Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, announced today
the onset of approximately 80% of the target aggregate number of
primary cardiovascular events within the REDUCE-IT study. This
milestone has triggered preparation for a pre-specified interim
efficacy and safety analysis by the study’s independent Data
Monitoring Committee (DMC). Amarin currently expects the
independent interim analysis to be conducted before the end of the
third calendar quarter of this year.
Interim Analysis Expected in Q3
The REDUCE-IT study's event rate continues to track consistently
with Amarin’s existing public guidance for the timing of the
interim analysis and study completion. A pre-specified interim
efficacy and safety analysis is designed to be conducted upon
achieving approximately 80% of the target 1,612 aggregate primary
major adverse cardiovascular events within the study. REDUCE-IT
patients are in the process of completing a study visit over the
coming months, after which additional time is required by the
contract research organizations to finish collecting and preparing
data for transfer to and analysis by the DMC. This data preparation
and transfer process is expected to take several months as is
typical for large-scale, multi-national studies, and consistent
with the process for the first pre-specified interim analysis of
the REDUCE-IT study, regardless of the strength of the study
results. The DMC's analysis is anticipated to occur before the end
of the third calendar quarter of 2017.
Amarin will remain blinded to the interim and ongoing results of
the REDUCE-IT study until after the study is ready to be stopped
either at the interim analysis or at the final analysis. Guidelines
for the independent DMC to recommend stopping the study for
overwhelming efficacy require that the study achieve statistical
significance on the primary endpoint and generate robust findings
on certain, pre-specified secondary outcome measures. Given the
high thresholds of overwhelming efficacy required prior to a DMC
recommending an early stop to a cardiovascular outcomes trial like
REDUCE-IT, Amarin continues to expect that the DMC's interim
analysis will result in a recommendation to continue the REDUCE-IT
study as planned to completion of 100% of the target events. The
efficacy requirements detailed to the DMC for early study stoppage
after the 80% interim assessment are high and include robustness
thresholds for underlying data that go beyond the assessment for
statistical significance on the analysis of the primary endpoint
after the expected completion of the study at 100% of planned
events.
First Multinational Outcomes Study to Evaluate
Cardiovascular Benefit of High-Dose EPA Therapy as an Add-on to
Statin Therapy
Heart disease remains the number one cause of death in the
United States. REDUCE-IT is the first multinational outcomes study
being conducted to evaluate the cardiovascular benefits of treating
patients with high cardiovascular risk who, despite having their
LCL-cholesterol controlled with statin therapy, have elevated
triglyceride levels. The study is designed to examine whether the
demonstrated clinical effects and postulated pleiotropic
cardioprotective benefits of high-dose EPA-only Vascepa therapy,
when added to statin therapy, will offer improved cardiovascular
outcomes for patients. The results of this important trial, if
successful, could lead to improved medical care for tens of
millions of patients.
The design of the REDUCE-IT cardiovascular outcomes study was
published in March 2017 in Clinical Cardiology. A copy of this
publication is available at:
http://onlinelibrary.wiley.com/doi/10.1002/clc.22692/full.
Amarin believes that the REDUCE-IT study is designed for success
based on extensive review of data from clinical, epidemiologic and
genetic studies. Amarin estimates that results of the trial will
become available to Amarin and be publicly communicated in
mid-2018. This estimated timing reflects our assumptions of the
time necessary to collect vital data from all patients in the
study, compile the results, and subject the results to scrutiny of
the independent review committees and the REDUCE-IT operational
team after reaching the onset of the target final aggregate
cardiovascular event in this study. The onset of the target final
aggregate cardiovascular event in this study is estimated to occur
near the end of 2017.
The primary endpoint of this global, double-blind study is the
time to the first occurrence of a composite of major adverse
cardiovascular events (MACE). Results will be compared between the
Vascepa and placebo groups. The study is being conducted under a
special protocol assessment (SPA) agreement with the FDA.
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 expectations for continued event rates, interim data
review, results and related timing and announcements with respect
to Amarin's REDUCE-IT cardiovascular outcomes study; expectations
related to the interim and final outcomes of the REDUCE-IT study
and the anticipated successful completion of the REDUCE-IT study;
and statements regarding the potential and therapeutic benefits of
Vascepa. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. In
particular, 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 historical REDUCE-IT event rates may not be predictive of
future results and related cost may increase beyond expectations;
the risk that regulatory reviews may impact the current design of
the REDUCE-IT study or cause a change in strategic direction with
respect to continuation of the study; 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
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 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:
Kristie Kuhl
Finn Partners
In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024