Amarin Corporation plc (NASDAQ:AMRN), hosted a webcast yesterday to
discuss important data with study authors who presented at the
American College of Cardiology’s 69th Annual Scientific Session
Together With World Congress of Cardiology (ACC.20/WCC), March
28-30. The data presented related to VASCEPA® (icosapent ethyl)
capsules, the landmark clinical outcomes study REDUCE-IT®, as well
as persistent cardiovascular risk in patients with elevated
triglycerides, a type of fat in the blood.
- Eicosapentaenoic Acid (EPA) levels
from VASCEPA® (Icosapent Ethyl) in REDUCE-IT® strongly correlated
to cardiovascular outcomes, more so than other biomarkers
- Over 70,000 cardiovascular
events/year in US adults with known CVD or diabetes mellitus may be
preventable from VASCEPA (Icosapent Ethyl) therapy, impacting
persistent CV risk despite statin-controlled LDL-C
- Analysis supports determination
that VASCEPA is highly cost-effective in patients from the
REDUCE-IT USA subgroup and, as is rarely found for any therapy, may
result in net healthcare cost-savings to patients, payers and
society
- Mechanism of icosapent ethyl is
distinct from docosahexaenoic acid (DHA) and other omega-3 fatty
acids in providing antioxidant effects
“Administration of 4 g/day of VASCEPA, a highly
cost-effective therapy, can potentially prevent over 70,000
cardiovascular events per year,” said Craig Granowitz, M.D., Ph.D.,
Amarin’s senior vice president and chief medical officer commenting
on presentations made at ACC.20/WCC. “It is apparent that icosapent
ethyl administration results in serum EPA levels necessary to
reduce cardiovascular events. This positive effect has not been
demonstrated for any other therapy on top of statin therapy. These
new and important data will help inform ways to manage persistent
cardiovascular risk and help curb the number one killer of
Americans.”
About Cardiovascular Risk
The number of deaths in the United States
attributed to cardiovascular disease continues to rise.1,2 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).3 In aggregate, from
cardiovascular disease there is one death, stroke or heart attack
every 14 seconds.
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.4 People with elevated triglycerides have 35% more
cardiovascular events compared to people with normal (in range)
triglycerides taking statins.5,6,7
Key Data Presented at ACC.20/WCC and
Reviewed During Amarin’s Webcast
“Eicosapentaenoic Acid Levels in
REDUCE-IT and Cardiovascular Outcomes” – presented on
behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and
Women’s Hospital
Highlights: Following
administration of VASCEPA, a pure, stable, prescription EPA
therapy, serum EPA levels showed an approximately 400% increase
across the study from baseline (26.1 μg/mL) versus placebo,
including to year 1 (144 μg/mL; p=1x10-30). Docosahexaenoic acid
(DHA) levels were measured and showed a decrease of 2.9%
(p=0.002).
On-treatment EPA levels in the VASCEPA group
were associated strongly with reduced cardiovascular events,
including benefits observed in the primary and key secondary
endpoints, each component of these endpoints such as cardiovascular
death, as well as benefits in heart failure and total mortality
with high on-treatment EPA levels.
These analyses suggest that achieved EPA levels
with 4 g/day of VASCEPA is a marker for the majority of the
relative risk reduction observed in REDUCE-IT. The EPA levels
achieved in REDUCE-IT were well above levels that can be achieved
with diet or with dietary supplements. The clinical results
achieved with VASCEPA have not been demonstrated for any other
therapy, reflecting the uniqueness of this FDA-approved
prescription therapy and its high EPA content, in stable form,
without offset or dilution by other omega-3 molecules each of which
act differently (e.g., enhanced dosing of DHA is associated with
increases in LDL-cholesterol levels). Further study is needed to
assess whether people with relatively large body mass might be
safely and effectively treated with higher than 4 g/day of
icosapent ethyl.
Biomarker analyses suggest minimal contribution
of changes in measured lipid, lipoprotein, and inflammatory
biomarkers to the cardiovascular benefit observed in REDUCE-IT.
“REDUCE-IT Eligibility and Preventable
First and Total Cardiovascular Events in the US Population: An
Analysis of the National Health and Nutrition Examination Survey
(NHANES)” – Nathan D. Wong, Wenjun Fan, Peter P. Toth,
Craig Granowitz, Sephy Philip
Highlights: The NHANES database
was used to identify approximately 3 million REDUCE-IT eligible
adults aged >45 years, 63% with prior CVD and 37% with DM +
>1 risk factor. While this is not the full extent of VASCEPA’s
label, this is the population reviewed in this presented
analysis.
Based on such eligibility criteria and event
rate applied to the US population, it is estimated that
administration of VASCEPA (icosapent ethyl) could prevent 71,391
cardiovascular events/year, consisting of 29,798/year fewer first
occurrence of a cardiovascular events, such as stroke, heart attack
or death, and 41,593/year fewer recurring cardiovascular
events.
“Cost-effectiveness of Icosapent Ethyl
in US REDUCE-IT Patients” – William S. Weintraub, Deepak
L. Bhatt, Zugui Zhang, Cheng Zhang, Sarahfaye Dolman, William E.
Boden, P. Gabriel Steg, Michael Miller, Eliot A. Brinton, Jordan B.
King, Adam P. Bress, Terry A. Jacobson, Jean-Claude Tardif,
Christie M. Ballantyne, Paul Kolm
Highlights: Based on a variety
of cost-effectiveness analyses conducted, icosapent ethyl is shown
to provide excellent value. The results show a dominant (better
outcome, lower cost) cost-effectiveness profile overall and in
patients with established atherosclerosis. Analyses conducted
consistently put icosapent ethyl within US willingness-to-pay
thresholds of <$50,000/QALY (Quality Adjusted Life Years)
gained. Administration of icosapent ethyl may result in net
healthcare cost-savings to patients, payers and society.
“Eicosapentaenoic Acid Inhibits
Oxidation of Very Large Density Lipoproteins (VLDL) in a
Dose-Dependent Manner over Time as Compared to Docosahexaenoic Acid
In Vitro” – R. Preston Mason, Samuel C. R. Sherratt
“Eicosapentaenoic Acid Inhibits High
Density Lipoprotein (HDL) Oxidation in a Synergistic Manner in
Combination with Atorvastatin In Vitro” – R. Preston
Mason, Samuel C. R. Sherratt
Highlights: In vitro studies
were conducted to ascertain EPA behavior under 2 scenarios;
antioxidant benefits in VLDL vs. DHA and effect on HDL oxidation in
the context of use with ATM (active, ortho-hydroxy metabolite of
atorvastatin.)
It was found that EPA exhibited
concentration-dependent antioxidant effects. These antioxidant
effects require pharmacologic concentrations for sustained activity
over time. Furthermore, it was found that the antioxidant benefits
with EPA in VLDL were not reproduced with DHA and that the
antioxidant benefits for EPA were enhanced with a statin. EPA
pretreatment prevented HDL oxidation in a significant fashion with
this benefit more than doubling when combined with ATM, suggesting
that synergistic antioxidant effects of EPA in combination with a
statin may preserve atheroprotective functions for HDL. Such
findings appear to be consistent with the multifactorial clinical
effects attributed to icosapent ethyl.
All analyses highlighted above were funded by
Amarin.
A replay of the call is available for a period
of two weeks. To hear a replay of the call, dial 877-481-4010, PIN:
33498. A replay of the call is also available through the company's
website beginning shortly after the call.
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 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.
Indications and Limitation of Use
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.
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 |
VASCEPAvs Placebo |
N = 4089n (%) |
Incidence Rate(per 100 patient years) |
N = 4090n (%) |
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 connections between EPA
blood levels and cardiovascular risk reduction in patient use, the
use of VASCEPA to help patients and the cost effectiveness of
VASCEPA. 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
_________________________________________
1 American Heart Association. Heart Disease and
Stroke Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.2 American Heart
Association / American Stroke Association. 2017. Cardiovascular
disease: A costly burden for America projections through 2035.3
American Heart Association: Heart Disease and Stroke Statistics --
2019 At-a-Glance.4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need
for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.5 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.6
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):e008740.7 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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