ANN ARBOR, Mich., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the launch of “Break the Cycle with NEXLETOL”, a national direct-to-consumer (DTC) campaign aimed at broadening awareness of NEXLETOL® (bempedoic acid) Tablets and the never-ending patient cycle of diet, exercise and a statin treatment without ever reaching guideline recommended cholesterol levels. Approved earlier this year by the U.S. Food and Drug Administration (FDA) and launched at the height of the COVID-19 pandemic, NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine available to indicated patients in nearly 20 years.
NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not yet been determined. Please see important safety information below.
The ”Break the Cycle with NEXLETOL” campaign represents the first phase of an adaptive, tiered approach to DTC promotion where Esperion is monitoring the market and listening to patients to inform strategic decisions on how to further resource for growth and move forward our DTC promotion initiatives. Given the challenges and changes in the current environment, this approach couldn’t be more important. Nor could it be more relevant.
High levels of bad cholesterol remain an all-too-common threat for many patients. In fact, 7 out of 10 people with high cholesterol¹ in the U.S. cannot reduce their bad cholesterol down to guideline recommended levels, even with statin treatment. The “Break the Cycle with NEXLETOL” campaign powerfully and memorably depicts this as a never-ending cycle of frustration, and highlights NEXLETOL as a once-daily pill that can be added to diet, exercise, and maximally tolerated statin therapy to help “Break the Cycle with NEXLETOL” and be the edge patients need to achieve lower, healthier LDL-C levels.
“Break the Cycle with NEXLETOL” unanimously resonated with patients during focus groups. Respondents agreed that the “cycle” represented their daily routine and their lack of results, and they appreciated the acknowledgement of their efforts to get to goal. The campaign reflects their reality, with NEXLETOL inspiring hope and excitement that they too could break the cycle.
“Break the Cycle represents the next phase of our U.S. launch strategy for NEXLETOL intended to heighten awareness of the never-ending cycle patients experience with lowering bad cholesterol and how NEXLETOL provides healthcare professionals an innovative solution to help break it,” said Renee Marotta, Executive Director of Marketing of Esperion. “Despite the current standard-of-care cycle - diet, exercise, statin – over 18 million patients in the U.S. require further LDL-C lowering. Through our focused and differentiated “Break the Cycle with NEXLETOL” DTC campaign, we reinforce our commitment to delivering these patients an affordable and convenient oral, once-daily solution to elevated LDL-Cholesterol.”
“Break the Cycle with NEXLETOL” is a multichannel campaign incorporating a unique approach adapted to address new, COVID-19 driven consumer trends. The campaign will launch across the Unites States, inaugurated by a full-page ad in the Wall Street Journal, to national consumer print media outlets, across digital and social media platforms, while also leveraging connected TV. To expand beyond typical point-of-care efforts, the campaign will feature coordinated teledoc placements with a preferred vendor, enabling direct integration within healthcare professional care-portals.
“In a recent internal survey of 100 healthcare professionals, approximately 90% of respondents indicated familiarity with NEXLETOL despite the ongoing COVID-19 pandemic and the resulting requisite for physician and practice adaptation,” said Mark Glickman, Chief Commercial Officer of Esperion. “While we are enthusiastic about our current standing with HCPs, we view the launch of our DTC campaign as an opportunity to accelerate awareness in the overall market, help drive patients to healthcare professional practices and position NEXLETOL for future growth.”
To view the “Break the Cycle with NEXLETOL” DTC campaign, and to learn more about NEXLETOL, including appropriate use and important safety information, please visit www.NEXLETOL.com/commercial.
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).
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 events². 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 goal³.
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.
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding commercialization plans for bempedoic acid tablet., 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, 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.
(1) Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011-2012. Clin Lipidol. 2016;10(5):1109-1118. 2. Lin I, Sung J, Sanchez RJ, et al. Patterns of statin use in a real-world population of patients at high cardiovascular risk. J Manag Care Spec Pharm. 2016;22(6):685-698. 3. Arnold SV, Spertus JA, Masoudi FA, et al. Beyond medication prescription as performance measures: optimal secondary prevention medication dosing after acute myocardial infarction. J Am Coll Cardiol. 2013;62(19):1791-1801.
(2) Esperion market research on file: research project interviewing 350 physicians. Esperion Therapeutics, Inc. Sept-Oct 2018.
(3) Data on file: analysis of NHANES database. Esperion Therapeutics, Inc. 2018.