Esperion Announces Two Data Presentations of NEXLETOL® (bempedoic acid) Tablet at the ESC Congress 2020

Rhea-AI Summary

Esperion (NASDAQ: ESPR) announced its participation in the ESC Congress 2020, presenting pooled analyses from four Phase 3 trials and long-term data on NEXLETOL (bempedoic acid). The presentations will cover its effects on uric acid in patients and the drug's long-term safety and efficacy. NEXLETOL was recently approved by the FDA and European Commission, with European availability expected by Q4 2020. This medicine represents a significant advancement as a non-statin LDL-C lowering option for patients at high risk of cardiovascular events.

Positive

• NEXLETOL received FDA approval in February 2020 and European Commission approval in April 2020.
• Expected availability in Europe by Q4 2020 enhances market presence.
• NEXLETOL is the first oral, once-daily non-statin LDL-C lowering medication in nearly 20 years.

Negative

• The effect of NEXLETOL on cardiovascular morbidity and mortality is undetermined.

ANN ARBOR, Mich., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that it will present a pooled analysis from four Phase 3 clinical trials of NEXLETOL^® (bempedoic acid) tablets as well as long-term safety and efficacy data from the CLEAR Harmony open-label extension study of NEXLETOL at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, being held virtually from August 29^th – September 1^st, 2020.

Details of the poster presentations are as follows:

Title: Effect of bempedoic acid on uric acid and gout in 3621 patients with hypercholesterolemia: pooled analyses from phase 3 trials
Presenting Author: Kausik K Ray, MBChB, MD, MPhil
Session: Risk Factors and Prevention ePosters

Title: Long-term safety and efficacy of bempedoic acid in patients at high risk of atherosclerotic cardiovascular disease: results from the CLEAR Harmony open-label extension study
Presenting Author: Christie Ballantyne, MD
Session: Pharmacology and Pharmacotherapy ePosters

Both presentations will be available as on-demand ePoster presentations beginning Friday, August 28, 2020.

NEXLETOL was approved by the U.S. Federal Drug Administration (FDA) on February 21, 2020 and by the European Commission on April 6, 2020 under the name NILEMDO™ (bempedoic acid). Daiichi Sankyo Europe has licensed exclusive commercialization rights to NILEMDO in the European Economic Area, Switzerland and Turkey from Esperion. It is expected to be commercially available in Europe in the fourth quarter of 2020.

NEXLETOL^® (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 the LDL receptors. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. 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™ (bempedoic acid) tablet was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL™ (bempedoic acid) tablet who had no prior gout history.
  • Tendon rupture has occurred. Discontinue NEXLETOL™ (bempedoic acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL™ (bempedoic acid) tablet 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:
  • Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg.
  • Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg.

You 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).

Please see the full Prescribing Information for NEXLETOL by clicking here.

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 clinical development and commercialization plans 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, timing for the review and approval of expanded indications for their effect on cardiovascular events, 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 in the United States and European Union. 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 clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, that Otsuka is able to successfully commercialize bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination tablet, the impact of COVID-19 on our business, clinical activities and commercial development plans, 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.

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.

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

FAQ

What were the key findings from Esperion's presentations at the ESC Congress 2020 regarding NEXLETOL?

Esperion presented pooled analysis data showing NEXLETOL's effect on uric acid in hypercholesterolemia patients and its long-term safety and efficacy results.

When did NEXLETOL receive FDA approval?

NEXLETOL was approved by the FDA on February 21, 2020.

When is NEXLETOL expected to be available in Europe?

NEXLETOL is expected to be commercially available in Europe by the fourth quarter of 2020.

What is the significance of NEXLETOL in LDL-C lowering treatment?

NEXLETOL is significant as it is the first oral, once-daily, non-statin medication approved in the U.S. for LDL-C lowering in nearly 20 years.