Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, announced data
analysis orally presented today at the American Heart Association
(AHA) 2017 Scientific Sessions in Anaheim, California. The oral
presentation used real world evidence (RWE) as a basis for the
analysis. This analysis of RWE is separate from and
independent of the RWE analysis referenced in Amarin’s press
release on November 12, 2017.
The oral presentation, “Increased Cardiovascular
Risk in Patients with Statin-Controlled LDL Cholesterol and
Residual Hypertriglyceridemia,” was done in collaboration with
Gregory A. Nichols, PhD, from Kaiser Permanente Center for Health
Research, and Sergio Fazio, MD, PhD, Director, Center for
Preventive Cardiology, Oregon Health & Science
University, Portland, OR. The study analyzed data from the
Southern California and Northwest regions of Kaiser Permanente, one
of America’s leading health care providers and not-for-profit
health plans. The patients selected had a diagnosis of
atherosclerotic cardiovascular disease (ASCVD: myocardial
infarction [MI], ischemic stroke, and peripheral artery disease)
and had statin-controlled LDL cholesterol (LDL-C). The study
concluded that during the study period, despite statin-controlled
LDL-C levels, ASCVD events were greater among patients with ASCVD
and high (200-499 mg/dL, n=2,361) vs. normal (<150 mg/dL,
n=14,454) triglyceride (TG) levels.
Over an average follow-up of 4.2 years,
statin-treated ASCVD patients with persistent high TGs, as compared
with the statin-treated normal TG group, were at increased risk of
cardiovascular outcomes after multivariable adjustment as
follows:
- 30% increased risk for myocardial infarction (95% CI
1.05-1.61)
- 30% increased risk for coronary revascularization (95% CI
1.08-1.57)
- 13% increased risk for the composite outcome (95% CI
1.02-1.26)
Composite outcome = nonfatal MI, nonfatal
stroke, coronary revascularization, unstable angina, or all-cause
mortality
Risk of all-cause mortality, which was the
largest contributor to the composite outcome, was similar between
TG groups. This study analyzed health data of real-world patients
and was not a prospective analysis of medical intervention.
Mortality attributable to cardiovascular conditions was not
evaluated separately from all-cause mortality for either of the TG
groups.
The study authors were Gregory A. Nichols,
Kaiser Permanente Northwest Center for Health Research, Portland,
OR; Sephy Philip, Craig B. Granowitz, Amarin Pharma, Inc,
Bedminster, NJ; Kristi Reynolds, Kaiser Permanente Southern
California, Pasadena, CA; Sergio Fazio, Oregon Health & Science
University, Portland, OR.
Gregory A. Nichols, PhD, stated, “The
collaborative efforts between Kaiser, Amarin, and Dr. Fazio enabled
data analysis to determine the cardiovascular risk profile of a
cohort of patients with high triglyceride levels despite statin
therapy. This patient risk profile, which may affect millions of
patients, has not been previously described in a real-world
dataset.”
Sergio Fazio, MD, PhD, stated, “These results
support long established knowledge that statin-treated patients
with persistent high TG levels in combination with other risk
factors remain at elevated risk of future cardiovascular events.
The REDUCE-IT trial should provide important information about the
effects, if any, of prescription EPA as an add-on to statins in
patients with high cardiovascular risk who, despite stable statin
therapy and LDL-C at target goal, have triglyceride levels in the
range 150-499 mg/dL at baseline.”
Potential limitations of this real-world data
include the observational, retrospective nature of the study which
can add to uncertainty regarding findings as compared to
prospectively collected data, the potential for inaccurate
recording of health events in the database and missing data which
may limit the usefulness of the findings. A biomarker such as
triglycerides may not be causally related to the clinical event as
supposed.
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 that the onset of the target final
primary cardiovascular event will be reached before the end of Q1
2018, with results announced before the end of Q3 2018.
Additional information on clinical studies of
Vascepa can be found at www.clinicaltrials.gov.
About Amarin
Amarin 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. Amarin's clinical program includes a
commitment to an ongoing outcomes study. 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 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 is known in scientific literature as
AMR101. 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.
Forward-looking statements
This press release contains statements related
to scientific presentations from real-world evidence and other
studies. 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
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 (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.
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: Ovidio Torres
Finn Partners In U.S.: +1 (312) 329-3911
Ovidio.torres@finnpartners.com
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