Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, today announced
that the last patient study visit has occurred in its potential
landmark cardiovascular outcomes study, REDUCE-IT™. The
company also reiterated that it anticipates having top-line results
for this important study reported before the end of Q3 2018.
REDUCE-IT Status
Update
In March 2018, patients commenced their last
study visits as participants in the REDUCE-IT study.
Completion of last patient visits is an important step towards
finalizing the REDUCE-IT study and announcing results. As
previously described, other important steps needed to complete the
study include finalizing adjudication of reported events, including
major adverse cardiovascular events (MACE) within the primary
endpoint, securing final vital status data from inactive patients,
and completing the review of data for consistency and completeness
across more than 35,000 patient years in the trial.
The company reported that adjudication of all
identified potential endpoints is approaching completion. As part
of their last site visits in the study, patients underwent
non-invasive diagnostic testing to determine whether silent
myocardial infarctions or other clinical events had occurred. Until
this testing was completed at the last patient visits, some
cardiovascular events could not be finally adjudicated, even if
these potential study endpoints occurred much earlier in the
trial.
As is typical of large, multi-national,
long-term outcomes studies, the final steps preceding REDUCE-IT
completion include resolving remaining queries to contribute to a
robust and accurate database. This “cleaning” process is
characteristically intensive and time consuming. Progress is being
made at a pace consistent with the company’s guidance of having
top-line results to report before the end of Q3 2018.
Amarin continues to be 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.
Communication of REDUCE-IT Progress and
Results
The series of steps being followed to complete
the REDUCE-IT study is intended to support a robust understanding
and reporting of results from this potentially landmark study.
Amarin is highly motivated to announce the REDUCE-IT top-line
results as soon as is practical. In parallel, the company is
continuing its preparations for commercial expansion on the
assumption of positive study results.
Once the REDUCE-IT database is locked,
consistent with other outcomes studies, the company and a team of
experts plan to confidentially review and analyze the data and
promptly announce top-line results publicly. Broader reporting of
results is targeted for a scientific conference in Q4 2018.
The time between the database lock and reporting top-line
results is intended to be as brief as is possible to support both
timely and accurate reporting of the results. Consistent with the
practices of most other companies, it is unlikely that Amarin will
separately announce the date the database is locked. Rather, the
company will focus on reporting the top-line results promptly after
top-line results are known following database lock.
The time between commencing last patient study
visits and reporting top-line results in other large outcomes
studies reviewed by the company has been approximately five to
seven months. There is no reliable correlation between the length
of time needed to wind down a study (i.e., the time interval
between commencement of patient last site visits and reporting
top-line results) and the outcome of reported results of a
study. Amarin’s anticipation of reporting top-line results
before the end of Q3 2018 is consistent with the wind-down timing
of these other outcomes studies, each of which were conducted by
companies much larger than Amarin.
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 for timing of completion of the
REDUCE-IT study and the individual steps leading to completion as
well as expectations on the company’s ability to complete these
steps in a manner that results in a robust and accurate database
for the REDUCE-IT study; expectation for timing of announcements
related to REDUCE-IT results and expectations regarding expanded
promotion of Vascepa. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties. In particular, as disclosed in its previous company
filings with the U.S. Securities and Exchange Commission,
completing and reporting results from cardiovascular outcomes
trials such as REDUCE-IT are complex undertakings that involve
substantial risks such as the complex nature of collecting and
analyzing clinical data and reliance on third parties. Vascepa may
not show clinically meaningful effects in REDUCE-IT or support
regulatory approvals for intended uses. In addition, Amarin's
ability to effectively 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 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 the sale of
pharmaceutical products, research and development, clinical trials
and related regulatory approvals; the risk that sales may not meet
expectations and related cost may increase beyond expectations; 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 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 (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 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)
378-2992lstern@troutgroup.com Media Inquiries: Kristie Kuhl Finn
Partners In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com
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