Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, announced today that
real-world data reported by the U.S. Veteran’s Administration
supports that patients with elevated triglyceride (TG) levels,
despite statin therapy, had a significant 19% relative risk
increase in a composite of cardiovascular events during a follow-up
period of up to five years. These findings are consistent with
previous observational, real-world, epidemiological, and genetic
data that have consistently found an association between elevated
TG levels and major adverse cardiovascular events.
These findings, in a poster titled, “Increased
Residual Cardiovascular Risk in US Veterans with
Moderately-Elevated Baseline Triglycerides and Well-Controlled
LDL-C Levels on Statins,” were presented at the American College of
Cardiology’s (ACC) 68th Annual Scientific Session today, March 18,
2019 in New Orleans, LA.
This research examined over 400,000 veterans,
30% of whom had elevated triglyceride levels. The data reported
that those with elevated TG levels (150-500 mg/dL) showed a
statistically significant 19% relative increase in cardiovascular
(CV) events comprised of nonfatal heart attack, nonfatal stroke,
unstable angina, and coronary revascularization despite
well-controlled LDL-C on statin therapy with adjustment for other
CV risk factors when compared with veterans whose baseline TG was
<150 mg/dL. Cardiovascular death was not included as an endpoint
for this analysis as the data was not readily available in this
database.
This poster was authored by Sarah Leatherman,
Ryan E. Ferguson, Isabelle R. Weir, Cynthia Hau, Craig B.
Granowitz, Kelly Harrington, Sephy Philip, Peter P. Toth, Deepak L.
Bhatt, and William E. Boden.
“These data highlight the high rate of
cardiovascular events in people with elevated triglyceride levels,”
said Craig B. Granowitz, M.D., Ph.D., senior vice president and
chief medical officer of Amarin. “Real-world data continues to
support that elevated triglycerides are a marker of cardiovascular
risk, separate from management of LDL-C and other risk
factors.”
In a separate presentation today at the ACC 68th
Annual Scientific Session, additional data was reported from the
Amarin cardiovascular outcomes study of Vascepa, the REDUCE-IT
study, which demonstrated that Vascepa lowers both primary major
adverse cardiovascular events (MACE) and recurrent MACE in patients
with elevated TG levels (≥135 mg/dL) and other cardiovascular risk
factors1. While lowering TG levels alone have not been demonstrated
to lower cardiovascular risk, the REDUCE-IT study demonstrated that
in patients with high levels of cardiovascular risk despite statin
therapy, as identified by having elevated triglyceride levels and
other risk factors, Vascepa significantly lowered the first
occurrence of primary MACE by 25% and primary plus recurrent MACE
by 30%, each compared to placebo. This benefit appears to derive
from the multifactorial effects of Vascepa, a portion of which
appear to be related to lowering TG levels with the balance of the
effects likely explained by other effects of Vascepa as separately
evaluated. As summarized below, in REDUCE-IT, 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.
Amarin Investor/Analyst Conference
Call
Amarin plans to webcast live a physician panel
discussion for investors and analysts today at 4:00 p.m. CT / 5:00
p.m. ET. During the panel discussion leading physicians are
anticipated to review data pertaining to Vascepa presented at ACC’s
68th Annual Scientific Session, including the presentation today in
the late-breaker session regarding additional data from the
REDUCE-IT cardiovascular outcomes study. The panel discussion may
also cover data from the above described poster and from other
posters presented at ACC.
This physician panel discussion will commence at
the time shown above and will be accessible via webcast through the
investor relations section of the company’s website at
www.amarincorp.com. The panel discussion can also be heard via
telephone by dialing 877-407-8033. A replay of the panel discussion
will be made available for a period of two weeks following the
webcast. To hear a replay of the call, dial 877-481-4010 (inside
the United States) or 919-882-2331 (outside the United States). A
replay of the panel discussion will also be available through the
company's website shortly after the webcast. For both dial-in
numbers please use conference ID 44518.
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.
About REDUCE-IT
REDUCE-IT2, an 8,179-patient cardiovascular
outcomes study, was completed in 2018. REDUCE-IT was a
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 portion 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 #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.3,
4
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.5
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. 6, 7, 8, 9
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
Medicine1 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
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
Cardiology1 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.
Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. Further detailed data
assessment by Amarin and regulatory authorities will
continue and take several months to complete and record. The final
evaluation of the totality of the efficacy and safety data from
REDUCE-IT may include some or all of the following, as well as
other considerations: new information 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; consideration
of REDUCE-IT results in the context of other clinical studies.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements related to cardiovascular risk in
patient groups based on data presented. 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 data of this type, research and development, clinical trials
and related regulatory approvals. A list and description of
uncertainties and 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.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the investor relations
website (http://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
1 Bhatt DL, Steg PG, Miller M, et al. Effects of
Icosapent Ethyl on Total Ischemic Events – Further Insights from
REDUCE-IT. J Am Coll Cardiol 2019. epub ahead of print.
http://www.onlinejacc.org/content/early/2019/03/01/j.jacc.2019.02.032
2 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
3 American Heart Association. 2018.
Disease and Stroke Statistics-2018 Update.
4 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.
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 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations:Elisabeth SchwartzInvestor
Relations and Corporate CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 719-1315investor.relations@amarincorp.com
(investor inquiries)PR@amarincorp.com (media inquiries)
Lee M. Stern Trout Group In U.S.: +1
(646) 378-2992lstern@troutgroup.com
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