Daiichi Sankyo Europe has entered into a European licensing agreement with Esperion for bempedoic acid, and the bempedoic acid/ezetimibe combination table.
Bempedoic acid is a first-in-class, oral, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol and fatty acid synthesis in the liver.
New treatment options are desperately needed for the large number of patients in Europe with hypercholesterolemia, who are not at their target low-density lipoprotein cholesterol (LDL-C) level. Even in very high risk patients, only 32% are at their target LDL-C level.
Bempedoic acid can be used in combination with other lipid lowering drugs and will offer an affordable oral, once-daily option for patients not at target who are experiencing adverse drug reactions (ADRs) under statins, according to the firms.
The treatment has a liver specific mode of action and therefore has the potential to avoid the muscle related ADRs associated with statin therapy.
The news comes off the back of a trial that consisted of almost 4,800 patients, of which 3,100 patients were treated with bempedoic acid with an additional LDL-C lowering of up to 30% LDL-C, and up to 48% LDL-C in combination with ezetimibe.
Daiichi will be responsible for commercialisation in these territories while Esperion will be responsible for the development and manufacturing. Under the terms of the licensing agreement, Daiichi will make an upfront payment of $150 million to Esperion as well as additional milestone payments, including $150 million upon first commercial sales and sales royalties.
Tim Mayleben, president and chief executive officer of Esperion commented: “This agreement represents the first step in the evolution of Esperion from a pioneering development-stage company to a successful commercial-stage company.”