Diurnal joins Er-Kim to distribute cortisol deficiency treatments in Turkey

pharmafile | January 13, 2021 | News story | Research and Development Diurnal, Diurnal Group, Er-Kim, Turkey 

Diurnal Group, a specialty pharmaceutical company targeting patient needs in chronic endocrine diseases, has announced a distribution agreement with Er-Kim, a leading partner for global biotech and pharma companies seeking to commercialise their products in Turkey.

The agreement covers the distribution of UK-based Diurnal’s products Alkindi (hydrocortisone granules in capsules for opening) and Chronocort (modified-release hydrocortisone), which will be available for eligible patients in Turkey through applicable early access programmes for those with cortisol deficiency diseases who have no other treatment option.

Er-Kim will receive the exclusive rights to distribute, and when approved, market Alkindi and Chronocort in Turkey. There are over 8,800 patients estimated to be currently receiving treatment for paediatric Adrenal Insufficiency (AI) and the genetic condition Congenital Adrenal Hyperplasia (CAH).

Alkindi is already approved in Europe, Israel, and Australia, and is the first preparation of hydrocortisone specifically designed for use in children suffering from AI, including the related condition CAH. The drug is known as Alkindi Sprinkle in the US, and was approved by the FDA in September last year.

Chronocort, a modified-release preparation of hydrocortisone given in a twice-a-day regimen to treat diseases of cortisol deficiency, is under review by the EMA and MHRA. If regulatory review is successful, a marketing authorisation opinion for Chronocort’s approval in the European Economic Area (and Great Britain and Northern Ireland) is anticipated during the first quarter of this year.

Diurnal will provide Alkindi – and Chronocort upon its approval – from its established European supply chain for sale by Er-Kim. The parties’ agreement adds to the Diurnal’s ongoing strategy for commercialisation of its lead products by entering marketing and distribution agreements with companies focused on niche and orphan conditions.

Martin Whitaker, CEO of Diurnal, commented: “We are pleased to sign this agreement with Er-Kim, who have the local expertise and proven track record in Turkey needed to successfully support requests for Alkindi and Chronocort under an Early Access programme.

“This distribution agreement may help support patient needs in diseases of cortisol deficiency. Working with Er-Kim broadens the future availability of both Alkindi and Chronocort outside of our core markets in line with our global strategy. We have been impressed with Er-Kim and believe that our strategy is aligned with theirs as a valued distribution partner.”

Darcy Jimenez

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