Diurnal granted Orphan Drug designation in the US
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FOR RELEASE ON |
25 March 2015 |
IP Group plc - Portfolio company Diurnal Limited granted Orphan Drug designation in the US
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.
For more information, please contact:
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IP Group plc |
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Alan Aubrey, Chief Executive Officer |
+44 (0) 20 7444 0050 |
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FTI Consulting |
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James Melville-Ross/Simon Conway/ |
+44 (0)20 3727 1000 |
Notes for editors
About IP Group
IP Group is a leading UK intellectual property commercialisation company, developing technology innovations primarily from its research intensive partner universities. The Group offers more than traditional venture capital, providing its companies with access to business building expertise, networks, recruitment and business support.
IP Group's portfolio comprises holdings in around 90 early-stage to mature businesses across the Healthcare, Biotech, Cleantech and Technology sectors. These businesses include Oxford Nanopore Technologies, the DNA sequencing development company, Revolymer, best known for its removable chewing gum, and Xeros, which has received many accolades for its revolutionary clothes washing techniques with a much reduced requirement for water.
For more information, please visit our website at www.ipgroupplc.com.
ENDS
This information is provided by RNS
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