Diurnal Group PLC Positive Scientific Advice from EMA for Chronocort (8331V)
April 11 2019 - 1:01AM
UK Regulatory
TIDMDNL
RNS Number : 8331V
Diurnal Group PLC
11 April 2019
11 April 2019
Diurnal Group plc
("Diurnal" or the "Company")
Positive Scientific Advice from European Medicines Agency for
Chronocort(R)
European Medicines Agency confirms the current clinical and
regulatory path for Chronocort(R)
Existing clinical data can be used to support a regulatory
submission
Diurnal on track to submit Market Authorisation Application in
Q4 2019
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces today that, following a positive meeting with
the European Medicines Agency (EMA) in March 2019, the Company has
received formal Scientific Advice from the EMA confirming the
current clinical and regulatory path for Chronocort(R) as a
treatment for patients with congenital adrenal hyperplasia (CAH).
Consequently, Diurnal intends to submit a Marketing Authorisation
Application (MAA) for Chronocort(R) (modified release
hydrocortisone) in Q4 2019 based upon the existing clinical data,
including additional data which will be required to support Orphan
Drug Status in the treatment of CAH. This positive outcome follows
the submission of a regulatory package requesting Scientific Advice
to the EMA for Chronocort(R) based on detailed analysis of data
from its Phase 3 study, the largest ever clinical trial programme
in CAH, and the open-label safety extension study.
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We welcome the outcome of our meeting with the EMA based on
detailed analysis of data from our studies in patients with
congenital adrenal hyperplasia (CAH). This condition still results
in significant increased morbidity and mortality for patients
worldwide, with new therapies needed to improve these outcomes. We
therefore continue to believe that Chronocort(R) represents a
valuable treatment option for these patients, in a market estimated
at $300 million in Europe, and we look forward to submitting a
Marketing Authorisation Application in Q4 2019."
CAH is an orphan condition caused by a block in cortisol
production, an essential adrenal steroid hormone required for
healthy life. A lack of cortisol in turn causes the over-production
of male steroid hormones (androgens). Cortisol deficiency and
over-production of androgens can lead to increased mortality,
infertility and severe development defects, including ambiguous
genitalia, precocious puberty and short stature. Sufferers, even if
treated, remain at risk of death through an adrenal crisis. 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.
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 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 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: April 2019 Code: Inf EU-GB-0109
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END
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