AMYT.L Regulatory News (AMYT)

10 December 2018

AIM: AMYT

ESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Grant Funding from Irish Government for AP103

Amryt led consortium to receive €8.4m from Disruptive Technologies Innovation Fund

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 been awarded grant funding totalling €8.4m over three years, from the Disruptive Technologies Innovation Fund ("DTIF"), part of the Irish Government's Department of Business, Enterprise and Innovation, to develop the Company's AP103 gene therapy platform.

The grant has been awarded to a consortium comprised of Amryt, University College Dublin ("UCD"), Curran Scientific Limited and DEBRA Ireland. The grant funding will be matched by the consortium partners at various funding levels over the three year term of the project.

The grant will fund further development of Amryt's AP103 non-viral gene therapy platform (in-licenced from UCD in March 2018) from pre-clinical testing to proof of concept in humans. Preliminary data suggest the platform could be a disease-modifying therapy for patients with Recessive Dystrophic Epidermolysis Bullosa ("RDEB"), a subset of Epidermolysis Bullosa ("EB"). The initial funds will be used for R&D and staff costs associated with the project and, if pre-clinical work is successful, to fund the initial phases of a clinical trial for AP103. In addition to the primary work on AP103, the funds will also support research into the platform's underlying High Branched Poly (β-Amino Ester) ("HPAE") polymer technology for the potential treatment of other genetic disorders.

As previously announced, Amryt intends to report initial results from ongoing pre-clinical studies on AP103 in the coming weeks.

Joe Wiley, CEO of Amryt Pharma, commented: "We are very pleased to have received the DTIF grant award and are grateful for the support of the Irish Government. Our innovative AP103 gene therapy platform can potentially provide new treatments for disease areas with a significant unmet medical need. This funding will help to accelerate the development of our platform from research through to patient treatment in clinical trials. We are also excited and proud to be working with our consortium partners in Ireland: UCD, Curran Scientific and DEBRA Ireland to progress AP103".

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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 is the marketing authorisation holder and has 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