Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, announced
today that its REDUCE-IT cardiovascular outcomes study of Vascepa®
(icosapent ethyl) is estimated to have reached the onset of the
targeted 1,612 primary major adverse cardiovascular events (MACE)
specified in the study design. The REDUCE-IT cardiovascular
outcomes study began with patient dosing at the end of 2011. The
onset of the targeted number of cardiovascular events in REDUCE-IT
is an important milestone toward completion of this potentially
landmark study.
The estimated onset of the targeted number of
cardiovascular events in REDUCE-IT is based on documented events
having exceeded 90% of target as reported in January 2018,
subsequently reported MACE in the adjudication process, and
projected events based on standard industry methodology. The MACE
onset projection was made by independent statisticians and reviewed
by Amarin and the independent steering committee for the trial.
Each group is blinded to the study results. Amarin anticipates that
MACE from the study will be adjudicated through Q2 2018, consistent
with the company’s objective of reporting top-line results from
this important study before the end of Q3 2018.
As previously reported, completion of the
REDUCE-IT study does not require reaching exactly 1,612 MACE. The
actual number of events is likely to differ from this study design
target. The powering assumptions for the study were based on 1,612
MACE with 90% power to detect a 15% relative risk reduction.
A final cumulative MACE tally from inception date of the
study which is slightly above or below 1,612 MACE is not
anticipated to have a significant impact on the overall powering of
the study results.
Amarin maintains its guidance to report top-line
results from the study before the end of Q3 2018.
"We are excited to be nearing conclusion of this
potentially landmark cardiovascular outcomes study," commented
Dr. Steven Ketchum, president of R&D and chief scientific
officer of Amarin. "We appreciate the continued dedication of
patients participating in this important study and the continued
commitment and hard work at the clinical sites and by the many
professionals involved in study conduct and completion. We will
work diligently to rapidly roll-up and report the results of the
study in the hope that such results can lead to better informed
preventative care of patients at high cardiovascular
risk."
Amarin is intentionally blinded to the results
of the study and will remain blinded to such results until after
the study is completed and the database is locked. Final patient
visits will be followed by adjudication of newly reported
cardiovascular events in the study, completing data entry for the
greater than 33,000 patient years of study in REDUCE-IT, and
typical database quality control measures, known as cleaning.
This will be followed by the database lock and final efficacy and
safety analyses, including analysis of the trial's primary endpoint
of first MACE events in the study, and the analyses of more than
thirty pre-defined secondary and tertiary endpoints. Publication of
the study design can be found
at https://doi.org/10.1002/clc.22692. The lead author of
this paper, published in Clinical Cardiology, is Deepak
L. Bhatt, M.D., M.P.H., executive director of the Interventional
Cardiovascular Programs at Brigham and Women's Hospital,
professor of medicine, Harvard Medical
School in Boston, Mass.
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 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.
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 expectations regarding anticipated MACE onset
in the REDUCE-IT study, the timing of clinical trial event
adjudication, clinical trial results and related announcement
timing associated with Amarin's REDUCE-IT cardiovascular outcomes
study; and expectations related to the successful completion of
REDUCE-IT. 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. 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 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.
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 CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com Lee M. SternTrout
Group In U.S.: +1 (646) 378-2992 lstern@troutgroup.com
Media Inquiries: Kristie KuhlFinn PartnersIn U.S.: +1 (212)
583-2791 Kristie.kuhl@finnpartners.com
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