Amarin's REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Moni...
August 14 2017 - 6:00AM
Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected,
the independent data monitoring committee (DMC) has completed its
review of the scheduled pre-specified interim efficacy and safety
analysis for the REDUCE-IT cardiovascular outcomes study and has
recommended that the trial continue as planned without
modification. Because REDUCE-IT is the first prospective clinical
trial of any therapy in the large patient population studied, the
bars for stopping this trial early for overwhelming efficacy were
intentionally set high with the understanding that a more robust
result, based on a larger number of cardiovascular events, could be
obtained by the study continuing to completion. Results from the
completed study are expected in Q2 or Q3 2018. The 8,175-patient
outcomes study is evaluating whether treatment with Vascepa®
(icosapent ethyl) reduces major adverse cardiovascular events in
patients who despite stabilized statin therapy have elevated
triglyceride levels and other cardiovascular risk factors.
In accordance with the study protocol, this interim
efficacy analysis was performed after adjudication of approximately
80% of the target 1,612 aggregate primary cardiovascular events
occurred within the study. Preparations for a final efficacy
analysis will be triggered by the onset of approximately 100% of
the target aggregate number of primary cardiovascular events.
Amarin anticipates that the onset of approximately 100% of events
will likely occur in early 2018. Amarin is intentionally blinded to
the interim analysis data and will remain blinded to results of the
study until after the study is stopped and the database is locked
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 30,000 patient years of study have
been accumulated to date in the ongoing REDUCE-IT study.
The review and recommendation of the DMC at this
interim look were made independently. Neither Amarin nor the FDA
has reviewed the interim clinical results and neither participated
in the DMC's closed session deliberation.
"We are pleased that we are nearing completion of
the REDUCE-IT study and thank the independent DMC members for their
diligence in overseeing this important study," said Steven Ketchum,
Ph.D., president of R&D and chief scientific officer of Amarin.
"This interim look provided important operational checks in
preparation for study completion. We remain confident that the
REDUCE-IT study is positioned for success based on our extensive
review of the existing and continually increasing body of data from
clinical, epidemiologic, genetic, and real-world evidence studies,
and we are preparing for the study conclusion."
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 $550 billion annually.1 In the United
States, about 40 million patients are treated with statins for the
primary and secondary prevention of atherosclerotic cardiovascular
events, including heart attacks and stroke.2 Despite the
demonstrated clinical benefits of lowering bad cholesterol (LDL-C)
with statins, 60% to 75% residual cardiovascular risk remains for
statin-treated patients.3 Vascepa is being studied in REDUCE-IT as
an add-on to statin therapy in patients with persistent elevated
triglycerides and other risk factors to further reduce
cardiovascular risk, not as a replacement for statin therapy.
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. 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. 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.
Forward-looking statements
This press release contains forward-looking
statements, including expectations for continued event rates,
interim data review, results and related timing and announcements
with respect to Amarin's REDUCE-IT cardiovascular outcomes study;
expectations related to the final outcomes of the REDUCE-IT study
and the anticipated successful completion of the REDUCE-IT study;
and statements regarding the potential and therapeutic benefits of
Vascepa. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. In
particular, as disclosed in filings with the U.S. Securities and
Exchange Commission, Amarin's ability to effectively develop and
commercialize Vascepa will depend in part on its ability to
continue to effectively finance its business, efforts of third
parties, its ability to create market demand for Vascepa through
education, marketing and sales activities, to achieve increased
market acceptance of Vascepa, to receive adequate levels of
reimbursement from third-party payers, to develop and maintain a
consistent source of commercial supply at a competitive price, to
comply with legal and regulatory requirements in connection with
the sale and promotion of Vascepa and to maintain patent protection
for Vascepa. 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 historical REDUCE-IT event rates may not be predictive of
future results and related cost may increase beyond expectations;
the risk that regulatory reviews may alter current expectations
related thereto; the risk that future legal determinations and
interactions with regulatory authorities may impact Vascepa
marketing and sales rights and efforts; the risk that Vascepa may
not show clinically meaningful effects in REDUCE-IT or support
regulatory approvals for cardiovascular risk reduction; and the
risk that patents may not be upheld in patent litigation. 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://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.
References
1 AHA Heart and Stroke
Statistics https://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf
2 http://www.acsh.org/news/2015/12/04/cdc-study-reveals-that-too-few-americans-are-on-statins3
Libby P. J Am Coll Cardiol. 2005:46(7):1225-1228.
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) 378-2992
lstern@troutgroup.com
Media Inquiries:
Ovidio Torres
Finn Partners
In U.S.: +1 (312) 329 3911
Ovidio.torres@finnpartners.com
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