Daiichi Sankyo to Pay Esperion $125M in Settlement of Milestone Payment Lawsuit

Gavel on table

Pictured: Brown gavel on a wooden table, with a book in the background/iStock, nathaphat

Daiichi Sankyo and Esperion Therapeutics have reached an “amicable” resolution toa legal battle over milestone payments related to their cardiovascular drug collaboration. Under a settlement announced on Wednesday, Daiichi has agreed to pay Esperion $125 million in two separate tranches.

Daiichi will pay Esperion $100 million in the middle this month ahead of a Type II variation approval by the European Medicines Agency for the cholesterol medications Nilemdo and Nustendi. In addition, Daiichi will make a $25 million payment to Esperion sometime in the quarter following the EMA’s decision.

The resolution between the two companies will also see Esperion have Daiichi Sankyo Europe handle all production and supply operations in the European Union and for other territories. Under the agreement, Daiichi will lead all regulatory communications with the EMA. Both companies also plan to expand the collaboration in Europe and elsewhere to include the development and eventual commercialization of a “triple formulation product,” which consists of bempedoic acid, ezetimibe and a statin.

Wednesday’s agreement resolves a dispute between the companies that boiled over in early 2023. At the time, Daiichi did not trigger a milestone payment to Esperion after Phase III trials for Nexletol (bempedoic acid) were presented, showing that the drug had reduced major adverse cardiovascular events by 13% while reducing heart attack risk by 23% and coronary revascularization by 19%.

While Esperion felt that the results necessitated some form of payment, Daiichi thought otherwise which led to a spat in payment in the courts being filed in March 2023.

As a result of the companies’ resolution to their commercial dispute, all further legal actions have been dismissed in the U.S. District Court for the Southern District of New York, according to Wednesday’s announcement.

“We are pleased that this settlement creates value for Esperion today through cash payments and includes additional terms that will continue creating value for both companies going forward. 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 CEO Sheldon Koenig said in a statement.

“This is a positive resolution for patients. We look forward to continuing to apply our combined strengths around the world to bring innovative pharmaceutical products to patients with cardiovascular disease, the greatest cause of death and disability globally,” Oliver Appelhans, head of Daiichi Sankyo Europe’s  specialty business unit, said in a statement. 

Another one of Daiichi Sankyo’s subsidiaries, Plexxikon, reached a $182 million settlement with Novartis in December 2023 over the sale of the cancer drug Tafinlar.  

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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