Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular (CV) health, announced
the presentation of two posters this week at the National Kidney
Foundation 2018 Spring Clinical Meetings in Austin, TX, April
10-14, 2018. These analyses highlight the need for further research
in patients with reduced kidney function in conjunction with
diabetes mellitus or ongoing inflammation, as denoted by elevated
high sensitivity C-reactive protein (hsCRP) levels, and persistent
high triglycerides (TG) despite statin therapy due to the
association with increased cardiovascular disease (CVD) risk.
The poster titled “Icosapent Ethyl Reduces
Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk
Statin-Treated Patients With Persistent High Triglycerides, eGFR
<90 mL/min/1.73 m2, and Diabetes Mellitus” showed that,
consistent with overall ANCHOR study results, compared with
placebo, icosapent ethyl (IPE) 4g/day significantly decreased the
primary endpoint of triglycerides (TG) (−19.7%; P<0.0001) and
other lipids without increasing LDL-C. Apolipoproteins and markers
of oxidation and inflammation were significantly improved. This
poster was authored by: Harold M. Szerlip, MD, Baylor University
Medical Center Dallas, TX; Krishnaswami Vijayaraghavan, MD, Abrazo
Arizona Heart Hospital, Phoenix, AZ; Christie M. Ballantyne, MD,
Baylor College of Medicine and the Houston Methodist DeBakey Heart
and Vascular Center, Houston, TX; Harold E. Bays, MD, Louisville
Metabolic and Atherosclerosis Research Center, Louisville, KY;
Craig Granowitz, MD, PhD, Ralph T Doyle, Rebecca A. Juliano, PhD,
& Sephy Philip, RPh, PharmD, Amarin Pharma, Inc., Bedminster,
NJ.
The poster titled “Icosapent Ethyl Reduces
Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk
Statin-Treated Patients With Persistent High Triglycerides, eGFR
<90 mL/min/1.73 m2, and Elevated High-Sensitivity C-Reactive
Protein ≥2.0 mg/L” showed that, consistent with overall ANCHOR
study results, in statin-treated patients with reduced kidney
function and elevated high-sensitivity C-reactive protein (hsCRP)
with persistent high TG, IPE 4g/day reduced TG and other
potentially atherogenic and inflammatory markers without raising
low-density cholesterol vs. placebo. This poster was authored by:
Krishnaswami Vijayaraghavan, MD, Abrazo Arizona Heart Hospital,
Phoenix, AZ; Harold M. Szerlip, MD, Baylor University Medical
Center Dallas, TX; Christie M. Ballantyne, MD, Baylor College of
Medicine and the Houston Methodist DeBakey Heart and Vascular
Center, Houston, TX; John R. Nelson, MD, California Cardiovascular
Institute, Fresno, CA; Craig Granowitz, MD, PhD, Ralph T Doyle,
Rebecca A. Juliano, PhD, & Sephy Philip, RPh, PharmD, Amarin
Pharma, Inc., Bedminster, NJ.
Both posters reported data from post hoc
analyses in statin-treated patients with reduced kidney function
and diabetes or elevated hsCRP with persistent high (200-499 mg/dL)
TG. In these patients, prescription pure EPA Vascepa® at
4g/day, compared to placebo, showed reductions in TG and other
potentially atherogenic lipid and inflammatory markers.
“More research is needed in elucidating future
CV risk in patients with reduced kidney function and high
triglycerides despite statin therapy,” said Harold M.
Szerlip, MD. “The REDUCE-IT trial will enroll some patients
with characteristics presented in these posters to determine if
intervention with high dose, prescription pure EPA will reduce CV
events in statin-treated patients with persistent
hypertriglyceridemia. I look forward to learning the results of
this important study.”
About AmarinAmarin Corporation
plc is a biopharmaceutical company focused on the commercialization
and development of therapeutics to improve cardiovascular
health. Amarin's product development program leverages its
extensive experience in lipid science and the potential therapeutic
benefits of polyunsaturated fatty acids. Vascepa® (icosapent
ethyl), Amarin's first FDA-approved product, is a highly-pure,
omega-3 fatty acid product available by prescription. For
more information about Vascepa visit www.vascepa.com. For
more information about Amarin visit www.amarincorp.com.
About REDUCE-IT
Amarin's clinical development program for
Vascepa includes a trial known as the REDUCE-IT cardiovascular
outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT
is the first multinational cardiovascular outcomes study evaluating
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, have
elevated triglyceride levels (150-499 mg/dL). A large portion of
the male and female patients enrolled in this outcomes study are
anticipated to also be diagnosed with type 2 diabetes. As reported
previously, Amarin expects to announce top-line results of this
important study before the end of Q3 2018. The REDUCE-IT
trial is being conducted under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of
Vascepa can be found at www.clinicaltrials.gov.
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. 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.
FDA-Approved Indication and Usage
- 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
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- 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.
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
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.
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.1,
2
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. 3, 4, 5, 6
Leading clinical investigations seeking to
address cardiovascular risk reduction beyond lowering LDL-C focus
on interrupting the atherosclerotic process (e.g., plaque formation
and instability) by beneficially affecting other lipid, lipoprotein
and inflammation biomarkers and cellular functions thought to be
related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements about the potential efficacy and
therapeutic benefits of Vascepa and EPA, including implications
about the potential clinical importance of the findings presented
as well as statements concerning the REDUCE-IT cardiovascular
outcomes study. These statements are not promises or guarantees
related to the potential for favorable outcomes from the ongoing
REDUCE-IT cardiovascular outcomes trial. As disclosed in filings
with the U.S. Securities and Exchange Commission, Amarin's ability
to effectively develop and commercialize Vascepa will depend in
part on its ability to continue to effectively finance its
business, efforts of third parties, its ability to create market
demand for Vascepa through education, marketing and sales
activities, to achieve increased market acceptance of Vascepa, to
receive adequate levels of reimbursement from third-party payers,
to develop and maintain a consistent source of commercial supply at
a competitive price, to comply with legal and regulatory
requirements in connection with the sale and promotion of Vascepa
and to maintain patent protection for Vascepa. 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 future legal
determinations and interactions with regulatory authorities may
impact Vascepa marketing and sales rights and efforts; the risk
that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for cardiovascular risk
reduction; and the risk that patents may not be upheld in
anticipated patent litigation. 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 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update.
2 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.
3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
4 Toth PP, Granowitz C, Hull M, et al. High triglycerides
increase cardiovascular events, medical costs, and resource
utilization in a real-world analysis of statin-treated patients
with high cardiovascular risk and well-controlled low-density
lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl
1):A15187.
5 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
6 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular
disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:Elisabeth Schwartz Investor
Relations and Corporate Communications Amarin Corporation plc
In U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com
Lee M. Stern Trout Group In U.S.: +1 (646) 378-2992
lstern@troutgroup.com Media Inquiries: Kristie Kuhl Finn Partners
In U.S.: +1 (212) 583-2791 Kristie.kuhl@finnpartners.com
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