Amarin Corporation plc (NASDAQ:AMRN), today announced support
for a clinical trial to investigate the effects of icosapent ethyl
(IPE) (VASCEPA®) on inflammatory biomarkers and other patient
outcomes in individuals with COVID-19. The trial is sponsored by
the Canadian Medical and Surgical Knowledge Translation Research
Group and is being led by Dr. Subodh Verma MD, FRCSC, FAHA, PhD,
cardiac surgeon‐scientist at St. Michael's Hospital in Toronto, and
professor at the University of Toronto, and Dr. Deepak L. Bhatt MD,
MPH, Executive Director of Interventional Cardiovascular Programs
at Brigham and Women’s Hospital and Professor, Harvard Medical
School. The trial primary endpoint is the effect of VASCEPA versus
usual care on high-sensitivity C-reactive protein levels from
baseline to 14 days in adults with a COVID-19-positive diagnosis.
The clinical study design also includes other endpoints that assess
rates and severity of COVID-19 infection in this high-risk group.
Based on our current understanding of the
biological effects of a COVID-19 infection, including that patients
at high risk of cardiovascular disease are at higher risk of
mortality and severe effects from a COVID-19 infection, and based
on data related to the mechanism of action and effects of VASCEPA
in lowering cardiovascular risk in certain high-risk patients, it
is believed that VASCEPA could play a beneficial clinical role in
helping patients infected by the virus.
The clinical effects of VASCEPA are
multi-factorial. Multiple mechanisms of action associated with
VASCEPA from clinical and mechanistic studies support the rationale
to study its effects in patients with the COVID-19 infection.
Additional postulated mechanisms that might play a role in the use
of VASCEPA in the patients infected with COVID-19 include the
following:
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Potential antiviral/antimicrobial effects1 |
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Fibrosis and cardiac damage mitigation in animal models2,3 |
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Anti-inflammatory effects (acute) in pulmonary/lung tissue4,5 |
“We believe that this pilot study may provide
important information on whether, how, and if icosapent ethyl has
biological activity that could have beneficial effects in
mitigating severity in COVID-19 infection. If a positive signal is
achieved in this study, larger, more definitive studies could then
be considered,” stated Dr. Bhatt. “This pilot will also provide
further insight into the effects of icosapent ethyl on various
biomarkers, as well as valuable information about higher loading
doses of this drug.”
For more information about Amarin’s COVID-19
research, please visit the COVID-19 Related Materials section on
Amarin’s publications page at
https://investor.amarincorp.com/publications.
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing and
commercializing therapeutics to cost-effectively improve
cardiovascular health. Amarin’s lead product, VASCEPA (icosapent
ethyl), is available by prescription in the United States, Canada,
Lebanon and the United Arab Emirates. Amarin, together with its
commercial partners in select geographies, is pursuing additional
regulatory approvals for VASCEPA in China, the European Union and
the Middle East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular Risk
The number of deaths in the United States
attributed to cardiovascular disease continues to rise.6,7 There
are 605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds), in the United States. Stroke
rates are similar, accounting for 1 of every 19 U.S. deaths
(approximately 1 every 40 seconds).8
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk for cardiovascular
events, such as heart attack, stroke or death. However, even with
the achievement of target LDL-C levels, millions of patients still
have significant and persistent risk of cardiovascular events,
especially those patients with elevated triglycerides. Statin
therapy has been shown to control LDL-C, thereby reducing the risk
of cardiovascular events by 25-35% – but that still leaves a 65-75%
risk remaining.9 People with elevated triglycerides have 35% more
cardiovascular events compared to people with normal (in range)
triglycerides taking statins.10,11,12
About VASCEPA®
(icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. 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 eight million times and is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019 based on the
results of the landmark REDUCE-IT trial.
Indications and Limitation of Use
VASCEPA is indicated:
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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 |
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established cardiovascular disease or |
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diabetes mellitus and two or more additional risk factors for
cardiovascular disease. |
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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
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VASCEPA is contraindicated in patients with known hypersensitivity
(e.g., anaphylactic reaction) to VASCEPA or any of its
components. |
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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. |
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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. |
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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. |
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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%). |
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Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%). |
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Adverse events may be reported by calling 1-855-VASCEPA or the FDA
at 1-800-FDA-1088. |
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Patients receiving VASCEPA and concomitant anticoagulants and/or
anti-platelet agents should be monitored for bleeding. |
Key clinical effects of VASCEPA on major adverse
cardiovascular events are included in the Clinical Studies section
of the prescribing information for VASCEPA, as set forth below:
Effect of VASCEPA on Time to First
Occurrence of Cardiovascular Events in Patients with Elevated
Triglyceride levels and Other Risk Factors for Cardiovascular
Disease in REDUCE-IT
|
VASCEPA |
Placebo |
VASCEPA vs Placebo |
N = 4089 n (%) |
Incidence Rate (per 100 patient years) |
N = 4090 n (%) |
Incidence Rate (per 100 patient years) |
Hazard Ratio (95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary
revascularization, hospitalization for unstable angina (5-point
MACE) |
705 (17.2) |
4.3 |
901 (22.0) |
5.7 |
0.75 (0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point
MACE) |
459 (11.2) |
2.7 |
606 (14.8) |
3.7 |
0.74 (0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250 (6.1) |
1.5 |
355 (8.7) |
2.1 |
0.69 (0.58, 0.81) |
Emergent or urgent coronary revascularization |
216 (5.3) |
1.3 |
321 (7.8) |
1.9 |
0.65 (0.55, 0.78) |
Cardiovascular death [1] |
174 (4.3) |
1.0 |
213 (5.2) |
1.2 |
0.80 (0.66, 0.98) |
Hospitalization for unstable angina [2] |
108 (2.6) |
0.6 |
157 (3.8) |
0.9 |
0.68 (0.53, 0.87) |
Fatal or non-fatal stroke |
98 (2.4) |
0.6 |
134 (3.3) |
0.8 |
0.72 (0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of
undetermined causality. [2] Determined to be caused by myocardial
ischemia by invasive/non-invasive testing and requiring emergent
hospitalization. |
FULL VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements regarding the potential for
benefit from the study of VASCEPA in the treatment of patients with
COVID-19. 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 the following:
uncertainties associated generally with research and development
and clinical trials. 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. 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
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(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 and Media Inquiries:Elisabeth
SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com (investor
inquiries)PR@amarincorp.com (media inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
References
________________________________1 Morita M, Kuba K, Ichikawa A,
et al. The lipid mediator protectin D1 inhibits influenza virus
replication and improves severe influenza. Cell. 2013;153:112-25.2
Eclov_EPA not DHA prevents fibrosis in pressure overload induced
HF_J Lipid Res 20153 Ito_EPA reduces cardiac fibrosis and diast
dysfunc in rat model of MetS_Obes Sci Pract 20164 Mickleborough_EPA
more effective than DHA on inflammation in human asthma alveolar
macrophage cells_Clin Nutr 20095 Kebir_resolvin E1 and pulm
inflamm_PNAS 20126 American Heart Association. Heart Disease and
Stroke Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.7 American Heart
Association / American Stroke Association. 2017. Cardiovascular
disease: A costly burden for America projections through 2035.8
American Heart Association: Heart Disease and Stroke Statistics --
2019 At-a-Glance.9 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need
for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.10 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.11 Toth PP, Granowitz C, Hull M, et al. High
triglycerides are associated with increased cardiovascular events,
medical costs, and resource use: A real-world administrative claims
analysis of statin-treated patients with high residual
cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.12
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology, genetics,
and biology. Circ Res. 2016;118:547-563.
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