Posted on Wednesday, 25/Jan/2017 Posted by michelle

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®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® 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® 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® 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® 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® 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: 

Diurnal Group plc     
Martin Whitaker, CEO  
Richard Bungay, CFO 
Tel: +44 (0)20 3727 1000

Numis Securities Ltd (Nominated Adviser)    
Nominated Adviser: Michael Meade, Freddie Barnfield,  Paul Gillam    
Corporate Broking: James Black    
Tel: +44 (0)20 7260 1000    

FTI Consulting     
Simon Conway    
Victoria Foster Mitchell
Tel: +44 (0)20 3727 1000   

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®
Infacort® 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®, 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