DNL.L Regulatory News (DNL)

25 February 2019

Diurnal Group plc

("Diurnal" or the "Company")

Diurnal announces submission of Marketing Authorisation Application for Alkindi® and grant of second Alkindi® patent in Israel

Significant opportunity to address unmet medical need, given the estimated higher prevalence of AI in Israel

Exemplifies Company's approach of seeking approval for lead products outside core territories

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that its marketing and distribution partner, Medison Pharma Ltd (Medison), has successfully submitted a Market Authorisation Application (MAA) for Alkindi® (hydrocortisone granules in capsules for opening) to the Ministry of Health in Israel. The Ministry of Health has validated the application and Diurnal anticipates that approval for Alkindi® could be towards the end of 2019, followed by the potential launch of Alkindi® in Israel in 2020.

This submission follows the highly statistically significant data previously reported in 2016 from the Company's pivotal Phase III study for Alkindi® in Europe for paediatric adrenal insufficiency (AI). Alkindi® was approved in Europe on 9 February 2018 and has been successfully launched in key European territories. If approved in Israel, Alkindi® has the potential to be the first licensed treatment in the country for paediatric AI (including the related condition congenital adrenal hyperplasia (CAH)) specifically designed for use in children under 18 years of age.

Separately, Diurnal announces the grant of its second patent for Alkindi® in Israel. IL242275, entitled "Composition Comprising Hydrocortisone", is a pharmaceutical composition-of-matter patent protecting Alkindi®'s proprietary formulation as a treatment for all forms of AI and is in addition to the already granted patent IL232065 "Pharmaceutical Composition for treatment of Adrenal Insufficiency". These patents afford in-market protection until 2034, providing a long and robust exclusivity position in Israel for Alkindi®.

Israel represents a significant patient population with an unmet need and a potential market opportunity for Diurnal, given the estimated higher prevalence of paediatric AI and CAH in Israel.[1] There are approximately 1,000 patients in Israel (paediatric AI and CAH), providing a total market opportunity for Alkindi® and Diurnal's second product, Chronocort®, for adults with CAH, estimated by the Company to be approximately $7m per annum.

Martin Whitaker, CEO of Diurnal, commented: 

"Medison is the pre-eminent marketing partner in Israel for enabling market access of niche healthcare products for Diurnal and other global pharmaceutical companies. Medison combines extensive in-territory knowledge and experience, marketing and regulatory capability and innovative solutions for market access. We are delighted that Medison has confirmed the successful submission of the Market Authorisation Application for Alkindi® in Israel, which Diurnal believes will allow Alkindi® to enter the Israeli healthcare market in 2020. This submission marks a further validation of our strategy to commercialise our products outside our core territories of Europe and the US."

Meir Jakobson, Founder and CEO of Medison, added:

"We are very happy that Diurnal recognises Medison as a partner not only for its proven marketing experience but also for its ability to provide meaningful value in one of the most advanced countries in healthcare solutions for patients."

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 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 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 ® in Europe.

About Paediatric Adrenal Insufficiency

Paediatric Adrenal insufficiency (AI), including the genetic condition Congenital Adrenal Hyperplasia (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). 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 hydrocortisone (the synthetic version of cortisol) as there was no licensed formulation available specifically designed for children.

About Medison Pharma Ltd

Medison is Israel's leading specialty pharmaceutical company, focused on delivering innovative healthcare solutions to the Israeli market. Medison is uniquely qualified to provide the complete spectrum of integrated services, including early access programs, regulatory affairs, registration and reimbursement, medical, marketing and logistics. Backed by three generations of experience in the healthcare industry since 1937, Medison is the exclusive Israeli partner for leading global pharma companies such as Amgen®, Biogen®, Shire® and Ipsen®. Medison also operates a fully owned subsidiary in Romania based on replicating its success in Israel.

For more information, please visit www.medisonpharma.com

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

Date of preparation: February 2019 Code: Inf EU-GB-0107