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. 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.