Cardiff, UK - Diurnal Limited (“Diurnal” or “the Company”) today announced that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for Chronocort® in the treatment of Adrenal Insufficiency (“AI”). The designation provides seven years of market exclusivity in the US following market authorisation and adds to the Orphan Drug Designation granted by the FDA in March 2015 for Chronocort® in the treatment of Congenital Adrenal Hyperplasia (“CAH”).
Chronocort® is a modified-release oral formulation of hydrocortisone under development for a range of diseases characterised by deficiency in the hormone cortisol, which include AI and CAH. Phase 3 studies of Chronocort® in CAH are due to start this year and Diurnal expects to initiate discussions with the EMA and FDA regarding clinical studies in AI during 2016. With Orphan Drug Designation now in place for Chronocort® in both indications, as well as for the company’s complementary Phase 3 product, Infacort®, in paediatric AI, Diurnal is increasingly well positioned to fulfil its ambition of becoming the market leader in the provision of therapies for all forms of cortisol deficiency, both infant and adult.
Martin Whitaker, CEO of Diurnal, said: “Obtaining orphan drug designation from the FDA for Chronocort® in Adrenal Insufficiency together with the recent designation for Congenital Adrenal Hyperplasia, will allow us to better serve the needs of patients with these rare conditions. I am proud of the work that has gone in from the team in achieving this and look forward to a successful completion of the clinical trials programmes in Europe and the US.”
About Adrenal Insufficiency. AI is a condition characterised by deficiency in cortisol, an essential hormone for regulating metabolism and the response to stress. Current treatments for AI do not adequately mimic the natural daily variation in levels of cortisol, leading to poor control of the disease which can predispose to weight gain, poor cardiovascular health and risk of life threatening adrenal crisis.
About Chronocort®. Chronocort® is a modified-release preparation of hydrocortisone specifically designed to replicate physiological cortisol replacement, as closely as possible, in a diurnal rhythm. Chronocort® is soon to enter phase 3 clinical trials in Europe with a US trial programme following shortly.
About Diurnal Limited Founded in 2004, Diurnal is a UK-based specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including CAH and AI. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
Please direct all enquiries to:
Martin Whitaker, CEO
+44 (0)871 716 8848