Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, today announced
that final study-related visits have commenced for patients
enrolled in its REDUCE-IT cardiovascular outcomes study. An
important step in completion of this potentially landmark study is
to have patients return to their clinical sites for final study
data collection. Commencing final patient visits on March 1, 2018
is consistent with the company’s estimated schedule of having
results of this first of its kind study announced before the end of
the third quarter of this year.
“We are excited that the REDUCE-IT trial is
nearing completion and appreciative for the participation of
patients and clinical sites in this important clinical study,"
commented Dr. Steven Ketchum, Amarin senior vice president,
president of R&D, and chief scientific officer. "The
commencement of final patient visits is a positive step towards
completing this six-year, 8,175 patient
study."
Amarin is intentionally blinded to the results
of the study and will remain blinded to such results until after
the study is completed and the database is locked. Final patient
visits will be followed by adjudication of newly reported
cardiovascular events in the study, completing data entry for the
greater than 33,000 patient years of study in REDUCE-IT, and
typical database quality control measures, known as cleaning.
This will be followed by the database lock and final efficacy and
safety analyses, including analysis of the trial's primary endpoint
of time to the first major adverse cardiovascular events (MACE) in
the study, and the analyses of more than thirty pre-defined
secondary and tertiary endpoints. Publication of the study design
can be found at https://doi.org/10.1002/clc.22692.
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 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.
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.1,
2
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. 3, 4, 5, 6
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 predictions and statements related to
operational activities to be carried in connection with the
REDUCE-IT cardiovascular outcomes study such as timing of last
patient visits, adjudication of newly reported cardiovascular
events, completion of data entry, typical database quality control
measures, database lock and final efficacy and safety analyses,
analysis of study results such as the trial's primary endpoint,
pre-defined secondary and tertiary endpoints and timing for related
announcements of such events. 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
the following: uncertainties associated generally with research and
development, clinical trials and related regulatory approvals; the
risk that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for intended uses. A
further list and description of these risks, uncertainties and
other risks 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 annual report on Form 10-K. 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 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update. 2 American Heart Association.
2017. Cardiovascular disease: A costly burden for America
projections through 2035. 3 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145. 4 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. 5 Nordestgaard BG. Triglyceride-rich lipoproteins
and atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563. 6 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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