Esperion (NASDAQ: ESPR) today announced an agreement with Currax
Pharmaceuticals LLC that provides for all of Currax’s 72 sales
representatives to co-promote NEXLETOL® (bempedoic acid) Tablets
and NEXLIZET® (bempedoic acid and ezetimibe) Tablets. This deal
more than doubles the sales representatives for NEXLETOL and
NEXLIZET and further demonstrates Esperion’s focus on driving
persistent growth to the business.
“We are excited to partner with Currax through the end of 2023
to continue raising awareness of NEXLETOL and NEXLIZET,” said
Sheldon Koenig, President and Chief Executive Officer of Esperion.
“We believe this performance-based agreement that provides a more
than doubling of our sales representatives will provide us with the
opportunity to build on the significant momentum we’ve seen since
the announcement of the positive results from our landmark
Cholesterol Lowering via
Bempedoic acid, an ACL-Inhibiting
Regimen (CLEAR) Outcomes trial.”
“Our entire commercial organization is charged with driving
additional awareness and utilization of NEXLETOL and NEXLIZET,”
said George Hampton, president and chief executive officer of
Currax. “This agreement aligns with Currax’s focus on patient
access to critical medicines and is a win for patients, physicians
and both companies.”
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 Therapeutics At 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
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Aug 2024 to Sep 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Sep 2023 to Sep 2024