Esperion Partner Otsuka Receives Regulatory Approval to Market NEXLETOL for the Treatment of Hypercholesterolemia
Esperion recently announced Otsuka Pharmaceutical Co., Ltd., the Company’s partner for the development and commercialization of NEXLETOL (bempedoic acid) tablets in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare to market NEXLETOL as a treatment for hypercholesterolemia and familial hypercholesterolemia.
“Securing regulatory approval in Japan – one of the top three global markets for cardiovascular prevention – represents a major step forward in our international growth strategy. With NEXLETOL now approved across the US, Europe, and Japan, we’ve established a strong global footprint and expanded access to a differentiated, non-statin LDL-C lowering therapy for patients who need alternatives,” said Sheldon Koenig, President and CEO of Esperion. “Our partnership with Otsuka positions us to unlock significant value in Japan, and we remain focused on driving long-term growth and shareholder value through continued innovation and market expansion.”
Under the terms of the collaboration and license agreement, Esperion is eligible to receive significant milestone payments upon regulatory approval and National Health Insurance Price Listing for NEXLETOL in the Otsuka territory. In addition, Esperion is eligible to receive additional sales milestone payments based on total net sales achievements by Otsuka in Japan, as well as tiered royalties ranging from fifteen percent to thirty percent on net sales in Japan.
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only US FDA-approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com.
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