Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a distribution agreement with Er-Kim, a leading partner for global biotech and pharma companies seeking to commercialise their products in Turkey. The agreement covers the distribution of the Company’s products Alkindi® (hydrocortisone granules in capsules for opening) and Chronocort® (modified-release hydrocortisone). The products will be available for the patients who qualify in Turkey through applicable Early Access programmes for patients with diseases of cortisol deficiency who have no other treatment option.
Under the terms of the agreement, Er-Kim will receive the exclusive rights to distribute, and when approved, market Alkindi® and Chronocort® in Turkey. There are over 8,800 patients estimated to be currently receiving treatment for paediatric Adrenal Insufficiency (AI) and the genetic condition Congenital Adrenal Hyperplasia (CAH).
Alkindi® is already approved in Europe, Israel and Australia 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. Alkindi® is known as Alkindi® Sprinkle in the US and was approved by the US Food and Drug Administration in September 2020.
Chronocort® is a modified-release preparation of hydrocortisone that is under review by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Chronocort® is given in a twice-a-day regimen to treat diseases of cortisol deficiency. If regulatory review is successful, a marketing authorisation opinion for Chronocort® approval in the European Economic Area (and Great Britain and Northern Ireland) is anticipated during Q1 2021.
Diurnal will provide Alkindi® (and subsequently Chronocort® on approval) from its established European supply chain for sale by Er-Kim. This agreement adds to 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.
Martin Whitaker, CEO of Diurnal, commented: “We are pleased to sign this agreement with Er-Kim, who have the local expertise and proven track record in Turkey needed to successfully support requests for Alkindi® and Chronocort® under an Early Access programme. This distribution agreement may help support patient needs in diseases of cortisol deficiency. Working with Er-Kim broadens the future availability of both Alkindi® and Chronocort® outside of our core markets in line with our global strategy. We have been impressed with Er-Kim and believe that our strategy is aligned with theirs as a valued distribution partner.” Cem Zorlular, Chairman and CEO of Er-Kim, commented: “We are excited to be working with Diurnal to bring Alkindi® and Chronocort® to Turkey where there is a significant unmet medical need for patients with adrenal insufficiency and congenital adrenal hyperplasia. We are both aligned to an objective of making these much needed, high quality medicines available to patients who currently have no other satisfactory option for treatment.”