AMYT.L Regulatory News (AMYT)

AIM: AMYT, ESM: AYP 

Amryt Pharma plc

("Amryt" or the "Company")

Grant of patent in Japan for lead drug candidate, AP101 (Episalvan)

for Treatment of Epidermolysis Bullosa

Amryt, the pharmaceutical company focused on best-in-class treatments for rare and orphan diseases, is pleased to announce that it has been granted a patent in Japan by the Japanese Patent Office for its lead drug candidate, AP101 (Episalvan), for the treatment of Epidermolysis Bullosa ("EB"), a rare genetic skin disorder which causes exceptionally fragile skin.  

Amryt expects AP101 (Episalvan), which has already successfully demonstrated accelerated healing in partial thickness wounds compared to standard therapy, to enter a pivotal Phase 3 clinical trial in late Q1 2017. The patent grant for AP101 (Episalvan) in Japan follows similar grants secured in the US in September 2016 and in Europe in March 2016 as well as other patent grants in other territories, including Canada and Australia. The global EB market is estimated to be worth c. EUR 1.3 billion per annum.

EB is a chronic and debilitating condition for which there is currently no known cure. Those born with the disorder are often referred to as 'butterfly children' reflecting the extremely fragile nature of their skin. There are approximately 500,000 people living with EB worldwide, with some 35,000 in Europe and 30,000 in the US.

Joe Wiley, Chief Executive Officer of Amryt, commented:

"We are delighted to announce that AP101 (Episalvan) has been granted a patent in Japan for the treatment of EB, widening the scope of our potential marketplace. It follows similar patent grants in the US and Europe as well as other territories which we have secured over the past 10 months or so.

EB is a rare and potentially disfiguring hereditary skin disorder with no available treatment option today. There are approximately 30,000 patients in the US and 35,000 patients in Europe and we believe that our product, AP101 (Episalvan), could potentially offer a compelling therapy in this disease. We are preparing for and look forward to starting our pivotal Phase 3 clinical trial over the coming months."

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About Amryt Pharma plc - see www.amrytpharma.com

Amryt Pharma is a specialty pharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases. The Company is building a diversified portfolio of commercially attractive, best-in-class, proprietary new drugs to help address some of these rare and debilitating illnesses for which there are currently no available treatments.

It recently acquired an exclusive licence to sell LOJUXTA (lomitapide), across the EU and other territories including the Middle East, North Africa, Turkey and Israel. LOJUXTA is used to treat a rare life-threatening disease called Homozygous Familial Hypercholesterolemia.

Amryt's lead development product, AP101 (Episalvan), received marketing approval for the treatment of partial-thickness wounds from the European Commission in January 2016. Amryt intends to develop AP101 (Episalvan) as a new treatment for Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children for which there is currently no treatment. The Company is currently planning a Phase 3 study of AP101 (Episalvan) in EB, which has been granted US and EU orphan drug designation. The market opportunity for EB is estimated to be circa EUR 1.3 billion.

Amryt's earlier stage product AP102 is focused on developing novel, next generation somatostatin analogue ("SSA") peptide medicines for patients with rare neuroendocrine diseases, where there is a high unmet medical need, including acromegaly and Cushing's disease. AP102 was recently granted orphan designation in the US in acromegaly by the FDA.

The Company joined AIM and Dublin's ESM in April 2016 following the reverse takeover of Fastnet Equity PLC.