Diurnal Group PLC (LON:DNL) rocketed nearly 200% higher on Thursday after the hormonal diseases specialist announced the grant of a second US patent for Chronocort, a cortisol replacement product for the life-long treatment of congenital adrenal insufficiency and adrenal insufficiency.
The AIM-listed group said US 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 delivers hydrocortisone in accordance with a circadian rhythm.
Diurnal said the patent provides in-market protection until 2033 and is in addition to the already granted pharmaceutical composition of matter patent US 9,750,704, which provides in-market protection until 2034.
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 US$1bn.
Martin Whitaker, Diurnal’s chief executive officer commented: "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.”
He added: “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."
Shares surge – but from low base
In afternoon trading, Diurnal was easily the London market’s top gainer, up 195% today to 63.50p, although the shares were trading at around 178p a year ago.
Diurnal’s share price more than halved in October after the Chronocort drug failed in a late-stage clinical trial.
Whitaker said then: “We will now analyse the full data set from this trial, along with interim data from the ongoing Chronocort long-term dosing study, to determine next steps in Chronocort development, and discuss these with the regulatory authorities.”
He added: “We remain confident that Chronocort will be a valuable treatment option for CAH patients.”