"Global new" fat-lowering drugs! The first three signed a $900 million deal with Esperion, which was awarded to the company.

Sankyo Europe, the European subsidiary of The First Third Communist Party of Japan, recently announced that it has signed an exclusive licensing agreement with Esperion Therapeutics, a US biopharmaceutical company, to allow Dayichi Sankyo Europe to sell the new cholesterol-lowering drug bempedoic acid and the bempedoic acid/ezetimibe compound tablets in the European Economic Area and Switzerland.
, Daiichi Sankyo Europe, will be responsible for the commercialization of these products in these regions, while Esperion will be responsible for development and manufacturing. The agreement will strengthen the cardiovascular portfolio of the first three in Europe and will act as a synergy in the commercialization of the daily anticoagulant Lixiana (edoxaban) and the daily commercialization of the antiplaterate drug Efient (prasugrel).
Under the terms of the agreement, Daiichi Sankyo Europe will pay An advance of $150 million from Esperion, as well as an additional $150 million milestone, including supervision and first commercial sales, as well as royalties based on product sales. Potential payments under the agreement amount to $900 million.
Esperion completed the Phase III LDL-C development project for bempedoic acid and bempedoic acid/ezetimibe compound tablets in October 2018, which identified the efficacy and safety of bempedoic acid in reducing LDL-C. Of the 4,800 patients, approximately 3,100 patients received bempedoic acid and bempedoic acid/ibud treatment, which showed that bempedoic acid therapy reduced LDL-C levels by up to 30% and bempedoic acid/imbemab treatments reduced LDL-C levels by up to 48%. In the study, bempedoic acid was well-to-resistant and confirmed its efficacy over the extended period. Adverse events, muscle-related adverse events, and suspension rates were similar in the bempedoic acid treatment group and the placebo group.
Esperion has plans to file a new drug application with the U.S. Food and Drug Administration (FDA) in the first quarter of 2019 and a listing permit application (MAA) with the European Medicines Agency (EMA) in the second quarter of 2019. The FDA and EMA expect to approve both drugs in the first half of 2020.
bempedoic acid is a pioneering, complementary, oral, daily ATP citric acid lysase (ACL) inhibitor, a synthetic ddioxic acid derivative that lowers the biosynthetic of cholesterol and fatty acids by raising the LDL acceptor and lowers LDL-C. Similar to statins, bempedoic acid also reduces high sensitivity to C-reactive protein (Hs-CRP), a key marker of inflammation associated with cardiovascular disease. Bempedoic acid is a prescive drug that requires the activation of extremely long chain acetyl coenzyme A synthase 1 (ACSVL1).
addition, studies have shown that the lack of ACSVL1 in skeletal muscles may provide a mechanism basis for bempedoic acid to potentially avoid statin-related muscle toxicity. In Phase II and III clinical studies, bempedoic acid can reduce LDL-C levels by an additional 20% when combined with the maximum dose-resistant statins; When combined with the maximum to-dosage statins, LDL-C levels can be reduced by an additional 35%, and when bempedoic acid/e-fold mebu is used as a monotherapy, LDL-C levels can be reduced by 48%
the effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. Esperion is currently conducting a global cardiovascular outcomes study, CLEAR Outcomes, which is expected to obtain cardiovascular risk reduction data by 2022. (Bio Valley)