Amarin Randomizes Final Patient into REDUCE-IT Cardiovascular Outcomes Study of Vascepa
August 31 2016 - 7:30AM
Amarin Corporation plc (NASDAQ:AMRN) announced that randomization
of patients into the REDUCE-IT cardiovascular outcomes study has
been completed with 8,175 individual patients randomized, in
accordance with the study protocol, on a 1:1 basis between Vascepa®
(icosapent ethyl) and placebo, slightly exceeding the 8,000
patients targeted for the trial.
The REDUCE-IT study is evaluating whether treatment with Vascepa
reduces cardiovascular events in patients who despite stabilized
statin therapy have elevated triglyceride levels and other
cardiovascular risk factors. Amarin closed enrollment at all global
clinical sites in June 2016. Before randomization, patients
enrolled in the trial went through a protocol-specified monitoring
period to ensure that their LDL-cholesterol was well-controlled on
statin therapy and that they were washed out of exclusionary
non-statin lipid modifying therapies.
“We are pleased to have completed the randomization of all
patients into REDUCE-IT,” said Steven Ketchum, Ph.D., president of
R&D and chief scientific officer of Amarin. “Our remaining
focus is on ensuring that this important study continues to
progress as planned. While we were confident in the design of
the study at the target of 8,000 patients, the yield of additional
patients from the screening and randomization process is consistent
with our efforts throughout this study to ensure that the trial
results are robust.”
Amarin continues to expect the onset of the final primary
cardiovascular event to occur in the second half of 2017 with
publication of trial results likely in 2018. An independent Data
Monitoring Committee (DMC) is expected to complete a protocol
pre-specified interim efficacy and safety analysis after
approximately 60% of the target aggregate primary cardiovascular
events have occurred within the study. This interim analysis is
most likely to occur in September 2016. A second interim efficacy
and safety analysis with approximately 80% of the primary
cardiovascular events is expected in mid-2017.
While it is possible that the study could terminate early for
overwhelming efficacy at either the 60% or 80% interim analysis,
guidelines for the independent DMC to recommend stopping the study
for overwhelming efficacy require that the study achieve a high
level of statistical significance on the primary endpoint and
generate other robust findings including on certain, pre-specified
secondary outcome measures to support an overall favorable
benefit/risk profile. Given the high threshold of
overwhelming efficacy required for a DMC to recommend an early stop
to a cardiovascular outcomes trial like REDUCE-IT, Amarin continues
to expect that the DMC’s interim analysis will result in a
recommendation to continue the REDUCE-IT study as
planned. REDUCE-IT is designed for Amarin to remain blinded to
results of the study until after the study is stopped at either of
the interim analyses or for the final analysis.
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 have persistently elevated triglyceride levels despite
stabilized statin therapy 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.
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 1 gram 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,
including statements about the company’s confidence in the design
of REDUCE-IT and efforts to help ensure robust results; the timing
of cardiovascular events in REDUCE-IT and the timing of occurrence,
assessment and publication of interim and final trial results from
REDUCE-IT; and expected outcomes from the REDUCE-IT DMC’s interim
analysis. 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 expected 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; and
reliance on third parties. 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 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 we communicate with our
investors and the public using our company website
(www.amarincorp.com), our investor relations website
(http://www.amarincorp.com/investor-splash.html), 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:
Kathryn McNeil
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) 378-2922
lstern@troutgroup.com
Media Inquiries:
Ovidio Torres
Finn Partners
In U.S.: +1 (312) 329 3911
ovidio.torres@finnpartners.com
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