Nexlizet (bempedoic acid/ezetimibe) / Esperion Therap, Otsuka, Daiichi Sankyo, NeoPharm, CSL Behring, HLS Therap - LARVOL DELTA

LDL-C targets after administration of the combination of bempedoic acid and ezetimibe in patients with acute coronary syndrome: an observational study with simulation analysis. (ESC-WCC 2025) - "At hospital discharge, all patients were prescribed high-intensity statins (atorvastatin 80 mg in 54.8% and rosuvastatin 40 mg in 45.2%)...The simulation analysis showed that after the administration of a fixed-dose combination of bempedoic acid and ezetimibe, the mean LDL-C could be reduced to 41.8 (14.8) mg/dL, with 79.5% of patients reaching the lipid goal. Despite receiving high-intensity statins, a considerable proportion of patients did not reach the LDL-C goal recommended by current guidelines. The systematic and early use of the combination of bempedoic acid and ezetimibe could enable a greater number of patients, following an ACS, to achieve LDL-C targets at 6 weeks."

Clinical • Observational data • Acute Coronary Syndrome • Cardiovascular

Esperion Reports First Quarter 2025 Financial Results (GlobeNewswire) - "Q1 2025 Total Revenue of $65.0 Million, a Decrease of 53% Y/Y; Adjusting for One Time Milestone Received in Q1 2024, Total Revenue Grew 63% Y/Y; Q1 2025 U.S. Net Product Revenue Grew 41% Y/Y to $34.9 Million; Bempedoic Acid Earned Level 1a Recommendations in the 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients with Acute Coronary Syndromes; Esperion’s European partner Daiichi Sankyo Europe (DSE) continues to show strong revenue growth and market penetration for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid and ezetimibe), providing increased royalty revenue and underscoring the significant market opportunity for Esperion’s bempedoic acid products worldwide."

Commercial • Dyslipidemia

Esperion Partners with HLS Therapeutics to Commercialize NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in Canada (GlobeNewswire) - "Esperion Therapeutics...announced it has entered into a license and distribution agreement with HLS Therapeutics...for the exclusive rights to commercialize NEXLETOL and NEXLIZET in Canada. Under the terms of the agreement, Esperion will receive an upfront payment, near-term milestone and tiered royalties on product sales. Esperion will be responsible for supplying finished product to HLS Therapeutics at a profitable transfer price...Under the terms of the license and distribution agreement, Esperion will grant HLS Therapeutics exclusive commercialization rights to NEXLETOL and NEXLIZET in Canada. HLS Therapeutics will be responsible for commercialization, including reimbursement and marketing....Esperion will receive an upfront payment and be eligible for milestone payments of up to approximately $5 million along with tiered royalties on product sales."

Licensing / partnership • Cardiovascular

ARTCAP: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: University of Louisville | N=200 ➔ 0 | Trial completion date: Jan 2029 ➔ Jan 2025 | Recruiting ➔ Withdrawn | Trial primary completion date: Jan 2029 ➔ Jan 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Myocardial Infarction

CSL Seqirus and Esperion Sign Licensing Agreement to commercialise Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) in Australia and New Zealand (CSL Behring Press Release) - "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."

Licensing / partnership • Cardiovascular

Bempedoic Acid: A Review in Cardiovascular Risk Reduction in Statin-Intolerant Patients. (PubMed, Am J Cardiovasc Drugs) - "Oral bempedoic acid (NEXLETOL® in the USA; Nilemdo® in the EU) and the fixed dose combination (FDC) of bempedoic acid/ezetimibe (NEXLIZET® in the USA; Nustendi® in the EU) are approved to reduce cardiovascular (CV) risk in statin-intolerant patients who are at high risk for, or have, CV disease. Bempedoic acid was generally well tolerated and, unlike statins, was associated with a low incidence of musculoskeletal adverse events (AEs). In conclusion, bempedoic acid as a monotherapy or adjunctive to other lipid-lowering therapies expands the treatment options available for the pharmacological reduction of CV risk in statin-intolerant patients, supporting achievement of low-density lipoprotein cholesterol (LDL-C) targets required for CV risk reduction."

Journal • Review • Cardiovascular • Dyslipidemia • Musculoskeletal Diseases • Myocardial Infarction

Esperion Partners with Neopharm to Commercialize NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in Israel (Esperion Therapeutics Press Release) - "Esperion Therapeutics...announced it has entered into a licensing agreement with Neopharm Israel for the exclusive rights to commercialize NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in Israel. Under the terms of the agreement, Esperion will receive an upfront and near-term milestone payments and will be eligible to receive tiered royalties on sales of NEXLETOL/NEXLIZET in Israel."

Licensing / partnership • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Esperion Announces New Drug Submissions in Canada for NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) Treatments to Reduce LDL-C and Cardiovascular Risk (GlobeNewswire) - "Esperion...announced that it has filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET, once-daily, accessible, oral non-statin medications that reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk."

Canada filing • Cardiovascular • Dyslipidemia

Esperion Highlights New Exploratory Data from CLEAR Outcomes Trial Highlighting Value of NEXLETOL (bempedoic acid) in Oral Featured Science Session and Multiple Poster Presentations at AHA Scientific Sessions 2024 (Esperion Therapeutics Press Release) - "Esperion...announced the presentation of an analysis from the CLEAR Outcomes study focused on patients with Peripheral Artery Disease (PAD) who were unable or unwilling to take statin medications....Additionally, two exploratory analyses from the CLEAR Outcomes trial and a real-world analysis of bempedoic acid usage were presented at the conference....Bempedoic acid reduced MALE (e.g. worsening PAD symptoms leading to revascularization, chronic limb threatening ischemia, and acute limb ischemia events) by 36% compared to placebo....After 3 months 67% of patients on bempedoic acid and ezetimibe had LDL-C <100 mg/dL, a significant increase over the 30% at baseline, and by 12 months 55% had maintained LDL-C levels <100 mg/dL."

P3 data • Real-world evidence • Cardiovascular • Dyslipidemia

Esperion Reports Third Quarter 2024 Financial Results and Provides a Business Update (Esperion Therapeutics Press Release) - "'We also have a significant market opportunity in Japan where our partner, Otsuka Pharmaceutical, is advancing toward filing for regulatory approval of our bempedoic acid product by the end of 2024 with approval and pricing anticipated in 2025'....Updated utilization management criteria for over 165 million lives now aligned to our new labels across Commercial, Medicare and Medicaid payers....With key restrictions and access barriers reduced, including prior authorization in some cases, physicians can now prescribe NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) with increased confidence, positioning the products for higher sales growth in the upcoming quarters and beyond."

Commercial • Filing • Pricing • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Esperion Announces a Featured Presentation in the Late Breaker/Featured Science Track and Three Poster Presentations Accepted for the 2024 American Heart Association (AHA) Scientific Sessions (GlobeNewswire) - "Esperion...announced that one featured presentation in the Late Breaker/Featured Science track and three poster presentations have been accepted for the AHA Scientific Sessions 2024 in Chicago, IL, November 16-18, 2024."

P3 data • Real-world • Cardiovascular • Dyslipidemia

Final Real-World Results from MILOS German Cohort Demonstrate Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid (Businesswire) - P=NA | N=5,000 | MILOS (NCT04579367) | Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | "Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced final 2-year follow-up data from the German cohort of the multinational, European observational MILOS study....The results, presented in Hamburg, Germany at DGK Hertztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies (LLTs) in clinical practice....Additionally, the percentage of patients reaching their LDL-C goals increased from 4.9% at pre-treatment to 35.3% at the 2Y follow-up – an approximately 7-fold increase. The proportions of high-risk and very high-risk patients reaching LDL-C goals increased from 5.6% to 32.5%, and 3.6% to 35.2%, respectively."

Observational data • Real-world • Cardiovascular • Dyslipidemia • Heterozygous Familial Hypercholesterolemia

Esperion Secures Additional Commercial and Medicare Formulary Coverage for NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) (GlobeNewswire) - "Esperion today announced that NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) have achieved additional coverage on national and large regional formularies since the U.S. Food and Drug Administration’s (FDA) approval of the expanded indications, increasing total coverage to more than 136 million commercially insured lives (92% of all commercial lives) and 34 million Medicare lives (65% of all Medicare lives). Additionally, many payers have accelerated alignment of utilization management criteria since the FDA approval of the expanded indications to the new labels."

Reimbursement • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Esperion Reports Second Quarter 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "The Company expects this expanded payer coverage to drive further increases in physician confidence to prescribe NEXLETOL and NEXLIZET, ultimately leading to higher product sales in the upcoming quarters and beyond....Research and development expenses for the three and six months ended June 30, 2024, were $11.5 million and $24.9 million, compared to $22.1 million and $53.5 million for the comparable periods in 2023, a decrease of 48% and approximately 53%, respectively. The decrease is primarily related to the close-out of our CLEAR Outcomes study."

Commercial • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

New Digital First Marketing Campaign from Esperion Alerts Patients with Uncontrolled LDL Cholesterol to the “Lipid Lurkers” Inside Their Arteries (GlobeNewswire) - "Targeted Campaign Reaches Patients at Risk for Heart Attack or Heart Procedures Because of High LDL Cholesterol (LDL-C)...Esperion...makers of NEXLETOL and NEXLIZET is on a mission to educate patients on the cardiovascular risks of uncontrolled or under controlled LDL cholesterol, an asymptomatic disease that 'lurks' inside artery walls."

Clinical • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

First-in-class cholesterol-lowering treatment NILEMDO and its combination with ezetimibe, NUSTENDI, approved in Europe to lower LDL cholesterol and reduce cardiovascular risk (Businesswire) - "Daiichi Sankyo Europe GmbH...and Esperion Therapeutics, Inc. jointly announced today, that the European Commission (EC) has approved the label update of both NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolaemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C-lowering treatments indicated for primary and secondary prevention of cardiovascular events....EC approval is based on results of the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial."

European regulatory • Cardiovascular • Dyslipidemia • Metabolic Disorders

Esperion Receives Five Year Patent Extension for Bempedoic Acid, Contained in NEXLETOL and NEXLIZET (GlobeNewswire) - "Esperion...announced today that the U.S. Patent and Trademark Office (USPTO) issued a U.S. Patent Term Extension (PTE) certificate for bempedoic acid, which is contained in NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets. The certificate extends the term of U.S. Patent No. 7,335,799 by five years through December 3, 2030. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984."

Patent • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women (clinicaltrials.gov) - P4 | N=16 | Completed | Sponsor: Esperion Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

A new indication for bempedoic acid (Nexletol). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

BESAFE: Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients (clinicaltrials.gov) - P4 | N=130 | Not yet recruiting | Sponsor: University of Salerno

New P4 trial • Cardiovascular • Dyslipidemia • Metabolic Disorders

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity (Esperion Therapeutics Press Release) - P3 | N=13,970 | CLEAR Outcomes (NCT02993406) | Sponsor: Esperion Therapeutics, Inc. | "Esperion...announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity....'In women and Hispanic/Latinx patients with or at risk for CVD, bempedoic acid decreased LDL-cholesterol (LDL-C) and inflammatory markers, did not worsen glucose or weight, and in turn reduced the risk of major adverse cardiovascular events (MACE). These results continue to reinforce the importance of early and aggressive LDL-C lowering in order to reduce cardiovascular events, underscoring the paradigm of ‘even lower, even earlier is even better.'"

P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Metabolic Disorders

Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants (clinicaltrials.gov) - P=N/A | N=39 | Completed | Sponsor: The Hospital for Sick Children | Recruiting ➔ Completed | N=304 ➔ 39

Enrollment change • Trial completion

Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session & Industry Expert Theatre to be Presented at ACC.24 (Esperion Therapeutics Press Release) - "Esperion...announced the acceptance of three CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Outcomes subgroup analyses as poster presentations at the 2024 American College of Cardiology’s Annual Scientific Session (ACC.24) in Atlanta, Georgia. Additionally, the Company will participate in a moderated session in partnership with UT Southwestern Medical Center, host an industry expert theatre, and have a commercial and medical information booth during ACC.24."

Clinical data • P3 data • Cardiovascular • Dyslipidemia

ARTCAP: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: University of Louisville | Not yet recruiting ➔ Recruiting

Enrollment open • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events (GlobeNewswire) - "Daiichi Sankyo Europe GmbH...and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk....The CHMP positive opinions are based on analysis from the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial....The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024."

European regulatory • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders