Esperion gets Japanese manufacturer for new cholesterol-buster

ANN ARBOR—Esperion Therapeutics Inc. announced a collaboration agreement with Otsuka Pharmaceutical Co. Ltd. for the development and commercialization of Nexletol and Nexlizet tablets in Japan.  Both medicines were recently approved in both the United States and the European Union.

This development and commercialization collaboration combines Esperion’s expertise in lipid management with Otsuka’s deep cardiovascular drug development and commercialization expertise in Japan.

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.

Said Tim Mayleben, Esperion president and CEO: “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 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.”

Both Nexletol and Nexlizet use a novel mechanism to lower cholesterol, and are intended for patients intolerant to today’s statin drugs at doses sufficient to reduce cholesterol levels.

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