AMYT.L Regulatory News (AMYT)

17 October 2018

AIM: AMYT

ESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Lojuxta to be reimbursed in France

Amryt's lead commercial product now available in all five of the EU's largest markets

Amryt, a revenue generating orphan drug company focused on acquiring, developing & commercialising products that help improve the lives of patients where there is a high unmet medical need, is pleased to announce that it has reached agreement with France's CEPS (Comité économique des produits de santé), to reimburse Lojuxta® (lomitapide) for the treatment of adult patients with Homozygous Familial Hypercholesterolaemia ("HoFH") in France.

From the first quarter of 2019, adult HoFH patients suffering with this ultra-rare, life-threatening genetic condition can receive a 'first in class' medicine to reduce low density lipoprotein (LDL) cholesterol, often referred to as 'bad cholesterol', when used as an adjunctive therapy to other lipid lowering medications and where available, apheresis. The clinical value of Lojuxta in managing adult HoFH has been demonstrated in clinical trials and in the real world (see previously announced study results on Amryt's website, here).

This approval now means that Lojuxta is available across all five of the EU's major markets (France, the UK, Italy, Germany and Spain), either by responding to named patient requests or on a fully reimbursed basis and is in line with Amryt's strategy to make Lojuxta available to more patients across Amryt's licensed territories.

Joe Wiley, CEO of Amryt Pharma, commented: "A clear aim in continuing the positive momentum in Lojuxta revenues is to ensure reimbursement in our core territories. Following closely on from our recent approval with the NHS in England, where we have already started treating patients, we are now very pleased to be able to make Lojuxta available to adult HoFH patients in France."

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About Amryt

Amryt is a revenue generating orphan drug company focused on acquiring, developing & commercialising products that help improve the lives of patients where there is a high unmet medical need.

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 low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature narrowing and blocking of blood vessels, heart attacks and strokes, even at a very young age if not properly diagnosed or receiving adequate treatment. Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without LDL apheresis in adult patients with HoFH.

Amryt holds an exclusive licence to sell Lojuxta (lomitapide) across the European Economic Area, Middle East and North Africa, Switzerland, Turkey, Israel, Russia, the Commonwealth of Independent States and the non-EU Balkan states.

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 €1 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, Amryt 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.

For more information on Amryt, please visit amrytpharma.com