Bempedoic acid

ANN ARBOR, Mich., May 12, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Micro Labs USA, Inc. and its affiliate Micro Labs Limited (together, Micro Labs). This agreement resolves the patent litigation brought by Esperion against Micro Labs in response to Micro Labs’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Micro Labs has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur. The pending patent litigation against the remaining defendants (Accord Healthcare Inc; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy’s Laboratories Inc. (along with an affiliate); Hetero USA Inc. (along with affiliates); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040. 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. 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 and follow Esperion on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding pending patent litigation and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. Esperion Contact Information: Investors: Alina Venezia investorrelations@esperion.com (734) 887-3903 Media: Tiffany Aldrich corporateteam@esperion.com (616) 443-8438

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. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence 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.”