TIDMDNL
RNS Number : 3999D
Diurnal Group PLC
29 June 2021
29 June 2021
Diurnal Group plc
("Diurnal" or the "Company")
Distribution agreement with Er-Kim for Bulgaria and Romania
Extends relationship with Er-Kim following Turkey agreement for
Alkindi(R) and Efmody(R)
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that it has extended its distribution
arrangements with Er-Kim, a leading partner for global biotech and
pharma companies seeking to commercialise its products in Turkey,
Europe and the Middle East, to include the distribution and
marketing of Alkindi(R) (hydrocortisone granules in capsules for
opening) and Efmody(R) ( hydrocortisone modified-release hard
capsules) in Bulgaria and Romania.
Under the terms of the agreement, Er-Kim will receive the
exclusive rights to distribute and market Alkindi(R) and Efmody(R)
in Bulgaria and Romania. The combined market in both countries is
estimated to be more than $13m in 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 (the synthetic
version of 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, to
facilitate timely commercial availability, the Company has
commenced market access activities with commercial launches in
European countries anticipated to commence from Q3 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 Er-Kim. 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.
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We are pleased to announce the extension of our relationship
with Er-Kim to make our products, Alkindi(R) and Efmody(R) ,
available to patients with diseases of cortisol deficiency in
Bulgaria and Romania. As Efmody(R) becomes available for patients
in Europe from Q3 2021, this agreement is in line with our strategy
to optimise global market access for our products. Since signing
our initial agreement with
Er-Kim in January 2021 for Turkey, we have been impressed with
Er-Kim's in-market expertise and with a strong track record of
commercialisation, we look forward to strengthening this
relationship going forward."
Cem Zorlular, Chairman and Chief Executive Officer of Er-Kim,
commented:
"We are incredibly motivated by the prospect of enabling access
for patients in Bulgaria and Romania to Diurnal's much needed
pediatric and adult cortisol deficiency treatments. Furthermore, we
feel privileged to expand our collaboration with Diurnal who share
our passion in addressing patients' unmet needs in rare and chronic
endocrine conditions."
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 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
(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 400,000 patients
worldwide.
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 market authorisation 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. 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.co.uk
About Er-Kim
Er-Kim is a leading commercial partner for global biotech and
pharma companies seeking to commercialise its products in Turkey,
Europe and Middle East. In its 40-year of presence, Er-Kim has
commercialised over 150 original therapies from more than 50
leading global pharmaceutical companies. Additionally, Er-Kim
operates in drug discovery for unmet needs in rare blood diseases
and R&D providing cost-effective manufacturing of advanced
medicinal products easing the economic burden of the healthcare
system.
For further information about Er-Kim, please visit
www.erkim-ilac.com.tr/en/
Date of Preparation: June 2021 Code: CORP-GB-0133
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