DNL.L Regulatory News (DNL)

28 March 2019

Diurnal Group plc

("Diurnal" or the "Company")

Diurnal signs marketing and distribution agreement for the commercialisation of Alkindi® in the Nordic region with Anthrop Pharma

Accelerates market access in valuable Nordic region to build on momentum in UK and Germany

First launch planned for Sweden in Q2 2019

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a marketing and distribution agreement with Anthrop Pharmaceuticals AB (Anthrop), a leading, specialist pharmaceutical company based in Sweden focused on the marketing and sales of niche, high quality medicines to the hospital sector in the Nordic region. The agreement covers the commercialisation of Diurnal's novel therapy, Alkindi® (hydrocortisone granules in capsules for opening) in Sweden, Norway, Denmark, Finland and Iceland.

Alkindi® is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from adrenal insufficiency (AI), including the related condition congenital adrenal hyperplasia (CAH). Alkindi® was granted a paediatric use marketing authorisation (PUMA) in the EU in February 2018 which affords 10 years data and market exclusivity.

Under the terms of the agreement, Anthrop will receive the exclusive rights to market and sell Alkindi® in the Nordic region. Diurnal will provide Anthrop with product for sale from its established European supply chain. The Nordic region represents a significant market opportunity for Diurnal, with around 490 paediatric patients, providing an estimated total market opportunity for Alkindi® of approximately $3.3 million per annum.

Martin Whitaker, Chief Executive Officer of Diurnal, commented: 

"We believe that Anthrop's local expertise in the Nordic region will significantly accelerate the commercial uptake of Alkindi® in these territories, whilst enabling us to focus the Group's resources on the larger European markets. In particular, we believe that Anthrop is well-placed to maximise the value of Alkindi® given their previous experience with paediatric products, including products authorised under a PUMA. This agreement is part of our continued strategy of building our marketing and distribution capabilities in high value markets outside our core European territories through local licensing or distribution arrangements."

Clas Lindbergson, Chief Executive Officer of Anthrop Pharma, added:

"We are looking forward to making Alkindi® available for children suffering from adrenal insufficiency in the Nordic region. As it is the first and only approved hydrocortisone specifically designed for use in children with a life-threatening condition, we believe Alkindi® can give value to not only the children but also to the caregivers and the healthcare providers."

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

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

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 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

About Anthrop

Anthrop Pharmaceuticals AB, based in Danderyd, Sweden, is specialized in the introduction, distribution and marketing of niche pharmaceuticals and hospital injectables in the Nordic region. Anthrops mission is to help children and adults in the Nordic countries to get access the best possible drug treatment where it exists an unmet medical need. They are present in different therapeutic areas such as endocrinology, neurology, anaesthesia, cystic fibrosis and pain management.

For more information about Anthrop, please visit www.anthroppharma.com.

Date of Preparation: March 2019 Code: Inf EU-GB-0108