Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced that an
independent organization that evaluates pricing of prescription
drugs has issued its final report assessing the cost-effectiveness
of Vascepa® (icosapent ethyl) capsules. The final assessment
confirms the cost-effectiveness of Vascepa across all the
non-profit organization’s analyses, including its most stringent
criteria.1
The review was derived from results of the landmark phase 3
clinical trial REDUCE-IT®2, focusing on the clinical benefit-risk
profile of Vascepa and its value as an additive therapy for
cardiovascular disease. The conclusion from the report is that
Vascepa easily meets “commonly cited thresholds for
cost-effectiveness and therefore represent a high long-term value
for money,” based on the organization’s value assessment
framework.3
“We are proud to have priced Vascepa to be cost-effective, and
we appreciate this positioning being recognized by third-parties,”
said Craig Granowitz, M.D., Ph.D., chief medical officer, Amarin.
“However, despite the report’s positive conclusion that Vascepa is
cost-effective, we believe that it understates the true value of
Vascepa. For example, the report’s base-case analyses reflect only
the costs of heart attack, stroke and cardiovascular death and
exclude other high costs associated with other cardiovascular
events demonstrated to be lowered by Vascepa in the REDUCE-IT
cardiovascular outcomes study (e.g., revascularization procedures
and hospitalization for unstable angina) as well as lower rates of
recurring cardiovascular events in patients treated with Vascepa
during the study.”
Another Cost-Effectiveness Analysis of Vascepa to Be
Presented at AHA
A separate independent, academic cost-effectiveness analysis of
Vascepa based on patient-specific data from the REDUCE-IT study
will be presented at the American Heart Association Scientific
Sessions 2019 on November 16 by William S. Weintraub, M.D.,
Director of Outcomes Research, MedStar Cardiovascular Research
Network. Amarin provided an unrestricted grant for this
academically driven analysis, titled “Cost-Effectiveness of
Icosapent Ethyl in REDUCE-IT.”
Cardiovascular Disease, an Urgent Public Health
Issue
“There is no doubt that cardiovascular disease is an urgent and
growing public health issue, with more than half of U.S. adults
impacted,” Dr. Granowitz added. “The U.S. spends approximately $555
billion on cardiovascular disease each year, and it is projected
that these direct and indirect costs could increase to more than
$1.1 trillion by 2035.4 Amarin has worked for over a decade to
develop and test Vascepa to create a new preventative care solution
that will potentially help many of our family, friends and
neighbors within this population. Our goal is to make Vascepa
accessible to as many patients as possible who can benefit.”
Vascepa is currently approved in the United States as an adjunct
to diet to reduce triglyceride levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridemia. Amarin has submitted a
supplemental new drug application (sNDA) to the U.S. FDA for a
label expansion based on the REDUCE-IT study results showing
reduction of cardiovascular events in high-risk patients. The
Prescription Drug User Fee Act (PDUFA) target action date set by
the FDA to act on the sNDA is December 28, 2019. Assuming FDA
approval, Vascepa is positioned to become the first drug indicated
to reduce persistent residual cardiovascular risk in statin-managed
patients with elevated triglycerides (135 mg/dL or greater) and
other risk factors for cardiovascular disease. The approval of such
label expansion and the wording of the indication statement is
under regulatory review.
Today, many insurance plans, or payers, already broadly cover
Vascepa. Upon assumed FDA label expansion, Amarin plans to use the
results of the REDUCE-IT study, further objective health-economic
analyses, and other medical information and data in negotiations
with payers to seek expanded Vascepa insurance coverage.
About AmarinAmarin Corporation plc. is a
rapidly growing, innovative pharmaceutical company focused on
developing therapeutics to improve cardiovascular health. Amarin’s
product development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa (icosapent
ethyl) is Amarin's first FDA-approved drug and is available by
prescription in the United States, Lebanon and the United Arab
Emirates. Amarin’s commercial partners are pursuing additional
regulatory approvals for Vascepa in Canada, China and the Middle
East. For more information about Amarin, visit
www.amarincorp.com.
REDUCE-IT® StudyREDUCE-IT, an 8,179-patient
cardiovascular outcomes study, was completed in 2018. REDUCE-IT was
the first multinational cardiovascular outcomes study that
evaluated the effect of prescription pure EPA therapy as an add-on
to statins in patients with high cardiovascular risk who, despite
stable statin therapy, had elevated triglyceride levels (at least
135 mg/dL). A large portion of the male and female patients
enrolled in this outcomes study were diagnosed with type 2
diabetes.
More information on the REDUCE-IT study results can be found at
www.amarincorp.com.
About Cardiovascular DiseaseWorldwide,
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.5,6
Multiple primary and secondary prevention trials have
shown a significant reduction of 25% to 35% in the risk
of cardiovascular events with statin therapy,
leaving significant persistent residual risk despite the
achievement of target LDL-C levels.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
About Vascepa® (icosapent ethyl)
CapsulesVascepa (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 from degradation. 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.
The FDA has not completed review and opined on a supplemental
new drug application related to REDUCE IT. FDA has not reviewed the
information herein or determined whether to approve Vascepa for use
to reduce the risk of major adverse cardiovascular events in the
REDUCE-IT patient population.
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results)
- 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 Based on Current
FDA-Approved Label (not including REDUCE-IT results) (Includes Data
from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients
with Triglycerides Values of 200 to 2000 mg/dL)
- 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.
Important Safety Information for Vascepa based on REDUCE-IT, as
previously reported in The New England Journal of Medicine
publication of the primary results of the REDUCE-IT
study:
- Excluding the major adverse cardiovascular events (MACE)
results described above, overall adverse event rates in REDUCE-IT
were similar across the statin plus Vascepa and the statin plus
placebo treatment groups.
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the statin plus
placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were: -
peripheral edema (6.5% Vascepa patients versus 5.0% placebo
patients), although there was no increase in the rate of heart
failure in Vascepa patients - constipation
(5.4% Vascepa patients versus 3.6% placebo patients), although
mineral oil, as used as placebo, is known to lower constipation,
and - atrial fibrillation (5.3% Vascepa
patients versus 3.9% placebo patients), although there were
reductions in rates of cardiac arrest, sudden death and myocardial
infarctions observed in Vascepa patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall rates were low
with no fatal bleeding observed in either group and no significant
difference in adjudicated hemorrhagic stroke or serious central
nervous system or gastrointestinal bleeding events between
treatments.
- In summary, Vascepa was well tolerated with a safety profile
generally consistent with clinical experience associated with
omega-3 fatty acids and current FDA-approved labeling of such
products.
Important Cautionary Information About These
Data Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. For example, detailed data
assessment by regulatory authorities, such as the FDA and Health
Canada, will continue and take months to complete and announce. The
FDA advisory committee process and the final evaluation by
regulatory authorities of the totality of efficacy and safety data
from REDUCE-IT may include some or all of the following, as well as
other considerations: new information or analyses affecting the
degree of treatment benefit on studied endpoints; study conduct and
data robustness, quality, integrity and consistency; additional
safety data considerations and risk/benefit considerations; and
consideration of REDUCE-IT results in the context of other clinical
studies. Because regulatory reviews are typically fluid and not
definitive interactions between sponsor and agency on individual
elements of an application and related information, Amarin does not
plan to update investors on ongoing communications with regulatory
authorities. Amarin plans to announce the final outcome of such
regulatory reviews when appropriate.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements regarding
the use of Vascepa to potentially help millions of patients. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. 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 reviews and approvals; the risk that data
interpretations or other information from third parties, the
regulatory review process, regulatory authorities and in connection
with an advisory committee could be made public that are negative
or may delay approval or limit Vascepa’s marketability; the risk
that special protocol assessment (SPA) agreements with the FDA are
not a guarantee that FDA will approve a product candidate; the risk
associated with the FDA's rescinding the REDUCE-IT SPA agreement;
the risk related to FDA advisory committee meetings; and the risk
that the FDA may not complete its review of the REDUCE-IT sNDA
within the timing expected. 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
AmarinInvestors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(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 InformationInvestor
Inquiries:Elisabeth SchwartzInvestor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
References___________________1
https://icer-review.org/wp-content/uploads/2019/02/ICER_CVD_Final_Evidence_Report_101719.pdf2
Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction
with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med
2019;380:11-22.3
https://icer-review.org/announcements/cvd_final_report/4 American
Heart Association. 2017. Cardiovascular Disease: A Costly Burden
for America. Projections Through 20355 American Heart Association.
2018. Disease and Stroke Statistics-2018 Update.6 American Heart
Association. 2017. Cardiovascular Disease: A Costly Burden for
America Projections Through 2035.7 Ganda OP, Bhatt DL, Mason RP, et
al. Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.8 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 are associated with increased cardiovascular
events, medical costs, and resource use: A real-world
administrative claims analysis of statin-treated patients with high
residual cardiovascular risk. J Am Heart Assoc.
2018;7(15):e008740.10 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 (NASDAQ:AMRN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Mar 2023 to Mar 2024