Ann Arbor-based Esperion has entered into a collaboration agreement with Otsuka Pharmaceutical Co. in Japan for the development and commercialization of NEXLETOL and NEXLIZET tablets in Japan. Both medicines were recently approved in the U.S. and the European Union.
The collaboration allows both companies to provide oral, once-daily, non-statin LDL-cholesterol lowering medicines for hypercholesterolemia patients in Japan. The development and commercialization collaboration combines Esperion’s expertise in lipid management with Otsuka’s cardiovascular drug development and commercialization expertise in Japan.
“We are thrilled to partner with Otsuka, one of the leading pharmaceutical companies in Japan,” says Tim Mayleben, president and CEO of Esperion. “Otsuka shares our vision of the potential for convenient oral, once-daily, non-statin LDL-C lowering medicines to help hypercholesterolemia patients in Japan.
“Otsuka’s history of successfully commercializing cardiovascular medicines in Japan and overlapping health care provider targets make this a highly synergistic collaboration. This collaboration continues the evolution of Esperion to a truly global research and development-driven commercial pharmaceutical company and further validates the global value of our medicines.”
Under the terms of the agreement, Esperion will grant Otsuka exclusive rights to NEXLETOL and NEXLIZET tablet development and commercialization in Japan. Otsuka will be responsible for all development, regulatory, and commercialization activities in Japan. In addition, Otsuka will fund all Japan-specific development costs associated with the program. Esperion estimates this amount to total up to $100 million over the next few years.
Esperion will receive an upfront cash payment of $60 million as well as up to an additional $450 million in total development and sales milestones. Esperion will also receive tiered royalties from 15 percent to 30 percent on net sales in Japan.
“We aspire to become an indispensable company for patients, physicians, and others around the world,” says Makoto Inoue, president and representative director of Otsuka Pharmaceutical. “If approved in our home market of Japan, bempedoic acid will represent another step forward in our fulfillment of that aspiration.”
Esperion’s lipid management team works to develop LDL-cholesterol lowering medicines designed to reduce global cardiovascular disease. High levels of LDL-cholesterol can lead to a buildup of fat and cholesterol in and on artery walls, potentially leading to cardiovascular events, including heart attack and stroke.
In the U.S., 96 million people, or more than 37 percent of the adult population, have elevated LDL-cholesterol. There are about 18 million people in the country living with elevated levels despite taking maximally tolerated lipid-modifying therapies. Esperion’s mission is to deliver once-daily oral medicines that complement existing oral drugs to provide additional treatment for these patients.