NEWS & MEDIA

Amryt Pharma plc – Positive Pre-Clinical Study Results

6 February 2017

Amryt Pharma plc

(“Amryt” or the “Company”)

Positive pre-clinical study results for drug compound with potential to treat acromegaly, AP102

Amryt, the pharmaceutical company focused on best-in-class treatments for rare and orphan diseases, announces positive results of a newly completed pre-clinical study that compared its drug compound AP102 (a somatostatin analogue therapy with the potential to treat acromegaly) with pasireotide, an approved product for treating patients with resistant acromegaly. Amryt’s AP102 did not demonstrate the potential to cause diabetes, an observation which, if replicated in clinical studies, could be clinically beneficial in treating acromegaly. As previously reported, the Company is preparing AP102 for clinical trials in 2017.

Amryt’s study used a well-established diabetic rat model to examine whether or not AP102 has an effect on glucose levels or on food/water intake compared with controls. The study results showed that AP102 had no effect on either in diabetic rats compared with controls. This indicates no impairment in glucose control in these diabetic animals when treated with AP102.

Mark Sumeray, Chief Medical Officer of Amryt Pharma, commented:

“We are very pleased to report these study results that indicate that our drug compound, AP102, does not impact glucose levels or food or water intake, when administered to diabetic rats. This suggests that it lacks the potential to cause or exacerbate diabetes, which is an issue with some other approved therapies.

These positive data results are encouraging and further reinforce our view that AP102 has the potential to improve outcomes for patients suffering from acromegaly, a rare and very distressing disorder which leads to excess growth of the body’s tissues over time.

As we previously reported in early November, the U.S. Food and Drug Administration granted orphan drug designation to AP102 and we are progressing AP102 towards clinical trials in 2017.”

Enquiries:

Amryt Pharma plc

C/o KTZ Communications

Joe Wiley, CEO

Rory Nealon, CFO/COO

Shore Capital

+44 (0) 20 7408 4090

Nomad and Joint Broker

Bidhi Bhoma, Edward Mansfield

Davy

+353 (1) 679 6363

ESM Adviser and Joint Broker

John Frain, Anthony Farrell

Stifel

+44 (0) 20 7710 7600

Joint Broker

Jonathan Senior, Ben Maddison

KTZ Communications

+44 (0) 20 3178 6378

Katie Tzouliadis

About Acromegaly

Acromegaly is a rare endocrine disorder that most commonly results from an adenoma, a benign tumour of the pituitary gland that secretes excessive growth hormone (GH) and leads to excess production of the hormone IGF-1. The progression of acromegaly is typically slow and diagnosis is often delayed by years. As the disease advances, patients typically exhibit abnormal growth throughout the body.

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.

The Company 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, 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.

This information is provided by RNS

The company news service from the London Stock Exchange

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