Melbourne, 4 March 2025 – CSL Seqirus and Esperion Therapeutics have today announced the signing of an exclusive license and distribution agreement to commercialize Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid/ezetimibe) in Australia and New Zealand.
Bempedoic acid inhibits adenosine triphosphate-citrate lyase, a factor in low-density lipoprotein cholestrol (LDL-C) synthesis in the liver. It works on a different pathway to current cholesterol lowering therapies.
Under the terms of the agreement, Esperion will be responsible for product supply and CSL Seqirus will be responsible for commercialisation, including regulatory approval, reimbursement and marketing.
In Australia, cardiovascular disease affects 1.2 million people and is a leading cause of death.1 In New Zealand, an estimated 175,000 adults are living with cardiovascular disease, and one in three deaths are caused by cardiovascular disease.2
High cholesterol is an established risk factors for cardiovascular disease. According to the latest data from the Australian Institute of Health and Welfare, 1 in 3 Australian adults had raised levels of LDL cholesterol.1
Danielle Dowell, CSL Seqirus Executive Director of Commercial Operations Asia Pacific, says that the agreement is an important step in helping address unmet need for Australians with high cholesterol.
"We’re committed to helping reduce the burden of cardiovascular disease in Australia and New Zealand, and we are delighted to be working with Esperion to help make new treatment options available," says Danielle Dowell.
“These products are an important addition to CSL Seqirus' portfolio of in-licensed medicines in Australia, alongside our work in respiratory diseases, pandemic preparedness and antivenoms.”
“We are excited to partner with CSL Seqirus to provide physicians and patients with additional options to treat high LDL-C cholesterol and reduce the risk of cardiovascular disease in Australia and New Zealand,” said Sheldon Koenig, President and CEO of Esperion. “This partnership expands the reach of our potentially lifesaving medications to another large market, further enhancing our global reach.”
Dr Jonathan Anderson, CSL Seqirus Executive Medical Director – International, says that reducing the burden of cardiovascular disease is a key health priority.
"Elevated LDL or ‘bad’ cholesterol levels are a major risk factor for the occurrence of significant cardiovascular events, such as heart attack and stroke. There remains a high unmet need in cholesterol management and an ongoing need for additional treatment options as many high-risk patients are not meeting their cholesterol targets,” says Dr Anderson.4
MEDIA CONTACT
Hamish Walsh
(+61) 0422 424 338
hamish.walsh@seqirus.com
About Esperion Therapeutics
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 U.S. Food and Drug Administration (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.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
In Australia, CSL Seqirus operates the only local manufacturing facility for seasonal and pandemic influenza vaccine, and produces a range of unique medicines in the national interest, including antivenoms and the world’s only human vaccine for Q fever. Our commitment to Australia’s health also extends to providing access to paediatric and adult vaccines, and innovative pharmaceuticals for patients living with allergies, cardiovascular disease, severe pain, dry eye disease, iron deficiency, kidney and rare diseases.
About CSL
CSL (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 30,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest
Intended Audience
This press release is issued from CSL Seqirus is intended to provide information to about our business to industry and business journalists. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products.
REFERENCES
- AIHW Australian Institute of Health and Welfare 2024. Heart, stroke and vascular disease: Australian Facts. https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/hsvd-facts/contents/summary Accessed February 2025.
- NZ Ministry of Health (2020) Annual Data Explorer 2020/21: New Zealand Health Survey. https://minhealthnz.shinyapps.io/nz-health-survey-2020-21-annual-data-explorer/. Accessed February 2025
- Australian Institute of Health and Welfare 2024. Abnormal blood lipids. https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/hsvd-facts/contents/risk-factors/abnormal-blood-lipids. Accessed February 2025.
- Baker Heart and Diabetes Institute (2020) Code Red: overturning Australia’s cholesterol complacency. https://www.baker.edu.au/impact/advocacy/code-red. Accessed February 2025.