Amarin Announces VAZKEPA® (Icosapent Ethyl) Approved by Israel's Ministry of Health
Amarin Corporation (NASDAQ:AMRN) has received regulatory approval from Israel's Ministry of Health for VAZKEPA (icosapent ethyl). This approval allows the use of VAZKEPA to reduce the risk of cardiovascular events in adult statin-treated patients with elevated triglycerides and other high-risk characteristics. Heart disease is a significant health concern in Israel, being the second leading cause of death among individuals aged 45 and older. Amarin is actively pursuing partnerships and will begin preparing for pricing and reimbursement strategies in Israel starting in 2024.
- Regulatory approval of VAZKEPA in Israel expands market access.
- Addresses significant cardiovascular risk in a target patient population.
- Partnership discussions are pending, creating uncertainty in market entry.
- Pricing and reimbursement preparations are not finalized and depend on future discussions.
-- Approval of VAZKEPA® to Reduce the Risk of Cardiovascular (CV) Events in Adult Statin-Treated Patients at High CV Risk with Elevated Triglycerides and Other High-Risk Characteristics as Studied in REDUCE-IT –-
-- Heart Disease Second Leading Cause of Death in Men and Women Aged 45 and Older in Israel --
DUBLIN, Ireland and BRIDGEWATER, N.J., April 04, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Israel’s Ministry of Health (MOH) Pharmaceuticals Division has granted regulatory approval to VAZKEPA (icosapent ethyl). The MOH issued its approval of VAZKEPA to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]) and either established cardiovascular disease or diabetes and at least one other cardiovascular risk factor.
“According to data from the Israeli Ministry of Health, heart diseases are the second leading cause of death in Israel, in both men and women, aged 45 and older.i Heart disease accounted for about one-sixth of all male and female deaths in recent years in Israel.i
“The regulatory approval of VAZKEPA in Israel marks continued progress in our effort to bring this product to patients with residual cardiovascular risk around the world,” said Steven Ketchum, PhD., President, Research & Development and Chief Scientific Officer, Amarin. “We are proud of this important milestone in that effort, and that patients in Israel may soon be able to access this important therapeutic option to address their residual cardiovascular risk.”
Amarin has partnership discussions underway in this territory and will be preparing for potential pricing and reimbursement in Israel beginning in 2024.
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our foundation in scientific research 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 increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk.
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 Amarin’s entry into Israel and continued expansion in other key international markets; Amarin’s partnership discussions for Israel; the potential pricing and reimbursement for VAZKEPA in Israel beginning in 2024; and the overall potential and future success of VASCEPA (marketed as VAZKEPA in Europe) and Amarin generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. 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 full year ended 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
Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs, 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:
Lisa DeFrancesco
Amarin Corporation plc
IR@amarincorp.com
Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com
i Israeli Ministry of Health – Health Information Division. Leading causes of death in Israel 2000 – 2019. https://www.gov.il/BlobFolder/reports/leading-causes-of-death-in-israel/he/files_publications_units_info_CausesOfDeaths2019_Summary.pdf
FAQ
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