Diurnal Group PLC Diurnal signs marketing and distribution agreement (2509U)
March 28 2019 - 3:02AM
UK Regulatory
TIDMDNL
RNS Number : 2509U
Diurnal Group PLC
28 March 2019
28 March 2019
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal signs marketing and distribution agreement for the
commercialisation of Alkindi(R) in the Nordic region with Anthrop
Pharma
Accelerates market access in valuable Nordic region to build on
momentum in UK and Germany
First launch planned for Sweden in Q2 2019
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces a marketing and distribution agreement with
Anthrop Pharmaceuticals AB (Anthrop), a leading, specialist
pharmaceutical company based in Sweden focused on the marketing and
sales of niche, high quality medicines to the hospital sector in
the Nordic region. The agreement covers the commercialisation of
Diurnal's novel therapy, Alkindi(R) (hydrocortisone granules in
capsules for opening) in Sweden, Norway, Denmark, Finland and
Iceland.
Alkindi(R) is the first preparation of hydrocortisone (the
synthetic version of cortisol) specifically designed for use in
children suffering from adrenal insufficiency (AI), including the
related condition congenital adrenal hyperplasia (CAH). Alkindi(R)
was granted a paediatric use marketing authorisation (PUMA) in the
EU in February 2018 which affords 10 years data and market
exclusivity.
Under the terms of the agreement, Anthrop will receive the
exclusive rights to market and sell Alkindi(R) in the Nordic
region. Diurnal will provide Anthrop with product for sale from its
established European supply chain. The Nordic region represents a
significant market opportunity for Diurnal, with around 490
paediatric patients, providing an estimated total market
opportunity for Alkindi(R) of approximately $3.3 million per
annum.
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"We believe that Anthrop's local expertise in the Nordic region
will significantly accelerate the commercial uptake of Alkindi(R)
in these territories, whilst enabling us to focus the Group's
resources on the larger European markets. In particular, we believe
that Anthrop is well-placed to maximise the value of Alkindi(R)
given their previous experience with paediatric products, including
products authorised under a PUMA. This agreement is part of our
continued strategy of building our marketing and distribution
capabilities in high value markets outside our core European
territories through local licensing or distribution
arrangements."
Clas Lindbergson, Chief Executive Officer of Anthrop Pharma,
added:
"We are looking forward to making Alkindi(R) available for
children suffering from adrenal insufficiency in the Nordic region.
As it is the first and only approved hydrocortisone specifically
designed for use in children with a life-threatening condition, we
believe Alkindi(R) can give value to not only the children but also
to the caregivers and the healthcare providers."
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 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
congenital adrenal hyperplasia (CAH). AI requires life-long
treatment and Diurnal's novel approach to product development has
the potential to significantly improve these young patients' lives.
The European Commission has 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)
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 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).
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 Anthrop
Anthrop Pharmaceuticals AB, based in Danderyd, Sweden, is
specialized in the introduction, distribution and marketing of
niche pharmaceuticals and hospital injectables in the Nordic
region. Anthrops mission is to help children and adults in the
Nordic countries to get access the best possible drug treatment
where it exists an unmet medical need. They are present in
different therapeutic areas such as endocrinology, neurology,
anaesthesia, cystic fibrosis and pain management.
For more information about Anthrop, please visit
www.anthroppharma.com.
Date of Preparation: March 2019 Code: Inf EU-GB-0108
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END
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