Esperion Retains Gibson Dunn to Secure $300 Million Payment From DSE; Will Announce First Quarter Financial Results Tuesday, May 9
May 04 2023 - 8:30AM
Esperion (NASDAQ: ESPR) announced today that it has retained Gibson
Dunn to vindicate its contractual rights against Daiichi Sankyo
Europe (“DSE”) and filed an amended complaint against DSE in the
Southern District of New York. The complaint seeks a judicial
declaration, on an expedited basis, that DSE is contractually
required to make a $300 million milestone payment to Esperion upon
regulatory approval. DSE recently stated it will not make the $300
million milestone payment that the contract requires.
The amended complaint, filed by Gibson Dunn’s Orin Snyder, one
of the country’s foremost trial lawyers, provides substantial new
evidence demonstrating that DSE’s repudiation of the agreement is
wrong and in bad faith:
- The amended complaint establishes that the key term in the
contract, “cardiovascular risk reduction,” is unambiguous and is
not limited to MACE-4 results, as DSE now says.
- The amended complaint includes previously undisclosed drafts of
the parties’ agreement in which Esperion specifically rejected
DSE’s proposal to limit “cardiovascular risk reduction” to MACE-4
results.
- The amended complaint makes clear that DSE is repudiating the
agreement in a transparent attempt to drive down Esperion’s stock
price and pressure it to re-negotiate the parties’ license
agreement.
“This amended complaint, filed by Gibson Dunn and supported by
new evidence, makes clear that we are entitled to the $300 million
milestone payment from DSE upon regulatory approval. We will not
acquiesce to DSE’s commercially dishonest tactics,” says Esperion
President and Chief Executive Officer Sheldon Koenig. “We are
working diligently to resolve this dispute as we continue to
commercialize bempedoic acid in Europe and around the world. And we
fully expect to receive the $300 million milestone payment from DSE
upon regulatory approval in the first half of 2024 – in full and on
schedule, when we always expected to receive it.”
The Company will host its Q1 2023 earnings call on May 9, during
which it will discuss first quarter performance in detail and
provide additional company updates. The Company will issue a press
release containing these financial results before the call begins,
and will concurrently post this to its website esperion.com within
the Investors and Media section.
INDICATIONBempedoic acid 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. Limitations of Use: The effect of
bempedoic acid on cardiovascular morbidity and mortality has not
been determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Hyperuricemia:
Bempedoic acid 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 bempedoic acid at the first sign of tendon rupture.
Avoid bempedoic acid in patients who have a history of tendon
disorders or tendon rupture.
Adverse Reactions: In 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.
Drug Interactions: Simvastatin and Pravastatin:
Concomitant use results in increased concentrations and increased
risk of simvastatin or pravastatin-related myopathy. Use with
greater than 20 mg of simvastatin or 40 mg of pravastatin should be
avoided.
Lactation and Pregnancy: It is not recommended
that bempedoic acid be taken during breastfeeding. Discontinue
bempedoic acid when pregnancy is recognized, unless the benefits of
therapy outweigh the potential risks to the fetus. Based on the
mechanism of action, bempedoic acid 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.
CLEAR Cardiovascular Outcomes TrialCLEAR
Outcomes is part of the CLEAR clinical research program for
NEXLETOL and NEXLIZET. The CLEAR Program seeks to generate
important clinical evidence on the safety and efficacy of bempedoic
acid, a first in class ATP citrate lyase inhibitor contained
in NEXLETOL and NEXLIZET and its potential role in
addressing additional critical unmet medical needs. More than
60,000 people will have participated in the program by the time of
its completion. The CLEAR Program includes 5 label-enabling Phase
III studies as well as other key Phase IV studies with the
potential to reach more than over 30 million people with or at risk
for CVD based on elevated LDL-C.
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 milestone payments from partners and
other statements containing the words “anticipate,” “believe,”
“entitle,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “provide,” “seek,” “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 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.
Esperion Contact Information:Investors: Alexis
Callahaninvestorrelations@esperion.com(406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com(616)
443-8438
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