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Diurnal inks marketing agreement with Emerge for alkindi, chronocort in Australia and New Zealand

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Diurnal inks marketing agreement with Emerge for alkindi, chronocort in Australia and New Zealand

Diurnal Group plc, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announced a marketing and distribution agreement with Emerge Health Pty Ltd (Emerge Health), a leading, specialised Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. The agreement covers 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 will receive the exclusive rights to market and sell Alkindi and Chronocort in Australia and New Zealand. Diurnal will provide Emerge Health with product for sale in Australia and New Zealand from its established European supply chain. This agreement marks an important commercialisation step as Diurnal seeks to further expand the reach of its lead products in diseases of cortisol deficiency.

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Following European marketing authorisation, announced on 13 February 2018, Emerge Health will submit Alkindi for marketing authorisation in Australia and New Zealand during 2018. The submission will be based on the European regulatory dossier and published clinical trial data, with the first potential for approval in Australia in 2020.

Australia and New Zealand represent significant market opportunities for Diurnal. There are around 1,750 patients in these territories suffering from paediatric adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH), providing an estimated total market opportunity for Alkindi and Chronocort of approximately $10 million per annum.

Alkindi is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related condition CAH. Chronocort is a modified release hydrocortisone preparation in development that has been designed to mimic the natural circadian rhythm of cortisol when given in a twice-a-day “toothbrush” regimen for the treatment of adult CAH.

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Diurnal inks marketing agreement with emerge for alkindi, chronocort in australia and new zealand

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chris rossidis, head of commercial operations of emerge health, commented: “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. 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, ceo of diurnal, added: “emerge health’s focus on niche, high quality medicines means that they are the ideal strategic partner to help us commercialise our novel products in the important australian and new zealand healthcare markets. these territories represent an estimated total market opportunity of $10 million 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.

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