Novelion Therapeutics, Inc announced that its subsidiary, Aegerion Pharmaceuticals Inc has entered into a licensing agreement with Amryt Pharma for the exclusive rights to LOJUXTA® (lomitapide) hard capsules in certain European and Middle Eastern territories.
LOJUXTA, marketed as JUXTAPID® in the United States, is currently approved by the European Commission 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 homozygous familial hypercholesterolemia (HoFH).
Under the terms of the agreement, Amryt will receive an exclusive license to promote and distribute LOJUXTA in the European Economic Area, Switzerland, Turkey, and certain Middle Eastern and North African countries, including Israel. Amryt will pay Aegerion sales-related milestone payments and royalties on product sales in the licensed territories. Amryt will also be responsible for ongoing regulatory and post-marketing obligations and commitments in support of the brand.
“We are very pleased that Aegerion has entered into this agreement with Amryt, which will enable adult HoFH patients in these markets to remain on treatment and continue benefiting from this important therapy,” said Mary Szela, chief executive officer of Novelion. “Our objective as a company is to always put patients at the center of our decisions, and we believe with this outcome we have achieved that goal. In addition to the critical benefit for patients, we believe this is the right decision for our business. Our ability to reduce both corporate expenses and post-approval commitments allows us to reprioritize resources. Additionally, our stakeholders will now benefit from a royalty and potential milestone stream to Aegerion derived from Amryt’s sales of LOJUXTA. 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.”
“We believe that LOJUXTA, which was approved in the EU in mid-2013, is an important and needed therapy,” said Joe Wiley, chief executive officer of Amryt. “We believe there are a meaningful number of adult HoFH patients for whom LOJUXTA is a vital therapeutic option, and given our management team’s in-depth knowledge of the drug, we look forward to contributing to their care. This agreement is tremendously exciting and underlines our focus on building our portfolio of medicines to treat rare and orphan diseases where there is large unmet medical need.”
Lomitapide was approved in July 2013 by the European Commission and, until assumed by Amryt under the announced transaction, was marketed by Aegerion Pharmaceuticals under the brand name LOJUXTA. Aegerion is commercializing lomitapide under the brand name JUXTAPID in the U.S., Canada, and certain countries in Latin America, and expects to launch in Japan next month.
About JUXTAPID (lomitapide) capsules
JUXTAPID is a prescription medicine used along with diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL (“bad”) cholesterol, total cholesterol, a protein that carries bad cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C).
Studies have not been conducted to tell us whether JUXTAPID can help prevent problems from high cholesterol, such as heart attack, stroke, death, or other health problems. Studies have also not been conducted to tell us whether JUXTAPID is safe for use in people with high cholesterol who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).
About Amryt Pharma
Amryt Pharma is a specialty pharmaceutical 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 therapies.
Amryt’s lead product, Episalvan, received marketing approval for the treatment of partial-thickness wounds from the European Commission in January 2016. Amryt intends to further develop Episalvan as a new treatment for Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children for which there is currently no treatment. Amryt is currently planning a phase III study of Episalvan in EB, which has been granted US and EU orphan drug designation. The market opportunity for EB is estimated to be circa US $1.5 billion.
Amryt’s earlier stage products are 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. These include acromegaly and Crushing’s disease.The Company joined AIM and Dublin’s ESM in April 2016 following the reverse takeover of Fastnet Equity PLC.
About Novelion Therapeutics, Inc.
Novelion Therapeutics is a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases. The company seeks to advance its portfolio of rare disease therapies by investing in science and clinical development. Novelion has a diversified commercial portfolio through its indirect subsidiary, Aegerion Pharmaceuticals, Inc., which includes MYALEPT® and JUXTAPID®, and is also developing zuretinol acetate for the treatment of inherited retinal disease caused by underlying mutations in RPE65 or LRAT genes.
Amanda Murphy, Associate Director, Investor & Public Relations