AMYT.L Regulatory News (AMYT)

10 May 2018

AIM: AMYT

ESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Exclusive Lojuxta® (lomitapide capsules) Licence Expanded to Russian Commonwealth & Non-EU Balkan States

Approximate 25% increase in total addressable patients in Amryt licensed territories

Amryt, a biopharmaceutical company focused on rare and orphan diseases, is pleased to announce that it has signed an agreement with Aegerion Pharmaceuticals, Inc. ("Aegerion"), a subsidiary of Novelion Therapeutics Inc., to significantly expand its exclusive licence agreement for Lojuxta (lomitapide) into Russia and the Commonwealth of Independent States ("CIS"), as well as the non-EU Balkan states.*

Amryt estimates there may be up to 450 additional patients who could benefit from treatment with Lojuxta across the countries covered by the extended agreement, representing an increase of approximately 25% in the total number of addressable patients in the Amryt territories. Amryt is actively seeking distribution partners in these new territories.

This licence expansion extends the original agreement, secured in December 2016, which covers the European Economic Area, Middle East and North Africa, Switzerland, Turkey and Israel. As part of this agreement Amryt will formally become the Marketing Authorisation holder for Lojuxta in Europe which will marginally increase the level of royalties payable to Aegerion.

Joe Wiley, CEO of Amryt Pharma, commented:

"A core focus for Amryt in 2018 is to drive further growth for Lojuxta in new and existing territories. Following closely on from our market expansion in the Middle East, these new markets, with their significant increase in total addressable patients, assist us in this goal and will allow us to make Lojuxta available to HoFH patients for the first time in the Russian Commonwealth, the surrounding states, and the non-EU Balkan states. We look forward to further updating the market on distribution agreements to access these markets in due course."

Jeff Hackman, Chief Operating Officer of Aegerion's parent company, Novelion, said:

"We are pleased to extend our licence agreement for Lojuxta with Amryt. Amryt has been an active partner helping to bring this important treatment to adult HoFH patients living with this very rare disorder."

Lojuxta is an approved treatment for adult patients with the rare cholesterol disorder Homozygous Familial Hypercholesterolaemia ("HoFH"). This disorder impairs the body's ability to remove LDL cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body and subsequent aggressive and premature narrowing and blocking of blood vessels. Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with HoFH.

Amryt generated revenues of €11.9m from sales of Lojuxta in 2017, which represents a 65% increase on the run rate from when Amryt initially in-licenced the Lojuxta business. Over the last seven months, Amryt has secured five distribution agreements, covering the Kingdom of Saudi Arabia, Switzerland, Central and Eastern Europe, Lebanon, Jordon and Syria.

*CIS comprises Russia, Kazakhstan, Belarus, Azerbaijan, Uzbekistan, Armenia, Moldova, Kyrgyzstan, Tajikistan, as well as the associate states of Ukraine and Turkmenistan, and the state of Georgia. The Non-EU Balkan states comprises Albania, Albania, Bosnia-Herzegovina, Macedonia, Montenegro, Serbia and Kosovo.

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) across the European Economic Area, Middle East and North Africa, Switzerland, Turkey and Israel. Lojuxta is used to treat a rare life-threatening disease called Homozygous Familial Hypercholesterolaemia, 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.

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 European and US 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. 

In March 2018, the Company in-licensed a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.