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Amarin - The Science Of Lipid Therapy - Die letzten 30 Beiträge



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Verschreibungen pro Woche erstmals übeer 70.000:eek::D, das wird ein Megablockbuster:

NORMALIZED Scripts Update for Week Ending 13/09

ATH Across the Board in Numbers & Market Share
TRx > 70,000 & NRx ~ 33,000
Sector’s TRx & NRx & Refills at levels not seen since June-2013

V
TRx: 70,559 {vs 63,318; +11.44%} Sector +9.31% --- (8,467,050 vs 7,598,119) --- ATH
NRx: 32,840 {vs 27,532; +19.28%} Sector +16.18% --- (3,940,842 vs 3,303,855) --- ATH
Ref: 37,718 {vs 35,786; +5.40%} Sector +3.87% --- (4,526,208 vs 4,294,264) --- ATH

GenL
TRx: 62,111 {vs 58,040; +7.01%} (7,453,301 vs 6,964,784)
NRx: 29,544 {vs 26,210; +12.72%} (3,545,228 vs 3,145,165)

L
TRx: 1,000 {vs 926; +8.02%} (119,966 vs 111,060)
NRx: 419 {vs 316; +32.52%} (50,318 vs 37,969)

V TRx Market Share: 52.79% vs 51.78% ---ATH
V NRx Market Share: 52.29% vs 50.93% ---ATH
V Ref Market Share: 53.22% vs 52.45% ---ATH

For those interested in Old Scripts Numbers ATH Across the Board in Numbers & Market Share except NRx 2nd ATH in Market Share;
V TRx 53,972 vs GL TRx 46,942 & L 653 -- ATH
V NRx 21,521 vs GL NRx 19,964 & L 245 -- ATH
V Refills 32,451 vs GL Refills 26,978 & L 408 -- ATH
Amarin | 15,10 €
Antwort auf Beitrag Nr.: 61.404.386 von flyingbeef am 03.09.19 23:44:59Ich denke da bist du auf dem Holzweg. 😉
Es ist ja nicht so, dass es momentan keine Medikamente gegen Herzkreislauferkrankungen bzw. die Prophylaxe gibt. Die werden ja alle massenhaft jetzt schon eingesetzt. Viele schlucken da mehrere Pillen an einem Tag. Aspirin, Statine, Blutverdünner usw. Das ist aber überwiegend generisch, also billig. Eine Kombipille ist da auch m.E. kein großer Vorteil. Das können die Ärzte individuell sicher besser zusammenstellen. Nebenwirkungen spielen ja auch eine Rolle.
Vascepa ist eine weitere Alternative, mit anderem Wirkansatz. Wahrscheinlich nehmen die meisten Vascepa Patienten jetzt auch noch weitere Medikamente ein. Von daher sehe ich da keine kommerzielle Gefahr.
Amarin | 16,14 $
11:25 Amarin call volume above normal and directionally bullish Bullish option flow detected in Amarin with 9,202 calls trading, 1.2x expected, and implied vol increasing almost 4 points to 65.82%. Mar-20 20 calls and Sep-19 16 calls are the most active options, with total volume in those strikes near 4,300 contracts. The Put/Call Ratio is 0.05. Earnings are expected on October 30th. Read more at: https://thefly.com/landingPageNews.php?id=2958517

Read more at:
https://thefly.com/landingPageNews.php?id=2958517
Amarin | 15,59 $
Antwort auf Beitrag Nr.: 61.400.003 von Magnetfeldfredy am 03.09.19 15:27:59Hallo,

kurz mal was zur aktuellen Presse zum Thema Polypille zu generellen kardiovaskulären Erkrankungen.

Heute zufällig auf diesen Artikel gestossen:

https://www.spiegel.de/gesundheit/diagnose/herz-kreislauf-er…

Falls dies sich durchsetzt würde es meinem Verständnis nach in Zukunft den potentiellen Markt für Vascepa (und anderen bisher bewährten Behandlungen) deutlich reduzieren, da wenn viele Menschen prohylaktisch mit solchen Polypillen behandelt werden das deutlich Herz Kreislauferkrankungen reduzieren würde, was ja grundsätzlich keine schlechte Nachricht ist...

Was meint Ihr dazu ? Kennt sich jemand damit näher aus und wie wahrscheinlich hier ein Durchbruch in näherer Zukunft ist ?

Oder bin ich hier auf dem Holzweg, wer kann hierzu evtl. was beitragen, Danke schonmal im voraus !
Amarin | 14,75 $
Top Meldung, Empfehlung für Europa::D

New 2019 Updates to the European Society of Cardiology’s and European Atherosclerosis Society’s Guidelines for the Management of Dyslipidaemias Incorporate Findings from the REDUCE-IT™ Cardiovascular Outcomes Study
GlobeNewswire•September 3, 2019

Clinical Practice Guidelines address how best to prevent cardiovascular events in high-risk patients with elevated triglycerides on statin treatment, among millions of people globally

BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) have updated their Clinical Practice Guidelines for the Management of Dyslipidaemias. This 2019 update incorporates findings from the REDUCE-IT™1,2 cardiovascular outcomes study and includes the recommendation that icosapent ethyl, 2g twice a day, should be considered for patients with cardiovascular disease who have triglyceride levels 135 mg/dL to 499 mg/dL despite statin treatment, which places them at high risk of cardiovascular events, such as heart attack, stroke or death.3 This new recommendation incorporates icosapent ethyl specifically.:eek::D

Icosapent ethyl, studied in a series of clinical trials, including the globally conducted REDUCE-IT study, was developed by Amarin and is exclusively marketed by Amarin and its commercial partners in capsule form under the brand name Vascepa® (icosapent ethyl). In the United States, Vascepa is currently approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Amarin has submitted a supplemental new drug application (sNDA) to the U.S. FDA for an expansion of the Vascepa U.S. FDA label based on the landmark REDUCE-IT results showing reduction of cardiovascular events in high risk patients. The company plans to submit an application seeking approval for icosapent ethyl in Europe for reducing cardiovascular events before the end of 2019. A similar application has already been submitted and is under priority review by Health Canada.

ESC and EAS do not provide endorsements or any form of certification for brand name commercial products. Accordingly, the inclusion of icosapent ethyl in the Clinical Practice Guidelines for the Management of Dyslipidaemias should not be understood as an endorsement or approval by ESC or EAS of Vascepa.

“We are pleased by ESC and EAS’s acknowledgement of the significance of the REDUCE-IT results as evidenced by their 2019 updates of the Clinical Practice Guidelines for the Management of Dyslipidaemias,” says Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. “Amarin believes strongly in the potential for icosapent ethyl to be an important treatment option for the millions of high-risk patients who are on statin therapy with controlled cholesterol levels, yet have elevated triglycerides and other cardiovascular risk factors. This update comes just weeks after the American Heart Association issued an advisory statement referencing REDUCE-IT and the cardiovascular risk-lowering effects of icosapent ethyl and months after the American Diabetes Association included the REDUCE-IT results as part of its updates to the Standards of Medical Care in Diabetes for 2019.4, [5] All of these updates further support the use of icosapent ethyl as an important treatment option for appropriate patients at high risk of cardiovascular events.”

Based on the results of REDUCE-IT, the 2019 updates to the Clinical Practice Guidelines for the Management of Dyslipidaemias specifically recommend that:

In high-risk (or above) patients with TG [triglycerides] levels between 1.5 – 5.6 mmol/L (135-499 mg/dL) despite statin treatment, n-3 PUFAs [polyunsaturated fatty acids] (icosapent ethyl 2x2 g/day) should be considered with a statin.6

The ESC and EAS recommendation is classified as a IIa recommendation denoting that icosapent ethyl should be considered for treatment of such patients. The classification is a Level B recommendation which reflects a relatively high weight of scientific evidence under ESC and EAS standards. Such recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study.

In the United States, approximately 15 million people match the criteria of the REDUCE-IT studied population, with triglycerides ≥ 135 mg/dL and other cardiovascular risk factors, despite statin treatment.7 About 25 percent of a representative sample survey of more than 7,800 patients from 27 European countries with coronary heart disease and controlled cholesterol levels had triglyceride levels of 150 mg/dL or greater, illustrating the potential pervasiveness of high-risk cardiovascular disease in Europe.8

“These updated guidelines from such prestigious organizations reaffirm the importance of the REDUCE-IT findings to patients globally, not only in enhancing care, but also in broadening awareness of the need for treatment among patients who may have their cholesterol controlled with a statin, but remain at risk because of elevated triglycerides,” says 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 and steering committee chair for REDUCE-IT. “Based on what we’re learning from REDUCE-IT and the related guidance from ESC and EAS, I foresee the beginning of a global change in clinical practice in how best to treat patients with multifactorial risks of cardiovascular events beyond cholesterol management.”

Amarin acknowledges the rigor with which the Clinical Practice Guidelines for the Management of Dyslipidaemias are crafted and approved by the ESC’s and EAS’s task force, which is comprised of more than 15 leading professionals in the European Union who specialize in the care of patients with dyslipidaemias.

The complete 2019 updates to the Clinical Practice Guidelines for the Management of Dyslipidaemias can be accessed online by clicking here.

About Amarin
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.

REDUCE-IT™ Study
REDUCE-IT, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of prescription pure EPA therapy as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated triglyceride levels (at least 135 mg/dL). A large portion of the male and female patients enrolled in this outcomes study were diagnosed with type 2 diabetes.

More information on the REDUCE-IT study results can be found at www.amarincorp.com.

About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In the United States CVD leads to one in every three deaths – one death approximately every 38 seconds – with annual treatment cost in excess of $500 billion.9,[10]

Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.11

Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease.12, 13,[14],[15]

About Vascepa® (icosapent ethyl) Capsules
Vascepa (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient from degradation. Vascepa, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.

The FDA has not reviewed and opined on a supplemental new drug application related to REDUCE IT. FDA has thus not reviewed the information herein or determined whether to approve Vascepa for use to reduce the risk of major adverse cardiovascular events in the REDUCE-IT patient population

Indication and Usage Based on Current FDA-Approved Label (not including REDUCE-IT results)

Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information for Vascepa Based on Current FDA-Approved Label (not including REDUCE-IT results) (Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)

Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
Use with caution in patients with known hypersensitivity to fish and/or shellfish.
The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.
Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Important Safety Information for Vascepa based on REDUCE-IT, as previously reported in The New England Journal of Medicine publication of the primary results of the REDUCE-IT study:


Excluding the major adverse cardiovascular events (MACE) results described above, overall adverse event rates in REDUCE-IT were similar across the statin plus Vascepa and the statin plus placebo treatment groups.
There were no significant differences between treatments in the overall rate of treatment emergent adverse events or serious adverse events leading to withdrawal of study drug.
There was no serious adverse event (SAE) occurring at a frequency of >2% which occurred at a numerically higher rate in the statin plus Vascepa treatment group than in the statin plus placebo treatment group.
Adverse events (AEs) occurring in 5% or greater of patients and more frequently with Vascepa than placebo were:
peripheral edema (6.5% Vascepa patients versus 5.0% placebo patients), although there was no increase in the rate of heart failure in Vascepa patients
constipation (5.4% Vascepa patients versus 3.6% placebo patients), although mineral oil, as used as placebo, is known to lower constipation, and
atrial fibrillation (5.3% Vascepa patients versus 3.9% placebo patients), although there were reductions in rates of cardiac arrest, sudden death and myocardial infarctions observed in Vascepa patients
There were numerically more SAEs related to bleeding in the statin plus Vascepa treatment group although overall rates were low with no fatal bleeding observed in either group and no significant difference in adjudicated hemorrhagic stroke or serious central nervous system or gastrointestinal bleeding events between treatments.
In summary, Vascepa was well tolerated with a safety profile generally consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling of such products.

Important Cautionary Information About These Data
Further REDUCE-IT data assessment and data release could yield additional useful information to inform greater understanding of the trial outcome. For example, detailed data assessment by regulatory authorities, such as the FDA and Health Canada, will continue and take several months to complete and announce. The FDA advisory committee process and the final evaluation by regulatory authorities of the totality of efficacy and safety data from REDUCE-IT may include some or all of the following, as well as other considerations: new information or analyses affecting the degree of treatment benefit on studied endpoints; study conduct and data robustness, quality, integrity and consistency; additional safety data considerations and risk/benefit considerations; and consideration of REDUCE-IT results in the context of other clinical studies. Because regulatory reviews are typically fluid and not definitive interactions between sponsor and agency on individual elements of an application and related information, Amarin does not plan to update investors on ongoing communications with regulatory authorities. Amarin plans to announce the final outcome of such regulatory reviews when appropriate.
Amarin | 14,00 €
Antwort auf Beitrag Nr.: 61.293.085 von Magnetfeldfredy am 19.08.19 18:23:53Nun normalisiert sich der Kurs langsam wieder, leider ist noch ein laanger Weg zu gehen bis der Kurs wieder bei über 22 Dollar ist, aber auch ich komme wieder in die grüne Zone 🙃.

Und 22 Dollar ist laange noch nicht das Schlusslicht, sonst hätte ich damals ja nicht investiert 📈, also alle die noch Geld übrig haben, meinen Segen habt ihr... 😜.

Nein Scherz beiseite meine Empfehlung gebe ich daher da sich die grundsätzliche Ausgangslage seit dem Höhenflug Ende Juli eigentlich nicht geändert hat ausser dass die Zulassung später kommt und Amarin nun viel Cash auf der hohen Kante hat.

Gerüchteküchen warum Amarin sich Cash holte oder warum das FDA nun so spät einen Adcom Termin doch noch anberaumt hat in Kombination mit 👍👎 Entscheidungen bei Pharmaaktien sind halt einfach Gift und bringen immer wieder grosse Schwankungen mit sich.

Durchhalten und gemeinsam gewinnen heisst hier die Devise, super Produkt, Vision, Management, und Marktchancen haben sich nicht im geringsten verändert !
Amarin | 16,05 $
Sorry, nochmals mit der heutigen Empfehlung der AHA, das ist mal eine Ansage für Amarin und Vascepa, Topmeldung:

Published on: August 19, 2019
Prescription Omega-3 Fatty Acids Effectively Reduce Triglycerides, AHA Says in Advisory
Mary Caffrey
Interest in omega-3 fatty acids have increased since publication of the results of REDUCE-IT.
Today’s prescription omega-3 fatty acid drugs effectively lower triglycerides, the American Heart Association (AHA) said today in an advisory report,1 which warned that patients should avoid treating themselves with fish oil supplements not approved by the FDA.

Prescription forms of omega-3 fatty acids can reduce triglyceride levels 20% to 30% for those who are diagnosed with high levels. Data from CDC show that about 25% of Americans have triglycerides above 150 mg/dL, which is above what is recommended;2 those with levels from 200 to 400 mg/dL are considered to have high triglycerides, and a those with 500 mg/dL have very high triglycerides.

Triglycerides are fats that circulate in the bloodstream. Once triglycerides reach 200 mg/dL, patients are at risk of atherosclerosis (narrowing of the arteries), heart attacks, and strokes. Those with triglycerides above 500 mg/dL are also at risk of pancreatitis, an inflammation of the pancreas.

“From our review of the evidence from 17 randomized, controlled clinical trials on high triglyceride levels, we concluded that treatment with 4 grams daily of any of the available prescription choices is effective and can be used safely in conjunction with statin medicines that lower cholesterol,” said Ann Skulas-Ray, PhD, an author of the advisory published in AHA journal Circulation,1 said in a statement.

The advisory comes as evidence accumulates that a formulation of omega-3 fatty acid, icosapent ethyl, sold as Vascepa, offers benefits beyond lowering triglycerides. The medication, a highly purified eicosapentaenoic acid (EPA), sold in a 4-gram capsule, has been shown to reduce the risk of heart attacks, strokes, and cardiovascular events by 25% among patients with high triglycerides when taken with a statin.3

FDA first approved Vascepa in 2012 to treat patient with high triglycerides. Amarin, which makes Vascepa, is seeking a cardiovascular indication for the medication from FDA. A decision had been expected in late September; however, FDA has now scheduled an advisory committee meeting for November 14, 2019, and a decision is not expected before December.

Highlights from today’s advisory include:



Two forms of omega-3 fatty acids are sold and no studies comparing them have been published, so the advisory does not recommend one over the other. Besides EPA, the other formulation combines EPA with docosahexaenoic acid (DHA).

The advisory said that “contrary to perception,” the EPA + DHA combination does not elevate low-density lipoprotein (LDL) cholesterol for most people with high triglycerides, although those with very high triglycerides (above 500 mg/dL) may see higher LDL cholesterol while taking this formulation.
Physicians should rule out other causes of high triglycerides, such as hypothyroidism and poorly managed type 2 diabetes, before prescribing medication, and urge patients to adopt a healthy lifestyle as well.
The review panel that issued the advisory found that prescription omega-3 drugs can reduce triglyceride levels with or without statin therapy.
In a statement, the AHA warns, “People should not try to treat the condition themselves with non-prescription fish oil supplements, since they are not reviewed or approved,” by FDA.

“Dietary supplements containing omega-3 fatty acids are not regulated by the FDA. They should not be used in place of prescription medication for the long-term management of high triglycerides,” said Skulas-Ray, who is an assistant professor in the Department of Nutritional Sciences at the University of Arizona in Tucson.

In an earlier advisory released in 2017, AHA said there was not enough evidence to support using omega-3 fatty acid supplements to prevent heart disease in the general population.

Interest in omega-3 fatty acids has increased with publication of results from REDUCE-IT, the study that identified Vascepa’s ability to reduce major cardiovascular events. REDUCE-IT was presented at the 2018 annual meeting of AHA, and additional results were presented at the 2019 meeting of the American College of Cardiology. The advisory notes that results from a trial involving a EPA + DHA medication are due in 2020.

References

Skulas-Ray AC, Wilson PWF, Harris WS et al on behalf of the American Heart Association. Omega-3 fatty acids for the management of hypertriglyceridemia. Circulation. 2019;140.
Carroll MD, Kit BK, Lacher DA. Trends in elevated triglyceride in adults: United States, 2001–2012. NCHS data brief, no 198. Hyattsville, MD: National Center for Health Statistics. 2015. https://www.cdc.gov/nchs/products/databriefs/db198.htm.
Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22. doi: 10.1056/NEJMoa1812792.
Amarin | 15,16 $
Prescription Omega-3 Fatty Acids Effectively Reduce Triglycerides, AHA Says in Advisory
Mary Caffrey
Interest in omega-3 fatty acids have increased since publication of the results of REDUCE-IT.
Today’s prescription omega-3 fatty acid drugs effectively lower triglycerides, the American Heart Association (AHA) said today in an advisory report,1 which warned that patients should avoid treating themselves with fish oil supplements not approved by the FDA.

Prescription forms of omega-3 fatty acids can reduce triglyceride levels 20% to 30% for those who are diagnosed with high levels. Data from CDC show that about 25% of Americans have triglycerides above 150 mg/dL, which is above what is recommended;2 those with levels from 200 to 400 mg/dL are considered to have high triglycerides, and a those with 500 mg/dL have very high triglycerides.

Triglycerides are fats that circulate in the bloodstream. Once triglycerides reach 200 mg/dL, patients are at risk of atherosclerosis (narrowing of the arteries), heart attacks, and strokes. Those with triglycerides above 500 mg/dL are also at risk of pancreatitis, an inflammation of the pancreas.

“From our review of the evidence from 17 randomized, controlled clinical trials on high triglyceride levels, we concluded that treatment with 4 grams daily of any of the available prescription choices is effective and can be used safely in conjunction with statin medicines that lower cholesterol,” said Ann Skulas-Ray, PhD, an author of the advisory published in AHA journal Circulation,1 said in a statement.

The advisory comes as evidence accumulates that a formulation of omega-3 fatty acid, icosapent ethyl, sold as Vascepa, offers benefits beyond lowering triglycerides. The medication, a highly purified eicosapentaenoic acid (EPA), sold in a 4-gram capsule, has been shown to reduce the risk of heart attacks, strokes, and cardiovascular events by 25% among patients with high triglycerides when taken with a statin.3

FDA first approved Vascepa in 2012 to treat patient with high triglycerides. Amarin, which makes Vascepa, is seeking a cardiovascular indication for the medication from FDA. A decision had been expected in late September; however, FDA has now scheduled an advisory committee meeting for November 14, 2019, and a decision is not expected before December.

Highlights from today’s advisory include:



Two forms of omega-3 fatty acids are sold and no studies comparing them have been published, so the advisory does not recommend one over the other. Besides EPA, the other formulation combines EPA with docosahexaenoic acid (DHA).

The advisory said that “contrary to perception,” the EPA + DHA combination does not elevate low-density lipoprotein (LDL) cholesterol for most people with high triglycerides, although those with very high triglycerides (above 500 mg/dL) may see higher LDL cholesterol while taking this formulation.
Physicians should rule out other causes of high triglycerides, such as hypothyroidism and poorly managed type 2 diabetes, before prescribing medication, and urge patients to adopt a healthy lifestyle as well.
The review panel that issued the advisory found that prescription omega-3 drugs can reduce triglyceride levels with or without statin therapy.
In a statement, the AHA warns, “People should not try to treat the condition themselves with non-prescription fish oil supplements, since they are not reviewed or approved,” by FDA.

“Dietary supplements containing omega-3 fatty acids are not regulated by the FDA. They should not be used in place of prescription medication for the long-term management of high triglycerides,” said Skulas-Ray, who is an assistant professor in the Department of Nutritional Sciences at the University of Arizona in Tucson.

In an earlier advisory released in 2017, AHA said there was not enough evidence to support using omega-3 fatty acid supplements to prevent heart disease in the general population.

Interest in omega-3 fatty acids has increased with publication of results from REDUCE-IT, the study that identified Vascepa’s ability to reduce major cardiovascular events. REDUCE-IT was presented at the 2018 annual meeting of AHA, and additional results were presented at the 2019 meeting of the American College of Cardiology. The advisory notes that results from a trial involving a EPA + DHA medication are due in 2020.

References

Skulas-Ray AC, Wilson PWF, Harris WS et al on behalf of the American Heart Association. Omega-3 fatty acids for the management of hypertriglyceridemia. Circulation. 2019;140.
Carroll MD, Kit BK, Lacher DA. Trends in elevated triglyceride in adults: United States, 2001–2012. NCHS data brief, no 198. Hyattsville, MD: National Center for Health Statistics. 2015. https://www.cdc.gov/nchs/products/databriefs/db198.htm.
Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22. doi: 10.1056/NEJMoa1812792.
Amarin | 15,16 $
Trotz des angekündigten Adcoms weitere positive Analysteneinschätzungen:

Amarin initiated with an Outperform at SVB Leerink SVB Leerink analyst Ami Fadia initiated coverage of Amarin with an Outperform rating and $26 price target. She sees the recent 20% pullback in the stock following news that the FDA will hold an advisory committee meeting to review the supplemental new drug application for Vascepa as offering a good entry point, as she believes that Vascepa's label expansion will be approved by the agency. If approved, she thinks Vascepa sales can grow to over $4B in the U.S. at their peak. Fadia added that the November 14 FDA committee meeting and PDUFA date, which she thinks is likely to be rescheduled for late December, are two catalysts that could drive greater than 20% upside in Amarin shares.

Read more at:
https://thefly.com/landingPageNews.php?id=2950858
Amarin | 14,69 $
Roth confident Amarin's Vascepa will be 'well-received' by FDA panel Roth Capital analyst Yasmeen Rahimi noted that the FDA's upcoming Advisory Committee reviewing the sNDA for Amarin's (AMRN) Vascepa will include ten voting and one non-voting committee members, including five endocrinologists, three cardiologists, a biostatistician, a pharmacoepidemiologist, a consumer representative and a non-voting nephrologist. Given that the American Diabetes Association has included Vascepa for CV risk reduction in its recommended treatment guidelines, and the panel has a majority of endocrinologists, she believes that "the committee is primed for a positive reception of Vascepa," Rahimi tells investors. Additionally, the AdCom Chairperson, Dr. Kenneth Burman, previously voted in favor of Novo Nordisk's (NVO) insulin degludec and insulin degludec/aspart when chairing a prior AdCom. Rahimi reads this as a strong sign that he is receptive to new therapies and as a positive for Vascepa's review, she said. The analyst keeps a Buy rating on Amarin shares with a price target of $31.

Read more at:
https://thefly.com/landingPageNews.php?id=2950505
Amarin | 12,80 €
Kursschwäche als Kaufchance:

Don’t Say Bye Bye to Amarin (AMRN) Stock, Say Buy Buy
[TipRanks]
TipRanks
,TipRanks•August 13, 2019

One week ago, Stifel analyst Derek Archila reiterated his "buy" rating on anti-cholesterol drugmaker Amarin (AMRN). He did this partly because he liked how Amarin's Q2 earnings report showed sales soaring, and losses lessening -- but also because he thought it unlikely the Food and Drug Administration would empanel an Advisory Committee to review Amarin's supplemental New Drug Application for expanded usage of "Vascepa," thus speeding the "sNDA" towards approval.

Last Thursday, Amarin announced that the FDA will be holding an AdCom after all, "tentatively scheduled for November 14, 2019, to review the data from Amarin's "REDUCE-IT cardiovascular outcomes study" and recommend whether the FDA should approve the expanded usage of Vascepa to treat "borderline" to "high" levels of triglycerides in the bloodstream. (I.e. levels from ranging from 151 mg/dL to 499 mg/dL).

Because of the late date of the AdCom, Amarin warned that it now "does not expect the FDA to take action on the sNDA by the previously announced September 28, 2019" deadline. Instead, it expects the deadline for approval under the Prescription Drug User Fee Act to be pushed back to "late December" -- postponing by three months the date at which Amarin might expect to begin booking new revenues under the expanded usage.

Because of that, Amarin stock plunged more nearly 17% in Friday trading, another 6% today, and at least one law firm filed a shareholders' class action lawsuit against Amarin, implying the company did something shady when it advised investors last week that "it was unlikely that the FDA would proceed with an advisory panel review."

Therein, says Archila, lies an opportunity.

Although frustrated by the FDA's decision, so at odds with his own guess, Archila urged investors to take advantage of Amarin's newly discounted stock price and buy some Amarin stock. The analyst reiterates a Buy rating on AMRN with a $26 price target, which implies nearly 90% upside from current levels. (To watch Archila's track record, click here)

His reasoning: "It's difficult to say why the FDA has chosen to convene an adcom this late in the game." Regardless, "our research and checks ... underlie our confidence that Vascepa's dataset will stand up to the scrutiny of a panel." But even more than that:

Under one possible scenario, Archila mused, it's possible the FDA might offer Amarin the option of labeling Vascepa for use "for cardiovascular risk reduction regardless of triglyceride levels" -- in other words, permitting the drug to be used by patients no matter how low, or how high, their triglycerides might be. No restrictions at all!

Such a labeling (if it's in fact on the table) would obviously be good news for Amarin. As Archila explains, it "would increase the commercial opportunity for the drug," meaning more sales and more profits for Amarin.

So as a pure question of risk and reward, Archila now believes the odds favor investing in Amarin.

All in all, AMRN has one of the best ratings by the Street. TipRanks reveals that the stock has a Strong Buy analyst consensus rating with 6 back-to-back buy ratings in the last three months. Meanwhile the average analyst price target of $32.67 suggests the stock has upside potential of nearly 135% from the current share price for the next 12 months. (See AMRN's price targets and analyst ratings on TipRanks)
Amarin | 12,00 €
Antwort auf Beitrag Nr.: 61.180.032 von flyingbeef am 05.08.19 20:44:46
Zitat von flyingbeef: Hi habe auf Yahoo Stock discussion folgende Erklärung für die 400 Millionen Finanzspritze die sich Amarin geholt hatte gesehen.

Ich finde der Poster hat absolut recht. Das passt und würde alle "Zweifler" hier ziemlich blöd aussehen lassen:

Why did Amarin need $400 M now?
If a broad label expansion is coming, if doctors are indicating an interest in an add on that focuses on the 75% of CVD risk that remains after statin use, if Insurance is looking at the ICER reprort and seeing a very positive benefit to cost when adding Vascepa maybe next year has a lot of potential.
Likely $500M in sales this year and $1500M (1.5 billion) next year is doable. That means you need $350 to $400 million in product to support those sales.
I'm in the 75% chance that at least a comarketer is coming soon after label expansion. In the recent conference call it was mentioned 3000 drug reps would be needed if you wanted to reach volume sales to come on at a faster clip

The recent fund raise was needed. We all had hoped for a rise at a much higher price. Amarin had to get the deal at what the market offered at this time. 100% think it had to be done before label expansion.

Für mich heisst es ich bin dabei Amarin glaubt voll an Ihren Erfolg und sie haben meiner Meinung nach auch beste Argumente und Gründe dafür. Besser kann es eigentlich nicht aussehen.

Natürlich weiss man nicht wie gross die Label Expansion am Schluss ausfallen wird, aber egal es wird eine Label Expansion geben und dass heisst der Kurs jetzt spiegelt ganz sicher nicht den Wert der Firma wieder. Ich denke bis 30 Dollar oder mehr sind selbst bei einer sehr eingeschränkten Label Expansion "sicher" drin.

Bleibt dabei, kauft am besten noch nach wenn ihr könnt und wollt, ich bin mittlwerweile sehr zuversichtlich !






ich vermerke Mich mal Hier.
Amarin | 12,60 €
Ok, oder denkst Du dass das Mineralöl Placebo wieder aufgewärmt wird oder vielleicht die Reichweite von Vascepa, 1/3-1/4 der US Bevölkerung ist potentielle Zielgruppe, der Grund ist?

Auf alle Fälle wird sich der Kurs bis zur Aufklärung nicht erholen, die Börse haßt Unsicherheit und das ist hier der Fall bis zum ADCOM Briefing also bis zum 12. November, 2 Tage vor dem Adcom werden die Fragen der FDA veröffentlicht!
Amarin | 12,40 €
Antwort auf Beitrag Nr.: 61.213.283 von Magnetfeldfredy am 09.08.19 10:03:29
Zitat von Magnetfeldfredy: Servsu Hexe, aber das PADUFA date war 28.09.2019, jetzt ADCOM am 14. November, das stinkt doch zum Himmel, oder wie siehst Du die Lage?



...ok Freddy, in diesem Punkt gebe ich dir zu 100% recht - das hätte vor dem PDUFA-Termin organisiert werden müssen. Aber sehr wahrscheinlich sind hierfür ganz banale Gründe wie "Volle Agenda" verantwortlich - an Verschwörungstheorien der FDA-Mitarbeiter kann und WILL ich nicht glauben.
Amarin | 12,40 €
Antwort auf Beitrag Nr.: 61.213.244 von Cyberhexe am 09.08.19 10:00:28Servsu Hexe, aber das PADUFA date war 28.09.2019, jetzt ADCOM am 14. November, das stinkt doch zum Himmel, oder wie siehst Du die Lage?
Amarin | 12,40 €
Antwort auf Beitrag Nr.: 61.211.603 von Magnetfeldfredy am 08.08.19 23:53:37
Zitat von Magnetfeldfredy: Korrupte Drecks FDA!


aber Freddy, ein AdCom ist doch kein Weltuntergang - und zudem daraus Korruptionsvorwüfe abzuleiten ist mehr als töricht. Eine grössere Transparenz als bei einem AdCom ist gar nicht möglich!
Amarin | 12,40 €
Ok Gestern war etwas emotional für alle...

Eigentlich wäre "kein Adcom" quasi ein Zeichen gewesen die werden das ablehnen.

Grund:
Ihr Entscheid für eine grosse Label Expansion wäre sehr angreifbar gewesen wenn sie kein Adcom einberufen hätten.

Da hätten alle Markbegleiter/Konkurrenten zurecht weiter auf den bisherigen Arguementen rumhacken können sprich Mineral-Öl Debatte usw. wenn das vorher nicht im Detail diskutiert worden wäre.

Für mich ist die Zulassung quais sicher, dass das FDA sich so spät und zögerlich entschlossen hat ist natürlich maximales Pech... Bleibt drin begrenzt den Schaden kauft am besten noch etwas nach und habt Geduld...

Jetzt verkaufen wäre eigentlich ein riesen Fehler, die Investoren werden spätestens nach ein paar Wochen merken dass sich nichts verändert hat und die Ausgangslage immer noch sehr gut aussieht...
Amarin | 12,30 €
Antwort auf Beitrag Nr.: 61.211.603 von Magnetfeldfredy am 08.08.19 23:53:37Ich glaube die hatten seit dem letzten Rechtsstreit mit AMRN noch eine Rechnung offen... :(
Amarin | 17,81 $
Antwort auf Beitrag Nr.: 61.211.336 von kmastra am 08.08.19 22:41:32Korrupte Drecks FDA!
Amarin | 17,81 $
Hui, da geht‘s nachbörslich aber ganz schön in den Keller...😦

Wollte demnächst ein paar Anteile erwerben, da ich von einer Übernahme in naher Auskunft ausgehe...
Amarin | 16,00 €
Antwort auf Beitrag Nr.: 61.141.730 von kmastra am 31.07.19 11:12:53
Zitat von kmastra: https://finance.yahoo.com/news/amarin-reports-second-quarter…

-Vascepa Umsatz: 100,4 Mio
-AMRN hält einen AdCom mittlerweile für unwahrscheinlich
Klingt insgesamt doch alles recht zuversichtlich!


Jetzt also doch ein AdCom und zwar am 14.11. und damit einhergehend eine Verzögerung der Zulassung. Irgendwie merkwürdig! Kommunikation von AMRN ist jetzt natürlich mehr als unglücklich.
Ist da jetzt AMRN oder FDA verantwortlich?
Amarin | 16,00 €
Biotech Stocks to Watch Through the 2nd Half of 2019
[GuruFocus.com]
GuruFocus.com
,GuruFocus.com•August 6, 2019

The biotechnology industry is an exciting one. A mix of technology and a better understanding of the human body has led to several very exciting breakthroughs over the past several years, and we're seeing improved quality of life, less abrasive therapies and longer lifespans among patients than ever before.

Of course, good health is highly valuable. Let's face it, we all want to live with a high quality of life for as long as possible. In fact, it's the human sense of self preservation that led to a market that's expected to rise to generate more than $10 trillion in annual value by 2022.

As you would expect, where there's this kind of market size, there are opportunities for investors. In fact, small biotechnology companies quite often become monsters after inventing breakthrough treatments. Here are a few that I've been following closely:

Amarin Corp. (NASDAQ:AMRN): Vascepa could quickly become a blockbuster

Amarin's claim to fame is a product known as Vascepa. The treatment is a single-molecule product that consists of an omega-3 fatty acid. Derived from fish through a stringent and complex Food and Drug Administration-regulated process, Vascepa is free of impurities and provides an isolated, single-molecule active ingredient.

At the moment, Vascepa is approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. While this indication has led to sales, it is a relatively narrow indication with a limited market potential. Nonetheless, the company may break into the big leagues in September.

Amarin is currently awaiting a decision from the FDA with regard to a supplemental New Drug Application. The application was submitted in hopes of expanding the label to include a blockbuster indication.

If it is approved, Vascepa will be the first drug that is indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but experience persistent elevated triglycerides. That's a big deal for two reasons:


If the sNDA is approved, it will greatly expand the patient population that could benefit from treatment with Vascepa. Of course, with a greatly expanded addressable patient population comes a greatly expanded revenue opportunity.

Moreover, the American Heart Association used to recommend patients that fall into this category take a baby aspirin daily to mitigate cardiovascular risk. However, the organization recently pulled this recommendation, leaving the patient population with no available options. So demand is likely to be very high from the very beginning.



It's also worth mentioning that the Prescription Drug User Fee Act date, or the date that the FDA will make a decision, for the sNDA is Sept. 28. That's just around the corner! Considering this, Amarin is a compelling opportunity to pay attention to.
Amarin | 15,50 €
Antwort auf Beitrag Nr.: 61.148.489 von Magnetfeldfredy am 01.08.19 07:13:44Hi habe auf Yahoo Stock discussion folgende Erklärung für die 400 Millionen Finanzspritze die sich Amarin geholt hatte gesehen.

Ich finde der Poster hat absolut recht. Das passt und würde alle "Zweifler" hier ziemlich blöd aussehen lassen:

Why did Amarin need $400 M now?
If a broad label expansion is coming, if doctors are indicating an interest in an add on that focuses on the 75% of CVD risk that remains after statin use, if Insurance is looking at the ICER reprort and seeing a very positive benefit to cost when adding Vascepa maybe next year has a lot of potential.
Likely $500M in sales this year and $1500M (1.5 billion) next year is doable. That means you need $350 to $400 million in product to support those sales.
I'm in the 75% chance that at least a comarketer is coming soon after label expansion. In the recent conference call it was mentioned 3000 drug reps would be needed if you wanted to reach volume sales to come on at a faster clip

The recent fund raise was needed. We all had hoped for a rise at a much higher price. Amarin had to get the deal at what the market offered at this time. 100% think it had to be done before label expansion.

Für mich heisst es ich bin dabei Amarin glaubt voll an Ihren Erfolg und sie haben meiner Meinung nach auch beste Argumente und Gründe dafür. Besser kann es eigentlich nicht aussehen.

Natürlich weiss man nicht wie gross die Label Expansion am Schluss ausfallen wird, aber egal es wird eine Label Expansion geben und dass heisst der Kurs jetzt spiegelt ganz sicher nicht den Wert der Firma wieder. Ich denke bis 30 Dollar oder mehr sind selbst bei einer sehr eingeschränkten Label Expansion "sicher" drin.

Bleibt dabei, kauft am besten noch nach wenn ihr könnt und wollt, ich bin mittlwerweile sehr zuversichtlich !
Amarin | 17,26 $
Das ist Börse, bei Amarin ist alles im Grünen Bereich, Zulassung steht vor der Tür!

Die Spielchen der shorts muss man aushalten!
Amarin | 18,59 $
Guten Abend zusammen,

würde gerne eure Meinung zu den Kursbewegungen wissen und mal meine "naive" Sicht auf die akutuelle Situation und was hier passiert darstellen...

Heute hat die Aktie meiner Meinung nach leider mal wieder bewiesen dass sie extrem unter Druck ist von sehr grossen Playern mit eigenen Interessen bestimmte Kurshöhen beizubehalten.

Leider ist auf der "dunklen" Seite der Macht sehr viel Geld im Spiel bei der 50/50 Chance mit Amarin wird alles gut oder es geht in den Keller... kann man gut auf beide Ausgänge spekulieren.

Wenn die Player die hier am Werk sind die Kursgewinne von uns Kleinanlegern so drücken können dass selbst mal 300 oder mehr Millionen nach oben locker runtergeschraubt werden können, sind wir wohl nur zum zuschauen verdammt..

Solche Player können sogar im Falle einer positiven Amarin Entscheidung schnell zu einem bis dahin immer noch sehr moderaten Kurs (den sie selbst ja verteidigt haben) Ihre Shorts auflösen und sich dann bei steigenden Kursen mit positiven Aktien eindecken und so dennoch profitieren. Sprich egal wie das Spiel ausgeht die machen Ihren Cash...

Wenn wir die Geldmauer nicht mit erheblich viel mehr Geld durchbrechen können so dass Sie schon vorher zum Rückkauf gezuwungen werden dann bleiben wir quasi bis zur Entscheidung festgenagelt... Sprich unsere einzige Chance wäre auf der positiven Seite große Geldgeber zu haben die nun einspringen.

Ich denke seit der Entscheidung sich eine große Menge Cash zu besorgen haben hier diese "dunklen" Player nun die Zügel des Spiels in der Hand und man kann wirklich nur noch von Kursmanipulation mit viel Geld sprechen, was meint Ihr könnte ich damit richtig liegen ?`

Hat jemand eine andere Theorie ?

An Mangel an positiven und Zuversichtlichen Aussichten kann es zumindest nicht liegen wir Kleinanleger sind ja eigentlich gesammelt sehr positiv und zuversichtlich eingestellt, sprich würde es von uns abhängen würde das Ding ordentlich steigen...
Amarin | 16,80 €
Top Zahlen, top Aussichten:

Amarin Reports Second Quarter 2019 Financial Results and Operational Update
GlobeNewswire•July 31, 2019

Record Total Revenue of $100.8 Million Achieved in Q2 2019

Commercial Expansion Plans on Track in Anticipation of September 28, 2019 PDUFA Date for Vascepa®

If Approved, Vascepa to Become First Prescription Therapy to Treat Patients with Underlying Cardiovascular Risk Beyond Cholesterol Management as Demonstrated in the REDUCE-IT™ Cardiovascular Outcomes Study

Millions of Patients in the U.S. Have Underlying Cardiovascular Risk Beyond Cholesterol Management

Increased Cash Balance to More Than $600 Million on a Proforma Basis to Ensure Robust Promotion and Education for Vascepa

Management to Host Conference Call Today at 7:30 a.m. ET

BEDMINSTER, N.J., and DUBLIN, Ireland, July 31, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for the three and six months ended June 30, 2019, and provided an update on company operations.

Key Amarin achievements since its last quarterly report include:

U.S. regulatory review progressing: The Priority Review of Amarin’s supplemental new drug application (sNDA) seeking to expand the indication for Vascepa® (icosapent ethyl) appears to be progressing in an orderly and timely manner toward the September 28, 2019 PDUFA goal date.

Second quarter net product revenue growth increased by 91%: Recognized $100.8 million in total revenue and $100.4 million in net product revenue from Vascepa sales in Q2 2019 compared to $52.5 million in Q2 2018, an increase of 91%. The total revenue result is at the upper end of the company’s previously estimated revenue of between $97 and $101 million announced on July 2, 2019.

U.S. prescriptions grew by more than 70%: Increased normalized prescriptions for Vascepa by 76% and 73% compared to Q2 2018 based on data from Symphony Health Solutions and IQVIA, respectively.

Commercial expansion preparation under way: Actively hiring additional sales managers and sales representatives to double the size of Amarin’s U.S. sales force to approximately 800 sales representatives by October 2019, while also executing on other plans to effectively educate healthcare professionals and consumers regarding the cardiovascular risk reduction profile of Vascepa and the significant unmet need for this disease, following an anticipated label expansion in late September.

International plans on track: Progressing through Amarin’s licensee, HLS Therapeutics Inc. (HLS.TO), towards anticipated approval of Vascepa in Canada in the fourth quarter of 2019. As previously disclosed, the application for Vascepa was granted a priority review designation by Health Canada. Other international progress is continuing, including Amarin’s plans to submit an application seeking approval for Vascepa in Europe before the end of 2019.

Increased cash balance to ensure robust launch of Vascepa: As of June 30, 2019, Amarin had a cash balance of $221.8 million. In July 2019, Amarin completed a $460.0 million equity offering resulting in an increase in Amarin’s cash balance to more than $600 million on a pro forma basis.

“Amarin made tremendous progress in the first half of 2019, including achieving $100 million in quarterly revenue which is a record for Vascepa sales,” stated John F. Thero, president and chief executive officer, Amarin. “We believe this is just the start of realizing the significant commercial opportunity for Vascepa, which will be driven by our passion to potentially help millions of at-risk patients and our ability to broadly communicate to healthcare professionals and patients the cost-effective value of Vascepa based on the FDA-approved expanded indication we’re anticipating in September. Our focus right now is ensuring we are prepared to robustly launch Vascepa based on that expanded indication.”

Regulatory Update

As previously announced, Amarin submitted an sNDA to the FDA on March 28, 2019, seeking to expand the indication for Vascepa. The sNDA was based on the positive results of the landmark REDUCE-IT™ cardiovascular outcomes study. If approved, the expanded label is anticipated to allow for considerably broader promotion of Vascepa in the United States. As announced in May 2019, the FDA accepted the sNDA for filing and granted Priority Review designation with an assigned PDUFA goal date of September 28, 2019.

To date, the FDA has not informed Amarin as to whether it plans to convene an Advisory Committee (AdCom) to review the sNDA. The FDA is not required to inform sponsor companies that it does not intend to hold an AdCom. While it remains possible that the FDA may elect to convene an AdCom, with less than two months remaining prior to the PDUFA date Amarin is now assuming that an AdCom is unlikely. If Amarin is informed definitively that there will or will not be an AdCom, the company plans to update investors accordingly.

Label negotiations in the sNDA process could commence as early as one month prior to the PDUFA date under FDA’s typical processes. As such, a final version of the updated Vascepa label is not available at this time. It would therefore be unproductive for Amarin to speculate on the wording of such a label before a final determination by the FDA except to express that Amarin is seeking a cardiovascular risk reduction label for Vascepa which is consistent with the results of the REDUCE-IT study.

Prescription Growth

Vascepa prescription growth in Q2 2019 stemmed from both prior prescribers and new prescribers. Normalized prescriptions for Vascepa (prescription of 120 grams of Vascepa representing a one-month supply) increased by approximately 76% and 73% in Q2 2019 compared to Q2 2018 based on data from Symphony Health and IQVIA, respectively. Estimated normalized Vascepa prescriptions, based on data from Symphony Health and IQVIA, totaled approximately 756,000 and 683,000 in the second quarter of 2019.

As there has been a trend of an increasing number of 90-day prescriptions (or scripts) vs. 30-day prescriptions, reporting from Symphony and IQVIA on prescription counts may not reflect the true demand for the product. Script counts from these services do not account for whether a script is for 90 days or 30 days as both are counted as one script. Accordingly, Amarin believes that pill counts reported as extended units by Symphony and IQVIA show a more accurate reflection of the demand for Vascepa. Normalized prescriptions, as referenced above, take this into account by using the extended unit number and dividing by the pill count in the bottle. Nonetheless, even when normalized, estimates from these independent sources for Vascepa and other drugs have historically been most accurate over longer periods of time, such as annually, while directionally informative over shorter periods of time.

As described more fully in Amarin’s Quarterly Report on Form 10-Q, Amarin recognizes product revenue when its customers, consisting mostly of independent commercial distributors, take possession of the product they order and Amarin ships to them. Amarin revenue is not recognized when individual patients fill prescriptions.

Commercial Update

Upon FDA approval of an expanded indication for Vascepa, Amarin’s goal is to be ready to launch a robust educational and promotional campaign aimed at healthcare professionals and consumers on the efficacy and safety profile of Vascepa as well as on the significant unmet need to help patients with underlying cardiovascular risks beyond cholesterol management.

When physicians become knowledgeable about the results of the REDUCE-IT study, it has been Amarin’s experience that they appreciate the importance of Vascepa and how it can be used to help the health of their patients. However, the vast majority of healthcare professionals have little knowledge of Vascepa. Amarin views this as an opportunity to be improved through expanded Vascepa promotion supported by an expanded label.

With the benefit of funds from recent financing, the company plans to create “surround sound” in its promotion of Vascepa. This surround sound will include more sales representatives, various forms of digital outreach, medical education, scientific presentations at industry meetings, direct-to-consumer advertising and other means of effective and responsible communications.

Most of the sales representatives hired at the start of 2019 are performing well and showing promise for greater contribution in the future. Their progress, together with the anticipated value of the expanded label for Vascepa, gives Amarin the confidence to double the size of its sales force.

To date, Amarin has hired most of the additional sales managers required for this expansion and is confident that it will have approximately 400 new sales representatives hired, trained and in the field promoting Vascepa by early October.

While the expanded sales team will reach a larger number of healthcare professionals, it is equally important to achieve more frequent interactions with targeted healthcare professionals. The current sales team calls on approximately 50,000 healthcare professionals. With the doubling of the sales force, Amarin expects to reach approximately 70,000 to 80,000 healthcare professionals. As of the end of June 2019, consistent with previously communicated projections, Amarin sales representatives called on approximately half of its current target physicians five or more times with the published results of the REDUCE-IT study.

Direct-to-consumer (DTC) promotion is likely to be a phased process. Upon label expansion, Amarin plans to increase promotion through more placement of Vascepa advertisement in platforms currently used. In parallel, new messaging for branded promotion based on the anticipated expanded label for Vascepa will be submitted to the FDA for review. Such submission for promotional review cannot be made until after the label is expanded. Subject to FDA review, Amarin anticipates launching that DTC campaign in the second quarter of 2020.

Managed care coverage for Vascepa continues to be favorable overall. Amarin anticipates marginal further improvement to such coverage in Q3 2019, prior to label expansion, and plans to pursue even broader managed care coverage following assumed label expansion.

The Institute for Clinical and Economic Review (ICER), an independent non-profit organization, released its draft evidence report regarding clinical effectiveness and economic impacts of Vascepa on July 24, 2019. ICER’s draft report concluded that Vascepa is cost effectiveness across all the non-profit organization’s analyses, based on its quality-adjusted life year (QALY) metrics Despite the draft report’s positive conclusion regarding cost effectiveness, Amarin believes that ICER understates the value of Vascepa. For example, the ICER base-case analyses reflect only the costs of heart attack, stroke and cardiovascular death and appear to exclude high costs associated with other cardiovascular events that were demonstrated to be lowered by Vascepa in the REDUCE-IT cardiovascular outcomes study (e.g., revascularization procedures and hospitalizations for unstable angina). Amarin believes this draft report, while not perfect in its value assessment, provides additional support for why medical insurance should broadly cover Vascepa for the population of patients studied in REDUCE-IT. While many payors already broadly cover Vascepa, upon anticipated label expansion, Amarin plans to use the results of the REDUCE-IT study, pharmaco-economic analysis, such as presented by ICER, and other medical information and data in negotiations with payers seeking expanded Vascepa insurance coverage.

Financial Update

Total revenue for the three months ended June 30, 2019 and 2018 was $100.8 million and $52.6 million, respectively. Net product revenue for the three months ended June 30, 2019 and 2018 was $100.4 million and $52.5 million, respectively. Total revenue for the six months ended June 30, 2019 and 2018, was $174.1 million and $96.6 million, respectively. Net product revenue for the six months ended June 30, 2019 and 2018 was $173.1 million and $96.3 million, respectively. The increase in net product revenue was primarily attributable to increases in new and recurring prescriptions of Vascepa as net selling price remained relatively unchanged for the six months ended June 30, 2019 as compared to the same period in 2018.

During the second quarter, based on data from Symphony Health Solutions and IQVIA, Amarin experienced continued prescription growth and an increase in Vascepa market share, particularly among physicians called on by Amarin’s sales professionals. Symphony Health Solutions and IQVIA reported estimated normalized total Vascepa prescriptions of approximately 756,000 and 683,000, respectfully, for the three months ended June 30, 2019, representing growth of approximately 76% and 73%, respectively, over levels estimated by these sources for the same three months of the prior year.

Licensing revenues recognized by the company were $1.0 million and $0.2 million in the six months ended June 30, 2019 and 2018, respectively, related to timing of milestones and other factors impacting revenue recognition for licensing fees under agreements for the commercialization of Vascepa outside the United States.

Cost of goods sold for the three months ended June 30, 2019 and 2018 was $22.8 million and $12.8 million, respectively. Cost of goods sold for the six months ended June 30, 2019 and 2018 was $39.9 million and $23.5 million, respectively. Gross margin on net product revenue for the three and six months ended June 30, 2019 and 2018 was 77% and 76%, respectively.

Selling, general and administrative (SG&A) expenses in the six months ended June 30, 2019 and 2018 were $145.0 and $97.4 million, respectively, an increase of 49%. This increase is due primarily to increased promotional activities, including commercial spend for expansion following successful REDUCE-IT results, as well as costs for sales force expansion, partially offset by elimination of expenses associated with the company’s prior co-promotion partner. As previously disclosed, the level of anticipated SG&A spending will increase as Amarin doubles the size of its sales force and increases its promotional and educational spending for Vascepa in conjunction with the anticipated label expansion.

Research and development (R&D) expenses in the six months ended June 30, 2019 and 2018 were $14.4 and $29.9 million, respectively, a decrease of 52%. This decrease in expense is primarily driven by a decline in REDUCE-IT related costs. Following the completion of the REDUCE-IT trial, costs consisted primarily of the clinical study’s wrap-up activities, regulatory support and publications. As previously disclosed, Amarin anticipates the level of spending on R&D will continue to decline as it has completed the REDUCE-IT study and initial publication of results from this important study.

Under U.S. GAAP, Amarin reported a net loss of $1.8 million in the three months ended June 30, 2019, or basic and diluted loss per share of $0.01. This net loss included $7.9 million in non-cash stock-based compensation expense. Amarin reported a net loss of $34.2 million in the second quarter of 2018, or basic and diluted loss per share of $0.12. This net loss included $3.6 million in non-cash stock-based compensation expense.

Under GAAP, Amarin reported a net loss of $26.3 million in the six months ended June 30, 2019, or basic and diluted loss per share of $0.08. This net loss included $14.8 million in non-cash stock-based compensation expense. For the six months ended June 30, 2018, Amarin reported a net loss of $58.3 million, or basic and diluted loss per share of $0.20. This net loss included $7.4 million in non-cash stock-based compensation expense.

Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net income was $6.1 million for the second quarter of 2019, or non-GAAP adjusted basic and diluted earnings per share of $0.02, compared to non-GAAP adjusted net loss of $30.6 million for the second quarter of 2018, or non-GAAP adjusted basic and diluted loss per share of $0.10.

Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net loss was $11.5 million for the six months ended June 30, 2019, or non-GAAP adjusted basic and diluted loss per share of $0.03, compared to non-GAAP adjusted net loss of $50.9 million for the six months ended June 30, 2018, or non-GAAP adjusted basic and diluted loss per share of $0.18.

As of June 30, 2019, Amarin reported cash and cash equivalents of $221.8 million, $95.4 million in net accounts receivable ($116.3 million in gross accounts receivable before allowances and reserves) and $46.3 million in inventory. As noted above, the company completed an equity offering in July 2019 for gross proceeds of approximately $460.0 million and issued approximately 25.5 million ADSs, including the full exercise of the underwriters’ 30-day over-allotment option to purchase up to an additional 15% of the ADSs issued in the offering. Net proceeds after fees and expenses from this financing were approximately $439.5 million. While Amarin was net cash flow positive in the three months ended June 30, 2019, the company expects net cash flow to be negative in the second half of 2019 reflecting planning increased spending for Vascepa promotion and anticipated increased purchases of Vascepa inventory.

As of June 30, 2019, prior to the above described financing, Amarin had approximately 331.3 million American Depository Shares (ADSs) and ordinary shares outstanding, 28.9 million common share equivalents of Series A Convertible Preferred Shares outstanding and approximately 16.6 million equivalent shares underlying stock options at a weighted-average exercise price of $5.86, as well as 9.3 million equivalent shares underlying restricted or deferred stock units.

Conference Call and Webcast Information
Amarin | 17,80 €
https://finance.yahoo.com/news/amarin-reports-second-quarter…

-Vascepa Umsatz: 100,4 Mio
-AMRN hält einen AdCom mittlerweile für unwahrscheinlich
Klingt insgesamt doch alles recht zuversichtlich!
Amarin | 17,50 €
Hallo zusammen,

der Abverkauf lief noch bis Gestern daher dieses Verharren auf den 18 Dollar Es gab noch ein Zusatzkontingent das nun auch weg ist.

siehe Pressemitteilung:
https://investor.amarincorp.com/news-releases/news-release-d…

Ab sofort sollte der Kurs wieder steigen und nun wieder etwas mehr Freude bringen ;)

Trittbrettfahrerthema:
Acasti Kurs ging übrigens weiter durch die Decke, hier könnte auch bald eine Ausschüttung neuer Aktien zu einer leichten Abwertung und einem ersten Abverkauf führen, sehe aber aktuell bis Amarin News da sind auch hier eine weitere ordentliche steigende Tendenz. 🙃
Amarin | 16,30 €


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