AMYT.L Regulatory News (AMYT)

13 September 2016

AIM: AMYT, ESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Grant of US patent for lead drug, Episalvan

Amryt, the clinical stage specialty pharma company focused on best in class treatments for orphan diseases, is pleased to announce that it has been granted a US patent for its lead drug, Episalvan, in the treatment of Epidermolysis Bullosa ("EB"). EB is a rare and distressing hereditary skin disorder, which leads to mechanical fragility of skin. All forms are considered serious and the most severe are disfiguring and cause intense suffering. Children with this disorder are frequently referred to as "Butterfly Children".

Amryt's lead drug, Episalvan, has already successfully demonstrated significantly faster healing in both recent wounds and chronic wounds compared with standard care therapy. The Company is now in the process of preparing for a pivotal phase III study for the drug's use in EB treatment.

This US patent follows the grant of a patent in January 2016 by the European Medicines Agency for the use of Episalvan in the European Union for the treatment of all partial thickness wounds ("PTWs").

Amryt estimates that the global EB market is worth c. US$1.5 billion per annum.

Joe Wiley, Chief Executive Officer of Amryt, commented:

"We are delighted to announce that our lead drug, Episalvan, has been granted a US patent, for the treatment of EB. EB is a rare, debilitating hereditary skin disorder with no available treatment option today.

Our US patent complements our existing patent in Europe for the use of Episalvan in the treatment of all partial thickness wounds and adds to our growing family of patents. We now hope - subject to regulatory approval - to move Episalvan into a pivotal phase III study in Q1 2017, which will focus specifically on its use for EB treatment.

We believe that the unique characteristics of Episalvan could substantially improve the quality of life for EB suffers and feel very optimistic as we progress towards our phase III study."

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