Diurnal Group PLC Market Authorisation Application in Australia (2407E)
03 July 2019 - 4:00PM
UK Regulatory
TIDMDNL
RNS Number : 2407E
Diurnal Group PLC
03 July 2019
3 July 2019
Diurnal Group plc
("Diurnal" or the "Group")
Alkindi(R) Market Authorisation Application Submitted in
Australia
Significant opportunity to address unmet medical need in
paediatric adrenal insufficiency in Australia
Continuation of strategy to expand global presence of lead
products
Second market authorisation submission for Alkindi(R) in 2019
following Israeli application
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that an application for market authorisation
for Alkindi(R) (hydrocortisone granules in capsules for opening)
has been submitted to the Australian Therapeutic Good
Administration (TGA) for the indication "replacement therapy of
adrenal insufficiency (AI) in infants, children and adolescents
(from birth to <18 years old)". Alkindi(R) was recently granted
Orphan Drug Designation in Australia, a valuable regulatory
privilege that provides significant benefits, including waiver of
application, evaluation and annual registration fees.
Diurnal's marketing and distribution partner in Australia and
New Zealand for Alkindi(R) and the Company's second product,
Chronocort(R) (modified release hydrocortisone), is Emerge Health
Pty Limited. Emerge Health is pursuing registration for Alkindi(R)
in Australia and New Zealand, which represent significant market
opportunities for Diurnal, with around 1,750 patients in these
territories suffering from paediatric AI and the genetic condition
congenital adrenal hyperplasia (CAH), providing an estimated total
market opportunity for Alkindi(R) and Chronocort(R) of
approximately $10 million per annum (USD).
Alkindi(R) is already approved and marketed in Europe 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. In February 2019, Diurnal
announced its partner, Medison Pharma Ltd, had submitted an
application for market authorisation for Alkindi(R) to the Ministry
of Health in Israel.
Martin Whitaker, Chief Executive Officer of Diurnal, added:
"We are pleased that our partner, Emerge Health, has
successfully submitted the market authorisation application for
Alkindi(R) in Australia. This builds on the grant of orphan drug
designation for Alkindi(R) in Australia received earlier in 2019,
which highlights the importance of this product as the first
specifically developed and licensed replacement therapy of
paediatric adrenal insufficiency designed to address the unmet need
in these young patients. We look forward to developing our already
successful relationship with Emerge Health as we continue to build
our marketing and distribution capabilities in high value markets
outside our core territories."
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 Joint Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns
+44 (0)20 7894
Cantor Fitzgerald Europe (Joint Broker) 7000
Corporate Finance: Phil Davies, Will Goode,
Michael Boot
Healthcare Equity Sales: Andrew Keith
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
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). 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
congenital adrenal hyperplasia (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.
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 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
About Emerge Health
Emerge Health Pty Limited 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
Date of Preparation: July 2019 Code: Inf EU-AUS-0002
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