In 2024, the medicines’ indications were expanded to include cardiovascular risk minimisation in individuals who are not to take recommended statin therapy. Credit: chayanuphol / Shutterstock.
HLS Therapeutics has signed an agreement with Esperion Therapeutics for in-licensing and commercialising the oral cardiovascular medicines, Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) in Canada.
HLS’s agreement with Esperion includes an upfront payment of $1m, another $1m upon Health Canada’s approval, customary royalties on future sales, and potential milestone payments related to pricing, reimbursement, and significant commercial sale goals.
In addition, Esperion will obtain an upfront payment and be qualified for milestone payments of up to nearly $5m alongside tiered royalties on product sales.
HLS plans to fund all upfront and milestone-based payments, as well as related launch expenses, via current cash reserves, negating the need for additional financing. The company also plans to utilise its existing commercial infrastructure, expecting no significant increase in operating costs.
HLS is tasked with receiving approval for these medicines from Health Canada, which is anticipated by the end of this year.
These medications are currently available in various European nations and the US.
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The US Food and Drug Administration (FDA) initially approved the medicines in 2020 for cutting low-density lipoprotein cholesterol (LDL-C) levels.
In 2024, their indications were expanded to include cardiovascular risk minimisation in individuals who are not to take recommended statin therapy. This decision was supported by data from the CLEAR Outcomes trial.
In fourth quarter (Q4) of 2024, Esperion made new drug submissions to Health Canada for both medicines.
The brand names for these drugs in Canada will be confirmed upon approval from the country’s regulator.
HLS noted that more than half a million individuals in Canada could potentially benefit from these treatments, particularly those with elevated levels of LDL-C and those who are either statin intolerant or not meeting LDL-C goals in spite of statins and ezetimibe combination therapy.
HLS Therapeutics CEO Craig Millian said: “We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease.”
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