Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected,
the independent data monitoring committee (DMC) has completed its
review of the first pre-specified interim efficacy analysis for the
REDUCE-IT cardiovascular outcomes study and has recommended that
the trial continue as planned without modification. The
8,175-patient outcomes study is evaluating whether treatment with
Vascepa® (icosapent ethyl) reduces cardiovascular events in
patients who despite stabilized statin therapy have elevated
triglyceride levels and other cardiovascular risk factors.
In accordance with the study protocol, the first interim
efficacy analysis was performed after adjudication of approximately
60% of the target 1,612 aggregate primary cardiovascular events
occurred within the study. Preparations for a second planned
interim efficacy analysis will be triggered by the onset of
approximately 80% of the target aggregate number of primary
cardiovascular events. Amarin anticipates that the onset of
approximately 80% of events will occur in the first half of 2017,
with the second pre-specified interim efficacy analysis and review
by the DMC expected around mid-2017. Amarin will remain
blinded to results of the study until after the study is stopped
and the database is locked at either the second interim analysis or
at the final analysis.
The DMC’s recommendation to continue as planned also reflects
its review of all available safety data. In accordance with the
study protocol and DMC charter, safety reviews have been performed
multiple times each year since REDUCE-IT began in December 2011,
and more than 23,000 patient years of study have been accumulated
to date in the ongoing REDUCE-IT study. The review and
recommendation of the DMC was made independently. Neither Amarin
nor the FDA has reviewed the interim clinical results and neither
participated in the DMC’s closed session deliberation.
“We have accepted the independent DMC’s recommendation, and we
are pleased that REDUCE-IT continues as planned. We continue to
anticipate that accumulation of additional cardiovascular events
will add further robustness to the results of this important study
which is the first outcomes study ever to evaluate if the addition
of pure EPA Vascepa to statin therapy confers a meaningful
reduction in the occurrence of major cardiovascular events in
patients with persistent elevated triglycerides and other
cardiovascular risk factors,” said Steven Ketchum, Ph.D., president
of R&D and chief scientific officer of Amarin. “We remain
confident that the REDUCE-IT study is positioned for success based
on our extensive review of existing data from clinical,
epidemiologic and genetic studies, and we look forward to the
study’s anticipated completion. We continue to expect the onset of
the final primary cardiovascular event to occur in the second half
of 2017 with the publication of results anticipated in 2018.”
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 disease manifestations exceeding
$300 billion annually.1 In the United States, more than 35
million patients are treated with statins for the primary and
secondary prevention of atherosclerotic cardiovascular events,
including heart attacks and stroke.2,3 Despite the
demonstrated clinical benefits of lowering bad cholesterol (LDL-C)
with statins, 60% to 75% residual cardiovascular risk remains for
statin-treated patients.4,5,6 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
(heart attack), 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 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.
1 Mozaffarian et al. Circulation. 2016;133: e43,
e184.
2 NCHS Data Brief No. 177, December 2014. Retrieved from
http://www.cdc.gov/nchs/products/databriefs/db177.htm.
3 U.S. Census Bureau. (2012). Age and Sex Composition in
the United States: 2012. Retrieved from
http://www.census.gov/population/age/data/2012comp.html
4 Hobbs FD, et al. BMC Med. 2016;14:4.
5 Cholesterol Treatment Trialists’ (CTT) Collaboration, et
al. Lancet. 2010;376(9753):1670–1681.
6 Koenig W. J Am Coll Cardiol. 2008;51(17):1642-4.
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 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 anticipated timing of cardiovascular
events in REDUCE-IT and the timing of occurrence, assessment and
publication of interim and final trial results from REDUCE-IT; the
company’s expectations that accumulation of additional
cardiovascular events will add further robustness to REDUCE-IT
study results; and the company’s confidence in REDUCE-IT being
positioned for success based on review of existing data from
clinical, epidemiologic and genetic studies. 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; 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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