Amarin Corporation plc (NASDAQ:AMRN) announced the publication
today of the rationale and design for the company’s REDUCE-IT Phase
3 cardiovascular outcomes study in Clinical Cardiology, available
at: http://onlinelibrary.wiley.com/doi/10.1002/clc.22692/full.
Deepak L. Bhatt, M.D., M.P.H., executive director
of the Interventional Cardiovascular Programs at Brigham and
Women’s Hospital, professor of medicine, Harvard Medical School in
Boston, Mass., is the lead author of the published article titled,
“Rationale and Design of REDUCE-IT: Reduction of Cardiovascular
Events with Icosapent Ethyl - Intervention Trial.”
REDUCE-IT is a landmark global study of
approximately 8,000 patients to evaluate whether treatment with
prescription pure EPA Vascepa® (icosapent ethyl) at four grams
per day reduces cardiovascular events in patients, who despite
having their LDL-cholesterol (LDL-C) controlled with statin
therapy, have elevated triglyceride levels and demonstrate other
risk factors, such as diabetes and previous cardiovascular
events.
“Controlling LDL-C is critically important but only
one aspect of overall good cardiovascular health,” said Dr. Bhatt.
“The risk of cardiovascular events remains high due to independent
factors that cannot be addressed only by reducing LDL-C. The
question of how best to achieve cardiovascular risk reduction
beyond the benefits realized from effective management of LDL-C
remains unanswered. The REDUCE-IT trial is designed to address
whether the demonstrated clinical effects and postulated
pleiotropic cardioprotective benefits of icosapent ethyl when added
to statin therapy will offer improved cardiovascular outcomes for
patients and provide physicians with a new treatment option in the
studied high cardiovascular risk population.”
The publication notes that, while clinical and
epidemiological studies have demonstrated patients with elevated
triglycerides remain at high cardiovascular risk despite
controlling LDL-C, to date no study has prospectively examined this
population. For this population, high dose prescription pure EPA
may prove beneficial. EPA has been shown to improve relevant lipid,
lipoprotein and inflammatory parameters without raising LDL-C and
may have pleiotropic benefits. An open label, blinded endpoint
outcomes study in Japan of low doses of prescription pure EPA added
to statin therapies has been shown to produce further
cardiovascular event reduction with moderately elevated
triglycerides, by 19% in the overall population and by 53% in a
subgroup of patients similar to those enrolled in the REDUCE-IT
study. REDUCE-IT is evaluating whether treatment with high dose EPA
reduces ischemic events in statin-treated patients with persistent
elevated triglycerides.
“Despite significant advances in the diagnosis,
management, and understanding of cardiovascular disease, it remains
the leading killer in this country,” said Steven B. Ketchum, Ph.D.,
president of R&D and chief scientific officer of Amarin. “We
are confident that REDUCE-IT will provide important answers on
whether the addition of prescription pure EPA Vascepa to patients
with persistent elevated triglycerides after statin therapy confers
a meaningful reduction in the occurrence of major cardiovascular
events in this high-risk patient population.”
Residual Cardiovascular Risk in
Statin-Treated Patients
Cardiovascular disease remains the leading cause of
death in the United States, with the estimated costs of treating
heart attacks, strokes and other cardiovascular diseases exceeding
$300 billion annually. In the United States, more than 35
million patients are treated with statins for the primary and
secondary prevention of atherosclerotic cardiovascular events,
including myocardial infarctions (heart attacks), and stroke.
Despite the demonstrated clinical benefits of lowering LDL-C with
statins, significant residual cardiovascular risk remains for
statin-treated patients. Vascepa is being studied in REDUCE-IT as
an add-on to statin therapy to further reduce cardiovascular risk,
not as a replacement for statin therapy.
About REDUCE-IT
REDUCE-IT is a global Phase 3, randomized,
multicenter, double-blind, placebo-controlled study designed to
evaluate whether treatment with Vascepa reduces cardiovascular
events in patients who despite stabilized statin therapy have
elevated triglyceride levels and other cardiovascular risk factors.
The primary endpoint of the study is the time to the first
occurrence of the composite endpoint of cardiovascular death,
nonfatal myocardial infarction, nonfatal stroke, coronary
revascularization, or hospitalization for unstable angina.
Secondary endpoints include time to event analyses of components of
the primary endpoint. The study is being conducted under a
special protocol assessment agreement with the FDA.
Additional information on the REDUCE-IT trial
and Amarin's other 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 is known in scientific literature as
AMR101.
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. Vascepa is under various stages of
development for potential use in other indications that have not
been approved by the FDA. 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 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. Amarin's clinical program includes a commitment to
the ongoing REDUCE-IT cardiovascular outcomes
study. Vascepa® (icosapent
ethyl), Amarin's first FDA-approved product, is a
highly-pure, EPA-only, 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.
Forward-looking statements
This press release contains forward-looking
statements such as expectations regarding the ability of REDUCE-IT
to provide important answers on whether the addition of Vascepa to
statin therapy would confer a meaningful reduction in the
occurrence of major cardiovascular events in the patient population
studied. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties.
For example, statements related to the potential efficacy and
therapeutic benefits of Vascepa have been subject to different
interpretations on matters such as the potential clinical
importance of lowering triglyceride levels in studied patients.
Among the factors that could cause actual results to differ
materially from those described or projected herein include
uncertainties associated generally with complex clinical trials
like REDUCE-IT and research and development and clinical trial risk
generally; differing views on interpretation of clinical trial
results including the results of the cited Japanese study and other
relevant studies; and reliance on third parties. Due to these risks
and other uncertainties, REDUCE-IT may not generate positive or
useful results. 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 we
communicate with our investors and the public using our company
website (www.amarincorp.com), our 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 we post on these
channels and websites could be deemed to be material
information. As a result, we encourage investors, the media,
and others interested in Amarin to review the information
that we post on these channels, including our investor relations
website, on a regular basis. This list of channels may be updated
from time to time on our investor relations website and may include
social media channels. The contents of our website or these
channels, or any other website that may be accessed from our
website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
Amarin Contact Information:
Investor Relations:
Elisabeth Schwartz
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com
Media Inquiries:
Ovidio Torres
Finn Partners
In U.S.: +1 (312) 329 3911
ovidio.torres@finnpartners.com
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Apr 2023 to Apr 2024