Amarin Corporation Announces National Reimbursement Approval for VAZKEPA in Italy to Reduce Cardiovascular Risk in High-Risk Patients
Amarin Corporation Announces National Reimbursement Approval for VAZKEPA in Italy to Reduce Cardiovascular Risk in High-Risk Patients
Italy's NHS approved VAZKEPA for reimbursement, enhancing access for high-risk cardiovascular patients in Europe.
意大利的国家卫生服务(NHS)批准了VAZKEPA的报销,提升了欧洲高风险心血管患者的可及性。
Quiver AI Summary
Quiver AI 概要
Amarin Corporation has announced that the Italian National Health Service has approved VAZKEPA (icosapent ethyl) for national reimbursement to help reduce cardiovascular risk in eligible high-risk patients. This approval makes Italy the third market in the EU5 to offer national reimbursement for VAZKEPA, and the ninth such approval in Europe overall. With cardiovascular disease being the leading cause of death and hospitalization in Italy, the approval addresses a critical clinical need for effective treatment options. The decision follows a new strategy implemented by Amarin in 2023 aimed at improving reimbursement and access in Europe, which has led to significant progress as now over half of the eligible cardiovascular disease population in Western Europe has access to VAZKEPA. Amarin's president and CEO emphasized the importance of this approval for patients in Italy and its potential to enhance treatment for millions of individuals worldwide.
阿玛琳公司宣布,意大利国家卫生服务已经批准VAZKEPA(icosapent ethyl)进行国家报销,以帮助降低符合条件的高风险患者的心血管风险。这项批准使意大利成为EU5中第三个为VAZKEPA提供国家报销的市场,也是欧洲整体第九个此类批准。由于心血管疾病是意大利主要的死亡和住院原因,这项批准满足了对有效治疗方案的关键临床需求。这一决定是阿玛琳在2023年实施的新策略的结果,旨在改善欧洲的报销和可及性,现如今西欧超过一半符合条件的心血管疾病人群已经能够使用VAZKEPA。阿玛琳的总裁兼首席执行官强调了这一批准对意大利患者的重要性,以及其对全球数百万人的治疗潜力。
Potential Positives
潜在的积极因素
- Italy's National Health Service approved VAZKEPA for national reimbursement, allowing broader access for high-risk cardiovascular patients.
- This marks the third EU5 market to grant national reimbursement for VAZKEPA, reflecting the company's growing recognition in Europe.
- The approval underscores the success of Amarin's new strategic approach implemented in 2023, resulting in significant advancements in reimbursement efforts across Europe.
- With the patent protection for VAZKEPA extended to 2039, the company has a long-term competitive edge in the European market, fostering growth potential.
- 意大利国家卫生服务批准了VAZKEPA进行国家报销,允许高风险心血管患者获得更广泛的可及性。
- 这标志着第三个EU5市场授予VAZKEPA国家报销,反映了公司在欧洲日益增长的认可度。
- 该批准突显了阿玛琳在2023年实施的新战略方法的成功,导致在欧洲的报销努力取得显著进展。
- 随着VAZKEPA的专利保护延长至2039年,公司在欧洲市场上拥有长期的竞争优势,促进了增长潜力。
Potential Negatives
潜在负面因素
- Despite progress in securing reimbursement across several European markets, there remains a significant portion of the eCVD population in Europe that has yet to receive access to VAZKEPA, indicating potential market limitations.
- The forward-looking statements included in the release highlight substantial risks and uncertainties, which could concern investors about the company's future performance and stability.
- The mention of 'tremendous untapped opportunity' suggests that the company may not be fully capitalizing on existing potential, raising questions about its marketing and sales strategies.
- 尽管在多个欧洲市场获得了报销方面的进展,但仍有相当一部分eCVD人群在欧洲尚未获得VAZKEPA的使用权限,这表明潜在的市场限制。
- 公告中包含的前瞻性声明突显出重大的风险和不确定性,这可能让投资者担心公司的未来表现和稳定性。
- 提到的'巨大的未开发机会'暗示该公司可能没有充分利用现有潜力,提出了对其市场营销和销售策略的质疑。
FAQ
常见问题
What is VAZKEPA approved for in Italy?
VAZKEPA在意大利获得了什么批准?
VAZKEPA (icosapent ethyl) is approved for national reimbursement to reduce cardiovascular risk in eligible high-risk patients.
VAZKEPA(乙酯冰醇)已获得国家报销批准,用于降低合格的高风险患者的心血管风险。
How does Italy's approval benefit patients?
意大利的批准对患者有什么好处?
The approval provides eligible high-risk patients access to an effective treatment option for reducing cardiovascular events.
该批准使符合条件的高风险患者能够获得一种有效的治疗选择,以减少心血管事件。
What is the significance of Italy in VAZKEPA's European launch?
意大利在阿玛琳的VAZKEPA欧洲上市中有什么重要意义?
Italy is the third EU5 market to grant national reimbursement for VAZKEPA, enhancing patient access in Europe.
意大利是第三个为VAZKEPA提供国家报销的EU5市场,增强了患者在欧洲的获取。
What percentage of eCVD patients in Europe have access to VAZKEPA?
在欧洲,有多少比例的CVD患者能够获得VAZKEPA?
Countries providing access to VAZKEPA now account for over 50% of the total established cardiovascular disease population in Western Europe.
目前提供VAZKEPA的国家占西欧总确诊心血管疾病患者的50%以上。
What strategic changes did Amarin implement in 2023?
阿玛琳在2023年实施了什么战略变化?
Amarin executed a focused strategy to advance reimbursement, access, and commercialization of VAZKEPA in European markets.
阿玛琳执行了一个集中策略,以推进VAZKEPA在欧洲市场的报销、获取和商业化。
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
免责声明:这是由GlobeNewswire分发的新闻稿的人工智能生成摘要。用于总结这份稿件的模型可能会出错。请在这里查看完整发布。
$AMRN Insider Trading Activity
$AMRN 内部人交易活动
$AMRN insiders have traded $AMRN stock on the open market 1 times in the past 6 months. Of those trades, 1 have been purchases and 0 have been sales.
$AMRN 内部人在过去 6 个月中在公开市场交易 $AMRN 股票 1 次。其中 1 笔是购买,0 笔是出售。
Here's a breakdown of recent trading of $AMRN stock by insiders over the last 6 months:
以下是过去 6 个月内部人对 $AMRN 股票的近期交易情况:
- AARON BERG (President and CEO) purchased 160,000 shares.
- 亚伦·伯格 (总裁兼首席执行官) 购买了 160,000 股。
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
要跟踪内部交易,请查看Quiver Quantitative的内部交易特斯拉-仪表。
$AMRN Hedge Fund Activity
$AMRN 对冲基金活动
We have seen 41 institutional investors add shares of $AMRN stock to their portfolio, and 83 decrease their positions in their most recent quarter.
我们看到 41 家机构投资者在最近的季度中增加了 $AMRN 股票的持仓,而 83 家减少了他们的持仓。
Here are some of the largest recent moves:
以下是最近的一些重大变动:
- DG CAPITAL MANAGEMENT, LLC removed 5,115,747 shares (-100.0%) from their portfolio in Q3 2024
- TANG CAPITAL MANAGEMENT LLC removed 2,500,000 shares (-100.0%) from their portfolio in Q2 2024
- PRICE JENNIFER C. removed 2,380,000 shares (-100.0%) from their portfolio in Q3 2024
- GSA CAPITAL PARTNERS LLP removed 1,183,917 shares (-100.0%) from their portfolio in Q3 2024
- EVERSEPT PARTNERS, LP removed 999,218 shares (-23.2%) from their portfolio in Q3 2024
- TWO SIGMA INVESTMENTS, LP removed 657,605 shares (-21.6%) from their portfolio in Q3 2024
- TWO SIGMA ADVISERS, LP removed 613,900 shares (-23.7%) from their portfolio in Q3 2024
- DG资本管理公司在2024年第三季度从其投资组合中移除了5,115,747股(-100.0%)
- 唐资本管理公司在2024年第二季度从其投资组合中移除了2,500,000股(-100.0%)
- 珍妮弗·C·普赖斯在2024年第三季度从其投资组合中移除了2,380,000股(-100.0%)
- GSA资本合伙公司在2024年第三季度从其投资组合中移除了1,183,917股(-100.0%)
- EVERSEPt合伙公司在2024年第三季度从其投资组合中移除了999,218股(-23.2%)
- TWO SIGMA INVESTMENTS合伙公司在2024年第三季度从其投资组合中移除了657,605股(-21.6%)
- TWO SIGMA ADVISERS合伙公司在2024年第三季度从其投资组合中移除了613,900股(-23.7%)
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
要跟踪对冲基金的股票投资组合,请查看Quiver Quantitative的机构持有情况仪表。
Full Release
完整发布
-- Italian Health Authorities Approve VAZKEPA (icosapent ethyl) for National Reimbursement to Reduce Cardiovascular Risk in Eligible High-Risk Patients
1
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-- 意大利卫生部门批准VAZKEPA(乙基icosapent)用于降低符合条件的高风险患者的心血管风险的国家报销
1
--
-- Italy is the Third EU5 Market to Grant National Reimbursement; Ninth
National Reimbursement for VAZKEPA Overall in Europe
--
-- 意大利是第三个给予国家报销的EU5市场;第九个
VAZKEPA在欧洲的国家报销总数
--
-- European Progress Has Advanced Patient Access: Countries That Have Provided Access to VAZKEPA Now Account for More Than 50% of the Total Established Cardiovascular Disease (eCVD) Population in Western Europe --
-- 欧洲的进展已促进患者的接入:现在提供VAZKEPA的国家占西欧所有确诊心血管疾病(eCVD)人群的50%以上 --
-- Italy Approval Further Validates the Progress Made by the Company Following Execution of a New Strategy Implemented in 2023 --
-- 意大利的批准进一步验证了公司在2023年实施的新策略所取得的进展 --
DUBLIN and BRIDGEWATER, N.J., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced that Italy's National Health Service (NHS) approved VAZKEPA for national reimbursement to reduce cardiovascular risk in eligible high-risk patients, as published in the Official Journal of the Italian Republic (i.e.
Gazzetta Ufficiale della Repubblica Italiana)
1
.
都柏林和新泽西州布里奇沃特,2024年12月16日(全球新闻稿)-- 阿玛琳公司(纳斯达克:AMRN)今天宣布,意大利国家卫生服务(NHS)已批准VAZKEPA为符合条件的高风险患者提供国家报销,以降低心血管风险,相关信息已在《意大利共和国官方公报》(即
《意大利共和国官方公报》)
1
.
As in most European countries, cardiovascular disease is the leading cause of death and hospitalization in Italy, with over 217,000 deaths
2
per year and over 107,000 hospitalizations annually due to myocardial infarction alone
3
. One in five cardiovascular patients experience another cardiovascular event within 12 months of their first event
4
, highlighting the urgent need for new treatment options to reduce cardiovascular risk.
与大多数欧洲国家一样,心血管疾病是意大利的主要死亡和住院原因,每年超过217,000人因心血管疾病去世,
2
每年仅因心肌梗死就有超过107,000人住院。
3
五分之一的心血管患者在第一次事件后的12个月内会经历另一次心血管事件
4
这突显了迫切需要新的治疗选择以降低心血管风险。
Commenting on the reimbursement, Dr Aldo Pietro Maggioni, Director of the Study Center of the Italian Association of Hospital Cardiologists (
centro studi ANMCO
) stated: "Patients with established cardiovascular disease and elevated triglycerides, despite a well-managed LDL-C level, still have a higher likelihood of experiencing subsequent CV events, as there are currently no effective therapies for this patient phenotype. The Italian regulatory authority addressed this clinical need by authorizing the reimbursement of icosapent ethyl which, in the REDUCE-IT study, has shown to reduce cardiovascular death as well as recurrent myocardial infarction, stroke and coronary revascularization. The reimbursement approval of icosapent ethyl offers clinicians an additional effective treatment option for high cardiovascular risk patients
."
评论报销问题时,意大利医院心脏病学会研究中心的董事阿尔多·皮埃特罗·马基奥尼博士(
centro studi ANMCO
)表示:“对于已经确诊为心血管疾病且甘油三酯升高的患者,即使LDL-C水平管理良好,仍然有更高的可能性经历随后的心血管事件,因为目前对这种患者表型没有有效的治疗方法。意大利监管机构通过授权报销icosapent ethyl来解决这一临床需求,研究显示该药物能减少心血管死亡率、复发性心肌梗死、中风和冠状动脉再血管化。对icosapent ethyl的报销批准为心血管高风险患者提供了额外的有效治疗选择。”
."
Italian Approval Underscores Impact & Progress of New Strategy
意大利的批准强调了新策略的影响和进展
As highlighted in Amarin's
Investor Day
in November, in 2023 the Company implemented a more focused strategic approach to advance reimbursement, access and commercialization in Europe. This improved strategy has delivered meaningful results. Over the last 18 months, and factoring in the Italy approval, the Company has now secured national reimbursement in 3 of the EU5 markets and nine European markets overall. This represents more than 50% of the current total eCVD eligible patient population across Western Europe.
正如阿玛琳在
投资者日
在2023年11月,公司实施了一种更为专注的战略,以推动在欧洲的报销、准入和商业化。这一改善的策略取得了显著成效。在过去18个月中,考虑到意大利的批准,公司现在已在欧盟5国的3个市场以及整体9个欧洲市场上获得了国家报销。这代表着当前西欧超过50%的eCVD符合患者人群总数。
Additionally, as a reminder, the intellectual property for VAZKEPA in Europe has recently been extended to 2039. Unlike the US, there is no "skinny label" risk that permits competitive entry prior to the 2039 expiration of the Company's patents for the cardiovascular risk indication for VAZKEPA.
此外,提醒一下,VAZKEPA在欧洲的知识产权最近已延长至2039年。与美国不同,这里没有"瘦标签"风险,允许在公司为心血管风险指示的专利到期之前竞争进入市场。
Commenting on the Italian approval, Aaron Berg, President & CEO of Amarin, said, "Today is an important day, not only for Amarin, but for patients in Italy, the third largest economy in Europe. We appreciate that the Italian authorities have recognized the strength of the clinical data supporting VAZKEPA and affirming the potential impact it can have for the many eCVD patients across all of Italy."
阿玛琳的总裁兼首席执行官亚伦·伯格评论意大利的批准时表示:"今天是一个重要的日子,不仅对阿玛琳来说,对意大利患者来说也是如此,因为意大利是欧洲第三大经济体。我们感谢意大利当局承认支持VAZKEPA的临床数据的实力,并确认它对意大利众多eCVD患者的潜在影响。"
Commenting on the Company's progress in Europe and globally, Berg said, "Today's announcement is another important step that builds upon the strong foundation to capitalize on the tremendous untapped opportunity for VAZKEPA globally. With recently granted patent protection extending the exclusivity in Europe to 2039, it is still early in the lifecycle with a long runway to generate growth. Backed by strong science validated through the endorsement of over 50 medical societies globally, and with 46 countries that have now approved VASCEPA/VAZKEPA for cardiovascular risk reduction, we know there remains significant potential to benefit millions of patients worldwide. Our focus remains clear: to capitalize on the global value opportunity for VASCEPA/VAZKEPA by getting it into the hands of as many patients as possible. That is our commitment to patients, providers, employees and shareholders."
伯格在评论公司在欧洲和全球的进展时说:"今天的公告是另一个重要步骤,基于强大的基础,利用VAZKEPA在全球未被开发的巨大机会。随着最近获得的专利保护将欧洲的独占权延长至2039年,这仍然是生命周期的早期阶段,有很长的增长发展空间。借助通过全球50多个医学协会的认可而验证的强大科学支持,以及现在已有46个国家批准VASCEPA/VAZKEPA用于心血管风险降低,我们知道仍然有巨大的潜力可以使全球数百万患者受益。我们的关注点依然明确:通过将VASCEPA/VAZKEPA交到尽可能多的患者手中,利用全球价值机会。这是我们对患者、提供者、员工和股东的承诺。"
About Amarin
关于阿玛琳公司
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.
阿玛琳是一家创新的药品公司,领导心血管疾病管理的新范式。我们致力于增加对超出传统疗法的心血管风险的科学理解,并推动全球患者治疗这一风险。阿玛琳在美国新泽西州布里奇沃特、爱尔兰都柏林、瑞士楚格以及其他欧洲国家设有办事处,并在全球范围内拥有商业合作伙伴和供应商。
Forward-Looking Statements
前瞻性声明
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.
本新闻稿包含根据1995年《私人证券诉讼改革法》的安全港条款所作出的前瞻性陈述,包括对VASCEPA(在欧洲以VAZKEPA销售)潜力的看法;关于适合的心血管疾病(CVD)患者与乙酰氧化氢(IPE)的关系以及潜在的群体健康影响的看法,以及对VASCEPA安全性和有效性的一般看法。这些前瞻性陈述并不是承诺或保证,涉及实质性风险和不确定性。有关这些风险、不确定性和与阿玛琳投资相关的其他风险的进一步清单和描述,可以在阿玛琳向美国证券交易委员会的文件中找到,包括阿玛琳2023年年度报告的10-K表格。
现有和潜在投资者被警告,不要过分依赖这些前瞻性声明,这些声明仅在作出时有效。阿玛琳没有义务更新或修订其前瞻性声明中包含的信息,无论是由于新信息、未来事件或情况或其他原因。阿玛琳的前瞻性声明并不反映公司可能进行的重大交易的潜在影响,例如合并、收购、处置、合资企业或阿玛琳可能进入、修订或终止的任何重要协议。
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the company website (
) 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.
Availability of Other Information About Amarin
阿玛琳通过公司网站与投资者和公众进行沟通(
)和投资者关系网站(
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 & Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com
阿玛琳联系信息
投资者和媒体咨询:
马克·马尔默
阿玛琳有限公司
PR@amarincorp.com
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Lstat 2021 -
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Lstat 2021 -
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PNE 2022
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PNE 2022
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Gargiulo G. et al. 2022
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Gargiulo G. 等人. 2022