Multiple Scientific Presentations Scheduled
for American College of Cardiology’s 68th
Annual Scientific Session
Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, is supporting the
presentation of six accepted scientific presentations at the
American College of Cardiology’s (ACC) 68th Annual Scientific
Session from March 16-18, 2019 in New Orleans, LA.
An Amarin investor/analyst conference call to
discuss the presented data, including data from the late-breaker
presentation, will be held on Monday, March 18 at 4:00 p.m. Central
Time (CT) / 5:00 p.m. Eastern Time (ET) with several prominent
physicians.
“Amarin remains committed to generating
important new information about the epidemiology and treatment of
patients with residual cardiovascular risk beyond LDL-C management
to advance the medical community’s understanding of relevant
factors to improve patient care,” said Craig B. Granowitz, M.D.,
Ph.D., senior vice president and chief medical officer of Amarin.
“The accepted ACC presentations sponsored by Amarin are a further
demonstration of Amarin’s leadership in this area.”
Data to be presented
includes:
Late-Breaking Clinical
Trial
- Reduction in Total Ischemic Events with Icosapent Ethyl in
REDUCE-IT™. Deepak L. Bhatt, Philippe Steg, Michael Miller, Eliot
Brinton, Terry Jacobson, Steven Ketchum, Ralph Doyle, Rebecca
Juliano, Lixia Jiao, Craig Granowitz, Jean Claude Tardif, John
Gregson, Stuart Pocock, and Christie Ballantyne, for the REDUCE-IT
InvestigatorsOriginal Presentation 409-16. March 18, 9:00 to 9:10
am Central Time (CT) in the Main Tent (Great Hall)Follow-up, Deep
Dive II Presentation 412-16. March 18, 1:30 to 1:35pm Central Time
(CT) in Room La Nouvelle C
Poster Presentations
- Eicosapentaenoic Acid Inhibits Membrane Lipid Oxidation in a
Concentration-Dependent Manner at Pharmacologic Doses In Vitro. R.
Preston Mason, and Samuel C. R. SherrattPresentation 1180-452 /
452. March 16, 3:45 PM - 4:30 PM CT in Poster Hall F
- Burden of Atherosclerotic Cardiovascular Disease Risk in
Persons with Elevated Triglyceride Levels According to Statin Use.
Nathan D. Wong, Wenjun Fan, Sephy Philip, Craig Granowitz, and
Peter TothPresentation 1178-417 / 417. March 16, 3:45 PM - 4:30 PM
CT in Poster Hall F
- Long-term Statin Persistence Is Poor Among High-Risk Patients
with Baseline Peripheral Artery Disease: A Real-World
Administrative Claims Analysis of the Optum Research Database.
Peter P. Toth, Craig Granowitz, Michael Hull, and Sephy
PhilipPresentation 1134-435 / 435. March 16, 10:00 AM - 10:45 AM CT
in Poster Hall F
- Triglycerides as a Risk Factor for Coronary Heart Disease: What
Measure and What Cutoff? Ann Marie Navar, Neha Pagidipati, Hillary
Mulder, Tsion Aberra, Sephy Philip, Craig Granowitz, and Eric
PetersonPresentation 1331-414 / 414. March 18, 9:45 AM - 10:30 AM
CT in Poster Hall F
- Increased Residual Cardiovascular Risk in US Veterans and
Moderately-Elevated Baseline Triglycerides and Well-Controlled
LDL-C Levels on Statins. Sarah Leatherman, Ryan Ferguson, Isabelle
Weir, Cynthia Hau, Craig Granowitz, Kelly Harrington, Sephy Philip,
Peter Toth, Deepak L. Bhatt, and William BodenPresentation 1060-09.
March 18, 1:15 PM - 1:25 PM CT in Prevention Moderated Poster
Theater Poster Hall F
Amarin Investor/Analyst Conference
Call
Amarin plans to hold a call on Monday, March 18
at 4:00 p.m. Central Time CT / 5:00 p.m. ET for investors and
analysts to discuss the results presented in the late-breaker
session and some of the poster data presented earlier in the day.
Amarin intends to broadcast this meeting live via webcast.
This call 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 call
can also be heard via telephone by dialing 877-407-8033. 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 (inside the United States) or 919-882-2331 (outside
the United States). A replay of the call will also be available
through the company's website shortly after the call. 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-IT1, 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.2,
3
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.4
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. 5, 6, 7, 8
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.
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. 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.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements related to timing and
announcements with respect to the subject clinical data. 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 approvals; 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. The
American College of Cardiology reserves the right to change or
rescind its invitation to present any and all clinical trial
results. 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.
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, Brinton EA,
Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C,
Tardif JC, Ballantyne CM. Cardiovascular Risk Reduction with
Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med
2019;380:11-22.2 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update.3 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.4 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 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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