Irish company focused on bad cholesterol treatment in 'significant' license agreement
Irish-listed Amryt Pharma has signed an agreement with Aegerion Pharmaceuticals to "significantly expand" its exclusive licence agreement for Lojuxta (lomitapide) into Russia and the Commonwealth of Independent States ("CIS"), as well as the non-EU Balkan states.
Amryt is focused on finding treatments for rare and orphan diseases, and Lojuxta is a treatment for Homozygous Familial Hypercholesterolaemia ("HoFH"), a rare, life-limiting disease, which impairs the body's ability to remove bad cholesterol from the blood.
The disease process starts before birth and progresses rapidly, and typically results in extremely high bad cholesterol levels in blood, leading to aggressive and premature narrowing and blocking of blood vessels.
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 25pc in the total number of addressable patients in the Amryt territories.
"A core focus for Amryt in 2018 is to drive further growth for Lojuxta in new and existing territories," Dr. Joe Wiley, chief executive officer of Amryt, said.
"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 Russia, the surrounding states, and the non-EU Balkan states."
This licence expansion extends the original agreement, secured in 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 Authorisation holder for Lojuxta in Europe, which will marginally increase the level of royalties payable to Aegerion, a company that is a subsidiary of Novelion Therapeutics.
Amryt said that it is now actively seeking distribution partners in these new territories.
Last year Amryt generated revenues of €11.9m from sales of Lojuxta, which represents a 65pc increase on the run rate from when Amryt initially in-licenced the Lojuxta business.
Over the last seven months, the company has secured five distribution agreements, covering the Kingdom of Saudi Arabia, Switzerland, Central and Eastern Europe, Lebanon, Jordon and Syria.