-- Spain's Drug Pricing Committee recommends reimbursement of VAZKEPA(®)
(icosapent ethyl) to reduce the risk of cardiovascular (CV) events in patients
with high cardiovascular risk(1) --
-- Positive recommendation marks the final step in the reimbursement process in
Spain following months of active negotiations between the Spanish Ministry of
Health, the regional authorities and Amarin --
-- Amarin expects eligible cardiovascular patients to be able to access VAZKEPA
under national reimbursement as of September 1, 2023 --
DUBLIN, Ireland and BRIDGEWATER, N.J., July 25, 2023 (GLOBE NEWSWIRE) -- 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 risk(1).
"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 cancer(2). 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 disability(3).
"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 Amarin
Amarin 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 Statements
This 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 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 Information
Investor Inquiries:
Jordan Zwick
Amarin Corporation plc
IR@amarincorp.com (mailto:IR@amarincorp.com)
Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com (mailto:PR@amarincorp.com)
____________________
(1) Spanish Ministry of Health.
https://www.sanidad.gob.es/profesionales/farmacia/pdf/NOTAINFORMATIVACIPM_JULIO23.pdf
(2) Instituto Nacional de Estadística. Defunciones según la Causa de Muerte.
Available from: https://www.ine.es/jaxiT3/Datos.htm?t=14819
(https://www.ine.es/jaxiT3/Datos.htm?t=14819)(3) 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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