Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal

Rhea-AI Summary

Amarin plc (NASDAQ:AMRN) has announced that the Portuguese Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement. This approval is aimed at reducing cardiovascular event risks in adult statin-treated patients with high cardiovascular risk, elevated triglycerides, and established cardiovascular disease or diabetes with at least one other cardiovascular risk factor.

The reimbursement, effective August 1, 2024, marks the eighth national reimbursement of VAZKEPA® in Europe, where Amarin has intellectual property protection until 2039. This approval addresses a significant need in Portugal, where cardiovascular disease accounts for 29% of total mortality. Amarin's CEO, Aaron Berg, emphasized the importance of this new treatment option for Portuguese patients and physicians.

Positive

• Approval of VAZKEPA® for national reimbursement in Portugal, expanding market access
• Eighth national reimbursement of VAZKEPA® in Europe, indicating growing acceptance
• Intellectual property protection for VAZKEPA® in Europe until 2039
• Addressing a significant market need with 29% of total mortality in Portugal due to cardiovascular disease
• Potential for accelerated European growth with the addition of a new territory

Negative

• None.

Insights

Financial Analyst

The national reimbursement approval for VAZKEPA® (icosapent ethyl) in Portugal is a significant development for Amarin Corporation. This move opens up a new market, thereby potentially increasing revenue streams for the company. Portugal, with its high prevalence of cardiovascular disease (29% of total mortality), represents a substantial market opportunity. This reimbursement ensures that the drug is accessible to a larger patient population, likely leading to higher sales volume.

From a financial perspective, the key metric to watch will be revenue growth stemming from Portuguese sales as early as August 2024. Investors should monitor quarterly earnings to see how quickly and effectively Amarin can capitalize on this new reimbursement approval. Additionally, Portugal marks the eighth European country to approve VAZKEPA, indicating Amarin’s growing footprint in Europe and its potential for further expansions.

However, investors should be cautious about potential execution risks. The speed at which Amarin can establish and grow its market share in Portugal will be crucial. Additionally, they should be aware of competitive dynamics and healthcare budget constraints that might affect reimbursement rates and overall adoption.

Medical Research Analyst

The approval of VAZKEPA® for reimbursement in Portugal is an important milestone in the medical and healthcare sector. VAZKEPA is indicated for reducing cardiovascular events in patients with high cardiovascular risk and elevated triglycerides, a important need in a country with a significant burden of cardiovascular disease.

Clinical trials have shown that VAZKEPA can significantly reduce the risk of major cardiovascular events such as heart attack and stroke. This makes it a valuable addition to the treatment arsenal for high-risk patients, particularly those who are already on statin therapy but still have elevated triglycerides.

For medical practitioners, this means having an effective new tool to manage cardiovascular risk, potentially reducing hospitalizations and healthcare costs in the long term. However, it is important for healthcare providers to closely monitor patients for any adverse effects and ensure that the drug is used in the appropriate patient population to maximize benefits.

-- Portuguese Ministry of Health approves VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular (CV) events in patients with established cardiovascular disease (CVD)¹ --

-- Approval marks eighth national reimbursement of VAZKEPA® in Europe --

DUBLIN, Ireland and BRIDGEWATER, N.J., July 17, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announces that the Portuguese 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 and elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor¹. The national reimbursement will now allow Amarin to begin commercialization efforts of VAZKEPA across Portugal as of August 1, 2024.

According to Statistics Portugal (Instituto Nacional de Estatística - INE), the prevalence of established cardiovascular disease in the adult population between 45 and 79 years of age in Portugal is 10.7%². The growing prevalence of cardiovascular risk factors in the country has resulted in more than 35,000 annual deaths from cardiovascular disease, constituting 29% of the total mortality in 2017³. These figures demonstrate a clear need for action to reduce the immense burden of this disease on patients, their families, and the Portuguese healthcare system.

“With the approval and reimbursement of VAZKEPA in Portugal, Portuguese cardiovascular patients and physicians now have access to an important new treatment option backed by strong clinical results to reduce cardiovascular risk and improve health outcomes,” said Aaron Berg, President and CEO of Amarin. “This approval marks the eighth national reimbursement of VAZKEPA in Europe, where we have intellectual property protection into 2039. This approval also adds a new territory and opportunity to reinforce the value of VAZKEPA for patients and accelerate our European growth.”  

Amarin 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.

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¹Infarmed, Relatório de avaliação de financiamento público de Vazkepa (eicosapente de etilo). Available: https://www.infarmed.pt/web/infarmed/infarmed?p_p_id=101&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&_101_struts_action=%2Fasset_publisher%2Fview_content&_101_returnToFullPageURL=%2Fweb%2Finfarmed%2Finfarmed&_101_assetEntryId=10172031&_101_type=document&inheritRedirect=false&redirect=https%3A%2F%2Fwww.infarmed.pt%2Fweb%2Finfarmed%2Finfarmed%3Fp_p_id%3D3%26p_p_lifecycle%3D0%26p_p_state%3Dmaximized%26p_p_mode%3Dview%26_3_redirect%3D%252Fweb%252Finfarmed%252Finfarmed%26_3_keywords%3Dvazkepa%2B%2528eicosapente%2Bde%26_3_groupId%3D15786%26_3_struts_action%3D%252Fsearch%252Fsearch
² “Portal do INE.” https://www.ine.pt/xportal/xmain?xpid=INE&xpgid=ine_indicadores&indOcorrCod=0007307&contexto=bd&selTab=tab2 (accessed Oct. 20, 2022).
³ Cristina Gavina 1,2, Daniel Seabra Carvalho 1,3, Marisa Pardal 4 , Marta Afonso-Silva 4, Diana Grangeia 4, Ricardo Jorge Dinis-Oliveira 5,6,7,8 , Francisco Araújo 9,† and Tiago Taveira-Gomes (The LATINO Study) J. Clin. Med. 2022, 11, 6825. https://doi.org/10.3390/jcm11226825, https://www.mdpi.com/journal/jcm

About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. 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 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 (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.

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 (investor.amarincorp.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 & Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com

FAQ

When will VAZKEPA® be available for reimbursement in Portugal?

VAZKEPA® will be available for reimbursement in Portugal starting August 1, 2024, as announced by Amarin plc (NASDAQ:AMRN).

What is the approved use of VAZKEPA® in Portugal?

VAZKEPA® is approved in Portugal to reduce cardiovascular event risks in adult statin-treated patients with high cardiovascular risk, elevated triglycerides, and established cardiovascular disease or diabetes with at least one other cardiovascular risk factor.

How many European countries have approved VAZKEPA® for national reimbursement?

As of July 17, 2024, VAZKEPA® has received national reimbursement approval in eight European countries, with Portugal being the latest addition.

What is the prevalence of established cardiovascular disease in the adult population in Portugal?

According to Statistics Portugal, the prevalence of established cardiovascular disease in the adult population between 45 and 79 years of age in Portugal is 10.7%.