AMYT.L Regulatory News (AMYT)

19 September 2016

AIM: AMYT

ESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Appointment of Chief Medical Officer

Amryt, the clinical-stage specialty pharma company focused on best-in-class treatments for orphan diseases, is pleased to announce the appointment of Mark Sumeray, MB BS, MS, FRCS, as Chief Medical Officer with immediate effect.  

Dr Sumeray has over 17 years' experience in the pharmaceutical, medical devices and biotech sectors both in the US and UK. Most recently, he spent approximately five years as Chief Medical Officer at Aegerion Pharmaceuticals, a US-based orphan disease biotech company. At Aegerion, he had clinical development, medical affairs and pharmacovigilance responsibility for the global approval and launch of a new treatment for a serious and rare genetic disease. Mark led clinical and scientific interactions with health authorities globally, and engaged at senior level with the US Food and Drug Administration ("FDA"). His role also encompassed negotiations with payers and developing a market access strategy. In addition, Mark was the key company presenter at a Scientific Advice Group meeting of the Committee for Medicinal Products for Human Use ("CHMP") in Europe.

Prior to working at Aegerion, Mark was at Bristol-Myers Squibb, where he led a large US medical affairs team within the cardiovascular and metabolics area. He also worked at The Medicines Company, a US based biopharmaceutical company focused on acute care hospital products, and at Ethicon, a J&J medical device company, where he was responsible for the clinical group.

Mark spent nine years in clinical practice in the NHS, specialising in cardiovascular surgery and physiology, having qualified as a medical doctor at the University of London. 

Joe Wiley, CEO of Amryt, said:

 "I am delighted to welcome Mark to Amryt as Chief Medical Officer. Mark brings invaluable global experience of clinical development and building the medical functions to support the launch and commercialisation of a product in the orphan disease space. 

Mark's experience of interacting with the FDA and EMA and of managing late stage clinical trials is especially relevant as Amryt moves to commence its pivotal phase III study for the treatment of Epidermolysis Bullosa, a distressing orphan condition for which there is significant unmet medical need."

Enquiries:

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.

Amryt's lead product, Episalvan, received marketing approval for the treatment of partial-thickness wounds from the European Commission in January 2016. Amryt intends to further develop 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. Amryt is currently planning a phase III study of Episalvan in EB, which has been granted US and EU orphan drug designation. The market opportunity for EB is estimated to be circa US$1.5 billion.

Amryt's earlier stage products are 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. These include acromegaly and Cushing's disease.

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