Amarin Receives Positive Recommendation from Spanish Drug Pricing Committee for National Reimbursement of VAZKEPA® (icosapent ethyl) in Spain
— Spain’s Drug Pricing Committee recommends reimbursement of VAZKEPA® (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in patients with high cardiovascular risk1 —
— 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 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.
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.
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.
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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
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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