Feraccru® receives EU marketing authorisation

RNS Number : 2319Q

Shield Therapeutics PLC

26 February 2016

 

Shield Therapeutics plc

("Shield" or the "Company")

Feraccru® receives marketing authorisation in Europe

London, UK, 26 February 2016. Shield Therapeutics plc (LSE:STX), a specialty pharmaceutical company focused on secondary care, whose Ordinary Shares and Warrants are expected to commence trading on the AIM market of the London Stock Exchange plc at 8.00am GMT today, is pleased to announce that the European Commission has granted marketing authorisation across all member states for its wholly owned product, Feraccru®, as a treatment for adults with iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD).  This approval allows Shield to begin a roll-out of commercialisation in the coming months. 

In Europe, there are currently an estimated 2.5 million people suffering from IBD¹ and IDA is a common complication affecting up to 74 per cent of patients².  The impact of IDA on IBD patients is substantial, affecting various aspects of a patient's quality of life such as physical, emotional and cognitive functions, as well as causing more regular hospitalisation and increased resultant healthcare costs. The Directors of Shield believe Feraccru has an achievable global peak annual sales opportunity in excess of £500 million.

Shield's Founder and Chief Executive Officer, Carl Sterritt, said: "Today is a landmark day for Shield, not only is it our first day of trading on AIM, but we have also secured Europe-wide approval to begin to market Feraccru on schedule and in line with our plans.  We now look forward to increasing the treatment options available to prescribers and improving the lives of patients who are able to receive Feraccru, a novel treatment for a serious unmet medical need."

Prof. Andreas Stallmach, Professor of Gastroenterology, University Clinic Jena, Germany added: "The Phase 3 clinical studies clearly demonstrated Feraccru's effectiveness and this pan-European marketing authorisation gives treating physicians like myself the opportunity to fulfil an important and currently unmet need for patients who are unable to tolerate other oral products, as Feraccru could provide an oral alternative to intravenous iron infusion.''

Commenting on the approval, Dr Fraser Cummings, Consultant Gastroenterologist, Southampton General Hospital, UK, also said: "There is a real unmet need for a well-tolerated and efficacious oral iron replacement in Inflammatory Bowel Disease patients. The approval of Feraccru for use in patients with this common and debilitating morbidity is an important step in making the product available for as many patients as possible as rapidly as possible."

References

1. IBDBIOM, http://www.ibdbiom.eu/community/ (Accessed Feb19th 2016)

2. Wilson, A, et al. (2004). Prevalence and Outcomes of Anemia in Inflammatory Bowel Disease: A Systematic Review of the Literature. Am J Med Sci, 116(7A), 44S-49S.

For further information please contact:

Shield Therapeutics plc	[phone]
Carl Sterritt, Chief Executive Officer Richard Jones, Chief Financial Officer
NOMAD Liberum Capital Limited Christopher Britton Steve Pearce Jamil Miah	[phone]
Financial PR Advisor Consilium Strategic Communications	[phone] [e-mail]
Mary-Jane Elliott Matthew Neal Lindsey Neville Hendrik Thys

About Shield Therapeutics plc

Shield Therapeutics is a specialty pharmaceutical company focused on the development and commercialisation of late-stage, hospital-focused pharmaceuticals which address areas of high unmet medical need. The Company's key products are Feraccru and PT20, two late-stage pharmaceuticals for the treatment of iron deficiency anaemia (IDA) and systemic phosphate accumulation (otherwise known as hyperphosphatemia), respectively. Shield was formed in 2008 and joined AIM in February 2016.  For more information please visit www.shieldtherapeutics.com.

 

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