Amarin Provides Pricing & Reimbursement Updates for VAZKEPA (icosapent ethyl) in The Netherlands and Italy
09 Agosto 2023 - 5:05PM
Amarin Corporation plc (NASDAQ:AMRN) today announced pricing and
reimbursement updates for VAZKEPA (icosapent ethyl) in the
Netherlands and Italy.
In the Netherlands, the Dutch Ministry of Health
has approved VAZKEPA® (icosapent ethyl) for national reimbursement
to reduce the risk of cardiovascular events in adult statin-treated
patients with established cardiovascular disease and elevated
triglycerides (≥ 1,7 and ≤ 5,6 mmol/l). The national
reimbursement will now allow Amarin to begin efforts to
commercialize VAZKEPA across the Netherlands in September.
Cardiovascular disease (CVD) is a substantial
issue in the Netherlands with ~1.7 million people suffering from
the disease. Every day, approximately 100 people die of CVD and
approximately 640 CVD patients are admitted to hospital1,
significantly impacting patients, their families and the Dutch
healthcare system.
“With the approval and reimbursement of VAZKEPA®
in the Netherlands, Dutch cardiovascular patients and physicians
now have access to an important new treatment option to reduce
cardiovascular risk and improve health outcomes,” said Patrick
Holt, President and CEO of Amarin. “Today’s approval is a testament
to the strength of VAZKEPA’s scientific data and evidence from the
REDUCE-IT study, which included more than 1,600 Dutch patients
across more than 40 clinical trial sites in the Netherlands.”
In Italy, AIFA has issued a decision to not
reimburse VAZKEPA at this time. The decision follows a positive
scientific assessment issued by the Italian Scientific Technical
Committee (CTS), support through positive interactions with Italian
healthcare professionals and collaborative negotiations with the
Italian authorities to reach an appropriate price for VAZKEPA.
Amarin is continuing to engage with AIFA on all possible
options – including a resubmission - to secure a positive pricing
outcome and ensure access to VAZKEPA in the interest of patients
across Italy.
“In Italy, cardiovascular diseases are responsible for 35.8% of
all deaths, exceeding 230,000 cases annually and represent the
leading cause of death and hospitalization2,” added Holt. “While we
are disappointed with today’s decision, we continue to stand behind
the proven therapeutic benefit of our product and we will continue
our efforts to ensure patients across Italy have access to VAZKEPA
to reduce their cardiovascular risk.”
Amarin continues to advance its pricing and
reimbursement discussions in a number of other European markets to
drive patient access across the region and will share updates as
these become available.
About AmarinAmarin is an
innovative pharmaceutical company leading a new paradigm in
cardiovascular disease management. We are committed to increasing
the scientific understanding of the cardiovascular risk that
persists beyond traditional therapies and advancing the treatment
of that risk for patients worldwide. 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.
Forward-Looking StatementsThis
press release contains forward-looking statements, within the
meaning of U.S. securities laws, including, but not limited to,
expectations regarding the Dutch approval of VAZKEPA for national
reimbursement and the market potential in that territory; the
negative decision on pricing in Italy, and Amarin’s plan to
continue seeking pricing and reimbursement in that country;
Amarin’s continued efforts to advance its pricing and reimbursement
discussions in a number of other European markets; and
beliefs about the overall world-wide market potential and success
of VASCEPA/VAZKEPA generally. These forward-looking statements are
not promises or guarantees and involve substantial risks and
uncertainties. A 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, 2022. 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
(amarincorp.gcs-web.com), including but not limited to investor
presentations and investor FAQs, U.S. 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:Jordan ZwickAmarin
Corporation plcIR@amarincorp.com
Media Inquiries:Mark MarmurAmarin Corporation
plcPR@amarincorp.com
1
https://www.hartstichting.nl/hart-en-vaatziekten/cijfers-hart-en-vaatziekten2
Prevenzione Italia 2021. Un update del Documento di consenso e
raccomandazioni per la prevenzione cardiovascolare in Italia
(https://www.siprec.it/prevenzione-italia-2021/)
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