Esperion and Daiichi Sankyo Europe Announce Amendment to License and Commercial Collaboration Agreement
June 22 2020 - 7:00AM
Esperion (NASDAQ: ESPR) announced the completion of an amendment to
the EU commercial collaboration agreement with Daiichi Sankyo
Europe (DSE). Earlier this month, Esperion completed the
transfer to DSE of Marketing Authorization Approvals (MAA) for
NILEMDO and NUSTENDI. DSE will now pay Esperion the second
$150 million milestone based on completion of the MAA transfer
rather than the first commercial product sale in the EU, as
previously agreed.
“Over the last eighteen months Esperion and DSE have formed a
true partnership which includes the earlier-than-expected European
Commission approval of NILEMDO and NUSTENDI and the acceleration of
the $150 million milestone payment,” said Tim M. Mayleben,
president and chief executive officer of Esperion.
“Together, we are delivering on our mutual commitment to
bring affordable and convenient oral, once-daily LDL-C lowering
medicines to the millions of patients with elevated
LDL-Cholesterol.”
The acceleration of the $150 million milestone payment from DSE
was made as a result of an amendment to the License and
Collaboration Agreement between the two companies, originally
signed in January 2019, which also added Turkey to existing rights
covering the European Economic Area and Switzerland. Previously,
the milestone payment was due upon the first commercial product
sale in Europe.
Under terms of the collaboration agreement with DSE, Esperion is
eligible to receive up to $900 million in total milestones as well
as tiered royalties between 15% – 25%. Upon receipt of the
$150 million milestone payment later this month, Esperion will have
received $300 million in total milestone payments.
CLEAR Cardiovascular Outcomes
Trial
The effect of bempedoic acid on cardiovascular morbidity and
mortality has not been determined. Esperion initiated a global
cardiovascular outcomes trial (CVOT) to assess the effects of
bempedoic acid on the occurrence of major cardiovascular events in
patients with, or at high risk for, cardiovascular disease (CVD)
who are only able to tolerate less than the lowest approved daily
starting dose of a statin and are considered "statin averse." The
CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an
event-driven, global, randomized, double-blind, placebo-controlled
study that completed enrollment in August 2019 of over 14,000
patients with hypercholesterolemia and high CVD risk at over 1,400
sites in 32 countries.
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 events1. 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 goal2.
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 Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding the clinical
development and commercialization plans for bempedoic acid tablet
and the bempedoic acid / ezetimibe fixed dose combination tablet,
including Esperion's timing, designs, plans for announcement of
results regarding its CLEAR Outcomes study and other ongoing
clinical studies for bempedoic acid tablet and the bempedoic acid /
ezetimibe combination fixed dose tablet, timing for the review and
approval of expanded indications for their effect on cardiovascular
events, and Esperion's expectations for the market for medicines to
lower LDL-C, including the commercial launch and market adoption of
bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose
combination tablet in the United States and European Union. 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) Esperion market
research on file: research project interviewing 350 physicians.
Esperion Therapeutics, Inc. Sept-Oct 2018. (2) Data on
file: analysis of NHANES database. Esperion Therapeutics, Inc.
2018.
Investor Contact: Alex Schwartz Esperion
734-249-3386 aschwartz@esperion.com
Media Contact: Ben Church Esperion 734-864-6774
bchurch@esperion.com
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