Daiichi Sankyo (TYO: 4568)’s European subsidiary, a Japanese pharmaceutical company, has entered into a collaboration amendment agreement with US-based Esperion Therapeutics (NASDAQ: ESPR) concerning Esperion’s antilipidemic drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid + ezetimibe). The revised agreement stipulates that Esperion will receive an immediate payment of USD 100 million this month, with an additional USD 25 million following the European Medicines Agency’s (EMA) approval of modifications to the marketing authorizations for the pills licensed to Daiichi.
Daiichi will assume responsibility for the European manufacturing and supply of the products, as well as communications with the EMA. The partners also plan to jointly develop a new formulation that includes bempedoic acid, ezetimibe, and a statin.
This arrangement resolves a legal dispute between the two companies over a USD 300 million milestone payment that was contingent on Nilemdo’s efficacy in a late-stage trial. The companies had differing views on whether the trial results demonstrated a 15% or greater reduction in cardiovascular risk, leading Esperion to file a lawsuit in 2023, which will now be withdrawn.- Flcube.com