DNL.L Regulatory News (DNL)

30 March 2022

Diurnal Group plc

("Diurnal" or the "Company")

Distribution agreement signed with Vector Pharma for Alkindi®

Exclusive partnership covers 14 countries across the Middle East and North Africa

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a distribution agreement with Vector Pharma FCZO ("Vector Pharma"), a leading full-service distributor, for the distribution of Alkindi® (hydrocortisone granules in capsules for opening) across the Middle East and North Africa regions.

Under the terms of the distribution agreement, Vector Pharma will receive the exclusive rights to distribute Alkindi® in Morocco, Tunisia, Algeria, Libya, Egypt, Saudi Arabia, Qatar, United Arab Emirates, Bahrain, Kuwait, Oman, Lebanon, Jordan and Iraq. Through Vector Pharma, Alkindi® will be available to paediatric patients who qualify through applicable Early Access programmes for patients with diseases of cortisol deficiency who have no other treatment options.

This latest distribution agreement for the Company will further extend the global rollout of Alkindi®, which is already approved in the UK, European Economic Area, Israel, Australia, and the US (where it is known as Alkindi Sprinkle®). Alkindi® is the first licensed 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).

In accordance with the Company's existing distribution agreements, Diurnal will provide Alkindi® from its established European supply chain for sale by Vector Pharma. It is expected that Alkindi® will be available to patients in the Middle East and North Africa during Q2 2022. This agreement adds to the Company's ongoing strategy for commercialisation of its lead products beyond the larger European markets, where Diurnal markets its products itself, through entering into international distribution agreements with companies focused on niche and orphan conditions.

Martin Whitaker, Chief Executive Officer of Diurnal, commented:

"We are pleased to be working with Vector Pharma to extend the availability of Alkindi® to a large geographic region where there is a significant unmet patient need in children suffering from AI and CAH. Working with Vector Pharma will further broaden the future availability of Alkindi® outside of our core markets and we believe that Vector Pharma is well-positioned to distribute Alkindi® across the 14 counties in this agreement and to ensure it reaches key healthcare providers and patients."

Samer Semaan, Managing Director of Vector Pharma, commented:

"I am excited to announce this regional distribution agreement between Vector Pharma and Diurnal. Congenital adrenal hyperplasia is the most common form of paediatric AI affecting young patients throughout the Middle East and North Africa, and we hope that allowing both patients and prescribers access to this important therapy will make a difference in the lives of families throughout the region."

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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 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 ® is approved and known as Alkindi Sprinkle® in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel and Australia.

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

Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. 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 Vector Pharma FZCO

Vector Pharma was founded in 2019 with the ambition to be the leading full-service distributor for rare diseases, oncology and highly specialised therapeutics in the Middle East, North Africa, and Turkish markets. As the only Trace-certified full-service distributor in the region, Vector has an equal emphasis on patient demand generation through evidence-based medicine, fast track market access solutions, and the highest compliance & ethical standards, all the while striving for the best outcomes for patients, prescribers, and partners. Vector Pharma is also a proud founding member of the World Orphan Drug Alliance (WODA), offering its services together with like-minded sister companies in Switzerland, Central and Eastern Europe, and Latin America.

More information can be found at www.vectorpharma.me

Date of Preparation: March 2022 Code: CORP-GLO-0028