n, public events have been cancelled and group gatherings have been
minimized. These steps are being taken to minimize personal
interaction as much as possible to stem disease spread and “flatten
the curve”. In the field of pharmaceutical marketing, increased
social contact, such as interactions between sales representatives
with healthcare providers, has the potential to counter-act these
important public health initiatives and to put our employees and
people in doctors’ offices at unnecessary risk.
Accordingly, as Amarin is intently focused on
improving public health by reducing cardiovascular risk, currently
the most damaging disease in the industrialized world, and
consistent with our corporate values, we have announced immediate
suspension of field based face-to-face interactions for the next
two weeks, until Monday, March 30th. To directly support patient
care, Amarin plans to continue to provide digital and
internet-based educational materials and copay cards and will
continue to ship samples. It is too early for the company to assess
the impact of the COVID-19 pandemic and these actions on Amarin’s
revenue growth and previously reported revenue guidance. Such
actions follow reports in early March of record prescription
levels, and record new prescription levels, for VASCEPA® (icosapent
ethyl). We understand that other pharmaceutical companies are
taking similar actions. We will continue during this period with
non-personal promotion initiatives and use some of the time for
further training of our field personnel. We will continue to
monitor the situation and provide updates at an appropriate
time.
“As a company focused for more than a decade on
fighting cardiovascular disease, which in the United States alone
results in one stroke, heart attack or death every 14 seconds, we
are determined to do our part to protect public health and the
health of our many valued employees,” said John Thero, president
and chief executive officer of Amarin. “We have developed a roadmap
of remote working activities for us to continue to help many
patients with persistent cardiovascular risk, including using
virtual customer tools to maintain contact and enhanced sales
training. Our efforts are designed to do our part to help reduce
the spread of COVID-19, protect the health of our employees and
their families and preserve healthcare resources at a critical
interim period for those most in need and, ultimately, to save
lives. We applaud the dedication and efforts of healthcare
professionals internationally as they prioritize their own efforts
to address the public health crisis presented by COVID-19. And, we
express our condolences to everyone who is suffering from this
pandemic. We will work to continue our diligent efforts to bring to
healthcare professionals and the public our contribution to
improved treatment of cardiovascular risk, which is not only an
enormous and growing medical issue worldwide but also a leading
factor of increased risk to those infected by COVID-19.”
In addition, the company responded to questions
regarding whether its supply chain for Vascepa is likely to be
significantly impacted by COVID-19. Amarin’s supply chain is
diversified and therefore mitigates geographical risks. None of
Amarin’s manufacturing is conducted in China. Furthermore, Amarin
has built significant stockpiles of VASCEPA in the United
States. VASCEPA is reported to be available in pharmacies
throughout the United States and similarly available in other
countries where it is approved for sale. From the information
that is currently available, Amarin does not believe coronavirus
will have a major impact, if any impact, on its ability to
supply VASCEPA to support its growing business.
About AmarinAmarin 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 Cardiovascular
DiseaseCardiovascular disease is an enormous and growing
medical issue worldwide.4, 5 In the United States alone, a
heart attack, stroke, death or other major cardiovascular event is
experienced every 14 seconds.6
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk of experiencing a
cardiovascular event. However, even with the achievement of target
LDL-C levels, millions of patients still have significant and
persistent cardiovascular risk, especially those patients with high
triglycerides. Statin therapy has been shown to control LDL-C,
thereby reducing the risk of cardiovascular events by 25-35% – but
that still leaves 65-75% of risk remaining.7 People with high
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking
statins.8,9,10
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (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 UseVASCEPA 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 º established cardiovascular disease or º 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 StatementsThis
press release contains forward-looking statements, including Amarin
efforts to stem the COVID-19 virus and cardiovascular disease,
efforts to continue to help patients with persistent cardiovascular
risk, such as through virtual customer tools to maintain contact
and enhanced sales training and Amarin’s current believe about the
impact of COVID-19 on its ability to supply VASCEPA to support its
growing business. These forward-looking statements are not promises
or guarantees and involve substantial risks and uncertainties. As
circumstances change, the proactive steps taken by Amarin may be
extended and it current outlook may change. 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 commercial success of pharmaceutical
products such as VASCEPA, reliance on third parties in the VASCEPA
supply chain and uncertainties related to virus containment efforts
worldwide. 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 maintain
exclusivity through patent protection and to comply with legal and
regulatory requirements in connection with the sale and promotion
of VASCEPA. 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 annual report on
Form 10-K. 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 and
Media 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
References
__________________________________________
1
https://www.who.int/emergencies/diseases/novel-coronavirus-20192
https://www.theguardian.com/world/2020/mar/15/100m-europeans-on-lockdown-as-countries-battle-coronavirus3
https://www.businessinsider.com/california-washington-state-of-emergency-coronavirus-what-it-means-2020-34
American Heart Association. Heart Disease and Stroke Statistics –
2019 Update: A Report from the American Heart Association.
Published January 31, 2019.5 American Heart Association / American
Stroke Association. 2017. Cardiovascular disease: A costly burden
for America projections through 2035.6 American Heart Association:
Heart Disease and Stroke Statistics -- 2019 At-a-Glance.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.
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