TIDMDNL
RNS Number : 6808M
Diurnal Group PLC
10 January 2019
10(th) January 2019
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal announces grant of second US patent for
Chronocort(R)
Method of treatment patent provides additional protection in key
US market where Chronocort(R) has already received two Orphan Drug
Designations
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces the US Patent and Trademark Office (USPTO) has
granted a second US patent for Chronocort(R) (modified release
hydrocortisone).
US 10,166,194, entitled "Hydrocortisone Controlled Release
Formulation", is a patent claiming a method of treatment for
adrenal dysfunction, including the diseases congenital adrenal
hyperplasia (CAH) and adrenal insufficiency (AI), that delivers
hydrocortisone in accordance with a circadian rhythm. The patent
provides in-market protection until 2033 and is in addition to the
already granted pharmaceutical composition of matter patent US
9,750,704, which provides in-market protection until 2034.
This patent expands the Company's strong exclusivity position in
the US, where Chronocort(R) has already received Orphan Drug
Designation for the treatment of both CAH and AI from the US Food
and Drug Administration (FDA), which provides the potential for
seven years of market exclusivity awarded on approval.
The US is expected to be a major territory for sales of
Chronocort(R) , with CAH and AI collectively estimated to affect
140,000 adult patients and have an addressable market of
approximately $1bn.
Martin Whitaker, CEO of Diurnal, commented:
"This second Chronocort(R) patent provides additional in-market
protection in the US, which remains a key target market for
Diurnal, in addition to the potential for market exclusivity
provided by the award of Orphan Drug Designation for both CAH and
AI. With patents now extending protection in the US for both
Chronocort(R) and our paediatric product Alkindi(R) to 2034, we are
confident that, if approved, these products will enjoy a long
period of exclusivity in the US market and provide the potential
for lifelong treatment of patients with CAH and AI."
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 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) to control androgen excess and chronic fatigue in patients
with diseases of cortisol deficiency. The first planned indication
for Chronocort(R) is Congenital Adrenal Hyperplasia (CAH) in
adults. Chronocort(R) has been extensively studied in humans having
completed four Phase I trials, a Phase II trial in 16 CAH patients
in the US in 2014, and a Phase III trial in 122 CAH patients in
Europe.
In Europe, Chronocort(R) has been granted Orphan Drug
Designation in the treatment of CAH, which, if confirmed at
marketing authorisation, provides market exclusivity for 10 years.
The market authorisation of Chronocort(R) in Europe is anticipated
in 2020.
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.
Current therapy for CAH uses a variety of generic steroids
(hydrocortisone, dexamethasone and prednisolone). 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 47,000 patients in
Europe, with over 400,000 in the rest of the world.
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. Chronocort(R) also benefits from Orphan
Drug Designation for AI in Europe.
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
Date of Preparation: January 2019 Code: CH US-GB-0005
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END
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