The amendment also consists of an amicable resolution to their commercial dispute and several other adjustments to improve the long-term value of their products
Esperion and Daiichi Sankyo Europe amend collaboration. (Credit: Ousa Chea on Unsplash)
Esperion Therapeutics and Daiichi Sankyo Europe (DSE), the European division of the Japanese pharmaceutical company Daiichi Sankyo, have reported a $125m amendment to their existing collaboration.
The amendment also consists of an amicable resolution to their commercial dispute and several other adjustments to improve the long-term value of their products.
DSE has agreed to pay Esperion $100m in mid-January ahead of an expected Type II(a) variation approval by the European Medicines Agency (EMA) for Nilemdo (bempedoic acid) tablet and Nustendi (bempedoic acid and ezetimibe) tablet.
Daiichi Sankyo Europe will pay Esperion an additional $25m in the calendar quarter that follows EMA’s decision on the pending application.
In addition, there will be a dismissal of the ongoing lawsuit in the Southern District of New York US District Court.
Esperion Therapeutics president and CEO Sheldon Koenig said: “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.”
Under the resolution, both parties have agreed for Esperion to switch to DSE manufacturing and supply responsibilities in Europe and other regions.
This will result in significant cost cuts and efficiencies for both companies, the European division of Daiichi Sankyo said.
Both firms will also expand their partnership in European and other territories to add possible development and commercialisation of a triple formulation product.
Furthermore, DSE has agreed to oversee all regulatory communications with the EMA related to the pending applications.
Daiichi Sankyo Europe Specialty Business Unit head Oliver Appelhans said: “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.”
Together, Esperion and DSE have been collaborating since 2019 to expand the patient group eligible for bempedoic acid and realise its potential for lowering cardiovascular risk.