Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular (CV) health, announced
the presentation of a poster today at the American College of
Cardiology 67th Annual Scientific Session and Expo in Orlando,
Florida. This analysis reinforces that statin-treated patients at
high CV risk with controlled LDL-cholesterol (LDL-C) and elevated
triglyceride (TG) levels, TG ≥ 150 mg/dL, had worse CV
outcomes and higher overall healthcare costs than statin-treated
patients with controlled LDL-C and normal TG levels, TG <150
mg/dL, and normal HDL-cholesterol, HDL-C > 40 mg/dL.
The poster was titled “Triglycerides ≥ 150 mg/dL
Associated With Greater Risk of Cardiovascular Events, Costs, and
Resource Utilization in High-Risk Statin-Treated Patients With
Controlled Low-Density Lipoprotein Cholesterol: A Real-World
Analysis.” The database utilized for the analysis had millions of
de-identified medical records from patient experience within a
leading national information and technology-enabled health services
business.
Patients with diabetes mellitus and/or
established atherosclerotic cardiovascular disease were followed
longitudinally for up to five years. Those patients with elevated
TG levels, defined as TG ³ 150 mg/dL, as compared with the normal
TG group defined as TG < 150 mg/dL and HDL-C> 40 mg/dL, were
at increased risk of adverse CV outcomes after multivariable
adjustment as follows:
- 26% increased risk for the
composite initial major adverse CV event (MACE) (95% confidence
interval [CI] 1.19-1.34)• The increase in composite MACE in
the elevated TG group was driven by a 32% (95% CI 1.20-1.45)
increased risk of non-fatal myocardial infarction and a 46% (95% CI
1.33-1.61) increased risk of coronary revascularization
- 12% higher average total healthcare
cost (95% CI 1.08-1.16)
- 13% higher rate of occurrence of
initial inpatient hospital stay (95% CI 1.10-1.17)
This study, in concert with real-world evidence
posters presented previously from two separate studies of patients
with different demographics and health care options, support
previous findings that patients with elevated TGs have increased
risk of future cardiovascular events, even when LDL-C is controlled
with statins. This analysis was not based on specific treatment
groups; these studies were based on patients with elevated/high and
normal TGs while controlling for other factors. Along with genetic
and epidemiologic studies, these real-world data further affirm the
association of elevated TGs in patients with residual risk that
remains after statin control of LDL-C.
The authors of this study were Peter Toth, MD, PhD, CGH Medical
Center, Sterling, IL, and Johns Hopkins University School of
Medicine, Baltimore, MD; Craig Granowitz, MD, PhD, Amarin Pharma,
Inc., Bedminster, NJ; Michael Hull, MS, Djibril Liassou, BA, &
Amy Anderson, MS, Optum, Eden Prairie, MN; Sephy Philip, RPh,
PharmD, Amarin Pharma, Inc., Bedminster, NJ.
“Research continues to show the association of
elevated and high triglycerides with cardiovascular risk and
healthcare costs,” said Peter Toth, MD, PhD. “Continued research in
this area is needed to find safe and effective therapeutic options
to combat the growing public health crisis of cardiovascular
disease.”
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 statements related
to scientific presentations from real-world evidence data. These
statements are not promises or guarantees related to the potential
for favorable outcomes from the ongoing REDUCE-IT cardiovascular
outcomes trial. 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 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 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 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
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Apr 2023 to Apr 2024