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
three scientific presentations this week at the American Diabetes
Association (ADA) Scientific Sessions in Orlando, FL, June 22-26,
2018. These analyses highlight the need for further research in
patients with diabetes mellitus and elevated or high triglyceride
(TG) levels despite statin therapy due to the association with
increased cardiovascular disease (CVD) risk.
The poster titled “Diabetes Mellitus and High
Triglycerides Are Significant Predictors of Major Cardiovascular
Events and Increased Health Care Costs and Resource Utilization: A
Real-World Analysis of High-Risk Statin-Treated Patients” studied
patients with diabetes mellitus and atherosclerotic cardiovascular
disease (ASCVD). Groups were segmented into people with high TGs
(200–499 mg/dL, n=13,411), as compared to a cohort with normal TGs
(<150 mg/dL) and high-density lipoprotein cholesterol (HDL-C)
>40 mg/dL (n=32,506). The analysis showed that patients with
high TGs were at a 35% increased risk of having an initial major CV
event per unit time. Diabetes mellitus was also found to be a
significant predictor of CV events, costs, and risk of inpatient
hospital stay. This poster was authored by Peter P. Toth, MD, PhD,
CGH Medical Center, Sterling, IL; Craig Granowitz, MD, PhD, Amarin
Pharma, Inc., Bedminster, NJ; Michael Hull, MS, Optum, Eden
Prairie, MN; Sephy Philip, RPh, PharmD, Amarin Pharma, Inc.,
Bedminster, NJ.
The poster titled “Increased Cardiovascular Risk
in Patients with Diabetes, Statin-Controlled LDL Cholesterol and
Residual Hypertriglyceridemia” reported data from electronic health
records of the Kaiser Permanente Northwest and Southern California
regions. The patients selected had a diagnosis of type 2 diabetes
and a prior diagnosis of myocardial infarction, ischemic stroke,
peripheral artery disease or at least one other CV risk factor, and
were on statin therapy with LDL-C between 40-100 mg/dL. Patients
were grouped into high (200-499 mg/dL, n=5,542) or normal (<150
mg/dL, n=22,411) TG and followed for a mean of five years. After
statistical adjustment for known CV risk factors, patients in the
high TG group had a 34% increased risk of non-fatal myocardial
infarction, a 25% increased risk of non-fatal stroke, a 60%
increased risk of hospitalization due to unstable angina, and a 30%
increased risk of coronary revascularization. This posted was
authored by Gregory A. Nichols, PhD, Kaiser Permanente Northwest
Center for Health Research, Portland, OR; Sephy Philip, RPh,
PharmD, Craig B. Granowitz, MD, PhD, Amarin Pharma, Inc.,
Bedminster, NJ; Kristi Reynolds, PhD, MPH, Kaiser Permanente
Southern California, Pasadena, CA; Sergio Fazio, MD, PhD, Oregon
Health & Science University, Portland, OR.
The research in the oral presentation titled
“Prevalence and Predictors of Residual Hypertriglyceridemia
According to Statin Use in US Adults with Diabetes” reported that
elevated and high TG levels remain common in more than one-third
(approximately 10 million) of US adults with diabetes mellitus,
even among statin users with well-controlled low-density
lipoprotein cholesterol (LDL-C) levels. A limitation of this study
was that information on statin dosage, duration, or adherence was
not available. This presentation was authored by Wenjun Fan, MD,
MS, Heart Disease Prevention Program, Division of Cardiology,
University of California, Irvine School of Medicine, Division of
Cardiology; Sephy Philip, RPh, PharmD, Craig Granowitz MD, PhD,
Amarin Pharma, Inc., Bedminster, NJ; Peter P. Toth, MD, PhD, CGH
Medical Center, Sterling, IL; Nathan D. Wong, PhD, Heart Disease
Prevention Program, Division of Cardiology, University of
California, Irvine School of Medicine.
“The medical community should take note of these
important findings reporting the prevalence and increased costs
associated with diabetes mellitus and high triglyceride levels
despite statin therapy,” said Nathan Wong, PhD, of the University
of California, Irvine. “REDUCE-IT, a potentially landmark CV
outcomes study of over 8,000 patients, is the first global study to
assess a medical intervention in this patient group. I look forward
to learning the results of this 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 pure EPA
(eicosapentaenoic acid) and 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™. The REDUCE-IT
cardiovascular outcomes study, a multi-national, 8,175-patient
study which commenced in 2011. REDUCE-IT is a
first-of-its-kind cardiovascular outcomes study evaluating the
effect of prescription pure EPA therapy as an add-on to statin
therapy in patients with high cardiovascular risk who have elevated
TG 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. Notably, the REDUCE-IT trial is an
event-driven CV outcomes study and is not designed to validate the
effect of lowering triglycerides. REDUCE-IT 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 pure 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 relevance of
elevated triglyceride levels to cardiovascular risk and clinical
outcomes and on the healthcare system as well as statements
concerning the REDUCE-IT cardiovascular outcomes study such as the
anticipated inclusion of certain patient populations, related
timing and announcements with respect to final outcomes and the
anticipated successful completion of the REDUCE-IT study. 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
research on biomarkers thought to be relevant in the treatment of
cardiovascular disease, healthcare costs and clinical trial risk,
that studied parameters may not have clinically meaningful effect
and the risk that patents may not adequately protect Vascepa
against competition. 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 quarterly report
on Form 10-Q. 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)
378-2992lstern@troutgroup.com
Media Inquiries: Kristie Kuhl Finn Partners
In U.S.: +1 (212) 583-2791 Kristie.kuhl@finnpartners.com
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