AMYT.L Regulatory News (AMYT)

24 January 2018

AIM: AMYT

ESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Senior Management Team Appointment

Amryt, a biopharmaceutical company focused on rare and orphan diseases, is pleased to announce the appointment of Derval O'Carroll as Head of Regulatory Affairs.

Derval has over 25 years' experience in pharmaceutical industry regulatory affairs. Prior to joining Amryt, Derval was Senior Director of Regulatory Affairs for the NASDAQ-listed rare diseases company Retrophin Inc., where she provided regulatory, strategic and operational input to product teams managing Retrophin's development-stage and commercial products. Before that, Derval worked for 11 years as a Managing Consultant at Real Regulatory Ltd, a consultancy specialising in European regulatory affairs, quality management systems and supply chain operations compliance.

As Amryt continues its pivotal Phase III trial, EASE, to assess the efficacy of AP101 in Epidermolysis bullosa ("EB"), the rare genetic skin disorder, Derval will assume responsibility for engagement with regulatory agencies. In addition, she will examine opportunities to pursue new orphan indications for AP101 and AP102.

Derval has an MBA, as well as an M.Sc. in Biochemistry from University College Dublin.

Dr. Joe Wiley, Chief Executive Officer of Amryt Pharma, said:

"We are delighted to further strengthen our senior management team with the appointment of Derval O'Carroll as Head of Regulatory Affairs. The quality of our interactions with regulatory agencies globally is a key driver of our success as we move our products through their lifecycle, and we are therefore very pleased to have someone of Derval's experience joining the team.

"Derval's expertise will be particularly valuable as we plan for completion of our ongoing AP101 Phase III trial in EB, followed by submission to the regulatory agencies. As part of the overall strategy to add value to our development projects, Derval will also explore opportunities to pursue new orphan indications for our AP101 and AP102 products."

Enquiries:

About Amryt Pharma plc

(www.amrytpharma.com)

Amryt Pharma is a specialty biopharmaceutical 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.

The Company holds an exclusive licence to sell Lojuxta (lomitapide) for adults, across the European Economic Area, Middle East and North Africa, Turkey and Israel. Lojuxta is used to treat a rare life-threatening disease called Homozygous Familial Hypercholesterolemia, which impairs the body's ability to remove LDL cholesterol ("bad" cholesterol) from the blood. This typically results in extremely high blood LDL cholesterol levels, leading to aggressive and premature narrowing and blocking of arterial blood vessels. If left untreated, heart attack or sudden death may occur in childhood or early adulthood.

Amryt's lead drug candidate, AP101, is a potential treatment for Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children for which there is currently no treatment. It is currently in Phase 3 clinical trials. The global market opportunity for EB is estimated to be in excess of 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. 

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