Business
Diurnal receives positive CHMP opinion for Alkindi
Diurnal receives positive CHMP opinion for Alkindi.
About this update from Ip Group Plc
[{"type":"text","content":"\n \nRNS Number : 5297Z IP Group PLC 15 December 2017 \n\n\n\n\n\nFOR RELEASE ON\n\n\n15 December 2017\n\n\n\n\n \n \nIP Group plc - Portfolio company Diurnal receives positive CHMP opinion for Alkindi® (Infacort®) for the treatment of paediatric adrenal insufficiency in Europe\n \nIP Group plc (LSE: IPO) (\"IP Group\" or \"the Group\"), the developer of intellectual property-based businesses, is pleased to note that portfolio company Diurnal Group plc (\"Diurnal\" or \"the Company\") has announced that the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has issued a positive opinion to the European Commission recommending Alkindi® (development programme name: Infacort®) as replacement therapy for paediatric adrenal insufficiency (AI).\n \nDiurnal is a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases in which IP Group holds a direct undiluted beneficial stake of 44.7%.\n \nIn accordance with the 60-day timeline following the adoption of the positive opinion by the CHMP, Diurnal anticipates the final decision on the paediatric use marketing authorisation (PUMA) from the European Commission in February 2018 and market launch for Alkindi® in Q2 2018.\n \nMartin Whitaker, CEO of Diurnal, said: \"We are delighted that the CHMP recognises Alkindi® as a treatment for paediatric patients with paediatric adrenal insufficiency. If approved by the European Commission, Alkindi® will be the first licensed treatment in Europe specifically designed for use in children with adrenal insufficiency. We are on track with establishing our European infrastructure to directly commercialise Alkindi® in key territories, subject to receiving paediatric use marketing authorisation for this important new treatment, which is anticipated in February 2018.\"\n \nThe Company noted that the positive opinion from the CHMP is based on review of data from the Company's pivotal open-label Phase III clinical trial conducted in 24 subjects before their sixth birthday, requiring replacement therapy for adrenal insufficiency due to congenital adrenal hyperplasia, primary adrenal failure or hypopituitarism. The study successfully met its primary endpoint and no serious adverse events were reported. Based on these d...