TIDMDNL
RNS Number : 0212V
Diurnal Group PLC
25 January 2017
25 January 2017
Diurnal Group plc
("Diurnal" or the "Company")
Update on commercial pre-launch activities for Infacort(R)
Appoints industry-leading outsourced commercial services
providers to support potential product launch in late 2017
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces significant progress in its commercial
pre-launch activities following its first market authorisation
submission for Infacort(R) to the European Medicines Agency (EMA)
in December 2016, for which the Company anticipates market
authorisation in late 2017.
As previously stated, Diurnal's ambition is to market
Infacort(R) itself in major European territories, thereby retaining
the full commercial value of the product. Consistent with this
strategy, Diurnal has signed a service agreement with Ashfield
Healthcare ("Ashfield"), part of UDG Healthcare plc (LSE: UDG), to
support the Company in building sales and medical infrastructure in
major European territories. Ashfield is a respected global contract
sales organisation that will focus in the next 12 months on
establishing a Europe wide network of medical liaison staff to
prepare the Company for the anticipated launch of Infacort(R) in
2018.
In addition, Diurnal has also signed an agreement with Sharp
Packaging Services ("Sharp"), a global leader in contract packaging
for the pharmaceutical and biotechnology industries, which is also
part of UDG Healthcare, to bring expertise to ensure our
Infacort(R) supply chain is managed by an internationally
recognised expert business.
Together, these agreements provide the foundation for Diurnal's
supply chain to deliver the commercial product to Europe and other
territories worldwide.
Dr Martin Whitaker, CEO of Diurnal, commented:
"Following the submission of our regulatory application for
Infacort(R) to the EMA and its subsequent validation, we are
focussed on pre-launch activities for this product in Europe. We
are confident that the agreements announced today with Ashfield and
Sharp, both leading providers of outsourced commercialisation
services to the pharmaceutical industry, will help ensure the
prompt and effective market introduction of Infacort(R) following
its anticipated approval in Europe, another key step in realising
our ambition of becoming the world's leading specialty pharma
company in endocrinology."
For further information, please visit www.diurnal.co.uk
or contact:
+44 (0)20 3727
Diurnal Group plc 1000
Martin Whitaker, CEO
Richard Bungay, CFO
Numis Securities Ltd (Nominated +44 (0)20 7260
Adviser) 1000
Nominated Adviser: Michael Meade,
Freddie Barnfield, Paul Gillam
Corporate Broking: James Black
+44 (0)20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
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. AI has been identified as a
rare disease in Europe where there are estimated to be
approximately 4,000 sufferers younger than the age of six.
Currently there are no licensed hydrocortisone preparations in
Europe specifically designed to treat these young patients. These
children are often administered compounded adult tablets or other
unlicensed products. Poor control of disease can result in
precocious puberty in young children, virilisation in girls and
chronic fatigue leading to a poor quality of life in adulthood
resulting in increased morbidity and mortality.
About Infacort(R)
Infacort(R) represents the first preparation of hydrocortisone
specifically designed for use in children suffering from AI. It is
a patented, immediate-release, oral, paediatric formulation of
hydrocortisone that allows for age-appropriate dosing in children.
This therapeutic approach has the potential to help young patients
less than six year of age suffering from diseases due to cortisol
deficiency including adrenal insufficiency and congenital adrenal
hyperplasia. 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 Medicines Agency
has already approved a Paediatric Investigation Plan
(EMEA-001283-PIP01-12) for Infacort(R) , which sets out the
regulatory pathway to market authorisation via the Paediatric Use
Marketing Authorisation (PUMA) route.
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 UDG Healthcare plc:
UDG Healthcare plc (LSE: UDG) is a leading international partner
of choice delivering commercial, clinical, communications and
packaging services to the healthcare industry, employing almost
8,000 people with operations in 23 countries and delivering
services in over 50 countries.
UDG Healthcare plc operates across three divisions: Ashfield,
Sharp and Aquilant.
The company is listed on the London Stock Exchange and is a
constituent of the FTSE 250.
For more information please go to: www.udghealthcare.com
About Ashfield Healthcare
Ashfield Commercial and Medical Services is a global leader in
providing outsourced healthcare services to pharmaceutical, device
and biotech companies. The company has 6,000 employees, operates in
22 countries across Europe, North America, South America and Asia
and works with more than 250 companies, including all of the
world's top 25 pharmaceutical companies. Its mission is to partner
with its clients, improving lives by helping healthcare
professionals and patients get the medicines, knowledge and support
they need.
For more information, go to www.ashfieldhealthcare.com.
About Sharp Packaging Services
Sharp Packaging Services is a global leader in contract
packaging and clinical services. Operating from state-of-the-art
facilities across the US and Europe, Sharp has built an
international reputation for delivering cost-effective blister
packaging, bottling, pouches and stick packs, compliance packaging,
formulation and manufacturing services, label design and printing.
Sharp is also a world leader in 'Track and Trace' serialisation
services, which will require all prescription drugs to have a
unique serial code for authentication and traceability.
For more information please go to: www.sharpservices.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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