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Mar 23, 2020

Esperion Announces Pooled Analyses from Phase 3 LDL-C Lowering Development Program of the NEXLETOL™ (bempedoic acid) Tablet and Phase 2 Study Results of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet to be Presented at the American College of Cardiology’s 69th Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC)

ANN ARBOR, Mich., March 23, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that two pooled analyses from four Phase 3 clinical trials of NEXLETOL and results from the Phase 2 (1002-058) study of NEXLIZET will be presented at the American College of Cardiology’s 69th Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) on March 28th – 30th 2020.

Esperion completed its global, pivotal, Phase 3 LDL-C lowering development program and announced positive cumulative results in October 2018. The program evaluated the safety, tolerability and LDL-C lowering efficacy of NEXLETOL and NEXLIZET in patients with hypercholesterolemia who either have atherosclerotic cardiovascular disease (ASCVD) or are at high risk of ASCVD, and who continue to have elevated levels of LDL-C despite the use of maximally-tolerated statins and ezetimibe, leaving them at high risk for cardiovascular events. The program included over 4,000 patients across five studies, four for NEXLETOL and one for NEXLIZET.

Esperion also completed a Phase 2 (1002-058) study and announced positive topline results in August 2019.  The study evaluated the efficacy and safety of NEXLIZET compared to ezetimibe and placebo in 179 patients with both hypercholesterolemia and type 2 diabetes.  Patients enrolled were on stable background diabetes medications and washed out of other lipid modifying therapies.

Details of the poster presentations are as follows:

Title: Factors that Influence Bempedoic Acid–Mediated Reductions in High-sensitivity C-reactive Protein: Analysis of Pooled Patient-level Data from Phase 3 Clinical Trials
Author: Eric S. G. Stroes, MD, PhD
Location: Session 1161, Poster 130

Title: Bempedoic Acid Efficacy and Safety in High CVD Risk Patients Treated With or Without Ezetimibe: Pooled Analysis of 4 Phase 3 Clinical Trials (BA with EZE)
Author: Maciej Banach, MD, PhD, FAHA, FESC
Location: Session 1313, Poster 107

Title: Bempedoic Acid 180 mg + Ezetimibe 10 mg Fixed-Dose Combination vs Ezetimibe Alone or Placebo in Patients with Type 2 Diabetes and Hypercholesterolemia (Study 058)
Author: Harold E Bays, MD, FOMA, FTOS, FACC, FACE, FNLA
Location: Session 1313, Poster 103

NEXLETOLTM (bempedoic acid) Tablet

NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating LDL receptors. Phase 3 studies detailed in the label were conducted in more than 3,000 patients, with over 2,000 patients treated with NEXLETOL, demonstrated an average 18 percent placebo corrected LDL-C lowering when used in patients on moderate or high-intensity statins. NEXLETOL was approved by the FDA in February 2020.

Indication and Limitation of Use

NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

Important Safety Information

• Warnings and Precautions:

  • Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLETOL was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL who had no prior gout history.
  • Tendon rupture has occurred. Discontinue NEXLETOL at the first sign of tendon rupture. Avoid NEXLETOL in patients who have a history of tendon disorders or tendon rupture.

• Adverse Reactions:

  • The most common (incidence ≥ 2% and greater than placebo) adverse reactions are upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes.

• Drug Interactions:

  • Simvastatin: Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg.
  • Pravastatin: Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg.

• Use in Specific Populations

  • Pregnancy: Based on mechanism of action, may cause fetal harm.
  • Lactation: Breastfeeding is not recommended with NEXLETOL.

Patients or their physicians are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPRMED).

Click here to see the full prescribing information for NEXLETOLTM (bempedoic acid) tablet.

NEXLIZETTM (bempedoic acid and ezetimibe) Tablet

NEXLIZET contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine. Phase 3 data demonstrated NEXLIZET lowered LDL-C by a mean of 38 percent compared to placebo when added on to maximally tolerated statins. NEXLIZET was approved by the FDA in February 2020.

Indication and Limitation of Use

NEXLIZET is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLIZET on cardiovascular morbidity and mortality has not been determined.

Important Safety Information

• Contraindications:

  • Known hypersensitivity to ezetimibe tablets.  

• Warnings and Precautions:

  • Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLIZET was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLIZET who had no prior gout history.
  • Tendon rupture has occurred. Discontinue NEXLIZET at the first sign of tendon rupture. Avoid NEXLIZET in patients who have a history of tendon disorders or tendon rupture. 

• Adverse Reactions:

  • The most common adverse events reported in the development program were generally reported at similar rates in patients who received placebo (incidence ≥ 2% and greater than placebo) were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis fatigue, influenza.  

• Drug Interactions:

  • Simvastatin: Avoid concomitant use of NEXLIZET with simvastatin great than 20 mg
  • Pravastatin: Avoid concomitant use of NEXLIZET with pravastatin greater than 40 mg.
  • Cyclosporine: Monitor cyclosporine concentrations in patients receiving NEXLIZET and cyclosporine.
  • Fibrates: If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, consider alternative lipid-lowering therapy.

• Use in Specific Populations

  • Pregnancy: Based on mechanism of action, may cause fetal harm.
  • Lactation: Breastfeeding is not recommended with NEXLIZET.

Click here to see the full prescribing information for NEXLIZET™ (bempedoic acid and ezetimibe) tablet.

Patients or their physicians are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPRMED).

CLEAR Cardiovascular Outcomes Trial

The effect of NEXLETOL or NEXLIZET on cardiovascular morbidity and mortality has not been determined. Esperion initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered "statin averse." The CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.

Esperion Therapeutics

Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

Esperion Therapeutics’ Commitment to Patients with Hyperlipidemia

High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack and stroke. In the U.S., 96 million people, or more than 37 percent of the adult population, have elevated LDL-C. There are approximately 18 million people in the U.S. living with elevated levels of LDL-C despite taking maximally tolerated lipid-modifying therapy — including individuals considered statin averse — leaving them at high risk for cardiovascular events1. In the United States, more than 50 percent of atherosclerotic cardiovascular disease (ASCVD) patients and heterozygous familial hypercholesterolemia (HeFH) patients who are not able to reach their guideline recommended LDL-C levels with statins alone need less than a 40 percent reduction to reach their LDL-C threshold goal2.

Esperion's mission as the Lipid Management Company is to deliver oral, once-daily medicines that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.

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 the regulatory approval pathway for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, the therapeutic potential of, and the clinical development plan for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including Esperion's timing, designs, plans for announcement of results regarding its CLEAR Outcomes study and other ongoing clinical studies for bempedoic acid tablet and the bempedoic acid / ezetimibe combination fixed dose tablet, timing for the review and approval of the NDAs and the MAAs, and Esperion's expectations for the market for medicines to lower LDL-C, including the commercial launch and market adoption of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, if approved. 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, delays or failures in Esperion’s studies, that positive results from a clinical study of bempedoic acid may not be sufficient for EMA approval or necessarily be predictive of the results of future or ongoing clinical studies, that notwithstanding the completion of Esperion’s Phase 3 clinical development program for LDL-C lowering, the FDA or EMA require additional development in connection with seeking regulatory approval, or approval of an expanded indication, that existing cash resources may be used more quickly than anticipated, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. 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.

References
(1)  Esperion market research on file: research project interviewing 350 physicians. Esperion Therapeutics, Inc. Sept-Oct 2018.
(2)  Data on file: analysis of NHANES database. Esperion Therapeutics, Inc. 2018.

Investor Contact:
Alex Schwartz
Esperion
734-249-3386
aschwartz@esperion.com

Media Contact:
Ben Church
Esperion
734-864-6774
bchurch@esperion.com