Clinigen, Diurnal to launch European managed access programme for adrenal drugs
AIM-listed Pharmaceuticals Clinigen and Diurnal are to launch a managed access programme in Europe for their drugs Infacort, which treats children with adrenal insufficiency, and Chronocort, which treat patients with congenital adrenal hyperplasia.
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The managed access programme, which will be run by Clingen’s Idis managed access division, will enable physicians in the European Union to access Infacort and Chronocort as unlicensed medicines on an individual named patient basis for people who have no other treatment options, ahead of European approval and a commercial launch.
Chronocort already has orphan drug designation in Europe and the US to treat congenital adrenal hyperplasia and adrenal insufficiency in adults, and is is not commercially available yet as it is currently in phase three development.
Infacort is currently undergoing regulatory review with the European Medicines Agency, and Diurnal chief executive Martin Whitaker, said that while this is ongoing, the company is “focused on putting in place the appropriate infrastructure to ensure that patients with cortisol deficiency but no other treatment options can access this medicine as efficiently as possible”.
Steve Glass, North America and Europe chief commercial officer at Clinigen said: "As the global leader in providing managed access programmes, we can leverage our international reach to support these patients by enabling their physicians to access these therapies safely, ethically and quickly, ahead of approval and launch."
Shares in Clinigen were up 1.07% to 796.42p at 0906 GMT and shares in Diurnal rose 2.22% to 138p at 0912 GMT.