Amarin Corporation plc (NASDAQ:AMRN), today announced that data
presented by Deepak L. Bhatt, M.D., M.P.H., Executive Director of
Interventional Cardiovascular Programs at Brigham and Women’s
Hospital and Professor of Medicine at Harvard Medical School, at
the American College of Cardiology’s 69th Annual Scientific Session
Together With World Congress of Cardiology (ACC.20/WCC),
demonstrated that on-treatment serum EPA levels from VASCEPA®
(icosapent ethyl), administered at 4 g/day, strongly correlated
with reductions in cardiovascular events in the REDUCE-IT® study.
As part of a prespecified analysis, serum EPA,
DHA (docosahexaenoic acid,) and other biomarkers were measured at
baseline and across several visits. 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). 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 benefit in heart failure and total mortality with
high on-treatment EPA levels.
These analyses also suggest that achieved EPA
with 4g/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.
Biomarker analyses suggest substantially less
contribution of changes in measured lipid, lipoprotein, and
inflammatory biomarkers to the cardiovascular benefit observed in
REDUCE-IT.
“Following the approval of icosapent ethyl as an
adjunct to maximally tolerated statin therapy for a broad range of
patients at risk for cardiovascular disease, a common question from
physicians has been, what is the mechanism behind the large
reductions in cardiovascular events such as heart attacks and
strokes seen in REDUCE-IT?” commented Deepak L. Bhatt, M.D.,
M.P.H., lead investigator of the REDUCE-IT trial. “Now we see that
the benefits appear to be driven primarily by on-treatment EPA
levels with icosapent ethyl, whereas changes in triglycerides
levels and other cardiovascular risk markers, including LDL, HDL,
apoB and CRP, appear to be responsible for a significantly lesser
proportion of the overall observed benefits.”
Importantly, REDUCE-IT administered an ethyl
ester form of EPA. Until the complexities of different chemical
forms of EPA are better understood, the benefits of icosapent ethyl
in REDUCE-IT cannot be assumed to apply to EPA levels achieved by
other chemical compositions.
“This analysis was conducted to better
understand the impact of serum EPA levels as delivered through
pure, stable, prescription VASCEPA and provides additional insight
into the unprecedented results seen in REDUCE-IT,” said Craig
Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief
medical officer. “These findings further enhance our understanding
that results achieved with VASCEPA in the REDUCE-IT study cannot be
extrapolated to other agents that continue to be routinely used to
reduce cardiovascular risk, despite not having outcomes data nor
being FDA approved for this use. Such agents include
fibrates, niacin, DHA-containing omega-3 prescription products, or
‘fish oil dietary supplements.’”
Slides from the presentation are available at
virtual.acc.org.
Audio Webcast Information:
Amarin will host an audio webcast March 30,
2020, at 5:30 p.m. ET to discuss this information. The webcast can
be heard live on the investor relations section of the company's
website at www.amarincorp.com, or via telephone by dialing
877-407-8033 within the United States, 201-689-8033 from outside
the United States, or by using the call back feature at
https://bit.ly/2VKMnt1. A replay of the call will be made available
for a period of two weeks following the conference call. To hear a
replay of the call, dial 877-481-4010, PIN: 33498. A replay of the
call will also be available through the Company's website 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 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
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
About REDUCE-IT®
REDUCE-IT is a global cardiovascular outcomes
study, which was designed to prospectively evaluate the effect of
Vascepa in adult patients with LDL-C controlled to between 41-100
mg/dL (median baseline 75 mg/dL) by statin therapy and various
cardiovascular risk factors including persistent elevated
triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and
either established cardiovascular disease (secondary prevention
cohort) or diabetes mellitus and at least one other cardiovascular
risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and
completed in 2018, followed 8,179 patients at over 400 clinical
sites in 11 countries with the largest number of sites located
within the United States. REDUCE-IT was conducted based on a
special protocol assessment agreement with FDA. The design of the
REDUCE-IT study was published in March 2017 in Clinical Cardiology8
and can be found in the R&D section on the company’s website at
www.amarincorp.com. The primary results of REDUCE-IT were published
in The New England Journal of Medicine in November 2018.9
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 |
VASCEPA vs Placebo |
N = 4089 n (%) |
Incidence Rate (per 100 patient years) |
N = 4090 n (%) |
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.
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;118:547-563.8 Bhatt DL, Steg PG, Brinton E, et
al. Rationale and Sesign of REDUCE‐IT: Reduction of Cardiovascular
Events with Icosapent Ethyl–Intervention Trial. Clinical
Cardiology, 15 March 2017.9 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
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