IP Group PLC EMA positive opinion for Diurnal's Chronocort (6775T)
March 26 2021 - 8:26AM
UK Regulatory
TIDMIPO
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(R)
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(R) (to be branded as Efmody(R) ), 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(R)
(hydrocortisone modified-release hard capsules - development name
Chronocort(R) ) 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(R)
(hydrocortisone granules in capsules for opening) by
commercialising the product itself in core European markets.
Efmody(R) 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
+44 (0) 20 7444 0050
Greg Smith, Chief Financial Officer +44 (0) 20 7444 0062/+44 (0)
Liz Vaughan-Adams, Communications 7979 853802
Charlotte Street Partners
David Gaffney +44 (0) 7854 609998
Andrew Wilson +44 (0) 7810 636995
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 .
ENDS
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