DNL.L Share News (DNL)

(Sharecast News) - Specialty pharmaceutical company Diurnal Group announced on Wednesday that, following a "positive" meeting with the US Food and Drug Administration (FDA), it intended to submit a new drug application (NDA) for 'Alkindi' (hydrocortisone granules in capsules for opening) in the fourth quarter of 2019 as previously planned, with final acceptance of the filing by the FDA expected in 2020.The AIM-traded firm said that during the meeting, the FDA confirmed the current clinical and regulatory path for Alkindi as a replacement therapy for paediatric adrenal insufficiency (AI) in the US.That followed the completion of a development programme for Alkindi, including a study to demonstrate bioequivalence with the US reference product, as the company announced on 17 October."We are pleased with the outcome of our meeting with the FDA following completion of the development programme for Alkindi in the US," said Diurnal Group chief executive officer Martin Whitaker."If accepted by the FDA, Alkindi will be the first licensed treatment in the US specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need."Following this positive development, we are now progressing discussions with potential partners for Alkindi in the US who are able to optimise market access for this important product."Diurnal described paediatric AI as a condition characterised by deficiency in cortisol - an essential hormone in regulating growth, metabolism and the response to stress.Paediatric AI had been identified as an orphan disease in the US, where there was estimated to be around 4,500 sufferers under the age of 16.Untreated, the disease was associated with significant morbidity and increased mortality.Alkindi had the potential to be the first pharmaceutically-defined dose and consistent formulation of hydrocortisone - the synthetic version of cortisol - designed specifically for paediatric patients, Diurnal claimed.In the US, the company held 'orphan drug designation' for Alkindi for paediatric AI, which afforded seven years' market exclusivity post-new drug application approval.A robust, granted, patent portfolio provided in-market protection for Alkindi to 2034, the board explained, which "significantly bolsters" the company's exclusivity position.