TIDMDNL
RNS Number : 2463A
Diurnal Group PLC
28 May 2021
28 May 2021
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal receives European Commission approval for Efmody(R)
First licensed treatment for European patients with CAH that
mimics the physiological circadian rhythm of cortisol
Diurnal's second product to receive marketing authorisation
Commercial launch anticipated in Q3 2021
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces the European Commission (EC) has approved the
marketing authorisation for 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). This
decision by the EC follows the positive opinion issued by the
European Medicines Agency (EMA) in March 2021.
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. The Company intends to mirror its strategy for Alkindi(R)
(hydrocortisone granules in capsules for opening) by
commercialising the product itself in core European markets. The EC
decision for Efmody(R) is valid in all countries of the European
Union, and will also be adopted by Norway, Iceland and
Liechtenstein.
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 36,000 in the European Economic Area.
Professor Dr med Nicole Reisch, Professor of Internal Medicine,
Endocrinology at the Ludwig-Maximilian-University Munich,
commented:
"We welcome today's decision by the European Commission for
Efmody(R) as treatment for adult and adolescent patients with the
rare disease of congenital adrenal hyperplasia. Efmody(R) has been
proven to provide control of the disease and the overall data shows
an improved hormone balance, which will provide a well-tolerated
and practical twice-daily treatment regimen for these patients
where there is a significant unmet need. As the first licensed
treatment for European patients with congenital adrenal hyperplasia
that mimics the physiological circadian rhythm of cortisol, we look
forward to having an additional therapeutic option for congenital
adrenal hyperplasia patients in the near future."
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We are delighted to have received European approval for
Efmody(R) , a significant milestone for Diurnal as our second
product to receive marketing authorisation. We look forward to
expanding our adrenal portfolio with the European launch of
Efmody(R) in Q3 2021 alongside our first product Alkindi(R) , to
provide treatment for patients with congenital adrenal hyperplasia,
enabling Diurnal to continue to drive towards becoming a
world-leading specialty endocrinology business. "
This is a business press release containing financial
information and/or data for the benefit of shareholders and
potential investors. Data are included to allow informed investment
decisions.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
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
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0)20 7886
and Sole Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Alex Davis
Notes to Editors
About Congenital Adrenal Hyperplasia
Congenital adrenal hyperplasia (CAH) is an orphan condition
caused by deficiency of adrenal enzymes, most commonly
21-hydroxylase. This enzyme is required to produce the adrenal
steroid hormone, cortisol. The block in the cortisol production
pathway causes the over-production of male steroid hormones
(androgens), which are precursors to cortisol. The condition is
congenital (inherited at birth) and affects both sexes. The
cortisol deficiency and over-production of male sex hormones can
lead to increased mortality, infertility and issues during sexual
development including ambiguous genitalia, premature (precocious)
sexual development and short stature. Sufferers, even if treated,
remain at risk of death through an adrenal crisis.
Current therapy for CAH uses a variety of generic glucocorticoid
(steroids including hydrocortisone, dexamethasone, prednisolone and
prednisone in the US) with no standard treatment regimen.
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 and the United Kingdom, with over 400,000 in the rest of the
world.
About Efmody(R) (hydrocortisone modified release hard
capsules)
Efmody(R) is a preparation of hydrocortisone that has been
specifically designed to mimic the circadian rhythm of cortisol
when given in a twice-a-day "toothbrush" regimen (administered last
thing at night before sleep and first thing in the morning on
waking) to control androgen excess and chronic fatigue in patients
with diseases of cortisol deficiency. The first indication for
Efmody(R) is Congenital Adrenal Hyperplasia (CAH) in adults and
adolescents (children older than 12 years of age). Efmody(R) has
been extensively studied in 239 human subjects including 138 CAH
patients who have taken part in clinical trials in Europe and the
US.
The European Commission approval of Efmody(R) is based on a
Phase 3 study conducted in a total of 122 patients enrolled across
11 clinical sites, the largest ever interventional clinical trial
completed in CAH. The Phase 3 data was supported by detailed
analysis of data from an open-label safety extension study for
patients completing treatment in the Phase 3 study, which is
assessing the impact of treatment with Efmody(R) over an extended
period, with a number of patients on this trial having been treated
for over 54 months. Patient retention rates in this study have been
high and patients on this trial have, to date, shown sustained
benefit from extended Efmody(R) treatment.
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty
pharmaceutical company dedicated to developing hormone therapeutics
to aid lifelong treatment for rare and chronic endocrine
conditions, including congenital adrenal hyperplasia, adrenal
insufficiency, hypogonadism and hypothyroidism. 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
Date of Preparation: May 2021 Code: CORP-GB-0119
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