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Diurnal inks pact with ExCEEd Orphan for marketing of Alkindi & Efmodyin Central and Eastern European countries

Saturday, October 16, 2021, 16:00 Hrs  [IST]

Diurnal Group plc, a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announced that it has signed a distribution agreement with ExCEEd Orphan, a company providing full business solutions for the treatment of rare diseases, for the distribution and marketing of Alkindi (hydrocortisone granules in capsules for opening) and Efmody (hydrocortisone modified-release hard capsules) in Central and Eastern European (CEE) countries.

This agreement extends the company’s commercial footprint to over two-thirds of the European Economic Area population.

Under the terms of the agreement, ExCEEd Orphan will receive the exclusive rights to distribute and market Alkindi and Efmody in the CEE countries including; Albania, Bosnia and Herzegovina, Croatia, Czechia, Hungary, Kosovo, Montenegro, North Macedonia, Poland, Serbia, Slovakia, and Slovenia. Based on the company’s estimates and market research conducted by ExCEEd Orphan, there are estimated to be in total around 9,500 patients in the CEE region suffering from paediatric adrenal insufficiency (AI) and adult congenital adrenal hyperplasia (CAH).

Alkindi already has marketing authorisation in the European Union and is the first preparation of hydrocortisone (synthetic cortisol) specifically designed for use in children suffering from adrenal insufficiency, including the related condition CAH. Efmody is a modified-release preparation of hydrocortisone for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes. In May 2021, Efmody was granted marketing authorisation in the European Union and was subsequently launched by the Company in Germany, Austria and the UK in September 2021.

In line with the Company’s other global distribution agreements, Diurnal will provide Alkindi and Efmody from its established European supply chain for sale by ExCEEd Orphan. This agreement adds to the Company's ongoing strategy for commercialisation of its lead products by optimising market access outside of the larger European markets, where Diurnal directly markets its products, through entering marketing and distribution agreements with companies focused on niche and orphan conditions. With the execution of this agreement, the Company’s two lead products will be available to over two-thirds of the European Economic Area (EEA) population, and ExCEEd Orphan will work to make these products available in territories beyond this region in Central and Eastern Europe.

Martin Whitaker, CEO of Diurnal, commented:“We are pleased to announce this distribution agreement with ExCEEd Orphan to make Alkindi and Efmody available to patients with diseases of cortisol deficiency across Central and Eastern Europe. Following this agreement, Diurnal’s products are now available to over two-thirds of the EEA population and we are looking forward to working with ExCEEd Orphan who have a strong track record of launching orphan medicines within this region. As Efmody has now launched for patients in Europe, this agreement is in line with our commercialisation strategy in order to optimise global market access for our products outside of large European markets.”

Jiri Hermanek, CEO and founding partner of ExCEEd Orphan, commented:“We are very pleased to announce this collaboration to make Alkindi and Efmody available to patients with diseases of cortisol deficiency across Central and Eastern European countries. Both products will represent an important addition to the continuously growing portfolio of rare disease medications marketed and distributed by ExCEEd Orphan and we are fully committed to bringing these unique medications to all patients in needs in all respective countries.”


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