Vascepa® (Icosapent Ethyl) Showed Reductions in Potentially Atherogenic Lipid Parameters in Statin-Treated Women With Type 2...
June 12 2017 - 7:00AM
Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, announced two
EPA-related data presentations unveiled this week at the American
Diabetes Association® 77th Scientific Sessions in San Diego, CA.
- A post-hoc analysis of the ANCHOR study further characterizing
the efficacy and safety of prescription pure EPA Vascepa®
(icosapent ethyl) in the subgroup of statin-treated women with
persistent high triglycerides and diabetes mellitus type 2, showed
that, compared with placebo, Vascepa reduced triglyceride levels
and several other potentially atherogenic lipid parameters and
inflammatory markers, and significantly increased blood EPA levels.
The study titled, “Icosapent Ethyl in Statin-Treated Women with
Persistent High Triglycerides and Diabetes Mellitus: ANCHOR Study
Subanalysis,” was led by Eliot A. Brinton, MD, FAHA, FNLA.
- An in vitro mechanistic study suggesting that EPA may be a
potential strategy for reducing blood vessel cell dysfunction is
summarized in a published presentation, “Eicosapentaenoic Acid
Reduces Small Dense Low-Density Lipoprotein Oxidation and Human
Endothelial Dysfunction in Vitro in a Manner Distinct from
Docosahexaenoic Acid,” by R. Preston Mason, PhD. The data
demonstrated that EPA has antioxidant properties, distinct from
DHA, that preserves certain cellular functions within blood vessel
cells under disease-like conditions.
“Amarin continues to invest in research into the management of
lipid disorders and patients at high risk of cardiovascular
disease,” expressed Eliot A. Brinton, MD. “The post-hoc analysis of
ANCHOR study data explores the potential benefits and side effects
of a therapy for women with diabetes that could help improve
patient care.” Amarin's ANCHOR trial was a 12-week trial that
studied the effects of Vascepa in adult patients at high risk for
cardiovascular disease with persistent high triglyceride levels
(≥200 mg/dL and < 500 mg/dL) after stable statin therapy.
The ANCHOR study analysis was conducted in light of the
correlation between elevated triglycerides and diabetes in women.
The Centers for Disease Prevention and Control has indicated that
without major changes in our diet and lifestyle, as many as 1 in 3
US adults could have diabetes by 2050. Analysis of study data on
women with diabetes is particularly important, since women have
often been underrepresented in clinical trials of patients with
diabetes.
As is typical with subgroup analyses, limitations of the ANCHOR
data analysis include the relatively small sample size (n=146), the
12-week study length and the post-hoc study design. Nonetheless,
the results show potentially valuable changes in triglyceride
levels and other lipoprotein parameters and inflammatory markers
with Vascepa compared with placebo. The efficacy and safety of
Vascepa 4 g/day in women were consistent with the overall ANCHOR
study results. Limitations of the mechanistic study data include
the simplistic and hypothesis-generating nature of in vitro
data.
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 (200-499 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. Amarin
recently announced that the REDUCE-IT study reached the onset of
approximately 80% of the target aggregate number of primary
cardiovascular events and that preparations are underway for an
associated pre-specified interim efficacy analysis by the
independent Data Monitoring Committee of REDUCE-IT. This
analysis is expected to occur before the end of Q3 2017. Amarin
expects that the trial will run to completion and that the onset of
the target final primary cardiovascular event will likely be
reached near the end of 2017.
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.
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. VASCEPA is under various stages of
development for potential use in other indications that have not
been approved by the FDA. 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 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 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
generally with retrospective subset analyses, research on
biomarkers thought to be relevant in the treatment of
cardiovascular disease, research and development and clinical trial
risk generally, including the risk that study results in small
sample sizes may not be predictive of future results in larger
studies and that studied parameters may not have clinically
meaningful effect. 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 we communicate with our
investors and the public using our company website
(www.amarincorp.com), our 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 we post on these channels and
websites could be deemed to be material information. As a
result, we encourage investors, the media, and others interested in
Amarin to review the information that we post on these channels,
including our investor relations website, on a regular basis.
This list of channels may be updated from time to time on our
investor relations website and may include social media
channels. The contents of our website or these channels, or
any other website that may be accessed from our 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) 378-2992
lstern@troutgroup.com
Media Inquiries:
Ovidio Torres
Finn Partners
In U.S.: +1 (312) 329 3911
Ovidio.torres@finnpartners.com
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