REDUCE-IT Study Remains On-Track for Report of
Top-Line Results Before the End of September 2018
Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, today commented
that following this week’s European Society of Cardiology (ESC)
Congress in Munich, Germany, Amarin’s landmark cardiovascular
outcomes study, REDUCE-IT™, is now likely to be the next large
cardiovascular outcomes study to report results. As
previously guided, top-line results from the REDUCE-IT study are
expected to be reported before the end of September 2018. REDUCE-IT
is evaluating the effect of Vascepa® (icosapent ethyl),
administered at four (4) grams per day, as an add-on to statin
therapy, on major adverse cardiovascular events (MACE) as compared
to statin treated patients plus placebo. REDUCE-IT is the
first cardiovascular outcomes study to be conducted in patients who
despite low density lipoprotein cholesterol (LDL-C) control have
risk factors for cardiovascular disease, including elevated
triglyceride levels.
Deaths from cardiovascular disease are
increasingly creating a worsening public health burden along with
considerable pain, suffering and lost productivity. In the United
States, heart disease is responsible for more than 800,000 deaths
per year which is more deaths than from all types of cancer
combined. Treatment of cardiovascular disease, including
costs of treating heart attacks and strokes, is the highest area of
healthcare treatment spending and projected to exceed USD 1
trillion within twenty years if not abated.1 It is estimated that
approximately one-fourth (57 million) of US adults, including
nearly a third of those on statin therapy, have triglyceride (TG)
levels that remain elevated (≥150 mg/dL).2 Epidemiology
studies show that this group has significant residual
cardiovascular risk not addressed by standard of care statin
therapy or other LDL (“bad”) cholesterol-lowering therapies3.
Despite being effective in lowering cardiovascular risk by 25%-35%,
very significant levels of residual cardiovascular risk (65%-75%)
remain for patients on statin therapy even after achievement of
target LDL-C levels, often defined as <70 mg/dl.3
Amarin’s REDUCE-IT study of Vascepa is
noticeably different than the recently completed ASCEND trial
presented today at ESC 2018. ASCEND studied a different drug
in a different patient population. Some differences between
the omega-3 arms of the ASCEND trial and the REDUCE-IT trial are
noted in the table below:
|
|
REDUCE-IT4 |
|
ASCEND (OMEGA-3 ARMS)5 |
RESULTS |
|
Pending |
|
Failed to
achieve primary endpoints |
SPONSOR/FUNDING |
|
Amarin |
|
Oxford
Univ./British Heart Foundation |
STUDY TYPE |
|
Randomized,
double-blind, placebo-controlled |
|
Randomized,
double-blind, placebo-controlled |
PATIENT POPULATION |
|
Statin-treated patients with high CV risk, including TG 150-499
mg/dL |
|
Patients
with diabetes, without evidence of cardiovascular disease |
STUDIED OMEGA-3 TREATMENTS |
|
Vascepa
4g/day (pure EPA) |
|
Omacor®
(Lovaza®) 1g/day (mixture of EPA, DHA and other) |
STATIN THERAPY |
|
Statin use
mandated for all patients |
|
Statin use
not mandated |
RESULT CAPTURE |
|
Clinically
run and monitored with periodic visits to clinical sites |
|
Self-reported (results documented with questionnaires filled out by
the patients every 6 months) |
NUMBER OF PATIENTS |
|
8,175 |
|
15,480 |
NUMBER OF PRIMARY EVENTS |
|
~1,612
(expected) |
|
1,401
(actual) |
PRIMARY ENDPOINT |
|
Risk
Reduction for CV events (composite endpoint) |
|
Risk
Reduction for CV events (composite endpoint) & cancer |
As reported today at ESC, the omega-3 arms of
the ASCEND trial did not demonstrate a reduction of first serious
vascular events with the therapy of omega-3 fatty acid
supplementation studied5. Such finding is consistent with
most prior studies of omega-3 mixtures.3 The failure of the ASCEND
study to demonstrate cardiovascular benefit serves as a reminder of
the challenges to lowering cardiovascular risk.
Amarin reiterated its thesis that to lower
cardiovascular risk beyond standard of care cholesterol management
through statin therapy, important considerations include:
- Drug being studied: Vascepa has been shown to
lower levels of triglycerides and other potential atherogenic and
inflammatory markers in studied patients without raising
LDL-(“bad”) cholesterol. DHA containing omega-3 products and
fenofibrates, in their approved labels report increases in
LDL-cholesterol and other differences.
- Dose of drug must be adequate to have effect:
Daily dose of 4g/day of Vascepa has been shown to have a
significantly more pronounced impact on lipid levels than lower
dose levels while maintaining a favorable safety profile.
- Population studied is important: Clinical
benefit is best measured in patients who without treatment have a
relatively high likelihood of experiencing a major adverse vascular
event. The REDUCE-IT population is at a higher risk and is
anticipated to show a higher event rate than reported in the ASCEND
trial.
Amarin’s thesis is being studied in the
REDUCE-IT cardiovascular outcomes study. Amarin believes that
REDUCE-IT is a study using the “right” drug, at the “right” dose in
the “right” patient population.
Amarin looks forward to learning and reporting
the top-line results of the REDUCE-IT study before the end of
September 2018. Amarin remains blinded to the results of the
REDUCE-IT study.
Vascepa capsules have been prescribed more than
four (4) million times since 20136, and are affordably priced and
covered by insurance for most patients.
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.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- 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.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
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,
7
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. 8, 9, 10, 11
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, the potential for the results of the REDUCE-IT
study to be positive and expectation for timing of announcements
related to REDUCE-IT results. 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 Benjamin EJ, et al. American Heart Association. 2018. Disease
and Stroke Statistics-2018 Update. Circulation.
2018;137:e67-e492.
2 Fan W, Philip S, Granowitz CB, Toth PP, Wong ND. Prevalence
and predictors of residual hypertriglyceridemia according to statin
use in U.S. adults with diabetes [abstract]. Diabetes.
2018;67(suppl 1):332OR.
3 Ganda OP, Bhatt DL, Mason RP, Miller M, Boden WE. Unmet need
for adjunctive dyslipidemia therapy in hypertriglyderidemia
management. J Am Coll Cardiol. 2018 (epub ahead of print).
4 Bhatt DL, Steg PG, Brinton EA, et al. Clin Cardiol.
2017;40(3):138-148.
5 Bowman L. Effects of n-3 fatty acid supplements in diabetes
mellitus. The ASCEND Study Collaborative Group. N Engl J Med.
2018.
6 Symphony Health, PHAST Monthly through July, 2018.
7 American Heart Association. 2017. Cardiovascular disease: A
costly burden for America projections through 2035. At:
http://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf
Accessed August 23, 2018.
8 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
9 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.
10 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
11 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: Christy Maginn
Burson-Marsteller In U.S.: +1 (646) 280-5210
Christy.Maginn@bm.com
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