TIDMDNL
RNS Number : 3223D
Diurnal Group PLC
08 October 2018
8 October 2018
Diurnal Group plc
("Diurnal" or the "Company")
Scottish Medicines Consortium approves the use of Alkindi(R) as
first-line treatment for paediatric adrenal insufficiency
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, is pleased to announce that the Scottish Medicines
Consortium (SMC) has today approved the routine use of Alkindi(R)
(hydrocortisone granules in capsules for opening) as the first-line
treatment of young children with adrenal insufficiency aged from
birth to less than six years of age for whom hydrocortisone must be
individually prepared by manipulation such as by compounding (or
crushing) or by production of special solutions in order to produce
age-appropriate doses, or hydrocortisone given as off-label buccal
tablets.
The decision by the SMC means that children in Scotland with
this rare condition, including those with congenital adrenal
hyperplasia (CAH), can now be treated with accurate dosing of
licensed hydrocortisone medicine and without the need to crush or
dissolve tablets. Importantly, the SMC recommended Alkindi(R) to be
cost-effective for use in children less than six years old, which
are the most vulnerable adrenal insufficiency (AI) patients and
where the unmet need is highest.
Given the concentrated prescribing base, and to retain the full
value of the product, Diurnal intends to commercialise Alkindi(R)
in the UK and other major European markets. Diurnal has established
the commercial infrastructure required to support a successful
launch of Alkindi(R) , focusing its marketing efforts initially on
these 0-6 year old patients. As part of the pan-European
commercialisation programme for Alkindi(R) , Diurnal is currently
in discussion with various health authorities across Europe to
ensure timely launches in other major European countries following
the grant of a paediatric use marketing authorisation (PUMA) by the
European Commission in February 2018. Alkindi(R) was launched in
Germany in May 2018 and in the UK in September 2018.
Diurnal estimates that there are approximately 4,000 patients in
Europe under the age of six requiring replacement therapy for AI
due to CAH, primary adrenal failure or hypopituitarism.
Prof Faisal Ahmed, Clinical Endocrinologist, University of
Glasgow, added:
"We welcome this decision by the SMC. Administering a
hydrocortisone dose titrated to children's needs is essential.
Previously, licensed hydrocortisone was only available in adult
dose sizes, making accurate dosing for children difficult.
Alkindi(R) provides the ability to prescribe and administer small
doses which is particularly important for young children. We look
forward to finally using a preparation which is specifically
designed for this group of patients."
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We are delighted that the SMC has recommended, in line with our
expectations, the first-line use of Alkindi(R) in paediatric
adrenal insufficiency in children under six years of age. Diurnal
believes the use of this product will improve the lives of patients
with this rare disease, and their families, by providing access to
the first formulation of hydrocortisone specifically designed for
paediatric dosing. Diurnal hopes that health providers in other
parts of the UK, and across Europe, will follow a similar positive
decision to enable parents to provide accurate dosing of
life-saving medicine for their children."
The full text of the SMC decision can be found at:
https://www.scottishmedicines.org.uk/medicines-advice/hydrocortisone-alkindi-fullsub-smc2088/
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 The Scottish Medicines Consortium
The SMC is part of Healthcare Improvement Scotland, the national
healthcare improvement organisation for Scotland. The SMC reviews
new medicines that have received a licence from the Medicines and
Healthcare products Regulatory Agency (MHRA - the licensing body
for the UK) or the European Medicines Agency (EMA - the licensing
body for the European Union). The SMC also reviews new formulations
of, and new ways to use, established medicines. Before a medicine
can be prescribed routinely in Scotland, it has to be accepted for
use by SMC. SMC advice helps the health service plan for the quick,
uniform introduction of beneficial treatments across
NHSScotland.
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 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 Adrenal insufficiency (AI), including the genetic
condition Congenital Adrenal Hyperplasia (CAH) 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 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: October 2018 Code: Inf EU-EU-0085
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END
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