TIDMDNL
RNS Number : 0161P
Diurnal Group PLC
14 October 2021
14 October 2021
Diurnal Group plc
("Diurnal" or the "Company")
Distribution agreement signed with ExCEEd Orphan for Central and
Eastern Europe
Agreement extends the Company's commercial footprint to over
two-thirds of the European Economic Area population
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that it has signed a distribution agreement
with ExCEEd Orphan, a company providing full business solutions for
the treatment of rare diseases, for the distribution and marketing
of Alkindi(R) (hydrocortisone granules in capsules for opening) and
Efmody(R) ( hydrocortisone modified-release hard capsules) in
Central and Eastern European (CEE) countries.
Under the terms of the agreement, ExCEEd Orphan will receive the
exclusive rights to distribute and market Alkindi(R) and Efmody(R)
in the CEE countries including; Albania, Bosnia and Herzegovina,
Croatia, Czechia, Hungary, Kosovo, Montenegro, North Macedonia,
Poland, Serbia, Slovakia, and Slovenia. Based on the Company's
estimates and market research conducted by ExCEEd Orphan, there are
estimated to be in total around 9,500 patients in the CEE region
suffering from paediatric adrenal insufficiency (AI) and adult
congenital adrenal hyperplasia (CAH).
Alkindi(R) already has marketing authorisation in the European
Union and is the first preparation of hydrocortisone (synthetic
cortisol) specifically designed for use in children suffering from
AI, including the related condition CAH. Efmody(R) is a
modified-release preparation of hydrocortisone for the treatment of
patients with CAH, a rare condition caused by a genetic deficiency
of adrenal enzymes. In May 2021, Efmody(R) was granted marketing
authorisation in the European Union and was subsequently launched
by the Company in Germany, Austria and the UK in September
2021.
In line with the Company's other global distribution agreements,
Diurnal will provide Alkindi(R) and Efmody(R) from its established
European supply chain for sale by ExCEEd Orphan. This agreement
adds to the Company's ongoing strategy for commercialisation of its
lead products by optimising market access outside of the larger
European markets, where Diurnal directly markets its products,
through entering marketing and distribution agreements with
companies focused on niche and orphan conditions. With the
execution of this agreement, the Company's two lead products will
be available to over two-thirds of the European Economic Area (EEA)
population, and ExCEEd Orphan will work to make these products
available in territories beyond this region in Central and Eastern
Europe.
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We are pleased to announce this distribution agreement with
ExCEEd Orphan to make Alkindi(R) and Efmody(R) available to
patients with diseases of cortisol deficiency across Central and
Eastern Europe. Following this agreement, Diurnal's products are
now available to over two-thirds of the EEA population and we are
looking forward to working with ExCEEd Orphan who have a strong
track record of launching orphan medicines within this region. As
Efmody(R) has now launched for patients in Europe, this agreement
is in line with our commercialisation strategy in order to optimise
global market access for our products outside of large European
markets."
Jiri Hermanek, Chief Executive Officer and Founding Partner of
ExCEEd Orphan, commented:
"We are very pleased to announce this collaboration to make
Alkindi(R) and Efmody(R) available to patients with diseases of
cortisol deficiency across Central and Eastern European countries.
Both products will represent an important addition to the
continuously growing portfolio of rare disease medications marketed
and distributed by ExCEEd Orphan and we are fully committed to
bringing these unique medications to all patients in needs in all
respective countries."
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.com 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 paediatric adrenal insufficiency
Paediatric AI, including the genetic condition CAH is a
condition characterised by deficiency in cortisol, an essential
hormone in regulating metabolism and the response to stress. The
primary symptoms of AI are chronic fatigue and patients are at risk
of adrenal crisis and death if they do not have adequate cortisol
replacement. AI is either primary or secondary, with primary AI
resulting from diseases intrinsic to the adrenal gland and
secondary AI resulting from pituitary diseases where there is a
failure of stimulation of the adrenal by the pituitary of the
signalling hormone ACTH (adrenocorticotropic hormone).
About Alkindi(R) (hydrocortisone granules in capsules for
opening)
Alkindi(R) is the first preparation of hydrocortisone
specifically designed for use in children suffering from paediatric
adrenal insufficiency (AI), including congenital adrenal
hyperplasia (CAH). Alkindi(R) is a patented, oral,
immediate-release paediatric formulation of hydrocortisone granules
in capsules for opening that allows for accurate age-appropriate
dosing in children. This therapeutic approach has the potential to
help young patients less than eighteen years of age suffering from
diseases due to cortisol deficiency including paediatric AI and
CAH. AI requires life-long treatment and Diurnal's novel approach
to product development has the potential to significantly improve
these young patients' lives. The European Commission has granted a
paediatric use marketing authorisation (PUMA) for Alkindi(R) as
replacement therapy of AI in infants, children and adolescents
(from birth to <18 years old) in Europe. Alkindi(R) is approved
and known as Alkindi(R) Sprinkle in the US where it is licensed and
marketed by Eton Pharmaceuticals. Alkindi(R) is also approved in
Israel and Australia.
The human medicine European public assessment report (EPAR) for
Alkindi(R) can be viewed here and the Summary of Product
Characteristics (SmPC) here .
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
(steroid) preparations 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) was 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 five years.
The human medicine European public assessment report (EPAR) for
Efmody(R) can be viewed here and the Summary of Product
Characteristics (SmPC) 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.com
About ExCEEd Orphan
ExCEEd Orphan was founded in 2018 by five rare disease experts
from multiple Central and Eastern European (CEE) countries. The
Company is focusing on innovative treatments for rare diseases and
has extensive experience in launching innovative medicines in this
field. The portfolio of ExCEEd Orphan includes products in
therapeutic areas like haematology, neurology, immunology, and
metabolic diseases.
For further information about ExCEEd Orphan, please visit
www.exceedorphan.com
Date of Preparation: October 2021 Code: CORP-GB-0153
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