Regulatory Affairs

Diurnal secures patents for Alkindi and Chronocort in Japan

Published 26 February 2018

Diurnal Group, a specialty pharmaceutical company focused on developing treatments for chronic endocrine (hormonal) diseases, has secured patents from the Japanese Patent Office (JPO) for Alkindi (Infacort) and Chronocort.

The Alkindi patent, entitled "Treatment of Adrenal Insufficiency", is a pharmaceutical composition-of-matter patent protecting Alkindi's proprietary formulation as a treatment for adrenal insufficiency in paediatric and elderly adult patients. The patent provides in-market protection until 2032.

The Chronocort patent, entitled "Hydrocortisone Controlled Release Formulation", protects the product as a modified-release hydrocortisone formulation. The patent provides in-market protection until 2033.

The US and UK counterparts for these patents have already been granted.

These patents provide Diurnal with a proprietary position for Alkindi and Chronocort in Japan, where the Company intends to secure a local distribution partner. Japan represents a significant market opportunity for Diurnal with the country being the third largest market for pharmaceutical products after the US and Europe.

The Company estimates that there are around 6,700 patients with congenital adrenal hyperplasia and around 58,000 with adrenal insufficiency eligible for treatment with Alkindi and Chronocort in Japan, providing an estimated total market opportunity for Alkindi and Chronocort of approximately $415 million per annum.

Diurnal CEO Martin Whitaker said: "Japan is a significant potential market for both Alkindi and Chronocort. We are therefore delighted that these patents have proceeded to grant and will create the cornerstone of our strong exclusivity position in this territory.

“We will now look to secure a local partner, in line with our commercialisation strategy outside of the US and Europe, and will liaise with local regulatory authorities to determine the clinical studies that will be required for approval."

Source: Company Press Release