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).
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 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.
Forward-Looking StatementsThis 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.
References(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.
Contact:Kaitlyn BroscoEsperioninvestorrelations@esperion.com
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