Phoqus' Chronocort gets European OD status

West Malling, UK-based Phoqus says that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA), has adopted a positive opinion on its application for Orphan Drug designation for Chronocort, a modified-release formulation of hydrocortisone, the first Circadian endocrine treatment for adrenal insufficiency. The decision awaits formal approval by the European Commission.

In Europe, Orphan status affords 10 years market exclusivity after the grant of a marketing authorization. Other benefits include protocol assistance, access to the centralized procedure for the application for marketing authorization and fee reductions. Following a licensing deal with Diurnal, a portfolio company of Biofusion, Chronocort has already been granted Orphan Drug Status for Chronocort in the treatment of congenital adrenal hyperplasia (CAH).

According to Phoqus, current steroid therapies for these conditions do not mimic the natural circadian rhythm of the endogenous steroid hormone, creating an unmet need in the annual worldwide market worth in excess of L75.0 million (L146.1 million). Phoqus believes that the Chronocort tablet would address this need effectively and provide a much needed treatment.