Esperion & Daiichi Sankyo Europe Announce Amendment to License & Commercial Collaboration Agreement

Esperion recently announced the completion of an amendment to the EU commercial collaboration agreement with Daiichi Sankyo Europe (DSE).  Earlier this month, Esperion completed the transfer to DSE of Marketing Authorization Approvals (MAA) for NILEMDO and NUSTENDI.  DSE will now pay Esperion the second $150- million milestone based on completion of the MAA transfer rather than the first commercial product sale in the EU, as previously agreed.

“Over the past 18 months, Esperion and DSE have formed a true partnership that includes the earlier-than-expected European Commission approval of NILEMDO and NUSTENDI and the acceleration of the $150-million milestone payment,” said Tim M. Mayleben, President and Chief Executive Officer of Esperion. “Together, we are delivering on our mutual commitment to bring affordable and convenient oral, once-daily LDL-C lowering medicines to the millions of patients with elevated LDL-Cholesterol.”

The acceleration of the $150-million milestone payment from DSE was made as a result of an amendment to the License and Collaboration Agreement between the two companies, originally signed in January 2019, which also added Turkey to existing rights covering the European Economic Area and Switzerland. Previously, the milestone payment was due upon the first commercial product sale in Europe.

Under terms of the collaboration agreement with DSE, Esperion is eligible to receive up to $900 million in total milestones as well as tiered royalties between 15% to 25%. Upon receipt of the $150-million milestone payment later this month, Esperion will have received $300 million in total milestone payments.

The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. Esperion initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered “statin averse.” The CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of over 14,000 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.

High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack and stroke. In the US, 96 million people, or more than 37% of the adult population, have elevated LDL-C. There are approximately 18 million people in the US living with elevated levels of LDL-C despite taking maximally tolerated lipid-modifying therapy — including individuals considered statin averse — leaving them at high risk for cardiovascular events. In the US, more than 50% of atherosclerotic cardiovascular disease (ASCVD) patients and heterozygous familial hypercholesterolemia (HeFH) patients who are not able to reach their guideline recommended LDL-C levels with statins alone need less than a 40% reduction to reach their LDL-C threshold goal.

Esperion’s mission as the Lipid Management Company is to deliver oral, once-daily medicines that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.