Daiichi Sankyo Europe (DSE) has amended its existing collaboration with Esperion Therapeutics. The collaboration is valued at $125m.
The amendment includes the resolution of a commercial dispute and specific adjustments to bolster the long-term value of their products.
The agreement involves the dismissal of pending litigation in the US District Court for the Southern District of New York.
DSE will pay $100m to Esperion in mid-January 2024, in anticipation of the European Medicines Agency’s (EMA) Type II(a) variation approval for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) tablets.
On receipt of EMA approval, Esperion is entitled to receive a further payment of $25m from DSE.
The resolution also includes shifting the production and supply activities of Esperion in Europe and other territories to DSE.
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This approach will result in substantial efficiencies and cost reductions for both parties.
The collaboration will be expanded to develop and market a triple formulation product that combines bempedoic acid, ezetimibe and a statin, in Europe and other regions.
DSE will now spearhead regulatory activities with the EMA regarding the pending applications.
The companies have been collaborating since 2019 to deliver bempedoic acid to patients, and exploring its potential to reduce cardiovascular risk.
Esperion president and CEO Sheldon Koenig stated: “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.
“Together, we are committed to making bempedoic acid a blockbuster franchise worldwide, based on the differentiating profiles of our products.”
Daiichi Sankyo signed an agreement in November 2023 with Japan’s Ministry of Health, Labour and Welfare to supply 1.4 million doses of its omicron XBB.1.5-adapted monovalent mRNA vaccine for Covid-19.