Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.
Amarin (NASDAQ:AMRN) has announced that the Greek Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement. This decision allows high-risk cardiovascular patients treated with statins and having elevated triglycerides to access the drug. VAZKEPA® has now achieved national reimbursement in seven European countries.
To commercialize VAZKEPA® in Greece, Amarin has partnered with Vianex S.A., a leading pharmaceutical company in Greece. Vianex will be the exclusive distributor, handling the import, registration, distribution, and commercialization of the product. Amarin will supply the finished product to Vianex at a transfer price. The distribution will commence in the coming weeks.
Amarin's President & CEO, Patrick Holt, highlighted that this approval underscores the strength of their scientific data and the value VAZKEPA® offers to patients at risk of cardiovascular events. Christos Papadopoulos, Amarin’s Senior VP and Head of Commercial Europe, emphasized Vianex's strong commercial capabilities and expertise in cardiology, which align well with successfully bringing VAZKEPA® to Greek patients.
- Greek Ministry of Health approved VAZKEPA® for national reimbursement.
- VAZKEPA® has now achieved national reimbursement in seven European countries.
- Amarin's partnership with Vianex S.A. provides strong commercial capabilities for effective product distribution.
- Vianex's expertise in cardiology and cardiovascular risk management aligns with VAZKEPA®'s target market.
- Approval offers a significant growth opportunity for Amarin in the European market.
- Amarin will supply the finished product to Vianex, ensuring control over product quality.
- Potential for increased operational costs due to new distribution partnership.
- Market competition in Greece may pose challenges to the commercialization of VAZKEPA®.
- The success of VAZKEPA® in Greece depends heavily on Vianex's performance, adding a layer of dependency risk.
Insights
The approval of VAZKEPA® for national reimbursement in Greece signifies a notable expansion in Amarin's market reach within Europe. For retail investors, this means potential revenue growth. Reimbursement approvals are critical as they often precede increased sales, given the accessibility they provide to patients.
Moreover, the exclusive marketing and commercialization agreement with Vianex S.A. is a strategic move. Vianex's established presence in Greece, with its centennial legacy and commercial strength, could significantly expedite market penetration. This partnership reduces Amarin's overheads related to local marketing and distribution, potentially boosting profitability. Investors should monitor the commercial performance in Greece over the coming quarters to gauge the financial impact.
Lastly, securing reimbursement in a European country can create a ripple effect, aiding approvals in other markets.
The national reimbursement of VAZKEPA® in Greece offers substantial potential benefits to patients with high cardiovascular risk, providing access to an established treatment shown to reduce cardiovascular events. From a medical perspective, the REDUCE-IT study underpins this approval, showcasing significant clinical data that supports the efficacy of icosapent ethyl in managing elevated triglycerides.
This approval could also bolster VAZKEPA's clinical credibility, prompting further adoption by healthcare providers in Greece and potentially other regions. The focus on patients treated with statins indicates a targeted approach to high-risk individuals, optimizing therapeutic outcomes in a population with pronounced cardiovascular threats.
The Greek market's inclusion in Amarin's European expansion for VAZKEPA® reflects a strategic geographic diversification. Cardiovascular diseases are a leading cause of death in Greece, presenting a substantial market for VAZKEPA®. The collaboration with Vianex S.A. leverages local expertise and established market channels, which are critical for effective product launch and sustained sales growth.
This move also aligns with Amarin's broader European strategy, having already secured reimbursement in six other countries, thereby reinforcing its market presence and competitive advantage. Investors should observe how this strategic alignment affects Amarin's market share in the cardiovascular treatment space.
-- Greek Ministry of Health approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce cardiovascular risk in statin-treated adult patients with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and other high-risk characteristics as studied in REDUCE-IT1 --
-- Approval marks seventh national reimbursement of VAZKEPA® in Europe --
-- Vianex S.A., one of the leading pharmaceutical companies in Greece, will commercialize VAZKEPA® as Amarin’s exclusive distributor in the country --
DUBLIN, Ireland and BRIDGEWATER, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announces that the Greek Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1.
As in most European countries, cardiovascular diseases are the main cause of death in Greece2. Today’s approval – which marks the seventh national reimbursement of VAZKEPA® in Europe – provides eligible patients across Greece access to a new treatment option to reduce their cardiovascular risk and help improve their overall heart health.
“We are very pleased with this seventh national reimbursement for VAZKEPA® supporting our continued growth opportunity in Europe which is a testament to the strength of our scientific data and the value of our product for patients at-risk for a cardiovascular event,” said Patrick Holt, President & CEO of Amarin.
To support the commercialization of VAZKEPA® in Greece, Amarin has entered into an exclusive agreement with Vianex S.A., one of the leading pharmaceutical companies in Greece celebrating its 100-year anniversary this year. Under the terms of the agreement, Vianex S.A. will be the sole and exclusive distributor of VAZKEPA® in the territory to import, register, distribute and commercialize the product. Amarin will be responsible for supplying finished product to Vianex at a transfer price paid to Amarin. Vianex will start commercializing VAZKEPA® in the course of the next weeks.
Christos Papadopoulos, Senior Vice President and Head of Commercial Europe at Amarin, commented: “We look forward to working with Vianex in bringing our VAZKEPA® treatment to healthcare providers and patients across Greece. As one of the country’s leading pharmaceutical companies, Vianex has strong commercial capabilities and deep expertise in cardiology and cardiovascular risk management. Their capabilities and experience align well with the opportunity to successfully commercialize VAZKEPA® and its proven ability to reduce cardiovascular risk and improve outcomes for patients.”
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.
About VIANEX S.A.
VIANEX S.A. is a Greek pharmaceutical company, founded in 1971 by the Giannakopoulos’ family that has been involved with the pharmaceutical industry since 1924. Through its 100-year history, VIANEX produces, imports, markets, packages and distributes a large number of pharmaceuticals, covering various therapeutic classes. It has formed strategic partnerships and alliances with major pharmaceutical entities across the globe.
VIANEX owns four state-of-the-art fully specialized Manufacturing Plants that guarantee outstanding production capabilities. It covers the entire spectrum of manufacturing activities while it continuously upgrades the range of services by investing in technological equipment. VIANEX has also been exporting registered products for over 20 years in 114 countries worldwide and is an approved supplier of the World Health Organization.
Strategic planning, focus to quality, operational excellence and long-term experience have contributed to a leading position in the Greek Pharmaceutical market, based on a long-term effort, that passes from generation to generation and constantly focuses to the future.
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 the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. 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 2023.
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 communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (https://amarincorp.com/investor-relations), 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 & Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com
1 https://www.moh.gov.gr/articles/times-farmakwn/epitroph-aksiologhshs-kai-apozhmiwshs-farmakwn/12338-entaksh-farmakwn-ston-katalogo-apozhmioymenwn-farmakwn?fdl=27053
2 European Commission – Greece Country Health Profile 2023 – access May 2024
FAQ
What is the recent approval received by Amarin for VAZKEPA® (AMRN)?
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