OREANDA-NEWS. March 26, 2015. IP Group plc (LSE: IPO) ("IP Group" or "the Group"), the developer of intellectual property-based businesses, is pleased to note that portfolio company Diurnal Limited ("Diurnal") has been granted Orphan Drug designation by the US Food and Drug Administration for its lead product Chronocort®. This affords Diurnal seven years of market exclusivity after the award of marketing authorisation for the drug in the US and adds to the two Orphan Drug designations that Chronocort® has already received from the European Medicines Agency, which afford ten years of market exclusivity after the award of marketing authorisation in Europe.

Diurnal, a spin-out company from the University of Sheffield and in which IP Group holds a 51.7% undiluted beneficial interest, has developed Chronocort® to treat the rare disease Congenital Adrenal Hyperplasia (CAH). CAH occurs when the body is unable to produce cortisol, an essential hormone for regulating metabolism and responding to stress.  It is estimated that there are over 250,000 CAH sufferers worldwide. Current therapy - the replacement of cortisol with its synthetic equivalent, hydrocortisone (and other steroid combinations) - is unable to simulate the distinctive daily rhythm of cortisol release. Poor control of the disease can result in precocious puberty in children and, in adulthood, causes virilization, infertility and fatigue, while overuse of steroids can result in obesity, hypertension, diabetes and osteoporosis. 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.

The drug is taken in oral form and has the potential to significantly improve the treatment of patients with CAH. In 2014, a six-month Phase 2 clinical study of Chronocort® was successfully completed in adults suffering from CAH, demonstrating the appropriate release profile of hydrocortisone and consequent control of androgen levels. Pivotal Phase 3 trials of Chronocort® are due to start during 2015 as Diurnal seeks to progress the drug towards market authorisation.