Esperion Therapeutics (NASDAQ: ESPR) has announced two strategic partnerships to expand the global reach of its oral cholesterol-lowering medications, NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe). The company has entered into separate agreements with CSL Seqirus for Australia and New Zealand, and with HLS Therapeutics for the Canadian market.
The agreements mark significant steps in Esperion's international expansion strategy, bringing its cardiovascular disease treatments to regions with substantial unmet medical needs.
Australia and New Zealand Partnership with CSL Seqirus
Under the license and distribution agreement with CSL Seqirus (ASX:CSL), Esperion will receive upfront and milestone payments totaling approximately $5 million. CSL Seqirus gains exclusive commercialization rights to NEXLETOL and NEXLIZET in Australia and New Zealand, with responsibility for regulatory approval, reimbursement, and marketing activities.
Esperion will supply finished products to CSL Seqirus at what the company describes as a "profitable transfer price."
"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," said Danielle Dowell, CSL Seqirus Executive Director of Commercial Operations Asia Pacific. "These products are an important addition to CSL Seqirus' portfolio of in-licensed medicines."
The partnership addresses significant health challenges in both countries. In Australia, cardiovascular disease affects 1.2 million people and remains a leading cause of death. Similarly, in New Zealand, an estimated 175,000 adults live with cardiovascular disease, which accounts for one in three deaths.
Canadian Market Entry with HLS Therapeutics
Simultaneously, Esperion has partnered with HLS Therapeutics to commercialize NEXLETOL and NEXLIZET in Canada. This agreement includes an upfront payment of $1 million to Esperion, with an additional $1 million upon Health Canada's approval.
HLS will also pay customary royalties on future sales and potential milestone payments related to pricing, reimbursement, and commercial sales targets. HLS plans to fund all payments and launch expenses through existing cash reserves without requiring additional financing.
New drug submissions for both medications were made to Health Canada in Q4 2024, with approval anticipated by the end of this year. The brand names for the Canadian market will be confirmed upon regulatory approval.
HLS Therapeutics CEO Craig Millian stated, "We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease."
According to HLS, more than half a million individuals in Canada could potentially benefit from these treatments, particularly those with elevated LDL-C levels who are either statin intolerant or not meeting cholesterol goals despite current therapies.
Clinical Significance and Indications
Both NEXLETOL and NEXLIZET were initially approved by the U.S. Food and Drug Administration in 2020 for reducing low-density lipoprotein cholesterol (LDL-C). In 2024, their indications were expanded to include cardiovascular risk reduction in individuals unable to take recommended statin therapy, based on data from the CLEAR Outcomes trial.
The medications are currently indicated to:
- Reduce the risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy with established cardiovascular disease or at high risk for a cardiovascular event
- Serve as an adjunct to diet, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)
"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."
Safety Considerations
The medications carry important safety information, including contraindications for patients with prior hypersensitivity to bempedoic acid or ezetimibe. Notable adverse reactions include hyperuricemia, which may lead to gout, and an increased risk of tendon rupture or injury.
The most common adverse reactions in clinical trials included upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain, bronchitis, pain in extremity, anemia, and elevated liver enzymes.
Strategic Importance for Esperion
These partnerships align with Esperion's strategy to expand its global footprint while maintaining focus on its next-generation program developing ATP citrate lyase inhibitors (ACLYi). The company continues to evolve from a U.S.-focused entity into a leading global biopharmaceutical company through commercial execution, international partnerships, and advancement of its pre-clinical pipeline.
The agreements provide Esperion with immediate financial benefits through upfront payments while establishing potential long-term revenue streams through milestone payments, royalties, and product supply arrangements in key international markets.
