TIDMDNL
RNS Number : 8917X
Diurnal Group PLC
15 August 2018
15 August 2018
Diurnal Group plc
("Diurnal" or the "Company")
Update on Alkindi(R) in Germany
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, notes the publication of a clinical benefit dossier
assessment of Alkindi(R) (hydrocortisone granules in capsules for
opening) by the German Institute for Quality and Efficiency in
Health Care (IQWiG) released today on the Gemeinsame
Bundesausschuss (G-BA) website, which states that Alkindi(R) 's
benefit over generic hydrocortisone has been not proven, as the
appropriate comparator therapy (hydrocortisone) was not implemented
in any of the studies. This assessment is as anticipated since
Diurnal did not include a hydrocortisone comparator arm in its
pivotal studies with Alkindi(R) , due to the lack of a specific
paediatric dose appropriate licensed form of hydrocortisone. This
assessment does not impact Diurnal's commercial expectations for
Alkindi(R) in Europe.
Diurnal announced the launch of Alkindi(R) in Germany in May
2018, following submission of a pricing and reimbursement dossier
to the G-BA. Alkindi(R) is now stocked at over 40 wholesaler depots
and is available to pharmacies across Germany, with initial
Alkindi(R) pricing and commercial sales to date in line with the
Company's expectations.
Diurnal submitted an Added Benefit dossier for Alkindi(R) to the
G-BA in May 2018. Part of the multi-faceted early benefit
assessments procedure according to the
Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) process is a clinical
benefit dossier assessment performed by the IQWiG. The Alkindi(R)
marketing authorisation was underpinned by the statistically
significant data previously reported from the Company's pivotal
open-label Phase III clinical trial. In this study, as agreed with
the European Medicines Agency (EMA), a comparator was not included
due to the lack of a regulated and licensed paediatric formulation.
The findings of IQWiG are non-binding on the G-BA.
The next scheduled step in the assessment process is a hearing
with the G-BA committee, which provides an opportunity for experts
in medical science and practice, physicians' associations,
self-help groups and patient representatives, as well as
manufacturers to contribute their expertise or their viewpoints to
the process. The assessment process, and therefore the
determination of the final price in Germany, is expected to be
completed by May 2019 by the G-BA.
Martin Whitaker, Chief Executive Officer of Diurnal, said, "As
part of the pan-European commercialisation programme for Alkindi(R)
, Diurnal is in discussions with various health authorities across
Europe to ensure timely launches in all major European countries.
Diurnal believes that Alkindi(R) represents a cost-effective and
major breakthrough for patients with adrenal insufficiency, being
the first licensed hydrocortisone treatment in Europe specifically
designed for use in children".
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
Cantor Fitzgerald Europe (Joint Broker)
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 Der Gemeinsame Bundesausschuss (G-BA)
The G-BA is the highest decision-making body of the joint
self-government of physicians, dentists, hospitals, and health
insurance funds in Germany. The G-BA's assessment procedures are as
follows:
-- A request for consultation must be submitted before the start of consultation.
-- The methods assessment is conducted according to specified criteria.
-- A hearing must take place before a resolution is drafted on
changes that affect third parties.
-- The G-BA requires scientific support, e.g. from IQWiG, to fulfil its duties
-- The G-BA drafts a resolution after consultations are completed.
-- Resolutions are submitted for review by the Federal Ministry of Health, which has legal
supervision over the G-BA.
The G-BA hearing procedure provides an opportunity for experts
in medical science and practice, umbrella organisations of
physicians' associations, central organisations of self-help groups
and patient representatives, as well as manufacturers to contribute
their expertise or their viewpoints as affected parties to the
decision-making process. The results of the hearing procedure are
evaluated by the subcommittee. For further information about G-BA,
please visit: www.english.g-ba.de/legalmandate/
About IQWIG
IQWiG is the independent Germany agency responsible for the
assessment of medical treatments based on their quality and
efficacy.
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
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). In Europe, 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 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
AI. Alkindi(R) is a patented, oral, immediate-release paediatric
formulation of hydrocortisone granules in capsules for opening that
allows for 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.
Date of Preparation: August 2018 Code: Inf EU-EU-0080
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END
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