelerates Alkindi® market access across Europe with additional planned country launches

Strengthens Diurnal’s European distribution platform ahead of anticipated approval of Chronocort®

Advances Company’s strategy of partnering outside key European territories

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces two further European market and distribution agreements for the Company’s products Alkindi® (hydrocortisone granules in capsules for opening) and Chronocort® (modified release hydrocortisone). These new agreements cover the distribution and marketing of Alkindi® and Chronocort® in the Benelux Union (consisting of Belgium, the Netherlands, and Luxemburg) and Alkindi® in Switzerland.

The agreement for the Benelux Union is with Consilient Health, a pharmaceutical company with a track record in commercialising products for endocrinology, women’s health and urology. Under the terms of the agreement, Consilient Health will receive the exclusive right to market and sell Alkindi® and Chronocort® in the Benelux Union in conjunction with its strategic partner, Goodlife Pharma. There are approximately 2,300 patients in the Netherlands and Belgium suffering from paediatric adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH), providing an estimated combined market opportunity for Alkindi® and Chronocort® of approximately $14 million per annum.

Separately, Diurnal has entered into an agreement for the marketing and distribution of Alkindi® in Switzerland with an undisclosed commercial-stage pharmaceutical company focused on prescription medications for niche and orphan indications. Under the terms of the agreement, Diurnal’s partner will receive the exclusive rights to market and sell Alkindi® in Switzerland and will submit Alkindi® for marketing authorisation in Switzerland during 2020. The submission will be based on the European regulatory dossier and published clinical trial data, with the first potential for approval in Switzerland in 2021. 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 part of the agreement, Diurnal’s partner has a right of first negotiation for the marketing and distribution of Chronocort®.

Diurnal will provide its partners with product for sale from its established European supply chain. The two agreements form 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.

Alkindi® is already approved and marketed in Europe and is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related condition CAH. Chronocort® is a modified release hydrocortisone preparation in that has been designed to mimic the natural circadian rhythm of cortisol when given in a twice-a-day “toothbrush” regimen for the treatment of adult CAH. Diurnal’s Market Authorisation Application (MAA) for Chronocort® is currently under review following submission to the European Medicines Agency (EMA) in December 2019 and validation in April 2020. Diurnal is anticipating approval of Chronocort® by the EMA in Q1 2021.

Martin Whitaker, CEO of Diurnal, commented:

“These two additional marketing and distribution agreements for Alkindi® and additional one for Chronocort® further validate the quality of our products and immediately broaden the future availability of Alkindi® in Europe. Both of our new partners are well-placed to distribute our products in their respective markets, and we believe that our strategy and global ambitions are aligned with them through these collaborations. We have made strong progress with the sales of Alkindi® across Europe since its approval and subsequent launch in 2018, and we are confident these agreements will enable further growth.”

Ahmed Al-Derzi, CEO of Consilient Health, commented:

“Consilient Health are delighted to form this partnership with Diurnal and to work with our Benelux partner, Goodlife Pharma, to bring Alkindi®, and future pipeline medicines, to patients in the Benelux region.”

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

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

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). 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 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.

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 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 currently under review by the EMA. 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, 17,000 in the US, 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 high quality 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

About Consilient Health

Established in 2005 with headquarters in Ireland, Consilient Health is an independent, dynamic and rapidly growing pharmaceutical company with a rich heritage of commercialising products in complex markets in therapeutic areas such as women’s health, urology and endocrinology. The company has a strategy of partnering with innovative companies to bring medicines to market that serve a clear unmet clinical need.

For further information about Consilient Health, please visit www.consilienthealth.com

 Date of Preparation: September 2020            Code: CORP-GB-0062