Posted on Monday, 19/Feb/2018 Posted by michelle

Further validation of Diurnal’s products and approach to global marketing and distribution in high value markets outside core Europe and US territories

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a marketing and distribution agreement with Emerge Health Pty Ltd (Emerge Health), a leading, specialised Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. The agreement covers the commercialisation of Diurnal’s novel therapies, Alkindi® (hydrocortisone granules in capsules for opening) and Chronocort® (modified release hydrocortisone), in Australia and New Zealand.

Under the terms of the agreement, Emerge Health will receive the exclusive rights to market and sell Alkindi® and Chronocort® in Australia and New Zealand. Diurnal will provide Emerge Health with product for sale in Australia and New Zealand from its established European supply chain. This agreement marks an important commercialisation step as Diurnal seeks to further expand the reach of its lead products in diseases of cortisol deficiency.

Following European marketing authorisation, announced on 13 February 2018, Emerge Health will submit Alkindi® for marketing authorisation in Australia and New Zealand during 2018. The submission will be based on the European regulatory dossier and published clinical trial data, with the first potential for approval in Australia in 2020.

Australia and New Zealand represent significant market opportunities for Diurnal. There are around 1,750 patients in these territories suffering from paediatric adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH), providing an estimated total market opportunity for Alkindi® and Chronocort® of approximately $10 million per annum.

Alkindi® 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 development 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.

Chris Rossidis, Head of Commercial Operations of Emerge Health, commented:
“As a leading Australian pharmaceutical company providing patients in areas of unmet clinical need with access to the best specialised medicines available globally, Alkindi® and Chronocort® are ideal products for us to market and distribute into our established network in secondary care. With the recent European approval, we look forward to initially working with Diurnal to register Alkindi® and, following anticipated market authorisations, to commercialise the product in Australia and New Zealand.”

Martin Whitaker, Chief Executive Officer of Diurnal, added: 
“Emerge Health’s focus on niche, high quality medicines means that they are the ideal strategic partner to help us commercialise our novel products in the important Australian and New Zealand healthcare markets. These territories represent an estimated total market opportunity of $10 million for Alkindi® and Chronocort®. Together with our commercialisation agreement with Medison Pharma in Israel, we continue to build our marketing and distribution capabilities in high value markets outside our core European and US territories through local distribution arrangements.” 

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 

Numis Securities Ltd (Nominated Adviser) +44 (0)20 7260 1000
Nominated Adviser: Michael Meade, Paul Gillam, Freddie Barnfield 
Corporate Broking: James Black 

Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley 
Corporate Broking: Tom Salvesen 

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

Notes to Editors

About Adrenal Insufficiency
Adrenal insufficiency (AI) 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). AI is estimated to affect over four million patients globally.

In the paediatric setting, AI, including the related genetic condition congenital adrenal hyperplasia, is estimated to affect approximately 400 patients in Australia and New Zealand. In Europe, AI has been identified as a rare condition, where there are estimated to be approximately 4,000 sufferers younger than the age of six, where the need for an effective replacement therapy is greatest. Prior to the European approval of Diurnal’s product, Alkindi®, paediatric AI was treated by compounding hydrocortisone or crushing/splitting tablets of adult preparations of hydrocortisone (the synthetic version of cortisol) as there was no licensed formulation available specifically designed for children.

Diurnal’s products, Alkindi® and Chronocort®, have been granted Orphan Drug Designations in the US for the treatment of AI. Chronocort® also benefits from Orphan Drug Designation for AI in Europe. These orphan drug designations mean Alkindi® and Chronocort® have the potential to be granted market and data exclusivity for seven years in the US and 10 years in Europe for Chronocort® post market authorisation.

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 severe development defects including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis.

Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect approximately 1,350 adult patients in Australia and New Zealand, 47,000 patients in Europe and over 400,000 patients globally.

Current therapy for CAH uses a variety of generic steroids (hydrocortisone, dexamethasone and prednisolone) which, at best, adequately treat approximately one-third of CAH patients. Other therapies being developed are at an early stage of development and not expected to receive approval in the short-term.

Diurnal’s product, Chronocort®, has been granted Orphan Drug Designations in Europe and the US in the treatment of CAH, providing the potential to be granted market exclusivity for 10 years in Europe and seven years in the US post market authorisation.

About Alkindi®
Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric AI. Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for 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 CAH. AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives.

On 9 February 2018, the European Commission 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), following the positive opinion issued by the European Medicines Agency in December 2017. The PUMA affords 10 years market and data exclusivity for Alkindi® in Europe

About Chronocort®
Chronocort® is a modified release preparation of hydrocortisone that has been 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). The first planned indication for Chronocort® is CAH in adults.

Chronocort® has completed three Phase I trials in 2011, 2012 and 2015, a Phase II trial in CAH patients in 2014 in the US and is currently in a Phase III trial in Europe. This pivotal Phase III trial for Chronocort® in Europe is scheduled to complete in Q3 2018, with market authorisation in Europe expected in 2020.

About Emerge Health
Emerge Health is an innovative, specialised Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. Emerge Health is dedicated to providing exceptional products and support to ensure it meets its customers and partners needs and priorities.

For more information, please visit  http://www.emergehealth.com.au

About Diurnal Group plc

Founded in 2004, Diurnal is a UK-based 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