After a dispute over milestone payments derailed a 2019 heart med collaboration, Daiichi Sankyo and Esperion Therapeutics have mended fences with a $125 million settlement.
Under the new agreement, Daiichi will pay Esperion $100 million in the coming weeks before an anticipated label expansion in Europe for their bempedoic acid products Nilemdo and Nustendi, which are branded as Nexletol and Nexlizet, respectively, in the U.S.
The company will pay a further $25 million in the quarter following the European Medicines Agency's (EMA) decision on whether to add language about a cardiovascular risk reduction to the drug's label.
Meanwhile, European manufacturing and supply responsibilities will change hands from Esperion to Daiichi, which will deliver “significant cost savings and efficiencies” to both companies, the partners said in a joint press release.
Going forward, the two companies will expand their collaboration to potentially work on a triple-formulation product using bempedoic acid. Daiichi will handle regulatory communications with the EMA.
The “amicable resolution” dismisses the U.S. pending litigation that Esperion filed in March, the companies said.
“Importantly, today’s settlement allows Esperion and DSE to focus on the business at hand—delivering life-saving drug therapies to millions with high cholesterol,” Esperion’s CEO Sheldon Koenig noted in the release.
For its part, Daiichi “looks forward to continuing to apply our combined strengths around the world,” said Oliver Appelhans, head of Daiichi’s European specialty business unit.
The conflict stemmed from the partners’ 2019 agreement to give Daiichi exclusive commercialization rights to Esperion’s bempedoic acid, which included regulatory milestone payments tied to certain outcomes, including a label expansion.
Further, one of the payments was tied to a trial that evaluated the med's ability to reduce the risk of heart attacks and coronary revascularization, along with a range of cardiovascular outcomes grouped together in an endpoint called MACE-4.
Daiichi and Esperion butted heads over the different trial endpoints related to a $300 million milestone payment. The milestone specifically covered a “cardiovascular risk reduction” of 15% or greater, which Esperion thought it was owed due to the 27% lower risk of heart attacks proved in the trial.
Daiichi instead pointed to the MACE-4 outcome, which only hit a 13% cardiovascular risk reduction over placebo.
While the Japanese company believed that specific endpoint had to be over 15%, Esperion thought that interpretation was “inconsistent with the plain and unambiguous language of the agreement,” it said in its lawsuit.

https://www.pharma.com/pharma/nexletol-partners-esperion-and-daiichi-sankyo-patch-milestone-payment-dispute-125m