IP Group subsidiary drug granted market exclusivity for seven years
IP Group subsidiary Diurnal has been granted Orphan Drug designation by the US Food and Drug Administration for its lead product Chronocort.
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The move grants Diurnal seven years of market exclusivity. The company is tied to the University of Sheffield and IP Group holds a 51.7% undiluted beneficial interest in it.
Chronocort is a modified-release form of hydrocortisone, specifically designed to provide cortisol replacement throughout the day in a manner that mimics the natural circadian rhythm. Current available therapies are unable to stimulate the distinctive daily rhythm of cortisol release.
The drug has been designed as an oral medication and has the potential to significantly improve treatment of patients, according to an investor note published on Wednesday.
A clinical study of the drug’s affect in adults with Congenital Adrenal Hyperplasia was successfully completed in 2014 and further trials are expected to take place later in 2015 as Diurnal seeks to progress the drug towards market authorisation.