Amryt and Aegerion Expand Agreement for HoFH Drug in Russia, CIS, and Non-E.U. Balkan States

Rare Daily Staff

Amryt said that it expanded its exclusive license agreement with Aegerion Pharmaceuticals for the rare cholesterol disorder homozygous familial hypercholesterolemia treatment Lojuxta into Russia and the Commonwealth of Independent States, as well as the non-E.U. Balkan states.

Aegerion and Amryt originally announced an agreement in December 2016 that allowed Amryt to market the drug in certain European and Middle Eastern territories. Aegerion markets the treatment as Juxtapid in the United States.

Amryt estimates there may be up to 450 additional patients who could benefit from treatment with Lojuxta across the countries covered by the extended agreement, representing an increase of approximately 25 percent in the total number of addressable patients in the Amryt territories. Amryt said it is actively seeking distribution partners in these new territories.

HoFH impairs the body’s ability to remove LDL cholesterol from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body and subsequent aggressive and premature narrowing and blocking of blood vessels. Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein apheresis in adult patients with HoFH.

Amryt estimates there may be up to 450 additional patients who could benefit from treatment with Lojuxta across the countries covered by the extended agreement, representing an increase of approximately 25 percent in the total number of addressable patients in the Amryt territories. Amryt is actively seeking distribution partners in these new territories.

The companies did not release financial terms of the agreement. The license expansion extends the original agreement, secured in December 2016, which covers the European Economic Area, Middle East and North Africa, Switzerland, Turkey, and Israel. As part of this agreement Amryt will formally become the Marketing Authorization holder for Lojuxta in Europe which will marginally increase the level of royalties payable to Aegerion.

“A core focus for Amryt in 2018 is to drive further growth for Lojuxta in new and existing territories,” said Joe Wiley, CEO of Amryt Pharma. “Following closely on from our market expansion in the Middle East, these new markets, with their significant increase in total addressable patients, assist us in this goal and will allow us to make Lojuxta available to HoFH patients for the first time in the Russian Commonwealth, the surrounding states, and the non-EU Balkan states.”

Over the last seven months, Amryt said it has secured five distribution agreements, covering the Kingdom of Saudi Arabia, Switzerland, Central and Eastern Europe, Lebanon, Jordon, and Syria.

The expanded agreement will allow Amryt to market Lojuxta in the Russian Commonwealth includes Russia, Kazakhstan, Belarus, Azerbaijan, Uzbekistan, Armenia, Moldova, Kyrgyzstan, Tajikistan, as well as the associate states of Ukraine and Turkmenistan, and the state of Georgia. The non-EU Balkan states covered in the agreement include Albania, Albania, Bosnia-Herzegovina, Macedonia, Montenegro, Serbia and Kosovo.

May 10, 2018
Photo: Joe Wiley, CEO of Amryt Pharma