Amarin Corporation plc (NASDAQ: AMRN) announced today a summary of
results from a patient-level, cost-effectiveness analysis of
icosapent ethyl (Vascepa®).1 This comprehensive analysis evaluated
the cost-effectiveness of icosapent ethyl in reducing
cardiovascular (CV) risk among high-risk patients as demonstrated
in the landmark REDUCE-IT®2 cardiovascular outcomes study. In
this newly reported analysis, use of icosapent ethyl was projected
to not only be cost-effective but also to reduce long-term health
care costs in a majority of the scenarios analyzed.
The findings were disclosed in an abstract titled,
“Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT,” in connection
with the 2019 Scientific Sessions of the American Heart Association
(AHA), scheduled for November 16 – 18 in Philadelphia, PA. William
S. Weintraub, M.D., director of Outcomes Research with MedStar
Cardiovascular Research Network, and lead author of the analysis,
is scheduled to present the results in more detail at AHA on
Saturday, November 16, at 7:30 a.m.
Dr. Weintraub and the MedStar Cardiovascular Research Network,
known for conducting thoughtful pharmacoeconomic analysis, used
available data for cost information for treatment and
rehabilitation of patients from stroke, myocardial infarction,
revascularization, hospitalization and cardiovascular death and
assessed how such costs decline relative to the cost of patient
treatment with icosapent ethyl based on the results of the
REDUCE-IT study.
Background: Despite statin therapy and
well-controlled LDL-C, many high CV risk patients continue to
experience CV events. This “persistent” CV risk was evaluated via
REDUCE-IT, which enrolled statin-treated patients with controlled
LDL-C (>40 - ≤100 mg/dL) and elevated triglycerides (≥135 -
<500 mg/dL), with established CV disease or diabetes combined
with other CV risk factors. Over 4.9 years median follow-up,
REDUCE-IT showed that icosapent ethyl lowered risk of first and
total CV events by 25% and 30%, respectively.
In REDUCE-IT, adverse events occurring with icosapent ethyl use
at greater than 5% and greater than placebo were: peripheral edema
(6.5% Vascepa versus 5.0%), although there was no increase in the
rate of heart failure in Vascepa patients; constipation (5.4%
Vascepa versus 3.6%), although mineral oil, as used as placebo, is
known to lower constipation; and atrial fibrillation (5.3% Vascepa
versus 3.9%), although there were reductions in rates of cardiac
arrest, sudden death and myocardial infarctions observed in Vascepa
patients. More information on safety data associated with REDUCE-IT
is provided further below.
Methods: The analysis applied treatment effects
from REDUCE-IT, health care costs from national sources, including
private insurance and Medicare, and conducted a combination
cost-effectiveness analysis utilizing both patient-level in-trial
cost and clinical outcomes and long-term costs, events and life
expectancy derived from Markov simulation models. The model
projected lifetime healthcare costs, CV events, survival and
quality-adjusted life-years (QALYs) for icosapent ethyl versus
placebo in REDUCE-IT eligible patients.
Results: Icosapent ethyl was a dominant
strategy (i.e., cost saving) in 70% of simulations, offering the
rare finding of better outcomes at lower healthcare costs. In
probabilistic sensitivity analysis, >85% of simulations
indicated that icosapent ethyl would be cost-effective (i.e., below
$50,000 per QALY gained) compared with placebo.
Conclusion: In this combined patient-level and
simulation cost-effectiveness analysis, icosapent ethyl in high CV
risk patients shows exceptional benefit with CV event reduction as
well as cost-savings in-trial and over patients’ lifetime in the
majority of simulations.
John Thero, president and chief executive officer of Amarin,
developer of Vascepa, commented, “This analysis helps to validate
something we’ve long believed, and that is central to our mission.
It is possible to deliver significant innovation that meaningfully
addresses our nation’s most prevalent and costly health epidemic,
reduces impacts on patients and families, and drives down costs
longer term in the health system. We are working to make this
therapy broadly available for improved patient care in high risk
patients subject to appropriate regulatory review.”
Other Considerations:MedStar Cardiovascular
Research Network (MedStar), which conducted this cost-effectiveness
analysis, led by its director of Outcomes Research, Dr. Weintraub,
is an organization dedicated to fighting heart disease, stroke and
other conditions affecting the heart and blood vessels and is
affiliated with MedStar Health Research Institute and Medstar
Health. Amarin funded this analysis.
The patient cost and actuarial information used by MedStar in
this cost-effective analysis were derived from sources independent
of Amarin. Data regarding cardiovascular risk reduction
demonstrated by Vascepa was sourced from previously published
information from the total cohort of the REDUCE-IT study (not from
the REDUCE-IT USA cohort published today in Circulation3 which
showed even more pronounced results albeit subject to the
limitations of subset analysis) with support provided by Amarin in
making the data available to MedStar for analysis. Included in this
data was outcomes results pertaining to first occurrences of
cardiovascular events and recurrent events. As disclosed in the
publication of the recurrent events analysis in the Journal of the
American College of Cardiology4, the analyses addressed tertiary or
exploratory endpoints using a series of statistical models, most of
which were prespecified and one of which was post hoc. Each
recurrent event statistical model has inherent strengths and
weaknesses, with no single model considered definitive or
outperforming the other models, as this is an evolving field of
science. Nonetheless, results from the total primary and total key
secondary endpoint events analyses are consistent across the
various recurrent event statistical models and are also consistent
with the original primary and secondary endpoint results.
Furthermore, the cost-effectiveness analysis conducted by
MedStar, as is typical of cost-effectiveness analyses, was not
prespecified. Amarin funded MedStar because of its expertise to
conduct this analysis, as opposed to Amarin conducting it on its
own, to mitigate perceptions of potential bias inherent in post hoc
analyses.
This press release is timed today pursuant to AHA’s release of
an abstract for this presentation. It is Amarin’s understanding
that AHA plans to release abstracts for some but not all (e.g. not
any presentation deemed a “late breaker,” such as the presentation
regarding EVAPORATE) of the seven scientific presentations Amarin
listed in its press release dated November 4, 2019. Without
potentially jeopardizing presentation at AHA, Amarin looks forward
to communications regarding all of these presentations pursuant to
their presentation at AHA.
About AmarinAmarin Corporation plc. is a
rapidly growing, innovative pharmaceutical company focused on
developing therapeutics to improve cardiovascular health. Amarin’s
product development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa (icosapent
ethyl) is Amarin's first FDA-approved drug and is available by
prescription in the United States, Lebanon and the United Arab
Emirates. Amarin’s commercial partners are pursuing additional
regulatory approvals for Vascepa in Canada, China and the Middle
East. For more information about Amarin, visit
www.amarincorp.com.
About REDUCE-IT® REDUCE-IT, an 8,179-patient
cardiovascular outcomes study, was completed in 2018. REDUCE-IT was
the first multinational cardiovascular outcomes study that
evaluated the effect of prescription pure EPA therapy as an add-on
to statins in patients with high cardiovascular risk who, despite
stable statin therapy, had elevated triglyceride levels (at least
135 mg/dL). A large proportion of the male and female patients
enrolled in this outcomes study were diagnosed with type 2
diabetes.
More information on the REDUCE-IT study results can be found at
www.amarincorp.com.
About Cardiovascular DiseaseWorldwide,
cardiovascular disease (CVD) remains the #1 killer of men and
women. In the United States CVD leads to one in every three deaths
– one death approximately every 38 seconds – with annual treatment
cost in excess of $500 billion.5,6
Multiple primary and secondary prevention trials have
shown a significant reduction of 25% to 35% in the risk
of cardiovascular events with statin therapy,
leaving significant persistent residual risk despite the
achievement of target LDL-C levels.7
Beyond the cardiovascular risk associated with LDL-C, genetic,
epidemiologic, clinical and real-world data suggest that patients
with elevated triglycerides (TG) (fats in the blood), and TG-rich
lipoproteins, are at increased risk for cardiovascular
disease.8,9,10,11
About Vascepa® (icosapent ethyl)
CapsulesVascepa (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 from degradation. 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.
The FDA has not completed its review and made a final
determination on a supplemental new drug application related to
REDUCE IT. FDA has not reviewed the information herein or
determined whether to approve Vascepa for use to reduce the risk of
major adverse cardiovascular events in the REDUCE-IT patient
population.
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results)
- 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 Based on Current
FDA-Approved Label (not including REDUCE-IT results) (Includes Data
from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients
with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of
its components.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- 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.
- Adverse events and product complaints may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients
receiving treatment with Vascepa and other drugs affecting
coagulation (e.g., anti-platelet agents) should be monitored
periodically.
- Patients should be advised to swallow Vascepa capsules whole;
not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on REDUCE-IT, as
previously reported in The New England Journal of Medicine
publication of the primary results of the REDUCE-IT study:
- Excluding the major adverse cardiovascular events (MACE)
results described above, overall adverse event rates in REDUCE-IT
were similar across the statin plus Vascepa and the statin plus
placebo treatment groups.
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the statin plus
placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were:
- peripheral edema (6.5% Vascepa patients versus 5.0% placebo
patients), although there was no increase in the rate of heart
failure in Vascepa patients
- constipation (5.4% Vascepa patients versus 3.6% placebo
patients), although mineral oil, as used as placebo, is known to
lower constipation, and
- atrial fibrillation (5.3% Vascepa patients versus 3.9% placebo
patients), although there were reductions in rates of cardiac
arrest, sudden death and myocardial infarctions observed in Vascepa
patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall rates were low
with no fatal bleeding observed in either group and no significant
difference in adjudicated hemorrhagic stroke or serious central
nervous system or gastrointestinal bleeding events between
treatments.
- In summary, Vascepa was well tolerated with a safety profile
generally consistent with clinical experience associated with
omega-3 fatty acids and current FDA-approved labeling of such
products.
Important Cautionary Information About These
Data Further REDUCE-IT data assessment and data
release are expected to yield additional useful information to
inform greater understanding of the trial outcome. For example,
detailed data assessment by regulatory authorities, such as the FDA
and Health Canada, will continue and take time to complete and
announce. The FDA advisory committee process and the final
evaluation by regulatory authorities of the totality of efficacy
and safety data from REDUCE-IT is anticipated to include some or
all of the following, as well as other considerations: new
information or analyses affecting the degree of treatment benefit
on studied endpoints; study conduct and data robustness, quality,
integrity and consistency; additional safety data considerations
and risk/benefit considerations; and consideration of REDUCE-IT
results in the context of other clinical studies. More detailed
presentation of such considerations is set forth in the risk
factors section of Amarin’s Quarterly Report on Form 10-Q filed
with the U.S. Securities and Exchange Commission. Because
regulatory reviews are typically fluid and not definitive
interactions between sponsor and agency on individual elements of
an application and related information, Amarin does not plan to
update investors further on ongoing communications with regulatory
authorities. Amarin plans to announce the final outcome of such
regulatory reviews when appropriate.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements regarding
the use of Vascepa to potentially help millions of patients and
projections related to 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, clinical trials
and related regulatory reviews and approvals; the risk that data
interpretations or other information from third parties, the
regulatory review process, regulatory authorities and in connection
with an advisory committee could be made public that are negative
or may delay approval or limit Vascepa’s marketability; the risk
that special protocol assessment (SPA) agreements with the FDA are
not a guarantee that FDA will approve a product candidate; the risk
associated with the FDA's rescinding the REDUCE-IT SPA agreement;
the risk related to FDA advisory committee meetings; and the risk
that the FDA may not complete its review of the REDUCE-IT sNDA
within the timing expected. 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
AmarinInvestors 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 Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
References_______________1 William S Weintraub,
MedStar Washington Hosp Ctr, Washington, DC; Deepak L Bhatt,
Brigham and Women's Hosp, Boston, MA; Zugui Zhang, Christiana Care
Health System, Newark, DE et al., Cost-Effectiveness of Icosapent
Ethyl in REDUCE-IT.2 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med 2019;380:11-223 Bhatt DL, Miller
M, Brinton EA, et al. REDUCE-IT USA: Results from the 3,146
Patients Randomized in the United States. Circulation 2019. DOI:
10.1161/CIRCULATIONAHA.119.044440.4 Bhatt DL, Steg PG, Miller M, et
al. Effects of Icosapent Ethyl on Total Ischemic Events: From
REDUCE-IT. J Am Coll Cardiol 2019; 73:2791-28025 American Heart
Association. 2018. Disease and Stroke Statistics-2018 Update.6
American Heart Association. 2017. Cardiovascular Disease: A Costly
Burden for America Projections Through 2035.7 Ganda OP, Bhatt DL,
Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.8 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.9 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):e008740.10 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.11 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014;384:626–635.
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