Esperion Announces Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of NEXLETOL™ (bempe...
April 20 2020 - 7:00AM
Esperion (NASDAQ: ESPR) today announced that they have entered into
a collaboration agreement with Otsuka Pharmaceutical Co., Ltd. for
the development and commercialization of NEXLETOL and NEXLIZET
tablets in Japan. Both medicines were recently approved in
both the US and EU.
The collaboration advances the commitment of both companies to
provide cost-effective, oral, once-daily, non-statin
LDL-cholesterol (LDL-C) lowering medicines for hypercholesterolemia
patients in Japan. This development and commercialization
collaboration combines Esperion’s expertise in lipid management
with Otsuka’s deep cardiovascular drug development and
commercialization expertise in Japan.
Under the terms of the agreement, Esperion will grant Otsuka
exclusive rights to NEXLETOL and NEXLIZET tablet development and
commercialization in Japan. Otsuka will be responsible for all
development, regulatory, and commercialization activities in
Japan. In addition, Otsuka will fund all Japan-specific
development costs associated with the program. Esperion
estimates this amount to total up to $100 million over the next few
years. Esperion will receive an upfront cash payment of $60
million as well as up to an additional $450 million in total
development and sales milestones. Esperion will also receive
tiered royalties from 15 percent to 30 percent on net sales in
Japan.
“We are thrilled to partner with Otsuka, one of the leading
pharmaceutical companies in Japan. Otsuka shares our vision
of the potential for convenient oral, once-daily, non-statin LDL-C
lowering medicines to help hypercholesterolemia patients in Japan,”
said Tim Mayleben, president and chief executive officer of
Esperion. “Otsuka’s history of successfully commercializing
cardiovascular medicines in Japan, and overlapping healthcare
provider targets make this a highly synergistic
collaboration. This collaboration continues the evolution of
Esperion to a truly global research and development driven
commercial pharmaceutical company and further validates the global
value of our medicines.”
Makoto Inoue, president and representative director of Otsuka
Pharmaceutical commented, “We aspire to become an indispensable
company for patients, physicians and others around the world.
If approved in our home market of Japan, bempedoic acid will
represent another step forward in our fulfillment of that
aspiration.”
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 events.1 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 goal.2
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 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, that Otsuka is able to
successfully commercialize bempedoic acid and the bempedoic acid /
ezetimibe fixed dose combination tablet, 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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