DNL.L Share News (DNL)

(Sharecast News) - Specialty pharmaceutical company Diurnal Group announced on Monday that its marketing and distribution partner, Medison Pharma has successfully submitted a market authorisation application (MAA) for its 'Alkindi' (hydrocortisone granules in capsules for opening) product to the Ministry of Health in Israel.The AIM-traded firm said the ministry had validated the application, with it anticipating that approval for Alkindi could be towards the end of 2019, followed by the potential launch of the product in Israel in 2020.It said the submission followed the "highly statistically significant data" previously reported in 2016 from its pivotal phase 3 study for Alkindi in Europe, for paediatric adrenal insufficiency (AI).Alkindi was approved in Europe on 9 February, and had been successfully launched in key European territories.If approved in Israel, Diurnal claimed Alkindi had 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.Additionally, Diurnal announced the grant of its second patent for Alkindi in Israel - IL242275, entitled 'Composition Comprising Hydrocortisone'.It explained that it was a pharmaceutical composition-of-matter patent protecting Alkindi's proprietary formulation as a treatment for all forms of AI, and was in addition to the already-granted patent IL232065 'Pharmaceutical Composition for treatment of Adrenal Insufficiency'.The patents afforded in-market protection until 2034, providing a "long and robust" exclusivity position in Israel for Alkindi.Diurnal said Israel represented a "significant" patient population with an unmet need, and a potential market opportunity, given the estimated higher prevalence of paediatric AI and CAH in the country.There were approximately 1,000 paediatric AI and CAH patients in Israel, which the board said provided a total market opportunity for Alkindi and Diurnal's second product, 'Chronocort' for adults with CAH, estimated to be approximately $7m per annum."Medison is the pre-eminent marketing partner in Israel for enabling market access of niche healthcare products for Diurnal and other global pharmaceutical companies," said Diurnal chief executive officer Martin Whitaker."Medison combines extensive in-territory knowledge and experience, marketing and regulatory capability and innovative solutions for market access."Whitaker said the company was "delighted" that Medison had confirmed the successful submission of the market authorisation application for Alkindi in Israel, which it believed would allow Alkindi to enter that country's healthcare market in 2020."This submission marks a further validation of our strategy to commercialise our products outside our core territories of Europe and the US."