TIDMDNL
RNS Number : 9349D
Diurnal Group PLC
02 July 2021
02 July 2021
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal receives Marketing Authorisation for Efmody(R) in Great
Britain from the MHRA
Efmody(R) provides a new treatment option for c.5,000 patients
suffering from CAH in GB
GB launch of Efmody(R) expected in Q1 2022
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that the UK Medicines and Healthcare Products
Regulatory Agency (MHRA) has granted a 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). The Marketing Authorisation
for Efmody(R) from the MHRA applies in Great Britain (England,
Wales and Scotland) and follows the recent approval of the product
in the European Economic Area (including Northern Ireland)(EEA) by
the European Commission as announced on 28 May 2021.
The submission to the MHRA included detailed analysis of data
from the Company's Phase 3 study, the largest ever completed
interventional clinical trial in CAH involving 122 subjects, and an
open-label safety extension study of Efmody(R) . To facilitate
timely commercial availability, Diurnal has already commenced
market access activities in Great Britain, with the commercial
launch anticipated in Q1 2022. The Company intends to mirror its
strategy for Alkindi(R) (hydrocortisone granules in capsules for
opening) by commercialising the product itself in Great Britain as
well as other core European markets.
Following feedback from the MHRA and consistent with the
approach taken in the EEA, the Company has decided not to pursue
Orphan Drug Status for Efmody(R) in Great Britain as it would
likely cause a significant delay to the commercial launch. Whilst
Orphan Designation provides market exclusivity for 10 years from
launch, the Company currently holds granted patents for Efmody(R)
for the treatment of patients with CAH and believes these patents
provide sufficient protection for Efmody(R) until at least 2033 in
Great Britain.
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 5,000 patients in Great Britain.
Professor Wiebke Arlt, Institute of Metabolism and Systems
Research, University of Birmingham, commented:
"I am excited to see Efmody(R) approved in Great Britain as a
treatment for patients with CAH, a rare condition where patients
and doctors need to face the challenge of deficient cortisol
production and adrenal androgen excess. Efmody(R) has been
developed for these patients and I believe this drug approval
provides a new option for the treatment of CAH patients, where
there is a significant unmet medical need."
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We are pleased to have received approval for Efmody(R) from the
MHRA and look forward to making Efmody(R) available to CAH patients
in Great Britain as the first licensed treatment specifically
designed to mimic the physiological circadian rhythm of cortisol.
Today's approval is yet another important step forward for Diurnal
as we continue to drive towards becoming the world's 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 a rare 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 Great Britain, 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 MHRA and European Commission marketing authorisation
approval of Efmody(R) is based on a Phase 3 study conducted in a
total of 122 patients enrolled across 11 clinical sites, including
sites in Great Britain, 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. Summary of Product
Characteristics (SmPC) for UK (Northern Ireland) can be found here
.
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: July 2021 Code: CORP-GB-0137
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
REAMZGGNLMNGMZM
(END) Dow Jones Newswires
July 02, 2021 02:00 ET (06:00 GMT)
Diurnal (LSE:DNL)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Diurnal (LSE:DNL)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024
