IP Group Plc. (IPO.L), a developer of intellectual property-based businesses, said portfolio company Diurnal Limited 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 authorization for the drug in the U.S.
It 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 in which IP Group holds a 51.7 percent undiluted beneficial interest, has developed Chronocort to treat the rare disease Congenital Adrenal Hyperplasia or 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.
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