Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced that
three Amarin-supported posters will be presented at the American
Diabetes Association 79th Scientific Sessions in San Francisco,
June 7 – 11, 2019. All three posters highlight important
findings regarding the challenges of current treatment options for
diabetes patients with cardiovascular risks. More than 30
million adults in the United States have diabetes, 10 million of
whom are considered at elevated risk for cardiovascular events,
despite being on cholesterol-management medicines.1,2
“What we have learned through our landmark clinical trial,
REDUCE-ITTM, as well as other research, is that cholesterol and
diabetes management is not enough to effectively treat
cardiovascular disease in patients with diabetes and other risk
factors,” said Craig Granowitz, M.D., Ph.D., chief medical officer
of Amarin. “Cardiovascular disease is the No. 1 cause of
death in people with diabetes. We applaud the ADA for highlighting
the need to better understand and address increased cardiovascular
risk in patients with diabetes.”
Recently, the ADA issued important updates to its Standards of
Care recommendations, now including a Level “A” recommendation to
consider icosapent ethyl to reduce cardiovascular (CV) risk in
patients with diabetes and atherosclerotic cardiovascular disease
(ASCVD) or other cardiac risk factors on a statin with controlled
LDL-C (bad cholesterol), but with elevated triglycerides (135-499
mg/dL), based on the outcome of the Reduction of Cardiovascular
Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT).
In REDUCE-IT, icosapent ethyl capsules provided a 25% relative
risk reduction compared to placebo in the first occurrence of a
major adverse CV event (MACE) in the intent-to-treat population
consisting of a composite of cardiovascular death, nonfatal
myocardial infarction (MI or heart attack), nonfatal stroke,
coronary revascularization (procedures such as stents and by-pass)
and unstable angina requiring hospitalization. For total (first and
subsequent) cardiovascular events, icosapent ethyl provided a
statistically significant 30% risk reduction compared to placebo in
the statin-treated patient population studied in REDUCE-IT.3,4 This
total event result reflects that for every 1000 patients treated
for 5 years, approximately 159 MACE (major adverse cardiovascular
events) could be prevented with icospent ethyl versus placebo,
including prevention of approximately 12 cardiovascular deaths, 42
heart attacks (myocardial infarctions), 14 strokes, 76 coronary
revascularizations and 16 episodes of hospitalization for unstable
angina. Among the patients studied, 59 percent had diabetes.
Adverse events occurring with icosapent ethyl use at greater
than 5% and greater than placebo were: peripheral edema (6.5%
icosapent ethyl versus 5.0%), although there was no increase in the
rate of heart failure in icosapent ethyl patients; constipation
(5.4% icosapent ethyl versus 3.6%), although mineral oil, as used
as placebo, is known to lower constipation; and atrial fibrillation
(5.3% icosapent ethyl versus 3.9%), although there were reductions
in rates of cardiac arrest, sudden death and myocardial infarctions
observed in icosapent ethyl patients. More information on safety
data associated with REDUCE-IT is provided below.
Amarin-Supported Research to be Presented at the ADA
Scientific Sessions
Poster Presentations
Association Between Triglycerides and Residual Cardiovascular
(CVD) Risk in Patients with Type 2 Diabetes and Established CVD: An
Analysis of the BARI2D Trial, Abstract 1472-P, Embargoed Until
Saturday, June 8, 11:30 a.m (Pacific Daylight Time).
- Neha J. Pagidipati, M.D., MPH; Ann Marie Navar, M.D., Ph.D.;
Hillary Mulder, M.S.; Daniel Wodjyla, M.S.; Sephy Philip, RPh,
PharmD; Craig Granowitz, M.D., Ph.D.; Eric D. Peterson, M.D.,
MPH.
Long-term Statin Persistence is Poor Among High-Risk Patients
with Baseline Diabetes: A Real-World Administrative Claims Analysis
of the Optum Research Database, Abstract 616-P, Embargoed Until
Monday, June 10, noon (Pacific Daylight Time),
- Peter P. Toth, M.D., Ph.D., Craig Granowitz, M.D., Ph.D.
Michael Hull, MS; Sephy Philip, RPh, PharmD.
Late-Breaking Poster
PresentationEicosapentaenoic Acid (EPA) Inhibits Human HDL
Oxidation in a Concentration-Dependent Manner at a Pharmacologic
Dose in Vitro, Abstract 612-P; Embargoed Until Saturday, June 8,
11:30 a.m. (Pacific Daylight Time) (New Concepts in Lipidology);
Monday, June 10, noon (Pacific Daylight Time) (General Poster
Session)
- Samuel, C.R. Sheratt, B.S.; R. Preston Mason Ph.D.
About Amarin
Amarin 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.
More About REDUCE-IT
REDUCE-IT3, 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). Fifty-nine
percent 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 Disease
Worldwide, cardiovascular disease (CVD) remains the No. 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)
Capsules
Vascepa (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.
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
Medicine3 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.
Vascepa has been approved for use by the United States Food and
Drug Administration (FDA) as an adjunct to diet to reduce
triglyceride levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. FDA has not reviewed and opined 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 MACE. Nothing in this press
release should be construed as promoting the use of Vascepa in any
indication that has not been approved by the FDA.
Important Cautionary Information About These
Data
Further REDUCE-IT data assessment and data release could 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 several months to complete and announce. The
final evaluation by regulatory authorities of the totality of
efficacy and safety data from REDUCE-IT may 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. 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 on
ongoing communications with regulatory authorities. Amarin plans to
announce the final outcome of such regulatory reviews when
appropriate.
Recurrent event analyses for the total primary endpoint events
and for the total key secondary endpoint in REDUCE-IT as published
in the Journal of the American College of Cardiology were
conducted using a series of statistical models. These analyses were
tertiary or exploratory endpoints; most of the models used were
prespecified and one was post hoc. Each recurrent event statistical
model has inherent strengths and weaknesses, with no single model
considered definitive or outperforming the other models, and 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. Together, the REDUCE-IT recurrent event analyses
and the original primary and key secondary endpoint analyses
support the robustness of the clinical benefit of Vascepa therapy
in reducing cardiovascular risk.
Forward-Looking Statements
This press release contains forward-looking statements,
including expectations regarding FDA regulatory review, the
applicability and reliability of REDUCE-IT results, expected
outcome and timing of review elements and market dynamics for
Vascepa. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. In
addition, Amarin's ability to effectively commercialize Vascepa
will depend in part on its ability to continue to effectively
finance its business, efforts of third parties, its ability to gain
regulatory approvals, create market demand for Vascepa through
education, marketing and sales activities, to achieve market
acceptance of Vascepa, 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 the sale and
promotion of Vascepa and to maintain patent protection for Vascepa.
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 sales may not meet expectations and
related cost may increase beyond expectations; the risk that
patents may not be upheld in patent litigation and applications may
not result in issued patents sufficient to protect the Vascepa
franchise. 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
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.
References
1Fan W, Philip S., Granowitz C, Toth P, Wong N. Prevalence and
Predictors of Residual Hypertriglyceridemia According to Statin Use
in US Adults with Diabetes. Presented at the American Diabetes
Association Scientific Sessions, June 22-26, 2018, Orlando,
Florida
2 Fan W, Philip S, Granowitz C, et al. Hypertriglyceridemia in
statin-treated US adults: the National Health and Nutrition
Examination Survey. J Clin Lipidol. 2019;13(1):100-108.
3Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N
Engl J Med 2019; 380:11-22.
4Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent Ethyl
on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol 2019.
Epub ahead of print.
https://doi.org/10.1016/j.jacc.2019.02.032.
5American 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.
Amarin Contact Information
Media Inquiries: Gwen Fisher
Corporate Communications Amarin Corporation plc In U.S.: +1
(908) 325-0735 pr@amarincorp.com
Investor Inquiries: Elisabeth Schwartz Investor
Relations Amarin Corporation plc In U.S.: +1 (908)
719-1315
investor.relations@amarincorp.com
Lee M. Stern Trout Group In U.S.: +1 (646)
378-2992 lstern@troutgroup.com
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