US commercial stage biopharmaceutical company Esperion Therapeutics Inc (NASDAQ:ESPR) announced on Friday that its partner, Japanese pharmaceutical company Otsuka Pharmaceutical Co., Ltd. (TYO:4578), has received approval from the Japanese Ministry of Health, Labour and Welfare to market NEXLETOL (bempedoic acid) for the treatment of hypercholesterolemia and familial hypercholesterolemia.
Japan represents one of the three largest global markets for cardiovascular prevention, positioning NEXLETOL for substantial international growth. With this milestone, the therapy is now approved across the United States, Europe, and Japan, strengthening Esperion's global footprint in non-statin low density lipoprotein cholesterol (LDL-C) lowering treatments.
Esperion's President and CEO Sheldon Koenig stated that the approval reinforces the company's international growth strategy and expands patient access to alternatives for cholesterol management.
Under its collaboration with Otsuka, Esperion is eligible for milestone payments tied to regulatory approval and National Health Insurance Price Listing in Japan. The company may also receive additional sales-based milestones and tiered royalties ranging from 15% to 30% on net sales achieved by Otsuka in the Japanese market.
Corstasis and U.S. Heart and Vascular partner to advance heart failure care with ENBUMYST
Eli Lilly and Company's orforglipron outperforms oral semaglutide in Phase 3 ACHIEVE-3 trial
Merck reports positive Phase 3 results for oral PCSK9 inhibitor enlicitide
Abbott's Navitor TAVI system granted CE Mark for expanded indication
Cereno Scientific receives FDA Fast Track designation for CS1 in pulmonary arterial hypertension
FDA lifts clinical hold on Rocket Pharmaceuticals' RP-A501 Phase 2 Danon disease trial
OptiBiotix signs distribution deal with major weight management company
Novartis to present cardiovascular abstracts portfolio data at ESC Congress in Madrid
LivaNova announces commercial launch of Essenz Perfusion System in China
Viatris' generic iron sucrose injection gains US FDA approval
CorMedix to acquire Melinta Therapeutics in USD300m deal to expand infectious disease portfolio
US FDA approves Innovent's IND application for IBI3032 oral GLP-1R agonist
GEN and Sulfateq report positive Phase 1 data for SUL-238 in Alzheimer's