Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, announced today
three new studies it is coordinating with leading health
organizations and physicians. These studies are described in
abstracts presented this week at the National Lipid Association
(NLA) 2017 Scientific Sessions in Philadelphia.
Two of the studies leverage real-world evidence (RWE):
- A study led by Peter Toth, M.D., Ph.D., Director, Preventive
Cardiology, CGH Medical Center, Sterling, IL, determined that the
use of RWE data from medical and pharmacy claims can provide strong
insight into medication patterns, cardiovascular events, healthcare
costs, and resource utilization in an at-risk population similar to
the patients being studied in Amarin’s REDUCE-IT outcomes study.
This RWE study is presented in a poster (abstract #139) titled,
“Baseline Characteristics of a Retrospective Claims Analysis of
Cardiovascular Outcomes and Health Care Resource Utilization and
Costs in High-Risk Statin-Treated Patients with
Hypertriglyceridemia.”
- In a study led by Gregory Nichols, Ph.D., from the Kaiser
Permanente Center for Health Research, and in collaboration with
Sergio Fazio, M.D., Ph.D., Director, Center for Preventive
Cardiology, Oregon Health & Science University, Portland, OR,
RWE data from a large integrated healthcare system determined that
electronic health records (EHRs) may be an efficient tool for
identifying and screening high-risk patients, such as those sought
for evaluation in outcome studies. This study is presented in
a poster (abstract #138) titled “The Potential of Electronic Health
Record Data to Optimize Recruitment Efficiency in Cardiovascular
Outcome Trials.”
Both of these studies utilize large patient databases to better
define and understand cardiovascular patient demographics and
profiles in the real world, particularly in a population of
statin-treated patients with dyslipidemia. Further study is
planned using this RWE with emphasis on better understanding the
increase in patient treatment costs associated with this at-risk
population. These studies are intended to complement Amarin’s
ongoing REDUCE-IT cardiovascular outcomes study.
A third study will evaluate the reduction of coronary plaque
using Vascepa® (icosapent ethyl). This study, titled EVAPORATE
(“Effect of Icosapent Ethyl on Progression of Coronary
Atherosclerosis in Patients with Elevated Triglycerides [200-499
mg/dL] on Statin Therapy”), will be led by Matthew J. Budoff, M.D.,
Professor, David Geffen School of Medicine at UCLA and program
director of Cardiac CT at Harbor-UCLA Medical Center. EVAPORATE
will be the first study to use MDCT to evaluate the effects of
icosapent ethyl on plaque characteristics in patients with
persistent high triglyceride (TG) levels. MDCT, multidetector
computed tomography, is an advanced technology for diagnostic
imaging. The EVAPORATE study will be presented as a poster
(abstract #143).
“Amarin is pleased to be working with many leading physicians,
academic centers and healthcare systems with a shared vision of
finding ways to cost-effectively improve patient care,” said Craig
B. Granowitz, M.D., Ph.D., chief medical officer of Amarin. “These
studies are intended to provide a deeper understanding of
cardiovascular disease and its cost and treatment.”
Amarin’s commitment to advancing scientific knowledge and
patient care is evidenced by the more than 30 scientific
publications and abstracts sponsored in 2016. The costs of these
new studies are included in the company’s previously provided
financial guidance for 2017.
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 an
ongoing outcomes study. 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 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.
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 results from real-world evidence studies, reduction of
coronary plaque using Vascepa®, costs of research and development;
expectations for 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 impact the current design of
the REDUCE-IT study or cause a change in strategic direction with
respect to continuation of the study; 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
anticipated 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.
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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