Amarin Announces Presentation of New MARINE and ANCHOR Post-Hoc Analyses at National Lipid Association Annual Scientific Sess...
May 02 2014 - 8:00AM
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company
focused on the commercialization and development of therapeutics to
improve cardiovascular health, announced today the presentation at
the National Lipid Association Annual Scientific Sessions, of new
post-hoc analyses of the MARINE and ANCHOR studies that showed the
use of Vascepa® (icosapent ethyl) capsules significantly reduced
apolipoprotein C-III (ApoC-III) levels. ApoC-III is a small protein
that resides on various lipoproteins, and is an important regulator
of lipoprotein and triglyceride (TG) metabolism.i This research is
being presented today by Christie M. Ballantyne, M.D. from Baylor
College of Medicine as part of a peer-reviewed poster session at
the National Lipid Association Annual Scientific Sessions in
Orlando, Florida.
"The significantly reduced Apo C-III levels with Vascepa in the
MARINE and ANCHOR trials add to previously reported TG- and
ApoB-lowering effects in patients from these studies," said Steven
B. Ketchum, Ph.D., President of Research and Development, Senior
Vice President, Amarin Corporation. "We are pleased to continue to
analyze and share data from these trials that support the clinical
value of Vascepa as an adjunct to diet to reduce triglyceride (TG)
levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia."
MARINE and ANCHOR were 12-week, phase 3, double-blind studies
that randomized patients to Vascepa 4 g/day, 2 g/day, or placebo.
MARINE randomized 229 patients with TG ≥ 500 and ≤ 2000 mg/dL while
ANCHOR randomized 702 patients at high risk for cardiovascular
disease with TG ≥ 200 and < 500 mg/dL despite low-density
lipoprotein cholesterol (LDL-C) control while on statin therapy. In
the MARINE study, stable statin therapy was permitted but not
required. In the ANCHOR study, patients were required to be at high
risk for cardiovascular disease as defined by the NCEP ATP III
guidelines and on stable statin dose (atorvastatin, rosuvastatin,
or simvastatin).
This post-hoc analysis assessed the median percent change from
baseline to study end in ApoC-III levels compared with placebo.
ApoC-III levels were measured post hoc and lipid levels were
measured as previously reported. Total ApoC-III levels were
assessed in 148 and 612 patients in MARINE and ANCHOR,
respectively. In MARINE, Vascepa 4 g/day and 2 g/day statistically
significantly reduced ApoC-III levels by 25.1% (P < 0.0001) and
14.3% (P=0.0154) versus placebo, respectively. In ANCHOR, Vascepa 4
g/day and 2 g/day statistically significantly reduced ApoC-III
levels by 19.2% (P < 0.0001) and 8.5% (P=0.0008) versus placebo,
respectively. In the MARINE and ANCHOR studies Vascepa
significantly reduced TG, Apo B- and ApoC-III levels without
increasing LDL-C levels in patients at the dose of 4 g/day.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules, known in scientific
literature as AMR101, is a patented, pure-EPA omega-3 prescription
product in a 1 gram capsule.
Indications 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 and should be used 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).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM
Vascepa is under various stages of development for potential use
in indications that have not been approved by the FDA, such as the
potential indications that are under development in the REDUCE-IT
trial. 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.
Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is
a patented, ultra-pure omega-3 fatty acid product comprising not
less than 96% EPA and is 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 potential efficacy, safety and
therapeutic benefits of Amarin's product candidates, Amarin's
clinical trial results, including statements about the clinical
importance of certain parameters and the impact of Vascepa on such
parameters. 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 projected herein include uncertainties
associated generally with research and development, clinical trials
and related regulatory reviews and approvals, including the risk
that historical clinical trial results may not be predictive of
future results in replicated in larger patient populations and that
studied lipid parameters may not have clinically meaningful effect
or support regulatory approvals. 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://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.
i Ooi EM, et al. Clin Sci (Lond). 2008;114:611-24.
CONTACT: Amarin contact information:
Michael Farrell or Joseph Bruno
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
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