Amarin Announces VAZKEPA® (icosapent ethyl) Receives Regulatory Approval in Switzerland
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Switzerland’s Swissmedic has granted approval to VAZKEPA (icosapent ethyl). Swissmedic approved VAZKEPA to reduce risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1.
-- Amarin Continuing Process for Obtaining National Pricing and Reimbursement in Switzerland in the Course of 2023 --
-- Swissmedic Approval Underpins Company’s Presence and Expansion in Switzerland as its Regional Commercial Hub for Europe --
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Switzerland’s Swissmedic has granted approval to VAZKEPA (icosapent ethyl). Swissmedic approved VAZKEPA to reduce risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1.
In parallel with the regulatory submission, Amarin had already initiated the process for obtaining national pricing and reimbursement in Switzerland, which is expected to conclude in the course of 2023.
According to the European Heart Network, the burden of cardiovascular disease (CVD) is greater than that of any other disease and the leading cause of death in Europe and in the world. 60 million people are living with CVD in the EU, with 13 million new cases of CVD each year2. Also in Switzerland, cardiovascular diseases are the most common cause of death – and the third most common cause of hospitalization – in the country3.
“This latest regulatory approval of VAZKEPA in Switzerland not only underscores the urgent need for proven therapies to help address residual cardiovascular risk for patients globally, it is also another example of an international health authority recognizing the value of our robust scientific evidence and innovative treatment to meet this need,” said Steven Ketchum, PhD., President, Research & Development and Chief Scientific Officer, Amarin.
The approval in Switzerland marks the sixth approval for the VASCEPA/VAZKEPA franchise within 2022. The approval also underpins the importance of Switzerland for Amarin’s European operations, having established its European Regional Hub in Zug, Switzerland in 2021. Today, the Company’s Zug office is the home to over 30 employees covering both local Swiss commercial and medical roles as well as global and regional roles providing support for the European teams.
Laurent Abuaf, SVP and President Amarin Europe: “Today’s regulatory approval of VAZEKPA in Switzerland is an important step as we seek national pricing and reimbursement and consider building out our local Swiss operations in support of a commercial launch in 2023. Switzerland is one of the most reputable and innovative biotech hubs in the world, with over 1,000 biotech and leading healthcare companies being based here. This provides companies such as Amarin with access to a tremendous talent pool that we are leveraging today in our regional hub to enable launch acceleration across Europe.”
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.
About VAZKEPA® (icosapent ethyl) Capsules
VAZKEPA capsules are the first prescription treatment comprised solely of the active ingredient, icosapent ethyl, a highly purified form of eicosapentaenoic acid. Since launch, icosapent ethyl has been prescribed over 18 million times. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, the United Arab Emirates under the brand name VASCEPA. In March 2021, marketing authorization was granted to icosapent ethyl in the European Union under the brand name 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 established cardiovascular disease or diabetes and at least one other cardiovascular risk factor4. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria and the UK.
EU Product Information
VAZKEPA® (ICOSAPENT ETHYL) 998 MG SOFT CAPSULES
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Indication: Vazkepa is indicated 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.
Further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, can be found here.
Globally, prescribing information varies; please refer to the individual country product label for complete information.
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 regulatory approval in Switzerland and the potential impact in that country; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA 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 2021. 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
[email protected]
Media Inquiries:
Mark Marmur
Amarin Corporation plc
[email protected]
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1 Swissmedic Journal: https://www.swissmedic.ch/swissmedic/de/home/ueber-uns/publikationen/swissmedic-journal/swissmedic-journal-2022.html
2 European Heart Network. Fighting cardiovascular disease – a blueprint for EU action https://ehnheart.org/eu-action-on-cvd.html#:~:text=Most%20recent%20data%20from%20the,of%20CVD%20occur%20every%20year. Accessed November 2022
3https://www.bfs.admin.ch/bfs/en/home/statistiken/kataloge-datenbanken/publikationen.assetdetail.1543-2200.html
4 Vazkepa® (icosapent ethyl): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf [accessed Nov 2022]
