Date: 2016-12-05
Type of information: Licensing agreement
Compound: Lojuxta® (lomitapide)
Company: Aegerion Pharmaceuticals (USA - MA), subsidiary of Novelion Therapeutics (Canada) Amryt Pharma (UK)
Therapeutic area: Rare diseases - Genetic diseases - Cardiovascular diseases
Type agreement: licensing
Action mechanism: protein inhibitor/microsomal triglyceride transfer protein (MTP) inhibitor. Lomitapide is a small molecule, microsomal triglyceride transfer protein inhibitor, or MTP-I. HoFH is a rare genetic disorder inherited from both parents, and characterised by significantly elevated low density lipoprotein cholesterol (LDL-C) levels. HoFH patients have LDL receptors that are either non-functional or are defective in their functioning. Patients diagnosed with HoFH typically have as much as three to six times the normal amount of LDL-C while on a variety of lipid-lowering drug treatments, putting them at risk for a major cardiovascular event. Most other drug treatments such as statins work by increasing the number of LDL-receptors and if these are defective or negative, the drugs that work by these mechanisms typically have limited effectiveness in HoFH patients. Inhibition of MTP reduces lipoprotein secretion and circulating concentrations of lipoprotein-borne lipids including cholesterol and triglycerides.
Disease: homozygous familial hypercholesterolemia (HoFH)
Details: * On December 5, 2016, Novelion Therapeutics announced that its subsidiary, Aegerion Pharmaceuticals 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).
Lojuxta® 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.
Financial terms: 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.
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