Amarin Receives Positive Recommendation from Spanish Drug Pricing Committee for National Reimbursement of VAZKEPA® (icosapent ethyl) in Spain
25 Julho 2023 - 5:05PM
Amarin Corporation plc (NASDAQ:AMRN) today announces that following
the most recent meeting of the Spanish Drug Pricing Committee
(Comisión Interministerial de Precios de los Medicamentos) on July
24, 2023, the Committee is recommending the national reimbursement
of VAZKEPA® (icosapent ethyl) to reduce the risk of cardiovascular
(CV) events in patients with high cardiovascular risk1.
“Cardiovascular disease is still one of Spain’s
leading causes of death and patients with this disease need access
to new treatments that can reduce their risk of having another
event. I am very pleased to see that our health authorities are now
making icosapent ethyl available in Spain which has shown to
significantly reduce cardiovascular risk and help to prevent future
heart attacks or strokes in these high cardiovascular risk
patients,” said Professor Luis Rodriguez Padial, cardiologist, and
elected president of the Spanish Society of Cardiology.
According to data published by the Spanish National
Statistics Institute (INE), in 2020 around 200,000 people died as a
result of cardiovascular disease (CVD), making it the leading cause
of death for the Spanish population as a whole, ahead of cancer2.
In addition, more than 457,000 new cases are diagnosed each year in
Spain. Cardiovascular health problems also have an impact on the
workplace and the economy, with an estimated impact of 0.7% of the
GDP in Spain, and a cost of more than 145 million euros per year in
temporary disability3.
“The positive recommendation for VAZKEPA in Spain
is an important step for the thousands of cardiovascular patients
who now have access to a new, innovative treatment option to reduce
their cardiovascular risk based on the robust clinical data and
evidence from the REDUCE-IT study,” said Patrick Holt, President
and CEO of Amarin. “Our team in Spain will now be
laser-focused on supporting efforts to reach healthcare
professionals and drive awareness and adoption of this important
new treatment for patients. I look forward to our launch efforts to
accelerate growth in this important market.”
The Company 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 Amarin’s financial performance, metrics, and
initiatives, including its 2023 revenues, operating expenses,
supply purchases, negotiations and settlements, product
prescriptions and managed care coverage, continued savings from
cost-cutting initiatives that is currently exceeding initial
targets, and Amarin’s overall ability to continue to deliver stable
revenues and cash position from its U.S. business; beliefs about
the timing and outcome of international commercial partnerships,
regulatory filings, reviews, recommendations, approvals, and
related reimbursement decisions and commercial launches of
VASCEPA/VAZKEPA outside of the U.S.; beliefs that Amarin’s current
resources are sufficient to fund projected operations; 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
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 (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 Spanish Ministry of Health.
https://www.sanidad.gob.es/profesionales/farmacia/pdf/NOTAINFORMATIVACIPM_JULIO23.pdf2
Instituto Nacional de Estadística. Defunciones según la Causa de
Muerte. Available from:
https://www.ine.es/jaxiT3/Datos.htm?t=148193 Institute for Health
Metrics and Evaluation (IHME). Global Burden of Disease Study 2019
[Internet]. 2021 [cited 2022 Dec 12]. Available
from: http://ghdx.healthdata.org/
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