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Includes transfer of certain manufacturing and supply rights to Daiichi Sankyo Europe and expansion of collaboration in Europe.
January 3, 2024
By: Anthony Vecchione
Esperion Therapeutics, Inc. and Daiichi Sankyo Europe GmbH (DSE), the European organization of Daiichi Sankyo Co., reported a $125 million amendment to their collaboration, which includes a resolution to their commercial dispute and certain other adjustments to enhance the long-term value of their products. DSE has agreed to pay Esperion $100 million ahead of an anticipated Type II(a) variation approval by the European Medicines Agency (EMA) for NILEMDO (bempedoic acid) Tablet and NUSTENDI (bempedoic acid and ezetimibe) Tablet. DSE will make an additional $25 million payment to Esperion in the calendar quarter immediately following EMA’s decision on the pending application. The legal action pending in the United States District Court for the Southern District of New York will be dismissed. As part of the resolution, Esperion will transition to DSE manufacturing and supply responsibilities in Europe and other territories, resulting in significant cost savings and efficiencies for both companies; an expanded collaboration in Europe and other territories to include the potential development and commercialization of a triple formulation product comprising bempedoic acid, ezetimibe, and a statin, which could represent significant long-term value for the collaboration, and for DSE to now lead all regulatory communications with the EMA regarding the pending applications. “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,” said Sheldon Koenig, Esperion’s President, and CEO. “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.” Oliver Appelhans, Head of the Specialty Business Unit of Daiichi Sankyo Europe said, “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.”
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