Amryt has made a deal with Aegerion Pharmaceuticals, the NASDAQ-listed biopharmaceutical company, for the exclusive rights to sell Aegerion’s drug, Lojuxta in the European Union (EU) and other territories.
Lojuxta is used to treat a rare life-threatening disease called Homozygous Familial Hypercholesterolemia (HoFH) and was approved in the EU in late 2013. Aegerion recorded $22.0 million in net product sales of lomitapide capsules in the third quarter of 2016, 15% of which was from prescriptions written outside of the US, including the territories now being licensed to Amryt. Amryt believes that there is significant potential for the drug to become a mainstay treatment for patients with HoFH.
Under the terms of the Licence Agreement, Amryt has the exclusive right to sell Lojuxta across the European Economic Area (EEA), Middle East and North Africa (MENA), Turkey and Israel (Licenced Territories) for the next 8 years, until 2024.
Homozygous Familial Hypercholesterolemia is a deadly disorder that impairs the body’s ability to remove LDL cholesterol from the blood. If left untreated, heart attack or sudden death may occur in childhood or early adulthood.
Current are not adequate to control LDL cholesterol levels in some patients, particularly those with the most severe genetic mutations. HoFH was historically estimated to occur in about one in one million people worldwide although more recent studies suggest it may affect up to 1 in 300,000 people.
Amryt’s Chief Medical Officer, Dr. Mark Sumeray, is very familiar with Lojuxta, having previously led the clinical development and regulatory approval of the drug while Chief Medical Officer at Aegerion.
Joe Wiley, CEO of Amryt, commented: “We are delighted to announce this landmark licensing deal. It transforms Amryt into a fully-fledged commercial orphan pharma company and comes only eight months after Amryt’s IPO in April.
“This agreement is tremendously exciting and underlines our clear focus on building our portfolio of medicines to treat rare and orphan diseases, where there is large unmet medical need. We look forward providing a further update in due course.”
Mary Szela, CEO of Novelion Therapeutics, Inc, parent company of Aegerion, said: “We are extremely pleased to enter into this agreement with Amryt. Amryt’s unique combination of orphan drug experience, commitment to developing and commercializing transformative rare disease therapies, and management’s familiarity with LOJUXTA, give us confidence in their ability to serve current and future adult HoFH patients. We are pleased to have them as a partner.”