Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, announced that new data
showing the reduction in total major adverse cardiovascular (i.e.,
ischemic) events shown in the landmark REDUCE-IT™ cardiovascular
outcomes trial has been accepted for presentation as late breaking
clinical trial data at the American College of Cardiology’s (ACC)
68th Annual Scientific Session on March 18, 2019 in New Orleans,
LA.
The presentation is planned for 9:00 to 9:10 am Central Time in
the Main Tent (Great Hall). The final presentation time will be
available here:
https://www.abstractsonline.com/pp8/#!/5758/presentation/57960.
These late-breaking clinical trial results have been characterized
by ACC as practice-changing cardiovascular research. These data
reflect important clinical findings beyond the positive primary
results of the study released in November 2018.
REDUCE-IT1, 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, or any triglyceride
lowering therapy, as an add-on to statins in patients with high
cardiovascular risk who, despite stable statin therapy, had
elevated triglyceride levels (135-499 mg/dL). A large portion of
the male and female patients enrolled in this outcomes study were
diagnosed with type 2 diabetes.
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 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 uncertainties associated with
clinical research. 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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