(Sharecast News) - Speciality pharmaceutical company Diurnal Group announced two further European market and distribution agreements for its products 'Alkindi', or hydrocortisone granules in capsules for opening, and 'Chronocort', or modified release hydrocortisone, on Thursday.
The AIM-traded firm said the new agreements covered the distribution and marketing of Alkindi and Chronocort in the Benelux Union, consisting of Belgium, the Netherlands, and Luxembourg, and Alkindi in Switzerland.
It said the deal for the Benelux Union was with Consilient Health - a pharmaceutical company with a record of commercialising products for endocrinology, women's health and urology.
Under the terms of the agreement, Consilient Health would receive the exclusive right to market and sell Alkindi and Chronocort in the Benelux Union, in conjunction with its strategic partner Goodlife Pharma.
Diurnal said there were around 2,300 patients in the Netherlands and Belgium suffering from paediatric adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH), providing an estimated combined market opportunity for Alkindi and Chronocort of around $14m per annum.
Separately, Diurnal said it had entered into an agreement for the marketing and distribution of Alkindi in Switzerland with an unnamed commercial-stage pharmaceutical company, which is focussed on prescription medications for niche and orphan indications.
Under the terms of the agreement, Diurnal's partner would receive the exclusive rights to market and sell Alkindi in Switzerland, and would submit Alkindi for marketing authorisation in Switzerland during 2020.
The submission would be based on the European regulatory dossier and published clinical trial data, with the first potential for approval in Switzerland in 2021.
There are around 200 patients in Switzerland suffering from paediatric AI, providing an estimated total market opportunity for Alkindi of approximately $1m per annum.
As part of the agreement, Diurnal's partner had the right of first negotiation for the marketing and distribution of Chronocort.
Diurnal said it would provide the partners with product for sale from its established European supply chain.
The two agreements form part of its ongoing strategy for commercialisation of its lead products by optimising market access outside of key European markets through entering marketing and distribution agreements with companies focused on niche and orphan conditions.
"These two additional marketing and distribution agreements for Alkindi and additional one for Chronocort further validate the quality of our products and immediately broaden the future availability of Alkindi in Europe," said chief executive officer Martin Whitaker.
"Both of our new partners are well-placed to distribute our products in their respective markets, and we believe that our strategy and global ambitions are aligned with them through these collaborations.
"We have made strong progress with the sales of Alkindi across Europe since its approval and subsequent launch in 2018, and we are confident these agreements will enable further growth."
At 1056 BST, shares in Diurnal Group were up 3.86% at 60.76p.
2 Dec 2019 13:19
Diurnal submits application for 'Alkindi Sprinkle' to US FDA
(Sharecast News) - Specialty pharmaceutical company Diurnal Group has submitted a 'New Drug Application' (NDA) to the US Food and Drug Administration (FDA), for the regulatory approval of 'Alkindi Sprinkle', or hydrocortisone granules in capsules for opening, as a replacement therapy of adrenal insufficiency in infants, children and adolescents in the US, it announced on Monday.
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