TIDMDNL
RNS Number : 2937Y
Diurnal Group PLC
02 March 2017
2 March 2017
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal signs marketing and distribution agreement for the
commercialisation of Infacort(R) and Chronocort(R) with Israel's
leading commercial group for niche healthcare products
Further validation of lead products in diseases of cortisol
deficiency
Significant market opportunity for Diurnal, given the estimated
higher prevalence of CAH in Israel
Agreement exemplifies Company approach to marketing and
distribution outside of core territories
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces a marketing and distribution agreement with
Medison Pharma Ltd (Medison), Israel's leading group for the
marketing of innovative niche healthcare solutions. The agreement
covers the commercialisation in Israel of Diurnal's novel therapies
for adrenal insufficiency, Infacort(R) and Chronocort(R) .
Infacort(R) is expected to be submitted for marketing authorisation
in Israel once approved by the European Medicines Agency (EMA).
Diurnal anticipates EMA marketing authorisation approval for
Infacort(R) could come towards the end of 2017 with the potential
of approval in Israel during 2018, based on the European regulatory
submission package and clinical trial data.
Under the terms of the agreement, Medison will receive the
exclusive rights to market and sell Infacort(R) and Chronocort(R)
in Israel. This agreement forms part of Diurnal's ongoing
activities for commercialisation of its lead products in diseases
of cortisol deficiency. Infacort(R) has the potential to be the
first preparation of hydrocortisone (the synthetic version of
cortisol) specifically designed for use in children suffering from
adrenal insufficiency (AI), including the related disease,
Congenital Adrenal Hyperplasia (CAH). Chronocort(R) is a modified
release hydrocortisone preparation that has been designed to mimic
the natural circadian rhythm of cortisol when given in a
twice-a-day "toothbrush" regimen for the treatment of adult
CAH.
Israel represents a significant market opportunity for Diurnal,
given the estimated higher prevalence of CAH in Israel(1) . There
are around 1,000 patients in Israel (paediatric AI and CAH),
providing a total market opportunity for Infacort(R) and
Chronocort(R) estimated by the Company to be approximately $7m per
annum.
Prof. Naomi Weintrob, MD, MHA, Senior Pediatric Endocrinologist,
Scientific Advisor, Israeli CAH Association, commented:
"Infacort(R) and Chronocort(R) have the potential to address a
significant unmet medical need for patients with adrenal
insufficiency and congenital adrenal hyperplasia who are not
currently being treated satisfactorily. Infacort(R) allows delivery
of hydrocortisone in accurate and small doses, which are best
suited for infants and young children, and Chronocort(R) is
designed to imitate diurnal physiologic cortisol secretion. I
therefore look forward to the introduction of these innovative
products in Israel."
Dr Martin Whitaker, CEO of Diurnal, added:
"Medison is uniquely qualified to provide the complete spectrum
of integrated sales and marketing services Diurnal requires to
enter the Israeli healthcare market. Given the estimated higher
prevalence of CAH in Israel(1) , this market represents a
significant opportunity for Diurnal. The agreement with Medison
marks a further validation of the quality of our products and
provides us with the ability to distribute Infacort(R) outside our
core territories of Europe and the US. We believe that our
strategic objectives and global ambitions are aligned with this
important new partner, which also provides a blueprint for other
similar agreements, addressing selected high value markets, in the
future."
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,
Freddie Barnfield, Paul Gillam
Corporate Broking: James Black
Panmure Gordon (UK) Limited (Joint +44 (0) 20 7886
Broker) 2500
Corporate Finance: Freddy Crossley
/ Duncan Monteith
Corporate Broking: Tom Salvesen
+44 (0)20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Adrenal Insufficiency
Adrenal Insufficiency (AI) is a condition characterised by
deficiency in cortisol, an essential hormone in regulating
metabolism and the response to stress. AI has been identified as a
rare disease in Europe where there are estimated to be
approximately 4,000 sufferers younger than the age of six.
Currently there are no licensed hydrocortisone preparations in
Europe specifically designed to treat these young patients. These
children are often administered compounded adult tablets or other
unlicensed products. Poor control of disease can result in
precocious puberty in young children, virilisation in girls and
chronic fatigue leading to a poor quality of life in adulthood
resulting in increased morbidity and mortality.
About Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia ("CAH") is an orphan condition
usually caused by deficiency of the enzyme 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 severe development defects including
ambiguous genitalia, premature (precocious) sexual development and
short stature. Sufferers, even if treated, remain at risk of death
through an adrenal crisis.
Approximately two thirds of CAH patients are estimated to have
poor disease control, leading to elevated androgen levels. The
condition is estimated to affect approximately 71,000 patients in
Europe (51,000) and the US (20,000), with approximately 405,000 in
the rest of the world.
Current therapy for CAH uses a combination of generic steroids
(hydrocortisone, dexamethasone and prednisolone) and, at best,
these adequately treat approximately one third of CAH patients.
Other therapies being developed are at an early stage of
development and not expected to receive approval in the
short-term.
About Infacort(R)
Infacort(R) represents the first preparation of hydrocortisone
specifically designed for use in children suffering from AI. It is
a patented, immediate-release, oral, paediatric formulation of
hydrocortisone that allows for age-appropriate dosing in children.
This therapeutic approach has the potential to help young patients
less than six year of age suffering from diseases due to cortisol
deficiency including adrenal insufficiency and congenital adrenal
hyperplasia. AI requires life-long treatment and Diurnal's novel
approach to product development has the potential to significantly
improve these young patients' lives. Diurnal has already submitted
for market authorisation to the European Medicines Agency via the
Paediatric Use Marketing Authorisation (PUMA) route in late
2016.
About Chronocort(R)
Chronocort(R) is a modified release hydrocortisone preparation
that has been designed to mimic the natural circadian rhythm of
cortisol when given in a twice-a-day "toothbrush" regimen (last
thing at night before sleep and first thing in the morning on
waking). Chronocort has been granted orphan drug designations in
Europe and the US in the treatment of Congenital Adrenal
Hyperplasia ("CAH") and Adrenal Insufficiency ("AI"). The first
planned indication for Chronocort(R) is CAH. Chronocort(R) has
completed three Phase I trials in 2011, 2012 and 2015 (food effects
study) and a Phase II trial in CAH patients in 2014, and is
currently in Phase III trials in Europe.
Phase II
Data from the Chronocort(R) Phase II trial demonstrate that the
trial met its primary endpoint of fully characterising the
pharmacokinetic profile of Chronocort(R) in 16 male and female
adult subjects with CAH. The results show Chronocort(R) provides
circadian levels of the stress hormone, cortisol, similar to the
healthy population mimicking the overnight rise in cortisol levels,
such that patients wake with a normal cortisol level.
In addition, the secondary objective of examining the effect of
Chronocort(R) on the morning biochemical efficacy markers of the
disease showed significant control in 94 per cent. of the patients
having their morning levels of the androgens,
17-hydroxyprogesterone (170HP) and androstenedione (A4), brought
into the optimal range after six months' treatment with titrated
Chronocort(R) , compared to poorer control (only 31 per cent.
controlled) on standard treatment at the beginning of the study.
Chronocort(R) was well-tolerated during the six month trial.
About Medison Pharma Ltd
Medison is Israel's leading specialty pharmaceutical company,
focused on delivering innovative healthcare solutions to the
Israeli market. Medison is uniquely qualified to provide the
complete spectrum of integrated services, including early access
programs, regulatory affairs, registration and reimbursement,
medical, marketing and logistics. Backed by three generations of
experience in the healthcare industry since 1937, Medison is the
exclusive Israeli partner for leading global pharma companies such
as Amgen(R), Biogen(R), Shire(R) and Ipsen(R). Medison also
operates a fully owned subsidiary in Romania based on replicating
its success in Israel.
For more information, please visit www.medisonpharma.com
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
(1) Speiser et al Am J Hum Genet 37: 650-667 (1985)
This information is provided by RNS
The company news service from the London Stock Exchange
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