Bempedoic acid

ANN ARBOR, Mich., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents. Pursuant to the agreement, Dr. Reddy’s Laboratories has agreed not to market a generic version of either NEXLETOL or NEXLIZET in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur. As previously disclosed, Esperion reached settlement agreements with Micro Labs USA, Inc. and its affiliate; Hetero USA Inc. and its affiliates; and Accord Healthcare Inc. earlier this year with respect to their generic versions of NEXLETOL. Bempedoic acid is claimed in Esperion’s U.S Patent No. 7,335,799, which is scheduled to expire in December 2030. With this latest settlement with Dr. Reddy’s Laboratories, there are no remaining challenges regarding the validity or infringement of U.S Patent No. 7,335,799 in the pending patent litigation. Certain of Esperion’s patents that remain subject to the pending patent litigation are scheduled to expire in March 2036, while others are scheduled to expire in June 2040. The pending patent litigation against the remaining defendants (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited (along with an affiliate); 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, patent expiration 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

RSS Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labour and Welfare（MHLW）has approved NEXLETOL®（bempedoic acid） for the treatment of hypercholesterolemia and familial hypercholesterolemia. NEXLETOL is an oral, non-statin treatment with a novel mechanism of action. It inhibits ACLY (adenosine triphosphate citrate lyase), an enzyme upstream of the statin target in the liver's cholesterol synthesis pathway, which ultimately leads to a reduction in blood LDL-cholesterol levels. NEXLETOL was created by Esperion Therapeutics, Inc. (Esperion). NEXLETOL is marketed as a treatment for hypercholesterolemia in several regions around the world, including the United States and Europe. In 2020, Otsuka acquired exclusive development and commercialization rights for NEXLETOL in Japan from Esperion and has been advancing its development. (https://www.otsuka.co.jp/en/company/newsreleases/2020/20200420_1.html) Some patients with hypercholesterolemia are unable to achieve their target cholesterol levels despite taking statins (insufficient response to statins), while others find it difficult to continue treatment with statins due to adverse events. NEXLETOL is expected to offer a new therapeutic option for these patients in Japan. A Phase 3 trial (NCT05683340) was conducted in Japan as a placebo-controlled, randomized, multicenter, double-blind, parallel-group comparative study, in 96 patients with high LDL cholesterol and in whom statins had insufficient effect or whom statin therapy is not suitable. Trial participants were orally administered either 180 mg of NEXLETOL or a placebo once a day, for 12 weeks to evaluate the efficacy and safety of NEXLETOL. The percentage change from baseline in LDL-C at Week 12, the primary endpoint, was -25.25% in the group receiving NEXLETOL group and -3.46% in the placebo group, demonstrating positive outcomes with statistical significance compared to placebo (p<0.001). Furthermore, the safety and tolerability of NEXLETOL were favorable, and no serious adverse events were observed. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit www.otsuka.co.jp/en/