TIDMDNL
RNS Number : 2854B
Diurnal Group PLC
09 January 2018
9 January 2018
Diurnal Group plc
("Diurnal" or the "Company")
End of Year Business Update and Notice of Interim Results
Imminent European approval of first product, Alkindi(R) ,
highlights Diurnal's ability to realise its vision of becoming a
world-leading endocrinology specialty pharma company
Clear registration pathway now established for Chronocort(R) in
the US
Transformational year ahead
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, today provides a business update ahead of the release of
its interim financial results for the six months ended 31 December
2017 on Monday, 12 March 2018.
Highlights:
European Commission Marketing Authorisation (MA) of Alkindi(R)
(development programme name: Infacort(R) ; hydrocortisone granules
in capsules for opening), the Company's first product, anticipated
in February 2018
-- Approval timeline expected to be in accordance with the
67-day timeline following the recently announced adoption of a
positive opinion by the Committee for Medicinal Products for Human
Use (CHMP)
o Anticipated indication as replacement therapy for paediatric
adrenal insufficiency (AI) in children up to 18 years of age
-- Robust supply chain in place in anticipation of launch
o Commercial supply agreement in place with Glatt Pharmaceutical
Services, a specialist global manufacturer of multi-particulate
pharmaceutical products
o Agreements in place with Ashfield Healthcare and Sharp
Packaging Services to facilitate supply chain requirements
o Wholly-owned subsidiary Diurnal Europe BV established in The
Netherlands to mitigate Brexit risk
Alkindi(R) US Phase III registration programme progresses -
approval anticipated in 2020
-- Investigational New Drug (IND) application with the US Food
and Drug Administration (FDA) successfully opened
o Alkindi(R) food matrix compatibility study meets primary
endpoint with high statistical significance (see separate
announcement issued today)
o Alkindi(R) continued to be well tolerated in adult
volunteers
o Proposed package of registration studies expected to be
completed during 2018
Chronocort(R) European pivotal Phase III trial expected to
complete enrolment by end of January 2018
-- Study now scheduled to complete in Q3 2018 and potential
market authorisation in Europe in 2020
o Phase III open label study in which adult patients with
congenital adrenal hyperplasia, currently treated with a single or
combination of generic steroids (standard-of-care), randomised to
receive Chronocort(R) on a twice daily "toothbrush" regimen or
continue on their standard-of-care regimen
o The primary endpoint of the trial is the control of androgens
on the same or lower total daily dose of steroid when treated with
Chronocort(R) compared to standard-of-care treatment, similar to
the previous successful Phase II clinical trial for
Chronocort(R)
Written feedback received from FDA on Chronocort(R) US Phase III
pivotal trial design
-- Company finalising study design and plans selection of
specialist global CRO; now expect to start US study in mid-2018
Strong financial position with cash and cash equivalents and
held-to-maturity financial assets (unaudited) at 31 December 2017
of GBP14.0m (31 December 2016: GBP25.6m)
Martin Whitaker, PhD, Chief Executive Officer of Diurnal,
commented:
"We are delighted to have ended a very productive 2017, with our
first product, Alkindi(R) , receiving a positive opinion from the
EMA. This positive momentum continues into 2018 as we expect to
receive the formal Marketing Authorisation from the European
Commission in February, followed by our first European launch of
this product with our own salesforce in the second quarter of
2018.
We are also making good progress elsewhere in the pipeline.
Notably, we have successfully opened an Investigational New Drug
Application for Alkindi(R) in the US and our recently completed
food matrix compatibility study (a prerequisite for a registration
package for this product) successfully met its primary endpoint. We
expect to complete enrolment of the European pivotal trial for
Chronocort(R) by the end of January. If successful, we could see
market approval in Europe for this product in 2020. In addition, we
expect to initiate the US Chronocort(R) Phase III pivotal trial in
mid-2018."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 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
Numis Securities Ltd (Nominated +44 (0)20 7260
Adviser) 1000
Nominated Adviser: Michael Meade,
Paul Gillam, Freddie Barnfield
Corporate Broking: James Black
Panmure Gordon (UK) Limited (Joint +44 (0) 20 7886
Broker) 2500
Corporate Finance: Freddy Crossley
Corporate Broking: Tom Salvesen
+44 (0)20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
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
END
NORFKFDKCBKDPDK
(END) Dow Jones Newswires
January 09, 2018 02:00 ET (07:00 GMT)
Diurnal (LSE:DNL)
Historical Stock Chart
From Apr 2024 to May 2024
Diurnal (LSE:DNL)
Historical Stock Chart
From May 2023 to May 2024