EMA positive opinion for Diurnal's Chronocort

RNS Number : 6775T

IP Group PLC

26 March 2021

 

FOR RELEASE ON

26 March 2021

IP Group plc - Portfolio company Diurnal announces European Medicine Agency issues positive opinion for Chronocort®

in Europe

IP Group plc (LSE: IPO) ("IP Group" or "the Group"), the developer of intellectual property-based businesses, is pleased to note that AIM-listed portfolio company Diurnal Group plc ("Diurnal"; AIM: DNL) has announced that the European Medicine Agency (EMA) has issued a positive opinion for Diurnal's second product, Chronocort^® (to be branded as Efmody^®), in Europe which is expected to launch commercially in Q3.

IP Group currently holds a direct undiluted beneficial stake of 31.9% in Diurnal which is a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases.

Dr Sam Williams, Managing Partner, IP Group Life Sciences , said: "We are delighted for the Diurnal management team and staff who, having already brought a first, ground-breaking drug to market in Alkindi, now have the realistic chance of a second, Chronocort. As Diurnal's largest shareholder since 2005, this news supports IP Group's approach to providing long-term backing for its core portfolio companies."

Diurnal announced that the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the EMA, had issued a positive opinion to the European Commission recommending Efmody^® (hydrocortisone modified-release hard capsules - development name Chronocort^®) as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH).

The formal approval of marketing authorisation from the European Commission is anticipated in June 2021, in accordance with the 67-day timeline following the adoption of the positive opinion by the CHMP, together with a decision on grant of Orphan Drug Status. To facilitate timely commercial availability, Diurnal has already commenced market access activities in its target European territories, with the first commercial launch anticipated in Q3 2021.

Diurnal intends to mirror its strategy for Alkindi^® (hydrocortisone granules in capsules for opening) by commercialising the product itself in core European markets.

Efmody^® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe.

For more information, please contact:

IP Group plc	www.ipgroupplc.com
Greg Smith, Chief Financial Officer Liz Vaughan-Adams, Communications	[phone] [phone]/[phone]
Charlotte Street Partners
David Gaffney	[phone]
Andrew Wilson	[phone]

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 early-stage to mature businesses across life sciences and technology. IP Group 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 .

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