Amarin Corporation plc (NASDAQ:AMRN) today announced in vitro
research results suggesting that Eicosapentaenoic Acid (EPA), in
combination with widely prescribed statins (often referred to under
brand names LIPITOR® and CRESTOR®), contributed to a reduction in
lipid oxidation in membranes in a manner that may be enhanced with
the use of these statins.
Amarin’s VASCEPA®/VAZKEPA® (icosapent ethyl) is the highly
purified, prescription form of the ethyl ester of EPA. The research
results will be presented on behalf of all authors by Preston
Mason, Ph.D., of Brigham & Women’s Hospital and Elucida
Research, LLC, during a poster session at the American College of
Cardiology’s 71st Annual Scientific Session in Washington, DC, on
Saturday, April 2nd. The experiment was conducted with financial
support from Amarin and Elucida Research.
The oxidation of lipids in vascular cell membranes can be an
important factor in heart disease and risk of an adverse
cardiovascular event, as it contributes to inflammation,
endothelial dysfunction, and cholesterol domain and foam cell
formation during atherogenesis,1-3 as well as to circulating levels
of oxidized LDL, which correlate with acute coronary syndromes and
increased risk for ischemic events (such as a heart attack or
stroke) and metabolic disease.4-7
In this experiment, the dose-dependent effects of EPA at
concentrations of 5 and 10 micromolar (µM) on rates of lipid
oxidation were measured by iodometric approaches with fixed
concentrations of ATM and rosuva (1.0 µM) under conditions of
autoxidation for 96 hr. After 96 h, control (untreated) membranes
underwent significant oxidation with lipid peroxide (LOOH) levels
reaching 2049 ± 286 µM.
EPA was found to have significantly reduced lipid oxidation in a
dose-dependent fashion in the absence and presence of either ATM or
rosuva. The combination of EPA/ATM and EPA/rosuva reduced lipid
oxidation by 86 and 75%, respectively (p<0.001). The antioxidant
activity of the EPA/ATM combination was more potent than EPA/rosuva
by 59% (p<0.01) due, in part, to the more potent activity of ATM
separately, which reduced LOOH levels 72% compared to rosuva alone
(p<0.001).
These results are in line with prior experiments which suggested
that treatment with EPA inhibited endothelial dysfunction following
challenge with oxidized LDL and high glucose levels in a manner
that may be enhanced with a high-intensity statin.8 The authors
posit that this may be due to increased antioxidant activity
achieved via the combination of EPA with statins due to
complementary physico-chemical properties.
“The message that emerged for us from these in vitro study
results was that, while statins and EPA can work independently to
reduce lipid oxidation which can contribute to cardiovascular risk,
they might work even better together,” said Dr. Mason. “This is an
important finding with potential implications in particular for
those facing persistent, elevated cardiovascular risk or who have
had a prior event, as they may need more potent solutions than the
standard of care can provide.”
“These findings are another compelling piece of evidence in line
with our beliefs regarding the potential for increased benefit to
appropriate high-risk patients from VASCEPA/VAZKEPA in combination
with statins, consistent with the results from the REDUCE-IT®
trial, and supports Amarin’s decision to focus on research and
development efforts toward the possible development of a
combination product,” said Karim Mikhail, Amarin’s president and
chief executive officer.
References
1 Witztum JL TheLancet.1994;344:793-7952 Chisolm GM and
Steinberg D. FreeRadicBiolMed. 2000; 28:1815-18263 Jacob RF and
Mason RP. JBiolChem. 2005; 280:39380-393874 Ehara S et al.
Circulation. 2001; 103:1955-19605 Walter MF et al. JAmCollCardiol.
2008; 51:1196-12026 Walter MF et al. JAmCollCardiol. 2004;
44:1996-20027 Holvoet P et al. Diabetes. 2004; 53:1068-10738 Mason
RP et al. Biomed Pharmacother. 2018; 103:1231-1237
About Amarin Amarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. From our foundation in scientific research to
our focus on clinical trials, and now our commercial expansion, we
are evolving and growing rapidly. Amarin has offices in
Bridgewater, New Jersey in the United States, Dublin in Ireland,
Zug in Switzerland, and other countries in Europe as well as
commercial partners and suppliers around the world. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. VASCEPA was initially
launched in the United States in 2013 based on the drug’s initial
FDA approved indication for use as an adjunct therapy to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been
prescribed over ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, Lebanon and the United Arab
Emirates. In Europe, in March 2021 marketing authorization was
granted to icosapent ethyl in the European Union for the reduction
of risk of cardiovascular events in patients at high cardiovascular
risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United
States)
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
- established cardiovascular disease
or
- diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of
its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of
atrial fibrillation or atrial flutter requiring hospitalization in
a double-blind, placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of
atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or
shellfish are at an increased risk of an allergic reaction to
VASCEPA. Patients with such allergies should discontinue VASCEPA if
any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of
bleeding in a double-blind, placebo-controlled trial. The incidence
of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants
and/or anti-platelet agents should be monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking StatementsThis press release
contains forward-looking statements which are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including statements regarding any new potential
clinical impact of VASCEPA, whether alone and/or in a combination
product, the outcomes or impact of any specific new or ongoing
clinical trials or studies, clinical, scientific, and/or
statistical significance of any data generated in new or ongoing
clinical trials or studies and general statements about the safety
and effectiveness of VASCEPA and/or a potential combination product
with VASCEPA and any specific statin. These forward-looking
statements are not promises or guarantees and involve substantial
risks and uncertainties, including that Amarin's ability to
effectively develop, obtain regulatory approval, commercialize and
maintain or grow its market share of VASCEPA and/or any combination
product which will depend in part on Amarin’s ability to continue
to effectively finance its business and development efforts; to
successfully achieve regulatory and marketing approvals in
geographies in the United States and outside the U.S., which may
rely on certain efforts of third parties; to maintain effective
education, marketing and sales activities to achieve broad market
acceptance; 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 its sales and
promotional efforts; and to secure, maintain and defend its patent
protection for VASCEPA and/or any combination product. 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
Amarin’s annual report on Form 10-K for the full year ended 2021.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date they are made. Amarin undertakes no obligation to
update or revise the information contained in its forward-looking
statements, whether as a result of new information, future events
or circumstances or otherwise. Amarin’s forward-looking statements
do not reflect the potential impact of significant transactions the
company may enter into, such as mergers, acquisitions,
dispositions, joint ventures or any material agreements that Amarin
may enter into, amend or terminate. Availability of Other
Information About Amarin communicates with its investors and the
public using the company website (www.amarincorp.com) and the
investor relations website (investor.amarincorp.com), including but
not limited to investor presentations, 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 Inquiries: Investor Relations Amarin
Corporation plc IR@amarincorp.com (investor inquiries)
Media Inquiries: Communications Amarin Corporation plc
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