Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, today announced
that its REDUCE-IT cardiovascular outcomes study has reported and
documented more than 90% of the targeted 1,612 primary major
adverse cardiovascular events (MACE). The vast majority of
these events have been confirmed (i.e., positively adjudicated as a
patient’s first on-study primary event) with some unable to be
fully adjudicated per study protocol until after completion of the
associated patients’ final study visits. For this first of
its kind, potentially landmark, REDUCE-IT cardiovascular outcomes
study, Amarin confirmed that it is on track for onset of the
targeted 1,612th event to occur before the end of Q1 2018. Patients
are being scheduled for final study visits commencing March 1,
2018. Amarin maintains its guidance to report top-line results from
the study before the end of Q3 2018.
"We are pleased to be nearing conclusion of this
important study," commented Dr. Steven Ketchum, Amarin senior
vice president, president of R&D, and chief scientific
officer. "The timing of accumulated events in this study and
the scheduling of final patient visits are two important steps
towards learning the results of this study and understanding the
extent to which Vascepa and the REDUCE-IT trial results can lead to
better informed preventative care of patients at high
cardiovascular risk."
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 first MACE events 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. The lead author of
this paper published in Clinical Cardiology is 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.
The estimate of timing of the onset of the
1,612th MACE event is based on actual adjudicated events from
inception to date in the study. The projection of the number of
MACE events that will ultimately be adjudicated as a primary event
(first event for the patient within the duration of the study) is
also based on historical data of adjudicated events within the
REDUCE-IT study. Such projections are made by independent
statisticians and reviewed by Amarin and the independent steering
committee for the trial, all of whom are blinded. The study was
designed to provide sufficient power to detect the anticipated
result, regardless of whether the final number of primary MACE is
slightly more or slightly fewer than 1,612 primary MACE.
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 REDUCE-IT
Amarin's clinical development program for
Vascepa includes a trial known as the REDUCE-IT cardiovascular
outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT
is the first multinational cardiovascular outcomes study evaluating
the effect of prescription pure EPA therapy, or any triglyceride
lowering therapy, as an add-on to statins in patients with high
cardiovascular risk who, despite stable statin therapy, have
elevated triglyceride levels (150-499 mg/dL). A large portion of
the male and female patients enrolled in this outcomes study are
anticipated to also be diagnosed with type 2 diabetes. As reported
previously, Amarin expects to announce top-line results of this
important study before the end of Q3 2018. The REDUCE-IT
trial is being conducted under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration.
Additional information on 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, 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.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements related to the REDUCE-IT
cardiovascular outcomes study including expectations for timing of
last patient visits, continued event rates, results and the timing
for related announcements of such events; expectations related to
the sufficiency of statistical measures and protocols; expectations
with respect to the successful completion of the REDUCE-IT study;
and statements regarding the potential efficacy, safety 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 its filings with the
U.S. Securities and Exchange Commission, Amarin's ability to
effectively 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
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 related cost may increase beyond expectations; the risk
that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for intended uses; the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents sufficient to protect
the Vascepa franchise. 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 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.
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: Kristie Kuhl Finn Partners In U.S.: +1
(212) 583-2791 Kristie.kuhl@finnpartners.com
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