Esperion Partners with Otsuka for NEXLETOL® Approval in Japan

Esperion and Otsuka Collaboration Marks Significant Milestone
Esperion, a biopharmaceutical company based in Ann Arbor, has made headlines with the recent approval granted to their partner, Otsuka Pharmaceutical Co., Ltd., by the Japanese Ministry of Health, Labour and Welfare. This approval allows Otsuka to market NEXLETOL® (bempedoic acid) in Japan, targeting patients suffering from hypercholesterolemia and familial hypercholesterolemia.
Sheldon Koenig, President and CEO of Esperion, expressed his enthusiasm for this achievement, highlighting the importance of Japan as a major global market for cardiovascular disease prevention. He noted that this development paves the way for Esperion to expand its footprint internationally and provide essential non-statin LDL-C lowering therapies for patients seeking alternatives.
Strategic Advantages of Regulatory Approval
The approval in Japan not only signifies a crucial step in Esperion's growth strategy but also positions the company to realize substantial benefits under the terms of their collaboration with Otsuka. The partnership will lead to milestone payments following the approval and price listing of NEXLETOL. Furthermore, Esperion will receive tiered royalties on the net sales generated by Otsuka, ranging from fifteen to thirty percent, adding financial incentives tied to sales performance.
Innovative Therapeutics on the Horizon
Beyond its current offerings, Esperion is dedicated to continuous innovation and advancing its pipeline with the aim of developing next-generation therapies. The company is leveraging insights from extensive clinical trials, particularly the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial, to inform the development of ATP citrate lyase inhibitors (ACLYi). This progress represents not only a commitment to creating effective treatments but also enhances Esperion's potential as a leader in biopharmaceuticals.
Commitment to Global Cardiac Health
Esperion's focus extends beyond just NEXLETOL. The company is determined to tackle the broader challenges posed by cardiovascular diseases. By establishing strategic international partnerships and enhancing its capabilities in commercial execution, Esperion is set to influence the landscape of cardiovascular health on a global scale.
This multifaceted approach exemplifies Esperion's proactive stance on improving patient outcomes and underscores its role in shaping the future of heart health. The commercial success anticipated from their products, particularly NEXLETOL, will undoubtedly contribute to the wellbeing of countless patients worldwide.
Contacting Esperion
For those interested in learning more about Esperion and its initiatives, the following contact information is available. For investor inquiries, Alina Venezia can be reached at investorrelations@esperion.com or by phone at (734) 887-3903. Media queries can be directed to Tiffany Aldrich at corporateteam@esperion.com, with a contact number of (616) 443-8438.
Frequently Asked Questions
What is NEXLETOL and its primary use?
NEXLETOL is a medication developed by Esperion to lower LDL cholesterol for patients with hypercholesterolemia and familial hypercholesterolemia.
Who partnered with Esperion to market NEXLETOL in Japan?
Otsuka Pharmaceutical Co., Ltd. is the partner responsible for the marketing of NEXLETOL in Japan.
What financial benefits does Esperion gain from the collaboration?
Esperion will receive milestone payments and tiered royalties based on net sales of NEXLETOL in Japan.
How does NEXLETOL differ from traditional cholesterol medications?
NEXLETOL is a non-statin therapy, offering an alternative for patients who may not tolerate statins effectively.
What future developments can we expect from Esperion?
Esperion is focused on advancing its pipeline with innovative treatments and ongoing research, particularly ATP citrate lyase inhibitors (ACLYi).
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