Diurnal Group PLC Grant of first US patent for Infacort (4747F)
18 May 2017 - 4:00PM
UK Regulatory
TIDMDNL
RNS Number : 4747F
Diurnal Group PLC
18 May 2017
18 May 2017
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal announces grant of first US patent for lead product,
Infacort(R)
Composition of matter patent in this key territory provides
protection to 2034
Company also announces receipt of Notice of Allowance for second
US Infacort(R) patent application, covering a method of treatment
for all forms of adrenal insufficiency
Emerging patent portfolio significantly strengthens in-market
protection in US where Infacort(R) already has Orphan Drug
Designation
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces the grant by the US Patent and Trademark Office
(USPTO) of its first US patent for Infacort(R) , the Company's lead
product.
US 9,649,280, entitled "Composition Comprising Hydrocortisone",
is a pharmaceutical composition-of-matter patent protecting
Infacort(R) 's proprietary formulation as a treatment for all forms
of adrenal insufficiency (AI). The patent provides in-market
protection until 2034.
The Company also announces that it has received a Notice of
Allowance from the USPTO for a second patent (application no.
US14/354651) entitled "Treatment of Adrenal Insufficiency". This
patent application claims methods of treatment of all forms of AI
using Infacort(R) and will also expire in 2034.
Together, this emerging patent portfolio significantly bolsters
the Company's exclusivity position in the US, where Infacort(R) has
already received Orphan Drug Designation in the treatment of
paediatric AI from the Food and Drug Administration (FDA),
providing seven years of market exclusivity awarded on approval.
The US is expected to be a major territory for sales of Infacort(R)
and, as previously announced, the drug is set to begin a US pivotal
trial in the second half of 2017, subject to Diurnal completing
discussions with the FDA, with approval anticipated for 2019.
In Europe, Infacort(R) is currently under regulatory review in
the European Medicines Agency (EMA) for the treatment of paediatric
AI having successfully completed a European pivotal trial in July
2016, with approval anticipated in late 2017.
Martin Whitaker, CEO of Diurnal, commented:
"The US is a key target market for Diurnal. Establishing a
robust Infacort(R) US patent portfolio is a significant milestone
for Diurnal for market entry in this territory, where the drug has
already been awarded Orphan Drug Designation for paediatric adrenal
insufficiency. With these patents extending protection to 2034 and
US approval for Infacort(R) anticipated in 2019, we are confident
that, if approved, Infacort(R) should enjoy a long period of
exclusivity on the US market."
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 an
orphan disease in the US where there are estimated to be
approximately 4,500 sufferers younger than the age of sixteen, with
a similar number in Europe. Currently there are no licensed
hydrocortisone preparations in the US or 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 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 sixteen years 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 in Europe to the
European Medicines Agency via the Paediatric Use Marketing
Authorisation (PUMA) route in late 2016.
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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