Amarin - The Science Of Lipid Therapy (Seite 13)

[lobberland]

Antwort auf Beitrag Nr.: 71.760.083 von Magnetfeldfredy am 11.06.22 17:22:04

Schöne News
Könnte man eigentlich noch mal nachlegen 🤔🤪

[Magnetfeldfredy]

Amarin

Englands renommierte Zeitung publiziert Amarin Riesenerfolg, big pharma läßt Amarin die Drecksarbeit mit Erstattung machen und schnappt sich dann die Firma, wenigstens wird uns in Europa kein Generika 10 Jahre in die Quere kommen:

The Telegraph
New heart attack drug to be offered to patients who need more than just statins
Laura Donnelly
Fri, June 10, 2022 at 7:45 PM·3 min read
Heart attack
Heart attack

Nearly 500,000 people for whom statins are not enough will be given extra drugs to cut the risk of heart attacks, following new NHS guidance.

Around one in three people who are already on statins because of high cholesterol levels also have raised blood fats, which put them in greater danger.

The draft guidance from the National Institute of Health and Care Excellence (Nice) means that, for the first time, many such patients will be offered tailored medication.

Studies have found that icosapent ethyl, the first licensed treatment for the condition, can cut the risk of heart attacks and strokes by more than a quarter.

The new guidance means it can be offered to about 425,000 people on statins who have raised levels of triglycerides.

The recommendation in favour of the treatment, also called Vazkepa and made by Amarin, will apply only to patients whose “bad” cholesterol levels - low-density lipoprotein cholesterol - are controlled.

Until now, there have been no medicines for people at risk of cardiovascular events who have raised levels of triglycerides despite taking statins or other anti-cholesterol drugs.
Final consultation with patients over drug

NHS England estimates that between 25 per cent and 35 per cent of the eight million people in the UK taking statins have elevated levels of the blood fat.

Triglycerides are our main source of energy and essential for good health. However, too much in your blood can indicate a higher risk of cardiovascular events. It can also cause damage to arteries in organs such as the brain, heart, kidneys and eyes.

Helen Knight, interim director of medicines evaluation at Nice, said: “Icosapent ethyl is the first licensed treatment of its kind for people who are at risk of heart attacks and strokes despite well-controlled LDL cholesterol because they have raised blood fats. And although lifestyle changes, including diet and exercise, can help to reduce their risk, these may not work for everyone.

“We have worked closely with the company to identify the population most likely to gain the greatest benefit from icosapent ethyl, striking a balance between effectiveness and the best use of public funding, delivering maximum value to the taxpayer.”

Final guidance is expected next month, following a consultation with patients and professional groups.

Heart and circulatory disease are one of the biggest killers in the UK, causing one quarter of all deaths. Four million men and about 3.6 million women suffer from heart disease.

Icosapent ethyl, which is given twice daily, is thought to reduce very low-density lipoprotein triglyceride synthesis and secretion in the liver, as well as enhance triglyceride clearance. The drug costs the NHS around £1.20 a pill, while statins cost pennies.

It follows warnings that heart attack deaths soared by one-fifth during the pandemic, according to a major review that warns of the huge “global collateral damage” of Covid and lockdowns.

An analysis of nearly 200 studies by researchers from Leeds University found deaths among people hospitalised due to severe heart problems increased by 17 per cent in two years. Patients also waited for more than an hour longer than usual for cardiac and heart attack callouts between December 2019 to December 2021.

Across the world, the number of heart operations carried out fell by 34 per cent. It follows warnings that many people kept away from GPs and hospitals or struggled to access services during the pandemic.

[oldguy2]

"Risiko lässt sich um bis zu 61 Prozent senken
Alle Teilnehmer erhielten alle drei Monate Kontrollanrufe und wurden jedes Jahr untersucht.

81 Teilnehmende entwickelten im Nachbeobachtungszeitraum eine Krebserkrankung. Als effektivste Krebsvorbeugung erwies sich die Dreier-Kombination aus Vitamin D, Omega-3-Fettsäuren und einem leichten Trainingsprogramm. Dieser Maßnahmen-Mix senkte das Krebsrisiko um 61 Prozent.

Wurden nur zwei Maßnahmen angewandt, ergab sich eine Risiko-Absenkung zwischen 44 und 48 Prozent. Nur eine Maßnahme zeigte eine Wirkung von 30 bis 34 Prozent.

Geringe Kosten, große Wirkung
Studienleiterin Heike A. Bischoff-Ferrari, Professorin für Geriatrie und Altersforschung an der Universität Zürich, erläutert in der Pressemitteilung: "Obgleich unsere Ergebnisse in einer längerfristigen und noch größeren Studie repliziert werden sollten, qualifizieren die drei Maßnahmen anhand ihrer hohen Sicherheit und den geringen Kosten bereits heute, um die hohe Last von Krebserkrankungen bei älteren Erwachsenen zu reduzieren."
https://www.t-online.de/gesundheit/krankheiten-symptome/id_9…

Tja, woher nur dieses Omega-3-Fettsäuren-Gebräu nehmen? Jeden Tag zwischen 300-500 g Fisch essen (lachs, Makrele)? Oder einen Teelöffel Leinöl? Oder ... 🤔😉

[Magnetfeldfredy]

Amarin

Das Management liefert endlich und mit 10 Jahre Exklusivität ist hier ein echter Turnaroundkandidat
am Markt zu Spottpreisen erhältlich, Amarin wird bald zweistellig übernommen!

Nochmals und weils so schön und wichtig ist, besonders der monatliche Preis ist zukunftsweisend für die anderen europäischen Länder:

Amarin: UK's NICE recommends reimbursement, use of VAZKEPA 06:03 AMRN Amarin announces that the UK's National Institute for Health and Care Excellence is recommending icosapent ethyl, marketed under the brand name VAZKEPA, for reimbursement and use across the National Health Service in England and Wales to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk who have elevated triglycerides, LDL-C levels greater than1.04 mmol/L, and established cardiovascular disease, at a price of GBP 144.21 per 120 soft capsules.

Read more at:
https://thefly.com/n.php?id=3529139

[Magnetfeldfredy]

Amarin

Top Meldung für Europa, NICE erstattet für England und Wales für EUR 170 im Monat, da wird sich Pfizer bald freuen:



Amarin Receives Positive Recommendation from United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE) for Reimbursement of VAZKEPA® (icosapent ethyl)

AMRN
-5.82%
Amarin Corporation plc
Fri, June 10, 2022, 12:00 PM
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AMRN
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Amarin Corporation plc
Amarin Corporation plc
UK’s NICE issued its draft Final Appraisal Document (FAD) recommending the use of VAZKEPA® (icosapent ethyl) in England and Wales to reduce the risk of cardiovascular (CV) events in adult statin-treated patients at high CV risk who have elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]) and established cardiovascular disease (eCVD) 1,2

Positive reimbursement recommendation follows the recent national reimbursement for VAZKEPA in Sweden and marks another major milestone in the company’s European growth strategy

DUBLIN, Ireland and BRIDGEWATER, N.J., June 10, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announces that the UK’s National Institute for Health and Care Excellence (NICE) is recommending icosapent ethyl (marketed under the brand name VAZKEPA®) for reimbursement and use across the National Health Service (NHS) in England and Wales to reduce the risk of cardiovascular (CV) events in adult statin-treated patients at high cardiovascular risk who have elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]), LDL-C levels >1.04 mmol/L (and ≤ 2.60 mmol/L) and established cardiovascular disease (eCVD), at a price of £144.21 per 120 soft capsules (i.e. 30-day supply; equivalent of approximately 170 EUR or 181 USD*).1,2

“We are extremely pleased with today’s positive recommendation by NICE,” said Karim Mikhail, president and chief executive officer. “This is another important step forward in successfully executing our European growth strategy, and considering that the UK has historically served as a reference market with regard to Health Technology Assessments, it is a major step toward unlocking the company’s multi-billion-dollar revenue opportunity outside of the U.S.**”

Cardiovascular disease ranks as one of the UK’s leading causes of death3. More than six million people live with cardiovascular disease in England, costing the NHS around £7.4 billion each year3,4. VAZKEPA represents an important scientific innovation for reducing cardiovascular risk in eligible patients across England and Wales, supported by the clinical data from the landmark REDUCE-IT® cardiovascular outcome study5.

The Final Appraisal Document (FAD) is part of NICE’s Health Technology Appraisal (HTA) process aimed at making recommendations on both the clinical and cost effectiveness of medicines and treatments in England to help ensure that the NHS uses its resources fairly and cost-effectively. Today’s FAD represents the NICE appraisal committee’s draft final guidance related to the use of icosapent ethyl within the NHS in England. NICE’s final guidance is expected to be published on the 13th of July 2022, after which all local NHS formularies are expected to make the product available within 3 months. Based on a collaboration with the Welsh Government and the All Wales Medicines Strategy Group (AWMSG), the final NICE guidances will also apply to Wales and be implemented across the NHS in Wales.

“This positive recommendation is the outcome of many months of constructive scientific discussions with multiple stakeholders and a detailed systematic review of clinical and economic evidence,” commented Laurent Abuaf, senior vice president and president Amarin Europe. “Following Sweden, this is now the second Health Technology Assessment in Europe that recognizes the potential value of VAZKEPA for strengthening cardiovascular care in England and Wales, following a very rigorous clinical and economic evaluation process. We look forward to working with all relevant stakeholders in the NHS to offer this important new treatment option to eligible cardiovascular patients across these countries in the UK.”

In parallel, Amarin continues to progress well with its reimbursement discussions in the other European markets and remains on track to receive pricing decisions in up to eight countries with plans to launch VAZKEPA in up to six European countries this year.

*Based on exchange rate of EUR and USD as of the date of this release.
** U.S. Dollar

About Amarin®
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation 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 rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.

About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules

VASCEPA capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over 18 million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, Germany and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain. The Great Britain Marketing Authorization for VAZKEPA applies to England, Scotland and Wales.

[Magnetfeldfredy]

Amarin

Neuer CFO, Alex Denner die Biotech Verkauslegende will ins BOD, Kostenreduktion, Nachtigall ich hör Dir trapsen, die Braut wird schön gemacht und Novartis wird meine Meinung nach kaufen, weltweit mehrere tausende Reps werden Vascepa zum Megablockbuster weltweit machen, KZ US Dollar 15:

Amarin Announces Comprehensive Cost Reduction Plan to Address Market Dynamics in U.S. Business

Amarin Corporation plc
Mon, June 6, 2022 at 2:30 PM
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Sarissa Capital Management Says Intends To Seek Representation On Amarin Corp PLC’S Board - SEC Filing

Amarin Corporation plc
Amarin Corporation plc

-- Company Expects to Achieve Approximately $100 Million in Cost Savings Over the Next 12 Months* While Continuing to Invest in European Launches and Global Expansion --

-- Reduces U.S. Commercial Organization by Ninety Percent of Pre-Pandemic / Pre-Generic Competition Levels --

-- Creates Core Focused U.S. Commercial Team to Support Branded VASCEPA Revenues --

-- Actions Optimize Operations While Maintaining Positive U.S. Contribution Margin to Support Company’s Next Steps --

DUBLIN, Ireland and BRIDGEWATER, N.J., June 06, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced important and critical actions including a comprehensive cost and organizational restructuring plan to address current shifts within the Company’s U.S. business. The Company expects these actions will reduce operating costs by approximately $100 million over the next 12 months* and enable Amarin to maintain a positive contribution margin in the U.S. while continuing to invest in its imminent European market launches and global expansion for VASCEPA/VAZKEPA.

“Our management team, with the guidance of our Board, conducted a comprehensive review of the business to ensure we are addressing the realities within our U.S. business while we focus on our global growth opportunities with efficiency and discipline,” said Karim Mikhail, Amarin’s president and chief executive officer. “While we continue to see value in branded VASCEPA in the U.S., the current operating landscape remains challenging with uncertainty related to future revenue from the U.S. business. As a result, today we are taking critical, proactive steps to reduce our U.S. commercial team by approximately 90% of our pre-pandemic and pre-generic competition levels. These reductions are necessary as we invest in our European launches while maintaining a strong, core U.S. Commercial team to support branded VASCEPA revenues in the U.S. These proactive steps also allow us to maintain a positive contribution margin for the U.S. business and continue our investments in other markets and our Fixed-Dose Combination (FDC) program to ensure we are positioned for a stronger future as we execute our European and global expansion plans.”

Mr. Mikhail added, “We have completely reshaped our investment plan for the future. We have tremendous confidence in our multi-billion dollar revenue opportunity for VASCEPA/VAZKEPA globally where we remain on track to launch in six markets and receive up to eight reimbursement decisions this year. These comprehensive actions will enable us to better serve patients while creating value for shareholders over the long-term.”

The Company will reduce its total operational expenditure by approximately $100 million over the next 12 months* while continuing its investments in European expansion. The Company’s cost reduction plan includes:

U.S. workforce reduction: The majority of the cost savings will result from a significant workforce reduction across the Company’s U.S. field force and corporate positions. Amarin will reduce its U.S. commercial team by approximately 65% from current levels and approximately 90% of pre-pandemic and pre-generic competition levels, resulting in a core team able to support branded VASCEPA revenues in the U.S. In total, these actions will result in a reduction of the total company employee base by over 40% from current levels.

Streamlined operational expenditures: Includes reductions and reallocations in overall selling, general and administrative (SG&A) expenses as well as savings related to refining the Company’s R&D strategy to a more focused, stepwise approach for its FDC program.

Mr. Mikhail concluded, “We value the tremendous contributions of our colleagues – whose dedication to our mission has helped build this Company and enabled us to launch an innovative product that has improved cardiovascular health for millions of patients. These changes, while difficult, are necessary to support our ability to continue bringing VASCEPA/VAZKEPA to patients around the world.”

*Compared to 2021 full year GAAP operating expenses and excludes restructuring charges.

[lobberland]

Ich hoffe das hier nimmt eines Tages ein gutes Ende
Ich hab rückblickend etwas oft nachgefasst 🙄

[Stevo0815]

Yes!!! Da geht was!

[Magnetfeldfredy]

Amarin

Sarissa Capital mit Legende Alex Denner steigt ein, Übernahme kommt näher:

Sarissa to seek Amarin board seats, says shares 'significantly undervalued' Sarissa Capital Management, which owns 6.05% of Amarin or 24M shares, disclosed that it has had discussions with the company and other interested parties about ways to maximize the value of its assets. More recently, Sarissa discussed with the Amarin "the disappointing first quarter results." Sarissa believes that the meaningful decrease in share price following the earnings announcement reflects the company's "insufficient adjustment to changing market conditions for its key drug Vascepa and investor concerns about the ability of leadership as currently constituted to navigate the Issuer during this critical time." Sarissa believes "that the expertise and experience of its principals would be extremely beneficial" to Amarin and intends to seek representation on its board of directors" It also believes the shares continue to be "significantly undervalued."

Read more at:
https://thefly.com/n.php?id=3525964

[Magnetfeldfredy]

AMRN

Servus,

sicher macht mich gar Nichts mehr bei Amarin, aber die GIA Strategie ist gescheitert und Pfizer zeigt in Canada wie es geht!

Gruß
Fredy