Diurnal Group PLC CHMP positive opinion for Alkindi® (Infacort®) (5124Z)
December 15 2017 - 6:11AM
UK Regulatory
TIDMDNL
RNS Number : 5124Z
Diurnal Group PLC
15 December 2017
15 December 2017
Diurnal Group plc
("Diurnal" or the "Company")
CHMP issues positive opinion for Alkindi(R) (Infacort(R) ) for
the treatment of paediatric adrenal insufficiency in Europe
Positive opinion for approval includes paediatric patients up to
18 years of age
Alkindi(R) will be Diurnal's first product to receive market
authorisation; market launch anticipated in Q2 2018
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces 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) ; hydrocortisone granules in capsules for opening) as
replacement therapy for paediatric adrenal insufficiency (AI). In
accordance with the 60-day timeline following the adoption of the
positive opinion by the CHMP, the final decision on the paediatric
use marketing authorisation (PUMA) from the European Commission is
anticipated in February 2018.
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.
Reflecting a concentrated prescribing base, and to retain the
full value of the product, Diurnal intends to commercialise
Alkindi(R) itself in the major European markets, focusing its
marketing efforts initially on patients aged 0-6 years where the
unmet need is highest. Diurnal has made significant progress during
2017 in establishing its European commercial operations to prepare
for the anticipated launch of Alkindi(R) in Q2 2018.
Paediatric AI, including the related genetic condition
Congenital Adrenal Hyperplasia (CAH), is a condition characterised
by deficiency in cortisol, an essential hormone in regulating
metabolism and the response to stress. Paediatric AI has been
identified as a rare disease in Europe where there are estimated to
be approximately 4,000 sufferers under the age of six. Untreated,
the disease is associated with significant morbidity and increased
mortality.
AI in children is currently treated by compounding
hydrocortisone or crushing/splitting tablets of adult preparations
of hydrocortisone (the synthetic version of cortisol) as there is
no licensed formulation available specifically designed for
children. Alkindi(R) is specifically designed to provide the first
regulated, consistent preparation of hydrocortisone to ensure
efficacy and safety and ease of use for children suffering from AI,
including CAH.
Dr Oliver Blankenstein of Charité-Universitätsmedizin Berlin and
co-investigator in the Phase III clinical trial commented:
"I am very pleased that this medicine, specifically designed to
treat children with adrenal insufficiency, may soon be available to
patients in Europe, following the issue of a positive opinion for
approval by the CHMP. I believe Alkindi(R) is a major breakthrough
in addressing the significant unmet medical need in the paediatric
population."
Martin Whitaker, CEO of Diurnal, added:
"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."
For further information, please visit www.diurnal.co.uk
or contact:
+44 (0)20 3727
Diurnal Group plc 1000
Martin Whitaker, Chief Executive
Officer
Richard Bungay, Chief Financial
Officer
Numis Securities Ltd (Nominated +44 (0)20 7260
Adviser) 1000
Nominated Adviser: Michael Meade,
Paul Gillam, Freddie Barnfield
Corporate Broking: James Black
Panmure Gordon (UK) Limited (Joint +44 (0) 20 7886
Broker) 2500
Corporate Finance: Freddy Crossley
Corporate Broking: Tom Salvesen
+44 (0)20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-based specialty pharma company
developing high quality products for the global market for the
life-long treatment of chronic endocrine conditions, including
Congenital Adrenal Hyperplasia and Adrenal Insufficiency. Its
expertise and innovative research activities focus on
circadian-based endocrinology to yield novel product candidates in
the rare and chronic endocrine disease arena.
For further information about Diurnal, please visit
www.diurnal.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCFFSFFIFWSEFE
(END) Dow Jones Newswires
December 15, 2017 07:11 ET (12:11 GMT)
Diurnal (LSE:DNL)
Historical Stock Chart
From Apr 2024 to May 2024
Diurnal (LSE:DNL)
Historical Stock Chart
From May 2023 to May 2024