Amarin Corporation plc (NASDAQ:AMRN) today announces that the
Company received its first national reimbursement in a European
country for VAZKEPA® in Sweden and provides an update on the status
of its international expansion strategy, including several
regulatory filing and reimbursement updates for VASCEPA®/VAZKEPA
globally.
“I am pleased to report the first national reimbursement
decision for VAZKEPA in Sweden, which marks the beginning of the
next phase of growth and expansion outside of the U.S. for Amarin,”
commented Karim Mikhail, president and chief executive officer.
“This important decision, is a critical milestone as we begin to
unlock a multi-billion dollar* revenue opportunity for
VASCEPA/VAZKEPA outside of the U.S., as part of our bold ambition
to lead a new paradigm in preventive cardiovascular care and grow
our impact for patients globally.”
Europe
On March 25, 2022, Amarin received official confirmation that
the Swedish Dental and Pharmaceutical Benefits Agency (TLV)
approved VAZKEPA (icosapent ethyl) for national
reimbursement in Sweden, restricted to the treatment of
statin-treated patients with established
cardiovascular disease (eCVD) and elevated triglycerides (≥
150 mg/dl [≥ 1.7 mmol/l]), which represents approximately 70% of
the studied patient population of REDUCE-IT ® 1 and where the
urgency and need to treat is the highest , at a price of 1,640 SEK
per month (equivalent of approximately 160 EUR or 175 USD per
month**). With this approval, the Company intends to commence
commercial activities in Sweden.
The role of the TLV is to evaluate all new pharmaceutical
products to determine their respective reimbursement in
Sweden. In addition to thoroughly examining the quality and
robustness of the scientific evidence presented in reimbursement
dossiers, TLV is widely regarded as utilizing some of the most
sophisticated Health Technology Assessment methods and models in
Europe. The Swedish decision follows the individual reimbursement
in Denmark in mid-February of 2022 and marks a significant
milestone for Amarin in Europe.
“A decision for reimbursement in Sweden by the TLV underscores
the quality of the REDUCE-IT® study results,” stated Laurent Abuaf,
senior vice president and president Amarin Europe. “Sweden is known
to be at the forefront in the prevention and treatment of
cardiovascular disease, as demonstrated by the SWEDEHEART registry,
a unique online registry that reports the outcome of every single
patient hospitalized at coronary care units for acute coronary
syndrome or undergoing coronary or valvular intervention2. I am
pleased that the TLV’s decision acknowledges the value of VAZKEPA
to further strengthen cardiovascular care in Sweden.”
Amarin continues to progress its reimbursement discussions with
national health authorities in Norway, Finland, Germany, the UK,
France, Italy, Spain and The Netherlands. While discussions in
Central and Eastern Europe may be impacted by local political
conditions, the Company’s partnership discussions in Greece, a key
market in the region, are advancing well. The Company remains on
track to receive reimbursement decisions in up to eight countries
and launch VAZKEPA in up to six European countries this year.
International
Outside of Europe, Amarin is also advancing its
international expansion plans.
Following the acceptances of VASCEPA for regulatory review in
Australia and New Zealand, the dossiers have now entered full
assessment by the respective national regulatory authorities in
these countries. In Israel, VASCEPA has also been accepted for
regulatory review by the relevant authority, and our submission is
advancing as per the local process. The Company is actively
evaluating partnerships for these countries. Amarin’s partner in
Middle East and North Africa (MENA), Biologix, has received the
official registration certificate from the Kingdom of Saudi Arabia
(KSA) regulatory authority for the treatment of severe
hypertriglyceridemia. This first approval in KSA enables the
preparation and submission of a variation to seek review and
approval of the cardiovascular risk reduction indication. In
Canada, HLS is in the final stages of the process for public plan
reimbursement of VASCEPA.
Lastly, the Company and partner Edding remain on
track to receive approval in Hong Kong and China this year.
The Company looks forward to providing future
updates on its progress including updates regarding reimbursement
decisions as part of its standard business updates, including
earnings reports and U.S. SEC filings.
*U.S. Dollar**Based on exchange rate of EUR and
USD as of the date of this release.
About Amarin® Amarin
is an innovative pharmaceutical company leading a new paradigm in
cardiovascular disease management. From our scientific research
foundation to our focus on clinical trials, and now our commercial
expansion, we are evolving and growing rapidly. Amarin has offices
in Bridgewater, New Jersey in the United States, Dublin in Ireland,
Zug in Switzerland, and other countries in Europe as well as
commercial partners and suppliers around the world. We are
committed to rethinking cardiovascular risk through the advancement
of scientific understanding of the impact on society of significant
residual risk that exists beyond traditional therapies, such as
statins for cholesterol management.
About VASCEPA® (icosapent ethyl)
Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. 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 ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, Lebanon and the United Arab
Emirates. In Europe, in March 2021 marketing authorization was
granted to icosapent ethyl in the European Union for the reduction
of risk of cardiovascular events in patients at high cardiovascular
risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United
States)
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 should be monitored for
bleeding.
Forward-Looking
Statements This press release contains
forward-looking statements which are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995, including beliefs about the market potential for
VASCEPA/VAZKEPA; expectations regarding performance such as
prescription growth and market access for VAZKEPA, the impact of
the COVID-19 pandemic including beliefs about patient needs for
VASCEPA/VAZKEPA; beliefs that Amarin's strategy for reducing the
effects of cardiovascular disease is sound and that Amarin is
efficiently reaching physicians, payors, pharmacists and patients;
plans for Amarin's go-to-market model; the timing and outcome of
regulatory reviews, recommendations and approvals and related
reimbursement decisions and commercial launches in Europe and
elsewhere; plans for Amarin's expected launch of VAZKEPA directly
in major markets in Europe, directly and indirectly; beliefs about
the cardioprotective and other benefits of VASCEPA/VAZKEPA; beliefs
about the strength of data in market access dossiers and other
reports; expectations for the timing, effectiveness and outcome of
promotional activities, including patient-oriented campaigns,
conference and posted presentations and education of healthcare
professionals; commercial and international expansion and
prescription growth and revenue growth and future revenue levels.
These forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Amarin's ability to
effectively commercialize VASCEPA/VAZKEPA and maintain or grow
market share will depend in part on Amarin’s ability to continue to
effectively finance its business, VASCEPA/VASKEPA approval in
geographies outside the U.S., efforts of third parties, Amarin’s
ability to create and increase market demand for VASCEPA/VASKEPA,
to achieve broad market acceptance, 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/VASKEPA. Among the factors that
could cause actual results to differ materially from those
described or projected include the following: the possibility that
VASCEPA/VASKEPA may not receive regulatory approval in various
international geographies on expected timelines or at all; the risk
that Amarin has overestimated the market potential for
VASCEPA/VASKEPA i; risks associated with Amarin's expanded
enterprise; 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. 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 Amarin’s annual
report on Form 10-K for the year ended December 31, 2021,
filed on or about the date hereof. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. Amarin undertakes no obligation to update or revise the
information contained in its forward-looking statements, whether as
a result of new information, future events or circumstances or
otherwise. Amarin’s forward-looking statements do not reflect the
potential impact of significant transactions the company may enter
into, such as mergers, acquisitions, dispositions, joint ventures
or any material agreements that Amarin may enter into, amend or
terminate.
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, 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
Media Inquiries:Communications Amarin Corporation
plcPR@amarincorp.com
Investor Inquiries: Lisa
DeFrancesco Investor Relations Amarin Corporation
plc investor.relations@amarincorp.com
1 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med.
2019;380(1):11-22.2 https://www.ucr.uu.se/swedeheart/dokument-sh/arsrapporter-sh/1-swedeheart-annual-report-2020-english-2/viewdocument/3140
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