Esperion (NASDAQ: ESPR) today announced the full results from the
landmark
Cholesterol
Lowering via
B
empedoic acid, an
ACL-Inhibiting
Regimen (CLEAR) Outcomes trial, which were
presented at the American College of Cardiology’s Annual Scientific
Session & Expo together with the World Congress of Cardiology
and simultaneously published in the New England Journal of
Medicine. CLEAR Outcomes was a global study of nearly 14,000
patients with or at risk for cardiovascular disease who were unable
to maximize or tolerate a statin.
The study showed that NEXLETOL significantly reduced the risk of
hard MACE-4 and MACE-3 by 13% and 15%, respectively, and
significantly reduced the risk of heart attack and coronary
revascularization by 23% and 19%, respectively, as compared to
placebo. These results were seen in a broad population of primary
and secondary prevention patients who are unable to maximize or
tolerate a statin. The proportions of patients experiencing adverse
events and serious adverse events were similar between the active
and placebo treatment groups. Bempedoic acid (contained in NEXLEOL
and NEXLIZET® (bempedoic acid and ezetimibe) tablets) now becomes
the first LDL-C lowering therapy since statins proven to lower hard
ischemic events, not only in those with ASCVD but also in the large
number of primary prevention patients for whom limited therapies
exist.
The Company believes that it remains on track to submit
regulatory filings to the FDA and EMA in 1H 2023. Based on the
robustness of the CLEAR Outcomes data, the Company believes it
would be entitled to receive $300 million in partner milestone
payments upon inclusion of certain required cardiovascular risk
reduction data in the EU label, for which payment is tied to the
magnitude of the risk percentage reduction included in the label
(among other requirements) and ranges from $200 million to $300
million, and up to $140 million in partner milestone payments upon
the achievement of other regulatory milestones, including inclusion
of certain required cardiovascular risk reduction data in the US
label.
“Esperion expresses its great appreciation for all the people
that brought CLEAR Outcomes to completion, especially the patients
and investigators and their colleagues at clinical sites that
participated in this study. We are incredibly proud that we have
successfully completed a 4-year cardiovascular outcomes study
during a global pandemic and these results have the potential to
bring significant benefits to the millions of primary and secondary
prevention patients who are unable to reach their goals with
current therapies,” said Sheldon Koenig, president and CEO of
Esperion. “These results are practice changing and exceed our
expectations. We expect applicable treatment guidelines to be
updated quickly which will then lead to a paradigm shift in patient
care. Based upon the strength of the data and the clinical
significance they represent, we will be filing with the FDA and EMA
by June 2023 and anticipate receipt of expanded CV risk reduction
labels in 1H 2024 that will more than double the addressable
treatment population for NEXLETOL and NEXLIZET.”
“We recognize that physicians and patients are eager for
additional non-statin oral treatments that lower LDL-C and hsCRP,
do not worsen glucose and reduce major adverse cardiovascular
events,” said JoAnne Foody, MD, FACC, FAHA, chief medical officer
of Esperion. “As we increasingly move to earlier initiation of
lipid lowering therapies to stay ahead of cardiovascular disease,
NEXLETOL and NEXLIZET will be integral treatments. These results
now position our products as the ‘go-to’ therapies for the large
number of primary and secondary prevention patients unable to
maximize or tolerate statins to reduce
cardiovascular risk. We believe NEXLETOL and NEXLIZET can be
next as physicians consider options for further lipid reduction
after statins.”
Recently conducted quantitative market research also validates
the significant role NEXLETOL and NEXLIZET will have as the
preferred next step after statins.
The Company expects full-year 2023 operating expenses to be
approximately $225 million to $245 million, including $25 million
in non-cash expense related to stock-compensation.
CLEAR Cardiovascular Outcomes Trial CLEAR
Outcomes is a Phase 3, event-driven, randomized, multicenter,
double-blind, placebo-controlled trial designed to evaluate whether
treatment with NEXLETOL reduces the risk of cardiovascular events
in patients with or who are at high risk for cardiovascular disease
with documented statin intolerance (inability to tolerate 2 or more
statins, one at a low dose) and elevated LDL-C levels (fasting
blood LDL-C ≥ 100 (2.6 mmol/L)). The study, which includes nearly
14,000 patients at over 1,200 sites in 32 countries, accumulated
the targeted 1,620 primary major adverse cardiovascular events
(MACE-4) in August 2022.
INDICATIONNEXLETOL and NEXLIZET are indicated
as adjuncts 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.Limitations of Use: The effect of
NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has
not been determined.
IMPORTANT SAFETY
INFORMATIONContraindications: NEXLETOL
has no contraindications. NEXLIZET is contraindicated in patients
with a known hypersensitivity to ezetimibe tablets.
Hypersensitivity reactions including anaphylaxis, angioedema, rash,
and urticaria have been reported with ezetimibe.
Warnings and Precautions: Hyperuricemia:
Bempedoic acid, a component of NEXLETOL and NEXLIZET, may increase
blood uric acid levels. Hyperuricemia may occur early in treatment
and persist throughout treatment, and may lead to the development
of gout, especially in patients with a history of gout. Assess uric
acid levels periodically as clinically indicated. Monitor for signs
and symptoms of hyperuricemia, and initiate treatment with
urate-lowering drugs as appropriate.Tendon Rupture: Bempedoic acid
is associated with an increased risk of tendon rupture or injury.
In clinical trials, tendon rupture occurred in 0.5% of patients
treated with bempedoic acid versus 0% of patients treated with
placebo, and involved the rotator cuff (the shoulder), biceps
tendon, or Achilles tendon. Tendon rupture occurred within weeks to
months of starting bempedoic acid. Tendon rupture may occur more
frequently in patients over 60 years of age, patients taking
corticosteroid or fluoroquinolone drugs, patients with renal
failure, and patients with previous tendon disorders. Discontinue
NEXLETOL or NEXLIZET at the first sign of tendon rupture. Avoid
NEXLETOL and NEXLIZET in patients who have a history of tendon
disorders or tendon rupture.
Adverse Reactions: In
NEXLETOL clinical trials, the most commonly reported adverse
reactions were upper respiratory tract infection, muscle spasms,
hyperuricemia, back pain, abdominal pain or discomfort, bronchitis,
pain in extremity, anemia, and elevated liver enzymes. Reactions
reported less frequently, but still more often than with placebo,
included benign prostatic hyperplasia and atrial fibrillation.In
the NEXLIZET clinical trial, the most commonly reported adverse
reactions observed with NEXLIZET, but not observed in clinical
trials of bempedoic acid or ezetimibe, a component of NEXLIZET, and
occurring more frequently than with placebo, were urinary tract
infection, nasopharyngitis, and constipation.Adverse reactions
reported in clinical trials of ezetimibe, and occurring at an
incidence greater than with placebo, included upper respiratory
tract infection, diarrhea, arthralgia, sinusitis, pain in
extremity, fatigue, and influenza. Other adverse reactions reported
in postmarketing use of ezetimibe included hypersensitivity
reactions, including anaphylaxis, angioedema, rash, and urticaria;
erythema multiforme; myalgia; elevated creatine phosphokinase;
myopathy/rhabdomyolysis; elevations in liver transaminases;
hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea;
dizziness; paresthesia; depression; headache; cholelithiasis;
cholecystitis.
Drug Interactions: Simvastatin and
Pravastatin: Concomitant use with bempedoic acid results in
increased concentrations and increased risk of simvastatin or
pravastatin-related myopathy. Use of either NEXLETOL or NEXLIZET
with greater than 20 mg of simvastatin or 40 mg of pravastatin
should be avoided.Cyclosporine: Caution should be exercised when
using NEXLIZET and cyclosporine concomitantly due to increased
exposure to both ezetimibe and cyclosporine. Monitor cyclosporine
concentrations in patients receiving NEXLIZET and cyclosporine. In
patients treated with cyclosporine, the potential effects of the
increased exposure to ezetimibe from concomitant use should be
carefully weighed against the benefits of alterations in lipid
levels provided by NEXLIZET.
Fibrates: Coadministration
of NEXLIZET with fibrates other than fenofibrate is not
recommended. Fenofibrate and ezetimibe may increase cholesterol
excretion into the bile, leading to cholelithiasis. If
cholelithiasis is suspected in a patient receiving NEXLIZET and
fenofibrate, gallbladder studies are indicated and alternative
lipid-lowering therapy should be considered.Cholestyramine:
Concomitant use of NEXLIZET and cholestyramine decreases ezetimibe
concentration. This may result in a reduction of efficacy.
Administer NEXLIZET either at least 2 hours before, or at least 4
hours after, bile acid sequestrants.
Lactation and Pregnancy: It is not
recommended that NEXLETOL or NEXLIZET be taken during
breastfeeding. Discontinue NEXLETOL or NEXLIZET when pregnancy is
recognized, unless the benefits of therapy outweigh the potential
risks to the fetus. Based on the mechanism of action of bempedoic
acid, NEXLETOL and NEXLIZET may cause fetal harm.
Please see full Prescribing Information here.
Esperion TherapeuticsAt Esperion, we discover,
develop, and commercialize innovative medicines to help improve
outcomes for patients with or at risk for cardiovascular and
cardiometabolic diseases. The status quo is not meeting the health
needs of millions of people with high cholesterol – that is why our
team of passionate industry leaders is breaking through the
barriers that prevent patients from reaching their goals. Providers
are moving toward reducing LDL-cholesterol levels as low as
possible, as soon as possible; we provide the next steps to help
get patients there. Because when it comes to high cholesterol,
getting to goal is not optional. It is our life’s work. For more
information, visit esperion.com and esperionscience.com
and follow us on Twitter at twitter.com/EsperionInc.
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 expected operational expenses, expected
revenue of our commercial products, future operations, expected
milestone payments from partners, commercial products and expected
growth, clinical development and regulatory submissions, and other
statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “suggest,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions. 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,
the impact of the ongoing COVID-19 pandemic on our business,
revenues, results of operations and financial condition, the net
sales, profitability, and growth of Esperion’s commercial products,
clinical activities and results, supply chain, commercial
development and launch 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.
Contact:Esperion Corporate
Communicationscorporateteam@esperion.com
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