(Sharecast News) - Speciality pharmaceuticals company Diurnal Group announced on Wednesday that its marketing and distribution partner in Switzerland, EffRx Pharmaceuticals, has submitted a market authorisation application to Swissmedic for the registration of 'Alkindi', or hydrocortisone granules in capsules for opening, in the country.
The AIM-traded firm said the submission was based on the European regulatory dossier and published clinical trial data, with EffRx expecting potential market launch in Switzerland by 2022.
It said there were around 200 patients in Switzerland suffering from paediatric AI, providing an estimated total market opportunity for Alkindi of about $1m (£0.76m) per annum.
As it had previously announced, Diurnal said EffRx would receive the exclusive rights to market and sell Alkindi in Switzerland once registered.
Alkindi is already approved and marketed in Europe, and is the first preparation of hydrocortisone, being the synthetic version of cortisol, specifically designed for use in children suffering from AI, including the related condition CAH.
Diurnal would provide EffRx with product for sale from its established European supply chain, with the board saying the partnership formed part of its ongoing strategy for the 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.
"We are pleased to see the submission of a market authorisation application for Alkindi in Switzerland by EffRx," said chief executive officer Martin Whitaker.
"Today's announcement is yet further validation of the quality of our products and broadens the future availability of Alkindi outside our core markets in line with our global strategy.
"We look forward to working with EffRx to make Alkindi available to patients suffering from paediatric AI in Switzerland."
At 1522 BST, shares in Diurnal were up 1.61% at 63p.
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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