Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company
focused on the commercialization and development of therapeutics to
improve cardiovascular health, announced today that it has entered
into a multi-faceted collaboration with Mochida Pharmaceutical Co.,
Ltd. (“Mochida”, TYO:4534), an integrated Japanese pharmaceutical
company. The collaboration is focused on the development and
commercialization of early-stage drug products and indications
based on the omega-3 acid, EPA (eicosapentaenoic acid). Amarin and
Mochida are recognized worldwide as the leading, innovation-driven
companies committed to the research and development of EPA-based
drug products to treat the needs of tens of millions of patients
who are at-risk of cardiovascular disease.
Amarin developed and markets Vascepa® (icosapent
ethyl) capsules in the United States, the first and only
FDA-approved, prescription pure EPA drug product. Vascepa is
indicated as an adjunct to diet to reduce triglyceride levels in
adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Amarin's clinical development program for Vascepa includes the
REDUCE-IT cardiovascular outcomes study, an 8,175-patient study
commenced in 2011.1 REDUCE-IT is the first multinational
cardiovascular outcomes study evaluating the effect of prescription
pure EPA therapy, or any triglyceride lowering therapy, as an
add-on to statins in patients with high cardiovascular risk who,
despite stable statin therapy, have elevated triglyceride levels
(150-499 mg/dL). Amarin expects to announce top-line results of
this landmark study before the end of Q3 2018.
Mochida is an integrated Japanese pharmaceutical
company that developed and markets a prescription pure EPA drug
product, Epadel, as a treatment for hyperlipidemia and
arteriosclerosis obliterans in Japan. Mochida sponsored and
successfully completed a cardiovascular outcomes trial with Epadel
in Japan, JELIS. JELIS was the world’s first large-scale
randomized controlled cardiovascular outcomes trial of a
prescription pure EPA drug product and showed beneficial effects of
the drug in further reducing cardiovascular events in
statin-treated, hypercholesterolemic Japanese patients.2, 3, 4
“We are excited to enter into a collaboration
with Mochida given our common mission to create preventative
healthcare solutions on a worldwide basis, and our mutual
commitment to continued innovation in the EPA research and
development area,” stated John F. Thero, president and chief
executive officer of Amarin. “This collaboration seeks to leverage
the decades of successful research and development experience at
Amarin and Mochida towards expediting the development of new
products and indications.”
“Mochida is delighted to partner with Amarin,”
stated Mr. Naoyuki Mochida, president of Mochida. “Both Mochida and
Amarin have demonstrated strong capabilities in developing and
commercializing EPA-based products and we believe that together we
can achieve much more to improve patient care in the years to
come.”
Among other terms in the agreement, Amarin
obtained an exclusive license to certain Mochida intellectual
property to advance Amarin’s interests in the United States and
certain other territories and the parties will collaborate to
research and develop new products and indications based on EPA for
Amarin’s commercialization in the United States and certain other
territories. The potential new product and indication opportunities
contemplated under this agreement are in relatively early stages of
development.
About Amarin
Amarin Corporation plc is a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health. Amarin's
product development program leverages its extensive experience in
lipid science and the potential therapeutic benefits of
polyunsaturated fatty acids. Vascepa® (icosapent ethyl),
Amarin's first FDA-approved product, is a highly-pure, omega-3
fatty acid product available by prescription. For more
information about Vascepa visit www.vascepa.com. For more
information about Amarin visit www.amarincorp.com.
About Mochida
Mochida Pharmaceutical Co. Ltd. has been
committed to research and development of innovative pharmaceutical
products since its establishment thereby providing distinctive
medicines to the medical field. Currently, the core pharmaceutical
business focuses resources on the targeted areas of cardiovascular
medicine, obstetrics and gynecology, dermatology, psychiatry and
gastroenterology while also providing medicine for intractable
disease as well as generics including biosimilars, to meet medical
needs.
Mochida markets the world's first high-purity
EPA drug, Epadel, developed and launched by Mochida as an ethical
drug. Epadel has been the leading drug in its class in Japan over
the past two decades with indications of hyperlipidemia and
arteriosclerosis obliterans. Epadel has been broadly studied in
Japan including the JELIS study which was successfully conducted to
investigate the long-term administration of Epadel in
statin-treated patients with hypercholesterolemia and the results
are described as evidence-based medicine information on treatment
with EPA pharmaceutical products in various clinical
guidelines.
For more information about Mochida
Pharmaceutical Co., Ltd., visit
http://www.mochida.co.jp/english/
About REDUCE-IT
Amarin's clinical development program for
Vascepa includes a trial known as the REDUCE-IT cardiovascular
outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT
is the first multinational cardiovascular outcomes study evaluating
the effect of prescription pure EPA therapy, or any triglyceride
lowering therapy, as an add-on to statins in patients with high
cardiovascular risk who, despite stable statin therapy, have
elevated triglyceride levels (150-499 mg/dL). A large portion of
the male and female patients enrolled in this outcomes study are
anticipated to also be diagnosed with type 2 diabetes. As reported
previously, Amarin expects to announce top-line results of this
important study before the end of Q3 2018. The REDUCE-IT
trial is being conducted under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of
Vascepa can be found at www.clinicaltrials.gov.
About VASCEPA® (icosapent ethyl)
Capsules
Vascepa® (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient. Vascepa, known in scientific literature as
AMR101, has been designated a new chemical entity by the FDA.
Amarin has been issued multiple patents internationally based on
the unique clinical profile of Vascepa, including the drug’s
ability to lower triglyceride levels in relevant patient
populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is
indicated as an adjunct to diet to reduce triglyceride (TG) levels
in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia.
- The effect of Vascepa on the risk
for pancreatitis and cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been
determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- Use with caution in patients with
known hypersensitivity to fish and/or shellfish.
- The most common reported adverse
reaction (incidence > 2% and greater than placebo) was
arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no
reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Nothing in this press release should
be construed as promoting the use of Vascepa in any indication that
has not been approved by the FDA. In particular, JELIS study
results, while supportive of the potential for cardiovascular risk
benefit in the statin-treated patients studied, are not to be
directly extrapolated to apply to statin-treated patients in the
United States due to various elements in the JELIS study design and
various differences in the patient populations.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.5,
6
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease. 7, 8, 9, 10
Leading clinical investigations seeking to
address cardiovascular risk reduction beyond lowering LDL-C focus
on interrupting the atherosclerotic process (e.g., plaque formation
and instability) by beneficially affecting other lipid, lipoprotein
and inflammation biomarkers and cellular functions thought to be
related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding future clinical
development activities, drug development collaboration activities
and anticipated timing for the announcement of top line results
from the REDUCE-IT outcomes trial. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties. Among the factors that could cause actual results to
differ materially from those described or projected herein include
uncertainties associated with drug development and dependence of
third parties. Importantly, the success of the JELIS study is not a
guarantee of the success of the REDUCE-IT study due to a number of
factors, risks and uncertainties inherent in complex clinical
studies like JELIS and REDUCE-IT. A description of these and other
risks and uncertainties associated with an investment in Amarin can
be found in Amarin's filings with the U.S. Securities and Exchange
Commission, including its most recent Quarterly Report on Form
10-Q. Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. Amarin undertakes no obligation to
update or revise the information contained in this press release,
whether as a result of new information, future events or
circumstances or otherwise.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the investor relations
website (http://investor.amarincorp.com/), including but not
limited to investor presentations and investor FAQs, Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that Amarin posts on
these channels and websites could be deemed to be material
information. As a result, Amarin encourages investors, the
media, and others interested in Amarin to review the information
that is posted on these channels, including the investor relations
website, on a regular basis. This list of channels may be
updated from time to time on Amarin’s investor relations website
and may include social media channels. The contents of
Amarin’s website or these channels, or any other website that may
be accessed from its website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
References
1 Bhatt DL, Steg PG, Brinton EA, Jacobson
TA, Miller M, Tardif J-C, Ketchum SB, Doyle RT Jr, Murphy SA, Soni
PN, Braeckman RA, Juliano RA, Ballantyne CM and on behalf of the
REDUCE-IT Investigators. Rationale and design of REDUCE-IT:
Reduction of Cardiovascular Events with Icosapent
Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138–148.
https://doi.org/10.1002/clc.22692.
2 Yokoyama M, Origasa H, Matsuzaki M, et al for
Japan EPA Lipid Intervention Study (JELIS) investigators. Effects
of eicosapentaenoic acid on major coronary events in
hypercholesterolaemic patients (JELIS): a randomised open-label,
blinded endpoint analysis. Lancet. 2007;369(9567):1090-1098.
3 Saito Y, Yokoyama M, Origasa H, et al; for
JELIS investigators, Japan. Effects of EPA on coronary artery
disease in hypercholesterolemic patients with multiple risk
factors: sub-analysis of primary prevention cases from the Japan
EPA Lipid Intervention Study (JELIS). Atherosclerosis.
2008;200(1):135-140.
4 Matsuzaki M, Yokoyama M, Saito Y, et al; for
JELIS investigators, Japan. Incremental effects of eicosapentaenoic
acid on cardiovascular events in statin-treated patients with
coronary artery disease. Circ J. 2009;73(7):1283-1290.
5 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update.
6 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.
7 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.
8 Toth PP, Granowitz C, Hull M, et al. High
triglycerides increase cardiovascular events, medical costs, and
resource utilization in a real-world analysis of statin-treated
patients with high cardiovascular risk and well-controlled
low-density lipoprotein cholesterol [abstract]. Circulation.
2017;136(suppl 1):A15187.
9 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
10 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:Elisabeth Schwartz Investor Relations and
Corporate Communications Amarin Corporation plc In U.S.: +1
(908) 719-1315 investor.relations@amarincorp.com Lee M. Stern Trout
Group In U.S.: +1 (646)
378-2992lstern@troutgroup.com Media Inquiries: Kristie
Kuhl Finn Partners In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com
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