25th Mar 2015 07:44
LONDON (Alliance News) - IP Group PLC said Wednesday its portfolio company Diurnal Ltd's lead product Chronocort for the treatment of congenital adrenal hyperplasia has been granted an orphan drug designation by the US Food and Drug Administration.
This designation grants Diurnal seven-years of market exclusivity from when it is awarded marketing authorisation in the US. The treatment has already received two orphan drug designations from the European Medicines Agency, giving the company ten years of market exclusivity in Europe.
IP Group has a 51.7% interest in Diurnal, which was spun-out of the University of Sheffield.
During 2014, a six months phase II study of Chronocort was completed and phase III trials of the product are due to start in 2015.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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