LONDON: Diurnal Group plc announced that Alkindi (hydrocortisone granules in capsules for opening) has received approval from the Ministry of Health in Israel as a replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to <18 years old).
Israel represents a significant potential market opportunity, given the estimated higher than global average prevalence of paediatric AI and congenital adrenal hyperplasia (CAH).
There are approximately 1,000 patients in Israel (paediatric AI and CAH), providing a total market opportunity for Alkindi and Chronocort estimated by the Company to be approximately $7 million per annum. Diurnal anticipates the first sales in Israel will be in H1 2021 following completion of pricing and market access activities. In Israel, Medison Pharma is Diurnal’s marketing and distribution partner for Alkindi and Chronocort and will hold the marketing authorisations.
Diurnal submitted its Marketing Authorisation Application (MAA) dossier for Chronocort to the European Medicines Agency (EMA) in December 2019. Assuming the EMA approves Chronocort as expected by Diurnal in Q1 2021, the European dossier will be used to submit Chronocort for regulatory approval in Israel.
Martin Whitaker, CEO of Diurnal, commented: “We are thrilled to announce the approval of Alkindi in Israel, an important market for us, and would like to thank Medison Pharma for their efforts in obtaining this approval, which further validates the quality of our products and, in line with our strategy, gives us the ability to provide Alkindi® to patients outside of our core territories in Europe and the US.”