The collaboration for development and commercialization combines Esperion’s knowledge in lipid management and Otsuka’s extensive cardiovascular drug advancement and marketing in Japan.
Esperion Therapeutics announced Monday they would be collaborating with Otsuka Pharmaceutical for the development and commercialization of NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid) tablets in Japan. Both drugs were approved earlier this year in the EU and the U.S. by the Food and Drug Administration (FDA).
The collaboration for development and commercialization combines Esperion’s knowledge in lipid management and Otsuka’s extensive cardiovascular drug advancement and marketing in Japan. Together, they will be able to advance their commitment to providing medications to patients with hypercholesterolemia.
“We are thrilled to partner with Otsuka, one of the leading pharmaceutical companies in Japan. Otsuka shares our vision of the potential for convenient oral, once-daily, non-statin LDL-C lowering medicines to help hypercholesterolemia patients in Japan,” said Tim Mayleben, president and chief executive officer of Esperion.
Under the agreement, Esperion will receive $60 million in upfront cash payment as well as the potential for the addition of $450 million in cumulative development and sales milestones. They will also receive tiered royalties on net sales in Japan, between 15 and 30%. Otsuka will be responsible for all Japan-specific development costs associated with the program. The total is estimated to be up to $100 million in years to come, according to Esperion. Additionally, Otsuka will take care of all development, regulatory and commercialization activities in Japan. Under the terms, Esperion will also be required to provide Otsuka exclusive rights to both NEXLETOL and NEXLIZET tablet development and commercialization in Japan.
“Otsuka’s history of successfully commercializing cardiovascular medicines in Japan, and overlapping healthcare 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,” Mayleben said.
Bempedoic acid is a novel first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor. In clinical trials, it has shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) levels, when added to other lipid-lowering therapies, in patients with primary hyperlipidemia who also need additional LDL-C lowering.
“We aspire to become an indispensable company for patients, physicians, and others around the world. If approved in our home market of Japan, bempedoic acid will represent another step forward in our fulfillment of that aspiration,” said Makoto Inoue, president, and representative director of Otsuka Pharmaceutical.
About one in three adults in the U.S. has elevated LCL-C. High levels of LDL-C can lead to atherosclerosis, a build-up of fat and cholesterol in and on artery walls. This can potentially lead to heart attack, stroke, and other cardiovascular events. In the US, someone has a heart attack every 40 seconds, and every 37 seconds, one person dies from cardiovascular disease.
