Novelion Therapeutics, Inc.,specialty pharmaceutical company, announced that its subsidiary, Aegerion Pharmaceuticals, Inc., has entered into a licensing agreement with Amryt Pharma (Amryt) 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 US, Canada, and certain countries in Latin America, and expects to launch in Japan next month. 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).
