13 Nov 2017 07:00
13 November 2017
AIM: AMYT
ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
Distribution Agreement Signed in Saudi Arabia
Amryt, a biopharmaceutical company focused on rare and orphan diseases, is pleased to announce that it has signed a distributorship agreement, with Faisal Musaed El Seif Saudi Pharmaceutical Company ("El Seif"), for Amryt's products in the Kingdom of Saudi Arabia ("Saudi Arabia"). This exclusive agreement covers Lojuxta (lomitapide) and AP101, the Company's clinical stage product, currently in Phase 3 trials. El Seif, an affiliate of El Seif Development Company, is a leading distributor of medical devices and pharmaceuticals in Saudi Arabia, and has a strong presence in the rare and orphan diseases drug sector.
Amryt acquired exclusive marketing rights for Lojuxta in the European Economic Area, Middle East, North Africa, Turkey and Israel in December 2016. Lojuxta is a treatment for Homozygous Familial Hypercholesterolaemia ("HoFH"), a rare, life-limiting disease, which impairs the body's ability to remove LDL cholesterol ("bad" cholesterol) from the blood. The disease process starts before birth and progresses rapidly. It typically results in extremely high blood LDL cholesterol levels, leading to aggressive and premature narrowing and blocking blood vessels. Left untreated, heart attack or sudden death may occur in childhood or early adulthood.
The Company estimates that there are currently in excess of 150 patients with HoFH in Saudi Arabia.
AP101 is currently in pivotal Phase 3 trials, which Amryt hopes will show its efficacy as a potential treatment for Epidermolysis bullosa, a life-limiting and particularly distressing genetic skin disorder. The Company's agreement with El Seif covers AP101 in anticipation of a successful conclusion of these trials.
Dr. Joe Wiley, Chief Executive Officer of Amryt Pharma, said:
"We are delighted to be working with El Seif and to have signed this exclusive distribution agreement which covers Lojuxta and AP101. El Seif has an extensive footprint in Saudi Arabia, and significant breadth and depth of experience and relationships across the institutional and Ministry of Health sectors."
"The signing of this partnership with El Seif is another key milestone for Amryt as we broaden our capability and reach to ensure complete coverage across our key territories."
Enquiries:
Amryt Pharma plc | C/o KTZ Communications (details below) |
Joe Wiley, CEO Rory Nealon, CFO/COO |
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Shore Capital | +44 (0) 20 7408 4090 |
Nomad and Joint Broker |
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Edward Mansfield, Mark Percy
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Davy | +353 (1) 679 6363 |
ESM Adviser and Joint Broker |
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John Frain, Anthony Farrell
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Stifel | +44 (0) 20 7710 7600 |
Joint Broker |
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Jonathan Senior, Ben Maddison
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KTZ Communications | +44 (0) 20 3178 6378 |
Katie Tzouliadis, Irene Bermont-Penn, Emma Pearson |
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) for adults, across the European Economic Area, Middle East and North Africa, Turkey and Israel. Lojuxta is used to treat a rare life-threatening disease called Homozygous Familial Hypercholesterolemia, 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. If left untreated, heart attack or sudden death may occur in childhood or early adulthood.
Amryt's lead drug candidate, AP101 (Episalvan), 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 global 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.
The Company joined AIM and Dublin's ESM in April 2016 following the reverse takeover of Fastnet Equity PLC.