Amarin Corporation plc (NASDAQ:AMRN), today announced that eight
presentations, including one Late-Breaking Science presentation and
seven poster presentations, relevant to VASCEPA® (icosapent ethyl)
and persistent cardiovascular risk (P-CVR), will be presented at
the American College of Cardiology’s 69th Annual Scientific Session
Together With World Congress of Cardiology (ACC.20/WCC), between
March 28-30. The presentations are from a variety of academic
collaborators based on research supported by Amarin.
“Cardiovascular disease is the leading cause of
death and the costliest disease in the U.S. today,” said Craig
Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief
medical officer. “It is of utmost importance to bring forth the
latest data on the unique aspects of VASCEPA and the role it can
play in helping to alleviate burdens of persistent cardiovascular
risk in appropriate patients. Several of the scheduled
presentations during ACC focus on providing further context on the
potential clinical and economic value of VASCEPA as a treatment for
the studied patient populations.”
Upcoming Late-Breaking Science
Presentation
- Session 411-14 –
Late-Breaking Clinical Trials“Eicosapentaenoic Acid Levels
in REDUCE-IT and Cardiovascular Outcomes” – presented on
behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and
Women’s Hospital – presented March 30, 11:30-11:40 a.m. Central
U.S. Time
Other Upcoming Amarin-Supported Data
Presentations
- Session 1263-090 – “REDUCE-IT
Eligibility and Preventable First and Total Cardiovascular Events
in the US Population: An Analysis of the National Health and
Nutrition Examination Survey (NHANES)” – Nathan D. Wong,
Wenjun Fan, Peter P. Toth, Craig Granowitz, Sephy Philip –
presented March 29, 10:00-10:45 a.m. Central U.S. Time
- Session 1161-128 – “Cost-effectiveness
of Icosapent Ethyl in US REDUCE-IT Patients” – William S.
Weintraub, Deepak L. Bhatt, Zugui Zhang, Cheng Zhang, Sarahfaye
Dolman, William E. Boden, P. Gabriel Steg, Michael Miller, Eliot A.
Brinton, Jordan B. King, Adam P. Bress, Terry A. Jacobson,
Jean-Claude Tardif, Christie M. Ballantyne, Paul Kolm – presented
March 28, 12:30-1:15 p.m. Central U.S. Time
- Session 1313-090 – “Residual
Cardiovascular Risk in U.S. Veterans with Moderately-Elevated
Baseline Triglycerides Across the Cardiovascular Risk
Spectrum” – Sarah Leatherman, Ryan E. Ferguson, Cynthia
Hau, Craig Granowitz, Kelly Harrington, Sephy Philip, Peter P.
Toth, Deepak L. Bhatt, William E. Boden – presented March 29,
12:30-1:15 p.m. Central U.S. Time
- Session 1212-205 – “Eicosapentaenoic
Acid Inhibits Oxidation of Very Large Density Lipoproteins (VLDL)
in a Dose-Dependent Manner over Time as Compared to Docosahexaenoic
Acid In Vitro” – R. Preston Mason, Samuel C. R. Sherratt –
presented March 28, 3:45-4:30 p.m. Central U.S. Time
- Session 1364-202 – “Eicosapentaenoic
Acid Inhibits High Density Lipoprotein (HDL) Oxidation in a
Synergistic Manner in Combination with Atorvastatin In
Vitro” – R. Preston Mason, Samuel C. R. Sherratt –
presented March 29, 3:45-4:30 p.m. Central U.S. Time
- Session 1309-177 – “Association of
Inflammatory Markers with Baseline Coronary Plaque Volumes by
Coronary Computed Tomography Angiography (CCTA) from EVAPORATE
(Effect of Vascepa on Improving Coronary Atherosclerosis in People
with High Triglycerides Taking Statin Therapy) Trial” –
Suvasini Lakshmanan, Chandana Shekar, Suraj Dahal, Afiachukwu
Onuegbu, April Kinninger, Andrew Cai, Vahid Rezvanizadeh, Ilana
Golub, Divya Birudaraju, Lavanya Cherukuri, Sajad Hamal,
Christopher Dailing, Ferdinand Flores, Sion K. Roy, John R. Nelson,
Matthew J. Budoff – presented March 29, 12:30-1:15 p.m. Central
U.S. Time
- Session 1158-161 – “Association of HDL
Subclasses with Baseline Coronary Plaque Burden By Coronary
Computed Tomography Angiography (CCTA) from EVAPORATE (Effect of
Vascepa on Improving Coronary Atherosclerosis in People with High
Triglycerides Taking Statin Therapy) Trial” – Suvasini
Lakshmanan, Chandana Shekar, Suraj Dahal, Afiachukwu Onuegbu, April
Kinninger, Andrew Cai, Divya Birudaraju, Ilana Golub, Vahid
Rezvanizadeh, Christopher Dailing, Ferdinand Flores, Sajad
Hamal, Sion K. Roy, John R. Nelson, Matthew J. Budoff – presented
March 28, 12:30-1:15 p.m. Central U.S. Time
Additional REDUCE-IT® and icosapent ethyl (EPA)-
related topics will be presented at ACC and can be found at
https://www.abstractsonline.com/pp8/#!/8992
Audio Webcast Information:
Amarin will host an audio webcast March 30,
2020, at 4:30 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 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 the use of VASCEPA to
help 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
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.
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