Diurnal awarded US patent for Chronocort product

The AIM-traded firm said US patent 10,166,194, entitled "Hydrocortisone Controlled Release Formulation", is a patent claiming a method of treatment for adrenal dysfunction, including the diseases congenital adrenal hyperplasia (CAH) and adrenal insufficiency (AI), that delivered hydrocortisone in accordance with a circadian rhythm.

It said the patent provided it with in-market protection until 2033, and was in addition to the already granted pharmaceutical composition of matter US patent 9,750,704, which provided in-market protection until 2034.

The patent expanded the company's strong exclusivity position in the US, where Chronocort already received Orphan Drug Designation for the treatment of both CAH and AI from the US Food and Drug Administration (FDA), which provided the potential for seven years of market exclusivity awarded on approval.

Diurnal said the United States was expected to be a major territory for sales of Chronocort, with CAH and AI collectively estimated to affect 140,000 adult patients and have an addressable market of around $1bn.

“This second Chronocort patent provides additional in-market protection in the US, which remains a key target market for Diurnal, in addition to the potential for market exclusivity provided by the award of Orphan Drug Designation for both CAH and AI,” said Diurnal chief executive officer Martin Whitaker.

“With patents now extending protection in the US for both Chronocort and our paediatric product Alkindi to 2034, we are confident that, if approved, these products will enjoy a long period of exclusivity in the US market and provide the potential for lifelong treatment of patients with CAH and AI.”