TIDMDNL
RNS Number : 2438E
Diurnal Group PLC
17 October 2018
17(th) October 2018
Diurnal Group plc
("Diurnal" or the "Company")
Update on late-stage development pipeline
Data from European Chronocort(R) Phase III safety extension
study shows sustained benefits of treatment over at least 12
months
Company believes total Chronocort(R) development package
warrants Scientific Advice meeting with EMA, with view to
potentially submitting MAA in Q4 2019
US Chronocort(R) development plans put on hold
Seeking end-of-Phase III meeting with FDA for Alkindi(R) ahead
of a potential NDA submission in Q3 2019
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, today provides an update on its late-stage pipeline
products for the replacement of cortisol deficiency, Alkindi(R)
(hydrocortisone granules in capsules for opening) and Chronocort(R)
(modified release hydrocortisone).
Following the Company's announcement on 8 October 2018 that
Chronocort(R) had not met the primary endpoint in its European
Phase III trial for the treatment of congenital adrenal hyperplasia
(CAH), Diurnal has undertaken further analysis of the clinical
trial data, identifying important differences between Chronocort(R)
and the control arm of the trial. Diurnal has also analysed interim
data from the ongoing safety extension study in Europe, an
open-label, 'roll-over' trial in which patients from the Phase III
trial have continued Chronocort(R) treatment. Notably, a number of
patients on the safety extension trial have now been treated for at
least 12 months and show sustained benefit from extended
Chronocort(R) treatment, consistent with feedback from the study
investigators in this open-label trial. Based on the further
analyses of data from these largest ever treatment studies in CAH,
Diurnal intends to request a Scientific Advice meeting with
European regulators before the end of the 2018, with a view to
submitting a Marketing Authorisation Application (MAA) for
Chronocort(R) in Q4 2019, including application for Orphan Drug
Designation in the treatment of CAH.
While the comprehensive dataset from the European trials is
analysed, and until the implications for CAH care are understood,
Diurnal has put on hold all activities relating to the US
development of Chronocort(R) .
Separately, for Alkindi(R) , Diurnal has now completed a
development programme for a US New Drug Application (NDA)
submission, including a study to demonstrate bioequivalence with
the US reference product. The Company will now proceed to an
end-of-Phase III meeting with the US Food and Drug Administration
(FDA) at the earliest opportunity to seek agreement that the
package of data is suitable for an NDA submission, planned for Q3
2019.
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We remain positive that Chronocort(R) will provide a valuable
treatment option for patients with CAH and look forward to
discussing our extensive data set with regulators. In light of our
observations regarding the European Phase III trial data, and the
requirement to manage our costs carefully, we have taken the
decision to put all Chronocort(R) US development activity on hold,
and to adjust our cost base accordingly.
We continue to be pleased with the progress of the commercial
roll-out of our lead product, Alkindi(R) , across Europe following
its launch in May 2018. We expect by early 2019 that Alkindi(R)
will be commercially available in the UK, Germany, Austria and the
Nordic region. We also remain focused on completing pricing
negotiations in key European territories as well as the
finalisation of the clinical data package for Alkindi(R) in the US
for submission to the FDA."
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 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
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 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 paediatric AI are precocious puberty, chronic
fatigue with the additional risk of adrenal crisis and death if
they do not have adequate cortisol replacement. Paediatric 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). In Europe, paediatric 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 hydrocortisone (the synthetic version of cortisol) as
there was no licensed formulation available specifically designed
for children.
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: Oct 2018 Code: CH EU-EU-0052
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