Amarin Sponsors Multiple Scientific Presentations Scheduled for 2018 American College of Cardiology Annual Scientific Session...
February 28 2018 - 5:00AM
Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, is supporting
the presentation of four accepted scientific presentations at the
American College of Cardiology’s 67th Annual Scientific Session and
Expo in Orlando, March 10-12, 2018. These presentations, and the
underlying data and findings to be presented, were prepared in
collaboration with leading health organizations and physicians.
“Amarin is pleased to be working in partnership
with leading academic institutions and healthcare providers to
research and identify these new and important findings,” said Craig
B. Granowitz, M.D., Ph.D., senior vice president and chief medical
officer of Amarin. “Analyses of cost and disease progression of
patients with high triglycerides and other health states are
important as tens of millions of adults have cardiovascular
disease.”
Data to be presented
includes:
Poster Presentations
- Triglycerides ≥150 mg/dL Associated With Greater Risk of
Cardiovascular Events, Costs and Resource Utilization in High-Risk
Statin-Treated Patients With Controlled Low-Density Lipoprotein
Cholesterol: A Real-World Analysis. Peter P. Toth, Craig Granowitz,
Michael Hull, Djibril Liassou, Amy Anderson, Sephy
Philip
- Long-Term Renal Function Worsens in High Cardiovascular Risk
Patients With High Triglycerides and Well-Controlled Low-Density
Lipoprotein Cholesterol in a Real-World Analysis. Peter P. Toth,
Craig Granowitz, Michael Hull, Djibril Liassou, Amy Anderson, Sephy
Philip
- Increased Medical Care Costs in Patients with Statin-Controlled
Low-Density Lipoprotein Cholesterol and Residual
Hypertriglyceridemia. Gregory A. Nichols, Sephy Philip, Craig
Granowitz, Kristi Reynolds, Sergio Fazio, Kaiser Permanente Center
for Health Research, Portland, OR, USA
- Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) Reduces
Potentially Atherogenic Lipid, Lipoprotein, Apolipoprotein, and
Inflammatory Parameters in High-Risk, Statin-Treated Patients With
Persistent Elevated Triglycerides and High-Sensitivity C-reactive
Protein: A Post hoc Subanalysis of the ANCHOR Study. Michael
Miller, Christie M. Ballantyne, Harold E. Bays, Craig Granowitz,
Ralph T. Doyle, Jr, Rebecca A. Juliano, Sephy Philip
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. 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.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements about the future promotion and
commercialization plans for Vascepa; expectations regarding future
Vascepa sales and resulting revenue and company expenses for 2018
and inclusive quarterly periods; expectations related to multiple
elements of Amarin's 2018 financial outlook such as anticipated
expenses, cash balances and financing needs under various
scenarios; expectations for continued event rates, timing of last
patient visits, results and related announcement timing associated
with Amarin's REDUCE-IT cardiovascular outcomes study; expectations
related to the successful completion of REDUCE-IT; and statements
regarding the potential efficacy, safety and therapeutic benefits
of Vascepa, regulatory reviews and approvals of Vascepa
internationally and related commercial potential. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. In particular, as
disclosed in its previous filings with the U.S. Securities and
Exchange Commission, Amarin's ability to effectively commercialize
Vascepa will depend in part on efforts of third parties, its
ability to create market demand for Vascepa through education,
marketing and sales activities, to achieve market acceptance of
Vascepa in new and current uses, 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
continue to effectively finance its business, 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 related cost may increase beyond expectations; the risk
that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for intended uses; the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents sufficient to protect
the Vascepa franchise. 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.
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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