Amarin Corporation plc (NASDAQ:AMRN), announced today that BioNJ
awarded Amarin with an Innovator Award in recognition of the
approval of a new indication for VASCEPA® (icosapent ethyl) by the
U.S. Food and Drug Administration (FDA) in December 2019. This
approval positions VASCEPA as the first and only drug approved to
reduce cardiovascular events in millions of select high-risk
patients. The approval follows over a decade of research and
development in a clinically challenging disease area characterized
by significant unmet medical need.
“Amarin is proud to be part of BioNJ’s business
community,” stated Steven Ketchum, PhD, Amarin’s president of
R&D and chief scientific officer, who accepted the award on
Amarin’s behalf. “New Jersey’s biotech hub has enabled Amarin to
hire world-class talent for its Bridgewater location. Through the
skills and dedicated efforts of such talented people, we have
pioneered an important, practice-changing therapy, VASCEPA, which
we believe will help millions of people avoid adverse
cardiovascular events. We are confident the region’s pool of
talented professionals will continue to be a valuable resource in
our continued expansion.”
“BioNJ is happy to present Amarin with the
Innovator Award for its dedication to expanding this affordable and
innovative therapy, VASCEPA, for use to reduce cardiovascular
risk,” said Debbie Hart, president and chief executive officer of
BioNJ. “Amarin has clearly demonstrated that it is a committed
corporate citizen and is dedicated to the continued expansion of
the biotech industry in the State of New
Jersey.”
The success of VASCEPA as a recognized new,
cost-effective therapy to reduce cardiovascular risk has propelled
Amarin’s growth from a dozen employees in 2011 to its current size
of over 1000 people in the United States and Ireland, over 100 of
whom are in New Jersey.
Amarin’s successful completion of the landmark
REDUCE-IT® clinical trial was the basis for FDA-approval of VASCEPA
in its important new cardiovascular risk reduction indication. In
this study of patients on statin therapy who, despite
well-controlled cholesterol had various cardiovascular risk
factors, VASCEPA demonstrated a robust 25% reduction in major
adverse cardiovascular events beyond the benefits of existing
standard of medical care. In recognition of these
unprecedented results, VASCEPA received a 16-0 vote in favor of
approval by the FDA Endocrinologic and Metabolic Drugs Advisory
Committee, with subsequent approval granted by the FDA.
VASCEPA has been recognized by eight major medical societies on
four continents as a new standard of medical care for treatment of
studied high-risk patients. VASCEPA is a prescription medicine used
along with statins to reduce the risk of heart attack, stroke and
certain types of heart issues requiring hospitalization in adults
with elevated (≥ 150 mg/dL) triglyceride levels and heart
(cardiovascular) disease, or diabetes and 2 or more additional risk
factors for heart disease.
Cardiovascular disease (CVD) is the leading
cause of death in the United States, resulting in one heart attack,
stroke or death every 14 seconds.1 Nearly half of the entire US
population, 121.5 million adults, have some form of heart disease.2
The U.S. spends approximately $555 billion in direct (medical) and
indirect costs on CVD each year. By 2035, 45.1% of the US
population is projected to have some form of CVD. Total costs of
CVD are expected to reach $1.1 trillion in 2035, with direct
medical costs projected to reach $748.7 billion and indirect costs
estimated to reach $368 billion.1
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing and
commercializing therapeutics to cost-effectively improve
cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent
ethyl), is available by prescription in the United States, Canada,
Lebanon and the United Arab Emirates. Amarin, together with its
commercial partners in select geographies, is pursuing additional
regulatory approvals for VASCEPA in China, the European Union and
the Middle East. For more information about Amarin, visit
www.amarincorp.com.
About BioNJ
BioNJ is the life sciences trade association for
New Jersey with nearly 400 Member companies representing
research-based life sciences organizations and stakeholders across
the ecosystem from the largest biopharmaceutical companies to early
stage start-ups. BioNJ is dedicated to ensuring a vibrant ecosystem
where Science is Supported, Companies are Created, Drugs are
Developed and Patients are Paramount. Because Patients Can’t Wait®,
BioNJ supports its Members in the discovery, development and
commercialization of therapies and cures that save and improve
lives and lessen the burden of illness and disease to society by
driving capital formation, fostering entrepreneurship, advocating
for public policies that advance medical innovation, providing
access to talent and education and offering a cost-saving array of
critical commercial resources. For more information about BioNJ,
please visit www.BioNJ.org
About VASCEPA®
(icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. VASCEPA was initially launched in
the United States in 2013 based on the drug’s initial FDA approved
indication for use as an adjunct therapy to diet to reduce
triglyceride levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. Since launch, VASCEPA has been prescribed
over eight million times and is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for
cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for
pancreatitis in patients with severe hypertriglyceridemia has not
been determined.
Important Safety Information
- VASCEPA is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to VASCEPA or any of its components.
- VASCEPA was associated with an
increased risk (3% vs 2%) of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled
trial. The incidence of atrial fibrillation was greater in patients
with a previous history of atrial fibrillation or atrial
flutter.
- It is not known whether patients
with allergies to fish and/or shellfish are at an increased risk of
an allergic reaction to VASCEPA. Patients with such allergies
should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an
increased risk (12% vs 10%) of bleeding in a double-blind,
placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as
aspirin, clopidogrel or warfarin.
- Common adverse reactions in the
cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent
than placebo): musculoskeletal pain (4% vs 3%), peripheral edema
(7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial
fibrillation (5% vs 4%).
- Common adverse reactions in the
hypertriglyceridemia trials (incidence >1% more frequent than
placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs
0.3%).
- Adverse events may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and
concomitant anticoagulants and/or anti-platelet agents for bleeding
should be monitored.
Key clinical effects of VASCEPA on major adverse
cardiovascular events are included in the Clinical Studies section
of the prescribing information for VASCEPA, as set forth below:
Effect of VASCEPA on Time to First
Occurrence of Cardiovascular Events in Patients with Elevated
Triglyceride levels and Other Risk Factors for Cardiovascular
Disease in REDUCE-IT
|
VASCEPA |
Placebo |
VASCEPA vs Placebo |
N = 4089n (%) |
Incidence Rate (per 100 patient years) |
N = 4090n (%) |
Incidence Rate (per 100 patient years) |
Hazard Ratio(95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary
revascularization, hospitalization for unstable angina (5-point
MACE) |
705(17.2) |
4.3 |
901(22.0) |
5.7 |
0.75(0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point
MACE) |
459(11.2) |
2.7 |
606(14.8) |
3.7 |
0.74(0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250(6.1) |
1.5 |
355(8.7) |
2.1 |
0.69(0.58, 0.81) |
Emergent or urgent coronary revascularization |
216(5.3) |
1.3 |
321(7.8) |
1.9 |
0.65(0.55, 0.78) |
Cardiovascular death [1] |
174(4.3) |
1.0 |
213(5.2) |
1.2 |
0.80(0.66, 0.98) |
Hospitalization for unstable angina [2] |
108(2.6) |
0.6 |
157(3.8) |
0.9 |
0.68(0.53, 0.87) |
Fatal or non-fatal stroke |
98(2.4) |
0.6 |
134(3.3) |
0.8 |
0.72(0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of
undetermined causality.[2] Determined to be caused by myocardial
ischemia by invasive/non-invasive testing and requiring emergent
hospitalization. |
FULL VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding VASCEPA use and
Amarin’s belief that the drug could help millions of people avoid
adverse cardiovascular events and statements about plans for
company expansion. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties. 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 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 determined to
be infringed or 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 (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 Information
Investor and Media Inquiries:Elisabeth
SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com (investor
inquiries)PR@amarincorp.com (media inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
References
1 Heart Disease and Stroke Statistics — 2020 Update: A Report
From the American Heart Association2 2020 Heart Disease and Stroke
Statistical Update Fact Sheet At-a-Glance
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