TIDMDNL
RNS Number : 2036F
Diurnal Group PLC
19 February 2018
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal signs marketing and distribution agreement for the
commercialisation of Alkindi(R) and Chronocort(R) in Australia and
New Zealand with Emerge Health
Further validation of Diurnal's products and approach to global
marketing and distribution in high value markets outside core
Europe and US 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
Emerge Health Pty Ltd (Emerge Health), a leading, specialised
Australian pharmaceutical company focused on the marketing and
sales of niche, high quality medicines to the hospital sector. The
agreement covers the commercialisation of Diurnal's novel
therapies, Alkindi(R) (hydrocortisone granules in capsules for
opening) and Chronocort(R) (modified release hydrocortisone), in
Australia and New Zealand.
Under the terms of the agreement, Emerge Health will receive the
exclusive rights to market and sell Alkindi(R) and Chronocort(R) in
Australia and New Zealand. Diurnal will provide Emerge Health with
product for sale in Australia and New Zealand from its established
European supply chain. This agreement marks an important
commercialisation step as Diurnal seeks to further expand the reach
of its lead products in diseases of cortisol deficiency.
Following European marketing authorisation, announced on 13
February 2018, Emerge Health will submit Alkindi(R) for marketing
authorisation in Australia and New Zealand during 2018. The
submission will be based on the European regulatory dossier and
published clinical trial data, with the first potential for
approval in Australia in 2020.
Australia and New Zealand represent significant market
opportunities for Diurnal. There are around 1,750 patients in these
territories suffering from paediatric adrenal insufficiency (AI)
and congenital adrenal hyperplasia (CAH), providing an estimated
total market opportunity for Alkindi(R) and Chronocort(R) of
approximately $10 million per annum.
Alkindi(R) 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.
Chronocort(R) is a modified release hydrocortisone preparation in
development 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.
Chris Rossidis, Head of Commercial Operations of Emerge Health,
commented:
"As a leading Australian pharmaceutical company providing
patients in areas of unmet clinical need with access to the best
specialised medicines available globally, Alkindi(R) and
Chronocort(R) are ideal products for us to market and distribute
into our established network in secondary care. With the recent
European approval, we look forward to initially working with
Diurnal to register Alkindi(R) and, following anticipated market
authorisations, to commercialise the product in Australia and New
Zealand."
Martin Whitaker, Chief Executive Officer of Diurnal, added:
"Emerge Health's focus on niche, high quality medicines means
that they are the ideal strategic partner to help us commercialise
our novel products in the important Australian and New Zealand
healthcare markets. These territories represent an estimated total
market opportunity of $10 million for Alkindi(R) and Chronocort(R)
. Together with our commercialisation agreement with Medison Pharma
in Israel, we continue to build our marketing and distribution
capabilities in high value markets outside our core European and US
territories through local distribution arrangements."
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,
Paul Gillam, Freddie Barnfield
Corporate Broking: James Black
Panmure Gordon (UK) Limited (Joint +44 (0) 20 7886
Broker) 2500
Corporate Finance: Freddy Crossley
Corporate Broking: Tom Salvesen
+44 (0)20 3727
FTI Consulting 1000
Investor Relations: 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. 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). AI is estimated to affect over four
million patients globally.
In the paediatric setting, AI, including the related genetic
condition congenital adrenal hyperplasia, is estimated to affect
approximately 400 patients in Australia and New Zealand. In Europe,
AI has been identified as a rare condition, where there are
estimated to be approximately 4,000 sufferers younger than the age
of six, where the need for an effective replacement therapy is
greatest. Prior to the European approval of Diurnal's product,
Alkindi(R) , paediatric AI was treated by compounding
hydrocortisone or crushing/splitting tablets of adult preparations
of hydrocortisone (the synthetic version of cortisol) as there was
no licensed formulation available specifically designed for
children.
Diurnal's products, Alkindi(R) and Chronocort(R) , have been
granted Orphan Drug Designations in the US for the treatment of AI.
Chronocort(R) also benefits from Orphan Drug Designation for AI in
Europe. These orphan drug designations mean Alkindi(R) and
Chronocort(R) have the potential to be granted market and data
exclusivity for seven years in the US and 10 years in Europe for
Chronocort(R) post market authorisation.
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 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 1,350 adult patients
in Australia and New Zealand, 47,000 patients in Europe and over
400,000 patients globally.
Current therapy for CAH uses a variety of generic steroids
(hydrocortisone, dexamethasone and prednisolone) which, at best,
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.
Diurnal's product, Chronocort(R) , has been granted Orphan Drug
Designations in Europe and the US in the treatment of CAH,
providing the potential to be granted market exclusivity for 10
years in Europe and seven years in the US post market
authorisation.
About Alkindi(R)
Alkindi(R) is the first preparation of hydrocortisone
specifically designed for use in children suffering from paediatric
AI. Alkindi(R) is a patented, oral, immediate-release paediatric
formulation of hydrocortisone granules in capsules for opening that
allows for 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.
On 9 February 2018, the European Commission 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), following the positive opinion issued by the
European Medicines Agency in December 2017. The PUMA affords 10
years market and data exclusivity for Alkindi(R) in Europe
About Chronocort(R)
Chronocort(R) is a modified release preparation of
hydrocortisone that has been designed to mimic the 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). The first planned indication for Chronocort(R) is CAH in
adults.
Chronocort(R) has completed three Phase I trials in 2011, 2012
and 2015, a Phase II trial in CAH patients in 2014 in the US and is
currently in a Phase III trial in Europe. This pivotal Phase III
trial for Chronocort(R) in Europe is scheduled to complete in Q3
2018, with market authorisation in Europe expected in 2020.
About Emerge Health
Emerge Health is an innovative, specialised Australian
pharmaceutical company focused on the marketing and sales of niche,
high quality medicines to the hospital sector. Emerge Health is
dedicated to providing exceptional products and support to ensure
it meets its customers and partners needs and priorities.
For more information, please visit
http://www.emergehealth.com.au
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
This information is provided by RNS
The company news service from the London Stock Exchange
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