Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, today
announced REDUCE-IT cardiovascular outcomes study clinical sites
have been instructed to begin scheduling patients for final study
visits commencing March 1, 2018. Amarin confirmed it is on
track to report top-line results from the first of its kind,
potentially landmark, REDUCE-IT cardiovascular outcomes study
before the end of Q3 2018. Amarin maintains its guidance that
the onset of the targeted 1,612th primary major adverse
cardiovascular event (MACE) in this study is projected to occur
before the end of Q1 2018.
Amarin is excited that this important study of
over 8,000 patients, which began in 2011, is nearing conclusion.
The company looks forward to learning and reporting the results of
this first ever prospective study of drug therapy to lower
cardiovascular risk in patients who, despite controlled
LDL-cholesterol, have elevated triglyceride levels and other
cardiovascular risk factors. The REDUCE-IT study is being conducted
at over 400 clinical sites in 11 countries. To facilitate a timely
study wrap-up, Amarin has informed clinical sites that study
completion is close at hand, and that they should begin to schedule
patients for their final patient visit. During on-site final
patient visits, clinical sites will confirm vital status, take a
lipid panel and other blood measures, and complete each patient’s
physical examination and updated medical history record including
any potential clinical events. This final patient visit process is
consistent with prior cardiovascular outcomes studies for other
drugs evaluating other indications for use, and consistent with the
study design of the REDUCE-IT trial, which is being conducted under
a Special Protocol Assessment agreement with the U.S. Food and Drug
Administration.
“Scheduling final patient visits is an important
step toward completion of the REDUCE-IT study,” commented Dr.
Steven Ketchum, Amarin senior vice president, president of R&D,
and chief scientific officer. “We are very appreciative of
the continued dedication of patients and clinical sites in this
study. We believe the results of this study will provide
valuable clinical and scientific information about the potential
outcomes benefit of Vascepa and lead to better informed
preventative care of patients at high cardiovascular risk. The
results of recent real-world evidence studies presented at the
annual scientific sessions of the American Heart Association in
November 2017 provide us further evidence of the increased
cardiovascular risk in patients with elevated triglyceride levels
and optimism for the potential impact of the first of its kind
REDUCE-IT study.”
Amarin is intentionally blinded to the interim
analysis data and will remain blinded to results of the study until
after the study is completed and the database is locked. Final
patient visits will be followed by adjudication of all newly
reported cardiovascular events in the study, completing data entry
for the now greater than 30,000 patient years of study in
REDUCE-IT, and typical database quality control measures, known as
cleaning. This will be followed by 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 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 was 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.
The timing of the announcement of the March 1,
2018 commencement of final patient visits in the REDUCE-IT study
reflects projections of the onset of the targeted 1,612th primary
MACE, and the practical reality that it requires time to
effectively schedule thousands of patients in multiple countries to
visit clinical sites in an orderly and timely manner. The
estimate of timing of the onset of the 1,612th MACE event is based
on actual adjudicated events from inception to date in the study.
The projection of the number of MACE events that will ultimately be
adjudicated as a primary event (first event for the patient within
the duration of the study) is also based on historical data of
adjudicated events within the REDUCE-IT study. Such projections are
made by independent statisticians and reviewed by Amarin and the
independent steering committee for the trial, all of whom are
blinded. The study was designed to provide sufficient power to
detect the anticipated result, regardless of whether the final
number of primary MACE is slightly more or slightly fewer than
1,612 primary MACE.
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 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 that the onset of the target final
primary cardiovascular event will be reached before the end of Q1
2018, with results announced before the end of Q3 2018.
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 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 related to the anticipated timing of events and the
evaluation thereof in the REDUCE-IT cardiovascular outcomes study
and Amarin and study site participants’ plans to collect, assess,
process, and analyze data and make relevant determinations on the
outcome of the study. These statements are not promises or
guarantees of the anticipated timing of such events, the level of
quality of the data and analyses or the potential for a favorable
outcome from the ongoing REDUCE-IT cardiovascular outcomes trial.
As disclosed in filings with the U.S. Securities and Exchange
Commission, Amarin is substantially dependent on third parties for
much of the relevant work described in this press release and
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 the aforementioned and other 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, data collection and assessment, clinical trials and
related regulatory approvals; risks associated with reliance on
third parties; 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 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 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.
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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