Diurnal finds partner to break Australia and New Zealand markets

Specialty pharmaceutical company Diurnal Group announced a marketing and distribution agreement with specialised Australian pharmaceutical firm Emerge Health on Monday.

The AIM-traded company said the agreement covered the commercialisation of Diurnal's novel therapies, ‘Alkindi’ - hydrocortisone granules in capsules for opening - and ‘Chronocort’ - modified release hydrocortisone - in Australia and New Zealand.

Under the terms of the agreement, Emerge Health would receive the exclusive rights to market and sell Alkindi and Chronocort in Australia and New Zealand.

Diurnal would provide Emerge Health with product for sale in Australia and New Zealand from its established European supply chain.

The board said the agreement marked an “important commercialisation step”, as Diurnal looked to further expand the reach of its lead products in diseases of cortisol deficiency.

Following European marketing authorisation as announced on 13 February, Emerge Health was set to submit Alkindi for marketing authorisation in Australia and New Zealand during 2018.

The submission would be based on the European regulatory dossier and published clinical trial data, with the first potential for approval in the two countries by 2020.

Diurnal added that Australia and New Zealand represented “significant market opportunities” for the company, with around 1,750 patients in the two nations suffering from paediatric adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH).

That would provide an estimated total market opportunity for Alkindi and Chronocort of approximately $10m per annum.

“As a leading Australian pharmaceutical company providing patients in areas of unmet clinical need with access to the best specialised medicines available globally, Alkindi and Chronocort are ideal products for us to market and distribute into our established network in secondary care,” said Emerge Health’s head of clinical operations Chris Rossidis.

“With the recent European approval, we look forward to initially working with Diurnal to register Alkindi and, following anticipated market authorisations, to commercialise the product in Australia and New Zealand.”

Martin Whitaker, chief executive officer of Diurnal, added that Emerge Health's focus on niche, high quality medicines meant they were the “ideal strategic partner” to help Diurnal commercialise its products in the important Australian and New Zealand healthcare markets.

“These territories represent an estimated total market opportunity of $10m for Alkindi and Chronocort.

“Together with our commercialisation agreement with Medison Pharma in Israel, we continue to build our marketing and distribution capabilities in high value markets outside our core European and US territories through local distribution arrangements.”