15 Dec 2017 12:50
FOR RELEASE ON | 15 December 2017 |
IP Group plc - Portfolio company Diurnal receives positive CHMP opinion for Alkindi® (Infacort®) for the treatment of paediatric adrenal insufficiency in Europe
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 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).
Diurnal 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%.
In 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.
Martin 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."
The 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 data, and a comprehensive dossier from Diurnal, the CHMP has recommended the product's use to include paediatric patients up to 18 years of age.
Dr Sam Williams, Head of Biotech at IP Group, said: "This is a major milestone for Diurnal which is one of IP Group's most advanced biotech assets. Diurnal has two products in Phase III, one of which now looks set for market launch in early 2018."
For more information, please contact:
IP Group plc | www.ipgroupplc.com |
Alan Aubrey, Chief Executive OfficerGreg Smith, Chief Financial OfficerLiz Vaughan-Adams, Communications | +44 (0) 20 7444 0050+44 (0) 20 7444 0062/+44 (0) 7979 853802 |
Charlotte Street Partners |
|
Andrew Wilson | +44 (0) 7810 636995 |
Martha Walsh | +44 (0) 7876 245962 |
Notes for editors
About IP Group
IP Group is a leading intellectual property commercialisation company which focuses on evolving great ideas, mainly from its partner universities, into world-changing businesses. The Group has pioneered a unique approach to developing these ideas and the resulting businesses by providing access to business building expertise, capital (through its 100%-owned FCA-authorised subsidiaries IP Capital and Parkwalk Advisors), networks, recruitment and business support. IP Group has a strong track record of success and its portfolio comprises holdings in approximately 100 early-stage to mature businesses across four main sectors -- Biotech, Cleantech, Healthcare and Technology. The Company is listed on the Main Market of the London Stock Exchange under the code IPO.
Group holdings in portfolio companies reflect the undiluted beneficial equity interest excluding debt, unless otherwise explicitly stated.
For more information, please visit our website at www.ipgroupplc.com.
ENDS