Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, announced an
oral presentation titled, “Icosapent Ethyl Reduces Potentially
Atherogenic Lipid and Inflammatory Markers in High-Risk
Statin-Treated Patients With Stage 3 Chronic Kidney Disease and
Persistent High Triglycerides.” This oral presentation was held at
the American Heart Association (AHA) 2017 Scientific Sessions in
Anaheim, California.
Patients with stage 3 chronic kidney disease
(CKD) and persistent high triglycerides (TG) despite statin therapy
have a high risk of cardiovascular disease (CVD). The presentation
of additional data from the phase 3 ANCHOR study of Vascepa®
(icosapent ethyl) showed, in a post hoc analysis, that consistent
with overall study results, Vascepa® 4 g/day (n=18) reduced
potentially atherogenic lipid and inflammatory markers without
raising LDL-C, and with a safety profile similar to placebo (n=35)
in patients with CKD. These hypothesis-generating data warrant
further prospective study to determine the clinical benefit of
Vascepa, if any, as an adjunct to statin therapy in patients with
CKD. The ongoing CVD outcomes trial with prescription, high-dose (4
grams/day) of icosapent ethyl in addition to statin therapy,
REDUCE-IT, while not designed specifically to evaluate CVD outcomes
in CKD patients, is expected to include some patients with CKD.
The authors of this presentation were
Krishnaswami Vijayaraghavan (Kris Vijay), Scottsdale Cardiovascular
Center, Scottsdale, AZ; Harold M. Szerlip, Baylor University
Medical Center Dallas, TX; Christie M Ballantyne, Baylor College of
Medicine and the Houston Methodist DeBakey Heart and Vascular
Center, Houston, TX; Harold E. Bays, Louisville Metabolic and
Atherosclerosis Research Center Louisville, KY; Sephy Philip, Ralph
T. Doyle Jr, Rebecca A. Juliano, Craig Granowitz, Amarin Pharma,
Inc., Bedminster, NJ.
“Amarin continues to delve into the potential
dangers of cardiovascular disease,” articulated Kris Vijay, MD. “We
estimate that over 30 million people or fifteen percent of US
adults have CKD1, therefore, much more research is needed in this
area. We look forward to the REDUCE-IT results to provide further
data in patients with CKD.”
As is typical with subgroup analyses, a
limitation of this ANCHOR dataset analysis includes the post-hoc
sub-analysis and relatively small sample sizes. Nonetheless, the
results show potentially important changes in triglyceride levels
and other potentially atherogenic lipid and inflammatory markers
with Vascepa compared with placebo. The efficacy and safety of
Vascepa 4 g/day in patients with Stage 3 CKD and persistent high
triglycerides were consistent with the overall ANCHOR study
results.
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
previously reported, Amarin expects that the onset of the target
final primary cardiovascular event will be reached in Q1 2018, with
results announced in Q2 or 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 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
such as the anticipated inclusion of certain patient populations,
related timing and announcements with respect to the onset of the
target final primary cardiovascular event and 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
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, 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
(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 https://www.cdc.gov/diabetes/pubs/pdf/kidney_factsheet.pdf
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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