Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company
focused on improving cardiovascular health, hosted a webcast today
to discuss important data with study authors who presented at the
American Heart Association 2019 Scientific Sessions, November
16-18. The data covered related to Vascepa® (icosapent ethyl)
capsules, the landmark clinical outcomes study REDUCE-IT®[1] , as
well as the cardiovascular risk of patients with elevated
triglycerides, a type of fat in the blood.
“The more we study the REDUCE-IT data and the at-risk conditions
of the patients studied in this important clinical trial, the
better we understand the nature and extent of persistent
cardiovascular risk among patients on statins and with elevated
triglycerides, and how to address it,” said Craig Granowitz, M.D.,
Ph.D., chief medical officer, Amarin. “At Amarin, we are proud to
have played a role in supporting and sharing data with the
scientific and medical communities that could make a major
difference in cardiovascular care, an area where the need for new
and innovative treatment options is urgent and growing.”
About Cardiovascular RiskThe number of deaths
in the United States attributed to cardiovascular disease continues
to rise.2,[3] 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).4
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 high triglycerides. Statin therapy has been shown to
control LDL-C, thereby reducing the risk of cardiovascular events
by 25-35% – but that still leaves 65-75% risk remaining.5 People
with high triglycerides have 35% more cardiovascular events
compared to people with normal (in range) triglycerides taking
statins.6,[7],[8]
Key Data Presented at AHA and Reviewed During Amarin’s
Webcast
- “REDUCE-IT USA: Results from the 3,146 Patients
Randomized in the United States,” – presented by
Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital and
Harvard Medical School. Highlights: This
prespecified REDUCE-IT subgroup analysis showed substantial risk
reductions in the USA patients treated with icosapent ethyl 4 g/day
versus placebo across all prespecified composite and individual
primary and secondary endpoints, including 31% relative risk
reduction and 6.5% absolute risk reduction in first occurrence of
5-point major adverse cardiovascular events (MACE), corresponding
to a number needed to treat of 15 (NNT=15), and a significant 30%
relative and 2.6% absolute risk reduction (NNT=39) in all-cause
mortality in the USA subgroup. Additional prespecified
cardiovascular endpoints in which the REDUCE-IT USA subgroup showed
significant relative risk reduction included myocardial infarction,
cardiovascular death, and stroke, similar to the full cohort in the
overall REDUCE-IT global results. These results were incremental to
the cardiovascular risk reduction achieved by conventional therapy
administered to the high-risk patients studied, including
incremental to statin therapy. The REDUCE-IT USA subgroup consisted
of 3,146 patients (nearly 40%) of the previously reported full
trial cohort. REDUCE-IT was not specifically powered to examine
individual subgroups. P-values presented for the USA subgroup are
nominal and exploratory with no adjustment for multiple
comparisons. Differences in efficacy outcomes for the USA patients
are best viewed as qualitative and not quantitative; nevertheless,
the data are useful and provide reassurance that the results in the
USA are at least as strong as the results seen outside the USA and
in the trial overall.The REDUCE-IT USA study results were also
published in Circulation, AHA’s official scientific journal.9
- “Cost-Effectiveness of Icosapent Ethyl in
REDUCE-IT,” – presented by William S. Weintraub,
M.D., MedStar Washington Hospital. Highlights: In
this combined patient-level and simulation lifetime
cost-effectiveness analysis, icosapent ethyl in high cardiovascular
risk patients shows exceptional benefit with cardiovascular event
reduction as well as cost-savings in-trial and over patients’
lifetime in many simulations. Findings of potential cost
effectiveness of a medical therapy are rare. This analysis
considered the current market cost for Vascepa and the potential
savings from avoiding major adverse cardiovascular events, such as
strokes and heart attacks, the cost of which can be high. This
cost-effectiveness analysis was conducted by MedStar. As is
typical, the cost-effectiveness analyses were not prespecified as
part of the REDUCE-IT clinical trial design but did rely on the
results of this landmark outcomes study.
- “Many Statin Treated Persons with Borderline
Triglyceride Levels are at Risk of ASCVD,” – presented by
Nathan D. Wong, Ph.D., M.P.H, University of California, Irvine.
Highlights: This study showed prevalence of
elevated risk of major cardiovascular events (a mean 10-year
atherosclerotic cardiovascular disease (ASCVD) risk score greater
than 20%) in more than 20% of patients on statins with
triglycerides below 150 mg/dL. This suggests the need for greater
lifestyle and other therapies to address remaining residual ASCVD
risk.
- “Effect of Icosapent Ethyl on Progression of Coronary
Atherosclerosis in Patients with Elevated Triglycerides (200 – 499
mg/dL) on Statin Therapy (EVAPORATE) study,” –
presented by Matthew J. Budoff, M.D., Los Angeles Biomedical
Research.Highlights: At the prespecified 9-month
interim analysis, there was slowing of total non-calcified plaque
(sum of LAP, fibrofatty, and fibrous plaque) (35% v. 43%, p=0.010),
total plaque (non-calcified + calcified plaque) (p=0.0004), fibrous
plaque (15% v. 26%, p=0.011) and calcified plaque (-1% v. 9%,
p=0.001), after adjustment by baseline plaque, age, sex, diabetes
status, baseline triglyceride levels, and statin use. However,
there was no significant change in the primary endpoint of low
attenuation plaque between active and placebo groups (74% vs 94%,
p=0.469) at this 9-month interim look. This investigator-initiated
study is continuing to its designed completion of an 18-month
review. EVAPORATE is the first study in the United States, which
enrolled a total of 80 patients, to use multidetector computed
tomography (MDCT) to evaluate the effects of icosapent ethyl as an
adjunct to statin therapy on plaque characteristics in a high
cardiovascular-risk population with persistent high triglyceride
levels. Patients underwent interim scans at 9 months and are
currently being followed for an additional 9 months with MDCT.
Final results from this study are anticipated in early 2020.
Arterial plaque and coronary atherosclerosis are key factors
leading to significant increases in the probability of acute
obstructions and angina or other coronary artery disease signs and
symptoms.
All of the analyses highlighted above were funded by Amarin.
A replay of the webcast will be available for two weeks
following the webcast. To hear a replay of the webcast, dial
877-481-4010 (inside the United States) or 919-882-2331 (outside
the United States). A replay of the webcast is also be available
through the company's website, Amarincorp.com, in the Investor
section. For both dial-in numbers please use conference ID
55923.
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 cardioprotective effect of icosapent ethyl, a unique
prescription therapy, as an add-on to statins in patients with high
cardiovascular risk. As defined in the published results of the
study, the high cardiovascular risk patients, despite stable statin
therapy, had elevated triglyceride levels (lower enrollment target
of TG >135 mg/dL). As per the study’s design, approximately 71%
of the enrolled patients had established cardiovascular disease and
the other patients were diagnosed, as per trial enrollment
requirements, as having diabetes and other cardiovascular risk
factors.
More information on the REDUCE-IT study results can be found at
www.amarincorp.com.
About Vascepa® (icosapent ethyl)
CapsulesVascepa (icosapent ethyl) capsules are a
single-molecule prescription product which has been developed and
studied for more than a decade and has been prescribed more than 8
million times in the United States. Vascepa, known in scientific
literature as AMR101, has been designated a new chemical entity by
the FDA. Amarin has been issued multiple patents in the United
States and 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 or 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. 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 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med 2019;380:11-22.
2 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.
3 American Heart Association / American Stroke Association.
2017. Cardiovascular disease: A costly burden for America
projections through 2035.
4 American Heart Association: Heart Disease and Stroke
Statistics -- 2019 At-a-Glance.
5 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.
6 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
7 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.
8 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
9 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.
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