IP Group PLC Diurnal receives positive CHMP opinion for Alkindi (5297Z)
December 15 2017 - 07:50AM
UK Regulatory
TIDMIPO TIDMDNL
RNS Number : 5297Z
IP Group PLC
15 December 2017
FOR RELEASE ON 15 December 2017
IP Group plc - Portfolio company Diurnal receives positive CHMP
opinion for Alkindi(R) (Infacort(R) ) 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(R) (development programme
name: Infacort(R) ) 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(R) in Q2 2018.
Martin Whitaker, CEO of Diurnal, said: "We are delighted that
the CHMP recognises Alkindi(R) as a treatment for paediatric
patients with paediatric adrenal insufficiency. If approved by the
European Commission, Alkindi(R) 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(R) 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
+44 (0) 20 7444 0050
Alan Aubrey, Chief Executive Officer
Greg Smith, Chief Financial Officer +44 (0) 20 7444 0062/+44 (0)
Liz Vaughan-Adams, Communications 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
This information is provided by RNS
The company news service from the London Stock Exchange
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