Auch wenn es noch einige Zeit dauern wird bis die Generika auf dem US-Markt verfügbar sein werden, stellt sich nun die Frage wieviel Amarin wert ist, ohne das US-Geschäft, dass auch absehbare Zeit wegzubrechen droht? In Europa gibt es noch keine Zulassung und die Umsätze sind ungewiss.
GSK, Teva appeals court ruling could benefit Amarin, says Citi 05:54 AMRN, TEVA, GSK A U.S. appeals court on Friday ruled that Teva (TEVA) infringed on GlaxoSmithKline's (GSK) carvedilol heart failure patent, despite Teva's generic carvedilol launching with a "skinny label" that "carved out" the heart failure indication, Citi analyst Joel Beatty tells investors in a research note. The analyst believes the ruling could potentially benefit Amarin (AMRN) by making potential generic Vascepa competitors more hesitant to launch a generic competitor, more open to a settlement, and more likely to be assessed "large and meaningful" damages if a generic Vascepa is launched. Over 90% of generic Vascepa Sales would likely be for the "carved out" REDUCE-IT indication, and this could be problematic for generics," says Beatty. He keeps a Buy rating on Amarin with a $12 price target. The stock closed Friday up 21c to $4.47.
Sehe ich das richtig? Der CEO hat Aktienoptionen zum Erwerb für 3.40$ ausgeübt und dann gleich wieder zu Marktpreisen von knapp über 4 $ verkauft? Leichte 20% für John Thero. Aber ein Vertrauensbekenntnis zu AMRN ist es in meinen Augen nicht.
Top Ergebnisse bei Covid Patienten mit Amarins Vascepa, müsste für eine Kursverdoppelung reichen, riesige Chance:
Amarin Reports Encouraging Efficacy and Safety Results from Pilot Study Treating COVID-19 Infected Outpatients with VASCEPA® (Icosapent Ethyl) in Late Breaker Presentation at National Lipid Association (NLA) Scientific Sessions 2020 Amarin Corporation plc Sun, December 13, 2020, 3:30 AM GMT+1
VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in patient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose
VASCEPA administration resulted in a significant 52% reduction of the total patient-reported symptom outcome prevalence score as compared to a 24% reduction in the usual care group
Larger follow-on clinical studies have commenced of VASCEPA as a therapeutic option in COVID-19 settings, anticipated to be completed in 2021
Amarin to Webcast Discussion of Presented Data on Monday, December 14, 2020 at 8:00 a.m., Eastern Standard Time
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 12, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of clinical results from the CardioLink-9 Trial, the first results of a study of VASCEPA® (icosapent ethyl) in COVID-19 infected outpatients. The presentation, ?First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial?, was made virtually as a Late Breaker at the National Lipid Association (NLA) Scientific Sessions 2020, and was presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women?s Hospital, Harvard Medical School, Boston, MA.
?In the current environment, most COVID-19 positive patients remain outside of the clinical setting, following the advice of their doctor to stay home and quarantine unless absolutely necessary to enter the hospital,? commented Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto and co-principal investigator of COVID-19 CardioLink-9 and the encouraging results of this pilot study. ?The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive option to impact upon COVID-19-related morbidity. The reduction in markers of inflammation with icosapent ethyl is also important given what we know about the pathobiology of COVID-19.?
The VASCEPA COVID-19 CardioLink-9 Trial was a randomized, open-label trial enrolling 100 SARS-CoV-2 positive and symptomatic outpatients displaying at least one of the following: fever, cough, sore throat, shortness of breath, myalgia. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Patients randomized to the non-active arm received usual care. Baseline characteristics were comparable between groups.
The primary biomarker endpoint of the study was within-group changes in high-sensitivity C-reactive protein (hsCRP), a measure of inflammation. Within-group changes in D-dimer were also examined. VASCEPA administration resulted in a 25% reduction in hsCRP (p=0.011) as well as a reduction in D-dimer (p=0.048).
In addition to these biomarker changes, assessment was made of COVID-19 symptom changes from baseline to 14 days in the influenza patient-reported outcome (FLU-PRO) score, a validated patient-reported outcome measure designed to evaluate the presence, severity and duration of flu symptoms in clinical trials. VASCEPA administration resulted in a significant 52% reduction of the total FLU-PRO prevalence score as compared to a 24% reduction in the usual care group (p=0.003 between groups), with reductions across individual score domains, including a significantly larger reduction compared to usual care in the body/systemic domain (54% vs. 26%; p=0.003). Significant reductions in the FLU-PRO symptom score compared to usual care were also observed in the total symptom score (p=0.003), as well as in the body/systemic (p=0.0007) and chest/respiratory (p=0.01) domains.
VASCEPA CardioLink-9 Study is an investigator-initiated study supported by Amarin and by HLS Therapeutics, Inc. The principal investigators of the study were Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto and Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women?s Hospital and Professor of Medicine at Harvard Medical School.
Limitations of this study include the modest sample size, the unblinded nature of this randomized trial, and that the trial was not powered for clinical events. These results have not yet been published or reviewed by regulatory authorities. Additional study is needed.
This randomized trial represents the first human experience with an 8 g/day loading dose of icosapent ethyl and has suggested short-term safety and tolerability in a modest sample size. Regarding COVID-19, this study provides the first evidence of potential early anti-inflammatory effect of icosapent ethyl in symptomatic, COVID-19 positive outpatients.
Amarin added that the VASCEPA COVID-19 CardioLink-9 trial is the first in a series of ongoing investigator-sponsored studies into the potential role of VASCEPA therapy in COVID-19 settings. Other ongoing trials include PREPARE-IT: Prevention of COVID19 With EPA in Healthcare Providers at Risk - Intervention Trial sponsored by Estudios Clínicos Latino América, and A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) sponsored by Kaiser Permanente.
This presentation of CardioLink-9 study results was one of multiple data presentations at the NLA Scientific Sessions supported by Amarin. Additional information on NLA Scientific Sessions 2020 can be found here.
Audio Webcast Information Amarin will host an audio webcast on Monday, December 14, 2020, at 8:00 a.m. EST to further discuss these and other VASCEPA-related findings presented during the NLA Scientific Sessions 2020. The discussion will include various clinicians and scientists and will be moderated by Amarin?s chief medical officer, Craig Granowitz, M.D., Ph.D. To listen please register here, listen live on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-407-8033 within the United States, 201-689-8033 from outside the United States. Any opinions or views expressed by the clinicians and scientists on the audio webcast are theirs alone. They have neither been scripted nor previewed by Amarin. While Amarin respects the scientific opinions of these clinicians and scientists, Amarin takes no responsibility for those opinions. Rather, this audio webcast is intended to provide summaries of recently presented scientific data for consideration by Amarin?s investors.
Nach der EU-Zulassungsempfehlung nun auch China und Honkong, Übernahme?
Amarin Provides Update on VASCEPA® (Icosapent Ethyl) Regulatory Review Processes in Mainland China and Hong Kong
Amarin Corporation plc Tue, February 9, 2021, 1:00 PM
DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that its corporate partner in China, Edding, has progressed VASCEPA® (icosapent ethyl) into commencement of the regulatory review processes in Mainland China and Hong Kong.
In Mainland China, the Chinese National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for VASCEPA. Edding is seeking labeling based on the entirety of clinical data available for VASCEPA, including the previously announced successful results of the Phase 3 study conducted by Edding as well as studies conducted by Amarin. Edding currently anticipates receiving a decision in Mainland China near the end of 2021.
In Hong Kong, on a separate track, the Hong Kong Department of Health is evaluating VASCEPA based on current approvals in the United States and Canada. The review process in Hong Kong is anticipated to conclude near the end of 2021.
?We congratulate our partner, Edding, on the advancements made in the regulatory submission and review processes of VASCEPA in Mainland China and Hong Kong,? stated Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. ?The progress made is important for our vision of offering the unique benefits of VASCEPA to at-risk patients throughout the world. We look forward to the potential of introducing, through Edding, this important treatment option in Mainland China and Hong Kong.?
?We are very glad to know that the applications for drug approval of VASCEPA were formally accepted by the National Medical Products Administration (NMPA) in Mainland China and the Department of Health in Hong Kong,? stated James He, chief medical officer, Edding. ?Prevention and treatment of cardiovascular disease (CVD) is one of the major initiatives promoted by Health China 2030. However, few new CVD medications other than statins were launched in the market during the past several decades. In November 2020, Edding announced the positive, statistically significant top-line results of the Phase 3 clinical trial conducted in Mainland China. We will continue working with Amarin to bring this cross-era innovative drug into China to benefit Chinese patients.?
About Amarin Amarin is a rapidly growing, 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. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and 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 REDUCE-IT® REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.1 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.3 These and other publications can be found in the R&D section on the company?s website at www.amarincorp.com.U
Alleine dies Meldung müsste Vascepa Zweistellig machen, unglaublich gute Wirkung:
VASCEPA® (Icosapent Ethyl) Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in Analyses of Landmark REDUCE-IT® Study Presented at International Stroke Conference 2021
Amarin Corporation plc Wed, March 17, 2021, 4:30 PM
28% and 32% significant reductions in first and total strokes, respectively, demonstrated with VASCEPA compared to placebo, as well as reductions in first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke, in statin-treated patients with elevated cardiovascular risk
Consistent reductions in overall stroke and in ischemic stroke observed across multiple subgroups
Administration of pure icosapent ethyl, VASCEPA, represents a novel clinical approach to stroke reduction
REDUCE-IT® STROKE abstract receives prestigious Paul Dudley White International Scholar Award to recognize the authors with the highest ranked abstract from the United States at the International Stroke Conference 2021
DUBLIN, Ireland and BRIDGEWATER, N.J., March 17, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of REDUCE-IT® STROKE at the International Stroke Conference 2021, being held virtually from March 17 ? March 19, 2021, adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin were presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women?s Hospital, Harvard Medical School, Boston, MA.
?The REDUCE-IT STROKE analyses provide important data supporting a new approach to prevent strokes using icosapent ethyl in appropriate patients,? commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women?s Hospital, Professor of Medicine at Harvard Medical School, and principal investigator of REDUCE-IT. ?The findings of benefit in at-risk patients include significant reductions in overall strokes and in ischemic strokes. Importantly, with respect to safety, we did not observe any significant increase in hemorrhagic stroke. These results further strengthen the case for pure eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl as a key intervention beyond statins for stroke prevention in studied patients.?
The REDUCE-IT STROKE analyses examined stroke rates across the enrolled patient population (n=8179). Enrolled patients were required to be treated with statins and other conventional therapies, and all patients had either established cardiovascular disease or diabetes and had other cardiovascular risk factors such as elevated triglyceride levels. Event rates for time to first fatal or nonfatal stroke were 2.4% for VASCEPA vs. 3.3% for placebo for a relative risk reduction (RRR) of 28% (p=0.01). Ischemic stroke time to first event rates were 2.0% for VASCEPA vs. 3.0% for placebo for a RRR of 36% (p=0.002). Hemorrhagic stroke occurred at low rates with no significant difference for VASCEPA vs. placebo (0.3% vs 0.2%; p=0.55).
Stroke is a major and often debilitating cardiovascular event significantly impacting not only patients and their loved ones, but also the healthcare system. Patients with elevated triglycerides despite statin therapy have increased risk for stroke-related events. Each year in the United States, about 795,000 people experience a new or recurrent stroke. Approximately 610,000 of these are first strokes, and 185,000 are recurrent strokes, or approximately 1 stroke every 40 seconds.1 The latest statistical update from the American Heart Association (AHA) shows that in the United States, the annual cost of stroke is $49.8 Billion.2
?Strokes significantly impact the healthcare system, driving substantial immediate and long-term costs,? said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. ?The subgroup data presented at ISC 2021 provide new insight into the unique potential benefits of VASCEPA administration on alleviating the societal burden of strokes.?
The REDUCE-IT STROKE abstract received the prestigious Paul Dudley White International Scholar Award, recognizing the authors with the highest ranked abstract across the United States at the International Stroke Conference 2021. The esteemed Paul Dudley White Award is named in honor of one of Boston?s most revered cardiologists, Dr. Paul Dudley White, who was a founding father of the American Heart Association and an early leader in preventive cardiology.
REDUCE-IT was designed and powered for the primary composite endpoint, of which stroke was one of five prespecified components; it was not powered for subgroup analysis. Stroke was a prespecified secondary endpoint within the testing hierarchy; ischemic stroke was a prespecified tertiary endpoint; stroke subgroup analyses were post hoc. No information was collected on stroke related disability, such as Rankin scores.
Brigham and Women?s Hospital receives research funding from Amarin for Dr. Bhatt?s work as the REDUCE-IT study Chair.
Additional information on ISC 2021 can be found here.
Amarin is a rapidly growing, 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. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and 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 Cardiovascular Risk The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.1 In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient?s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.3 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.4,5,6
Stellt euch mal vor Amarin ist bei 95 Prozent der Ärzte noch relativ unbekannt,und machen über 600 Millionen Umsatz,wenn die in ein paar Monate bekannter werden und die Zullassung auch noch in Europa kommt,dann werden weltweit Milliarden verdient, und das jedes Jahr.Deshalb bin ich hier langfristig investiert und werde langfristig mein Bestand erhöhen.Für mich ist die Aktie stark unterbewertet.