Esperion, Daiichi Sankyo Europe Announce Amendment to License, Commercial Agreement

Esperion 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 last eighteen months Esperion and DSE have formed a true partnership which 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% – 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.