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Amarin Jumps After Diabetes Association Adds Drug to Its 'Must Have' List
The American Diabetes Association adds Amarin's Vascepa drug to its standard of care recommendation list.

Tony Owusu
Mar 28, 2019 8:11 AM EDT
Istock

Shares of pharmaceutical company Amarin (AMRN) were up more than 6% in premarket Thursday after the company's Vascepa drug was added to the American Diabetes Association's Standards of Medical Care in Diabetes list for 2019.

The drug, along with a specialized diet, has been shown to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Amarin has agreed to give the Food and Drug Administration data to support the ADA's finding in order expand Vascepa's FDA label to include its recommendation.

"As we have commenced transmission of data to the FDA for the submission of our sNDA seeking an expansion of the Vascepa label based on the landmark REDUCE-IT results, we are pleased by ADA's acknowledgement of the importance of the REDUCE-IT results in its 2019 update of the Standards of Care," said Dr. Craig B. Granowitz, senior vice president and chief medical officer of Amarin.

Amarin said that Vascepa works without raising bad cholesterol when a four-gram dose is taken daily.
Amarin takes application to expand Vascepa label to the FDA as M&A chatter heats up

by Natalie Grover

— on March 29, 2019 06:16 AM EDT
Updated: 08:26 AM

PDF

Having unveiled an unexpected set of heart protective results for their fish oil-derived pill Vascepa, Amarin is marching ahead to fulfill blockbuster expectations for its cholesterol-lowering drug by submitting an application to expand Vascepa’s label to include the reduction in cardiovascular risk.

The company sparked a flurry of M&A chatter after revealing data from the REDUCE-IT study last year — a 25% reduction in the risk for the first occurrence of a major cardio event, and a 26% reduction for 3-point MACE, a composite of cardiovascular death, nonfatal heart attack and nonfatal stroke — although concerns about the impact of the mineral oil placebo on the results prompted lingering questions. Earlier this month, Amarin debuted its exploratory analysis of the trial, with researchers suggesting a 30% reduction in cardiovascular events compared to the placebo arm.

John Thero

“The REDUCE-IT results support that approximately 1 fewer major cardiovascular adverse event would occur on average for every 6 patients treated with Vascepa for 5 years on top of statin therapy compared to placebo,” Amarin chief John Thero said in a statement.

On Thursday, Amarin said it was operating under the assumption that the sNDA will be reviewed over a standard ten months resulting in a PDUFA date near the end of January 2020, and that it expects the regulator with organize an advisory committee meeting of outside experts to deliberate and recommend whether Vascepa’s label should be expanded before the FDA makes its final decision.

Earlier in the week, the American Diabetes Association issued fresh “standards of care” guidelines to include Vascepa. They recommended that Vascepa “be considered for patients with diabetes and atherosclerotic cardiovascular disease or other cardiac risk factors on a statin with controlled LDL-C, but with elevated triglycerides to reduce cardiovascular risk.”

Vascepa, which generated about $229 million in 2018 sales, comprises omega-3 acid called EPA derived from fish — was originally approved in 2012 for patients with severe hypertriglyceridemia. It is reasonably priced with an annual price tag of roughly $2400, Amarin contends, adding that the majority of insured patients insurance who obtain Vascepa prescriptions pay a monthly co-pay charge of $9.99 or less.

Meanwhile, PCSK9 inhibitors that were approved in 2015 carried a price close to $14,000 and were pegged to attain blockbuster status for their ability to dramatically lower levels of LDL cholesterol, facing pushback from insurers for their high sticker prices that led to lower adoption than expected, despite later trials that demonstrated they also significantly cut the risk of heart attacks and stroke. Following Amgen’s decision to slash the price of its PCSK9 drug Repatha by 60% to $5,850 last year, the team behind their main rival treatment, Praluent — Regeneron $REGN and Sanofi $SNY — have followed suit with the same discount, beginning early March.

In 2016, Amarin $AMRN won a landmark ruling against the FDA, which allowed the drugmaker to exercise its first amendment rights by promoting Vascepa for off-label uses as long as it does so ‘truthfully.’ The company was also seeking to market the drug to patients with not just severe triglyceride levels, but those considered to have ‘high’ levels of the blood fat.
Heute haben wir einen schönen Anstieg, $23.30 wäre das nächste Ziel, schönes Wochenende.
Jefferies-Potential Beat On Growing Q1 Vascepa Sales - Debate on Expectations $30 target Price



Potential Beat On Growing Q1 Vascepa Sales - Debate on Expectations


Michael J. Yee, Andrew Tsai, Kelechi Chikere, Ph.D., Arshad Haider

April 24, 2019


Key Takeaway

AMRN could report Q1 EPS results in the first week of May and we note IMS scripts have reached all-time highs over the past 9 of 10 weeks, tracking to perhaps ~$75-80M and possibly well above consensus $67M (4 ests). 2019 guidance of $350M would then look conservative and too low. For 2019, we are above at $385M and above cons $365M and guidance could eventually move higher towards our estimate.

Insights

Weekly scripts appear to reach record highs, setting up AMRN for a pot'l Q1 sales beat

Despite management cautioning to expect seasonality in Q1, scripts are up +16% Q/Q (accelerated even more than the +13-15% in Q4) - appearing to track to ~$75-80M in Q1 vs cons $67M (4 ests) and Jefferies at $79M. Historically, Vascepa sales have declined in Q1 over the past couple of years, but we see an increase this year instead due to 1) major new CVOT data during Q4 now published in the NEJM, 2) huge salesforce increase to 400 from 150 recently, and 3) positive doc channel checks suggesting reimbursement has not been much issue. We also note Q4 reported sales were even higher than third-party data (+40% vs +13%) suggesting Q1 IMS script data could be inaccurate (under-capturing) as well although management recently confirmed weekly scripts are tracking fairly accurately to AMRN's internal datapoints. Bigger picture, 2019 guidance of $350M appears conservative and only suggests an $80M+$85M+$90M+$95M trajectory (i.e. modest growth), even though sales grew by a whopping $20M+ Q/Q to $77M in Q4.

Additional Q1 dynamics and thoughts

We acknowledge some buysiders think a beat is already expected given third-party data is available though we argue confirming these strong results after last quarters doubt (huge beat in Q4) would be positive and it means consensus is going up. We also understand the stock has been in a trading range from teens to low $20s and investors seem to want to debate "M&A takeout or bust" more than anything with bears saying no takeout until litigation is settled and FDA label expansion confirmed.

Our estimated $79M in Q1 considers 1) a +9% price increase Dec 2018, 2) offset by increased gross to net typical of Q1, and 3) higher capture of 75% vs 72% for Q4 to be conservative. We can derive Q1 sales of ~$80M were we to assume a G2N of 55% (vs 50% for other quarters). Alternatively, adjusting the capture to historical of 83% (our est) would yield Q sales closer to the $70-75M range, which would still be above consensus estimates of $67M.

Our doctors consistently provide positive feedback on Vascepa

Anecdotally, docs inform us they have "accelerated their prescriptions" post the Nov 2018 AHA conference. The LDL increase in the placebo arm (mineral oil) has not deterred docs from prescribing Vascepa. From our NYC Doc Panel day last month, post the data, one doc increased his prescriptions by 3x-4x to 10/month, while the other doctor now prescribes it several times a month. The latter was formerly not a strong believer in triglyceride (TG) therapies unless patients exceeded the >500mg/dL threshold, but he now envisions his overall usage for "elevated" TG patients to increase as he becomes more familiar and comfortable and reimbursement has been easy.


Company Description

Amarin Corporation

Amarin Corporation, headquartered in Dublin, Ireland and Bedminster, New Jersey is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's approved drug, Vascepa, is an ultra-pure, EPA-only, omega-3 fatty acid, oral product for the treatment of severe high triglycerides and mixed dyslipidemia. The company’s cardiovascular programs capitalize on Amarin's expertise in the field of lipid science and the known therapeutic benefits of essential fatty acids in treating cardiovascular disease. AMRN reported a positive REDUCE-IT CVOT result in September 2018.
Company Valuation/Risks

Amarin Corporation

Our $30 PT is DCF-based. Risks: clinical, regulatory, a
New Drug Submission Filed for Vascepa® with Health Canada
GlobeNewswire•April 29, 2019

BEDMINSTER, N.J., and DUBLIN, Ireland, April 29, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that its licensee in Canada, HLS Therapeutics Inc. (HLS.TO), has filed a New Drug Submission (“NDS”) with Health Canada for Vascepa® (icosapent ethyl) capsules. The NDS seeks an indication for promotion of Vascepa in Canada to reduce the risk of major adverse cardiovascular events (“MACE”) in statin-treated patients with elevated triglycerides and other risk factors. This is the first submission of Vascepa to Health Canada for any indication and, if approved, Vascepa will be the first drug approved in Canada for this important indication.

As previously announced, Vascepa has been granted priority review status by Health Canada. Priority review could accelerate the launch of Vascepa in the Canadian market by up to four-and-a-half months if the product is ultimately approved by Health Canada. Priority review status may be granted to regulatory filings in Canada for new treatments that potentially address serious, life-threatening conditions for which no drug is currently marketed in Canada, and for which there is substantial evidence of clinical effectiveness of that new treatment.

While the NDS includes results from the REDUCE-IT™ cardiovascular outcomes study of Vascepa, review of this regulatory submission in Canada is anticipated to be independent of the review of the supplemental new drug application which Amarin recently filed with the U.S. Food and Drug Administration regarding Vascepa based on the same clinical study results.

“We are hopeful that Vascepa will soon be approved to treat at-risk patients in Canada and we applaud HLS Therapeutics for moving rapidly with this filing,” commented Amarin’s president and chief executive officer, John F. Thero. “Cardiovascular disease is a major health issue in Canada as it is throughout the world. Vascepa provides physicians with a new treatment option to address cardiovascular risks beyond cholesterol management for at-risk patients.”
Amarin selloff creates attractive entry point, says Citi Citi analyst Joel Beatty believes the selloff yesterday in shares of Amarin (AMRN) brings an attractive entry point. He raised his price target for the stock to $23 from $20 and keeps a Buy rating on the name. The analyst sees five potential upside catalysts this year, including a likely supportive ICER cost-effectiveness review and potential priority review from the FDA. Further, while an acquisition of Amarin is possible, the company acquiring The Medicines Co. (MDCO) or Esperion (ESPR) "could also be a viable path," says Beatty.

Read more at:
https://thefly.com/landingPageNews.php?id=2901824
Amarin to seek European approval for heart drug Vascepa
Clinical trials show Irish company’s fish-oil drug cut incidence of heart attacks and strokes
about 20 hours ago
Dominic Coyle
Amarin chief executive John Thero: ‘Our guidance is for 50 per cent greater growth over the prior year’

Amarin chief executive John Thero: ‘Our guidance is for 50 per cent greater growth over the prior year’



Irish drug company Amarin will seek European approval for its cardiovascular drug Vascepa before the end of the year.

The drug is in the process of seeking broader FDA approval in the US as well, following clinical trial results last year which showed its fish-oil drug dramatically cut the incidence of heart attack and strokes in high-risk patients.

Until now,it has been approved only for the treatment of patients with very high levels of blood fats – indicators of cardiovascular risk – as a treatment to reduce those levels, but without making any claims on cardiovascular events.

Chief executive John Thero said the company was “hoping to have submitted in Europe sometime towards the end of the year”. Amarin, which is based in Dublin but operates largely in the United States, has yet to decide whether it will manage the European rollout in-house or through partnerships with other companies.
‘Death benefits’

Citing the 25 per cent reduction in risk of an adverse cardiovascular event – such as a heart attack or stroke – and a 20 per cent reduction in deaths among high-risk patients, Mr Thero said: “You don’t even see those death benefits with statins. It is rare to see a reduction in these outcome studies in death.

“And we have more recently shown that not only do we reduce the first occurrence of a cardiovascular event but, even if someone has had a heart attack, we help to prevent the second occurrence, a third occurrence. So essentially, over a five-year period, we have one fewer cardiovascular event for every six patients treated. And that’s a number I’ve not seen before,” he said, noting that the equivalent number for statins is around one in 45.

The company said it has seen a strong increase in prescribing of Vascepa by both cardiologists and endocrinologists, as well as GPs, since its clinical trial results were published.

“In the first four months after we had the new data, we had more new physicians prescribing the product than we had in the previous nine months on aggregate,” said Mr Thero.
Bullish expectations

But he cautioned against overly bullish expectations against the company’s target for sales this year of $350 million.

“We don’t yet have an [expanded] label for the product and our sales force, two-thirds of it is brand new, and we only have one reported quarter at this point,” Mr Thero said. “That quarter did go better than expected, but it is only one quarter . Our guidance is for 50 per cent greater growth over the prior year.

“Each quarter last year got better [in sales] and we would expect each quarter this year to get better,” he said. “I do really think of this year as a step [in the company’s development]. It’s sort of that second phase and it is the third phase that really excites.

One in three adults have some risk for cardiovascular disease and we want them to be asking their doctors about it

“From the beginning, we recognised that what we needed was a label approved for cardiovascular risk prevention and it is [now] right around the corner. And that’s really where things begin.”

Mr Thero said an expanded permission on its label would see a further significant increase in its sales force and, for the first time, would allow the company to start promoting the drug directly to consumers for the first time as a therapy that can help prevent heart attacks and strokes.

“One in three adults have some risk for cardiovascular disease and we want them to be asking their doctors about it,” he said.

Cardiovascular disease is also the single biggest cause of death in Ireland, accounting for up to 10,000 deaths a year, according to the Irish Heart Foundation. That is one-third of all deaths, it says, and one in five of all premature deaths.
"Halbzeitbericht" -Händler Jon Najarian entdeckt ungewöhnliche Optionsaktivitäten in Aktien von Square und Amarin

https://finance.yahoo.com/video/options-traders-hip-square-1…
Supergeil, burn shorties burn:

U.S. FDA Grants Priority Review for Vascepa® (Icosapent Ethyl) Supplemental New Drug Application Seeking Cardiovascular Risk Reduction Indication
GlobeNewswire•May 29, 2019

- PDUFA date assigned is September 28, 2019, four months sooner than expected
- Vascepa, assuming approval, will be first drug indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides, as studied in the landmark REDUCE-IT™ cardiovascular outcomes study
- Cardiovascular disease is the No. 1 cause of death for U.S. men and women
- Amarin is accelerating plans for commercial expansion, based on Priority Review designation

BEDMINSTER, N.J. and DUBLIN, Ireland, May 29, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN) announced today that its supplemental new drug application (sNDA) for Vascepa® (icosapent ethyl) capsules has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this sNDA is September 28, 2019. Because of the Priority Review designation, the timing of this PDUFA date is four months earlier than the anticipated standard ten-month review for applications.

Assuming FDA approval, Vascepa will be the first drug indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides, an important indicator of cardiovascular disease. This is a serious health challenge experienced by millions of people.

The FDA grants Priority Review designation to applications for drugs that, if approved, have the potential to offer significant improvements in the effectiveness and safety of the treatment of serious conditions when compared to standard applications.

“We expect earlier approval of an expanded indication for Vascepa to lead to faster improvements in care for millions of patients with residual cardiovascular risk after statin therapy,” said John F. Thero, president and chief executive officer of Amarin. “These patients will be the focus of our planned expanded REDUCE-ITTM promotional efforts. We are very pleased that the FDA has accepted our application and granted it priority review. We believe the unprecedented REDUCE-IT results position Amarin to lead a transformative change in clinical practice for preventative treatment of cardiovascular disease, the leading cause of death for both men and women in the United States. Our plans to significantly expand promotion of Vascepa following label expansion are being accelerated to reflect the upcoming PDUFA date."

sNDA Based on Landmark REDUCE-IT Trial

The sNDA for Vascepa is based on the landmark REDUCE-IT cardiovascular outcomes study, primary results of which were published in The New England Journal of Medicine in November 2018.1 Additional results and analysis of total recurrent events observed were subsequently published in the Journal of American College of Cardiology in March 2019.2 Vascepa is currently indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG >500 mg/dL) hypertriglyceridemia, an important but much smaller patient population than can be addressed with an approval of this sNDA.

In REDUCE-IT, Vascepa achieved the primary endpoint with a 25% relative risk reduction compared to placebo (95% confidence interval [CI], 0.68-0.83; p<0.001) in the first occurrence of a major adverse cardiovascular event (MACE) in the intent-to-treat population. In REDUCE-IT, MACE consisted of a composite of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularization (procedures such as stents and by-pass) and unstable angina requiring hospitalization.

As further evidence of the robustness of the REDUCE-IT results, Vascepa achieved the study’s key secondary endpoint with a 26% relative risk reduction (HR, 0.74; 95% CI, 0.65-0.83; p<0.001) in 3-point MACE in the intent-to-treat population consisting of a composite of cardiovascular death, nonfatal heart attack and nonfatal stroke. Vascepa also achieved seven other secondary endpoints in the pre-specified hierarchical order below the key secondary endpoint, including a 20% relative risk reduction in cardiovascular death compared to placebo (HR, 0.80; 95% CI, 0.66-0.98; p=0.03). REDUCE-IT, a global study of 8,179 statin-treated adults with elevated CV risk, was performed based on a special protocol assessment (SPA) agreement with the FDA.

In REDUCE-IT, adverse events occurring with Vascepa use at greater than 5% and greater than placebo were: peripheral edema (6.5% Vascepa versus 5.0%), although there was no increase in the rate of heart failure in Vascepa patients; constipation (5.4% Vascepa versus 3.6%), although mineral oil, as used as placebo, is known to lower constipation; and atrial fibrillation (5.3% Vascepa versus 3.9%), although there were reductions in rates of cardiac arrest, sudden death and myocardial infarctions observed in Vascepa patients. More information on safety data associated with REDUCE-IT is provided below and in the published results.

FDA Advisory Committee Update

In its sNDA filing acceptance communication to Amarin, the FDA did not indicate whether it plans to hold an advisory committee (AdCom) meeting to discuss this application. Amarin previously expressed that it believes an AdCom meeting organized by the FDA in conjunction with its review of the expanded label for Vascepa is likely. It is not uncommon for clarification on this topic to be provided by the FDA later in its review process.

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.

More About REDUCE-IT

REDUCE-IT1, 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 No. 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.3, 4

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.5

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.6, 7, 8, 9

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.

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 Medicine1 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.

Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. FDA has not reviewed and opined on a supplemental new drug application related to REDUCE-IT. FDA has not reviewed the information herein or determined whether to approve Vascepa for use to reduce the risk of MACE. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

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 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.

Recurrent event analyses for the total primary endpoint events and for the total key secondary endpoint in REDUCE-IT as published in the Journal of the American College of Cardiology were conducted using a series of statistical models. These analyses were tertiary or exploratory endpoints; most of the models used were prespecified and one was post hoc. Each recurrent event statistical model has inherent strengths and weaknesses, with no single model considered definitive or outperforming the other models, and this is an evolving field of science. Nonetheless, results from the total primary and total key secondary endpoint events analyses are consistent across the various recurrent event statistical models and are also consistent with the original primary and secondary endpoint results. Together, the REDUCE-IT recurrent event analyses and the original primary and key secondary endpoint analyses support the robustness of the clinical benefit of Vascepa therapy in reducing cardiovascular risk.

Forward-Looking Statements

This press release contains forward-looking statements, including expectations regarding FDA regulatory review, the applicability and reliability of REDUCE-IT results, expected outcome and timing of review elements and market dynamics for Vascepa. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition, Amarin's ability to effectively commercialize Vascepa will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to gain regulatory approvals, create market demand for Vascepa through education, marketing and sales activities, to achieve market acceptance of Vascepa, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the Vascepa franchise. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

References

1 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.

2 Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol 2019. Epub ahead of print. https://doi.org/10.1016/j.jacc.2019.02.032.

3 American Heart Association. 2018. Disease and Stroke Statistics-2018 Update.

4 American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.

5 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.

6 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.

7 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.

8 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.

9 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.

Amarin Contact Information

Investor Relations:
Elisabeth Schwartz
Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2992
lstern@troutgroup.com

Media Inquiries:
Gwen Fisher
Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 325-0735
PR@amarincorp.com

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Die Meldung FDA Grants Priority Review, für das überdurchschnittliche Volumen
von Call Optionen.

Opinion: These 6 biotech stocks are promising takeover targets
by Micheal Brush

Amarin AMRN, + 8,70% hat ein Medikament gegen Herz-Kreislauf-Erkrankungen namens Vascepa. Es ist eine verschreibungspflichtige Omega-3-Fettsäure-Kapsel, die Triglycerid bei Menschen mit erhöhten Blutspiegel reduziert. Eine im vergangenen September veröffentlichte Studie zeigte, dass Vascepa das Risiko für Herz-Kreislauf-Erkrankungen um 25% senkte. Amarin hat bei der FDA die Ausweitung der Bezeichnung Vascepa auf Patienten mit einem Risiko für Herz-Kreislauf-Probleme, Herzinfarkt und Schlaganfall beantragt.

Vascepa ist kein Fischöl, das als rezeptfreies Mittel gegen Herz-Kreislauf-Probleme diskreditiert wurde. Vascepa wird jedoch durch einen Prozess aus Fisch gewonnen, der Verunreinigungen beseitigt, einen Wirkstoff isoliert und ihn vor Abbau schützt. Yee beschreibt Amarin als einen der offensichtlichen Übernahmekandidaten. "Wir sind weiterhin der Meinung, dass Vascepa viele Kisten als potenzieller Blockbuster betrachtet, der sich in den Händen der großen weltweiten Pharmadistribution noch besser behaupten würde", sagt er.
H.C. Wainwright Survey Shows Substantial Runway For Amarin Corporation's (AMRN) Vascepa
June 26, 2019 8:21 AM
H.C. Wainwright analyst Andrew Fein reiterated a Buy rating and $51.00 price target:D on Amarin Corporation (NASDAQ: AMRN) after conducted ...

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Analyst Comments
Amarin | 16,30 €
$51 Full Report

H.C. Wainwright analyst Andrew Fein raised the price target on Amarin Corporation (NASDAQ: AMRN) to $51.00 (from $31.00) while maintaining a Buy rating.

Fein commented, "The detailed data presentation of the REDUCE-IT trial of Vascepa at this year’s American Heart Association (AHA) conference in conjunction with the publication in the New English Journal of Medicine (NEJM) provided much anticipated color on Vascepa’s clinical benefits and commercial potential, which in our view, landed in the best scenario and surpassed our expectation. We believe that beyond the topline of 25% reduction of MACE score, the robustness of the data is highlighted by the consistency across pre-specified analyses. A key secondary composite, namely 3-point MACE score (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke), which assesses the major CV events (and reflects the most important clinical relevance), showed an even higher reduction of risks at 26% compared to placebo. The clinical benefits as measured by the primary endpoint of MACE score and the key secondary 3-point MACE score are observed across subgroups (statistically significant in the vast majority of the subgroups), which speaks to the validity and robustness of the data. We echo the sentiment expressed by some KOLs present at the meeting that the REDUCE-IT trial data may be viewed as “unprecedented” and “paradigm-changing” in the context of minimal or modest benefits historically achieved by various therapies on top of statins. We point out that the subgroup analysis may give the first peek into the commercial potential of Vascepta: regardless of baseline triglycerides levels (≥150 vs. <150 mg/dL), diabetes status, baseline LDL-C, Vascepta provides similarly robust CV benefit. This, compared to the current label of Vascepa which is only indicated in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL), should significantly broaden Vascepa’s target patient population if the FDA grants the label expansion. With regard to the placebo (mineral oil) controversy, we view it as temporary noise that has been given an oversized weight by the bears. We are not aware of any strong evidence supporting that mineral oil contributed to the worsened outcome on the placebo arm. At most, we believe it mounts to speculation and hypothesis of the potential physiological activity of mineral oil without any clinical validation of such claims. In any case, the possibly minimal biological activity of the placebo arm would not negate the robustness of the results, in our view. We expect the placebo issue to be raised during the FDA review, but do not believe it would negatively impact the regulatory outcome. As far as the safety signals go, the increased risk of atrial fibrillation should be offset by the reduction in stroke, according to our KOL, since atrial fibrillation often leads to stroke which was actually decreased with Vascepa’s treatment. We think perhaps a more relevant question for Vascepa now is how the data is received by physicians and how the REDUCE-IT results would change the uptake of the drug and physicians’ prescription regimen. If there is any indication, we point to the survey conducted at AHA after the presentation where it asked physicians how they plan to change practice after the REDUCE-IT data, and 87% of the audience said they would prescribe Vascepa to all high risk patients with moderate TG levels."
Amarin | 18,21 $
Amarin Is A Long-Term Buy With Potential Blockbuster Drug Vascepa
Jul. 1, 2019


Summary
Amarin is preparing for a monumental label expansion for their flagship product Vascepa with a PDUFA date in September.

I have been waiting patiently for an opportunity to buy some cheap shares but the market is not providing me a chance. I am looking for a speculative buy.

With an expanded label, Vascepa could be a blockbuster drug that is a mainstay in the cardiac patient paradigm.

https://seekingalpha.com/article/4272946-amarin-long-term-bu…
Amarin | 19,39 $
Guiadance erhöht, Amarin wie geil:

Amarin's stock surges after raised revenue outlook, increased commercial expansion of Vascepa

Published: July 2, 2019 6:47 a.m. ET








Author photo

By
Tomi
Kilgore
Reporter and editor

Shares of Amarin Corp. AMRN, -0.77% surged 9.2% in premarket trading Tuesday, after the pharmaceutical company raised its full-year revenue outlook and announced plans to double its U.S. sales force to further increase commercial expansion of Vascepa for the treatment of cardiovascular disease. The company now expects 2019 revenue of $380 million to $420 million, above previous guidance of $350 million, and above the FactSet consensus of $364.3 million. Amarin said it increasing the size of its U.S. sales force to about 800 representatives, with the aim of having the expanded team deployed by October. The accelerated expansion followed the priority review designation of the supplemental new drug application (sNDA) for Vascepa. "We anticipate Vascepa revenue growth to accelerate further after label expansion approval and with a larger sales team, and then again after we commence promotion of Vascepa for cardiovascular risk reduction on television and through other media," said Chief Executive John Thero. Amarin's stock has soared 41.4% year to date through Monday, while the S&P 500 SPX, +0.77% has climbed 18.3%.
Amarin | 19,20 €
Hier die komplette Pressemeldung, super kann ich nur sagen:

Amarin Provides Mid-2019 Update, Including Commercialization Plans for Vascepa® and Updates Full Year 2019 Revenue Guidance
GlobeNewswire•July 2, 2019

Record Revenue Achieved in 1H19 Primarily Due to Increased Demand for Vascepa
Guidance for Total 2019 Revenue Increased to a Range of $380 to $420 Million from $350 Million Following Unaudited Second Quarter Results Estimated Between $97 and $101 Million, or Between $170 and $174 Million for the First Half of 2019
U.S. Sales Force to Double in Size; Recruiting Commenced
Vascepa sNDA PDUFA Goal Date On-Track for September 28, 2019; Potential for Therapy to Become First Prescription Product Available for Cardiovascular Risk Reduction in Patients with Elevated Triglyceride Levels, Despite Statin Therapy

BEDMINSTER, N.J. and DUBLIN, Ireland, July 02, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today provided a business update, including that the company is increasing revenue guidance for 2019 and planning to further increase its commercial expansion efforts to align with its progress and outlook that the realizable opportunity for Vascepa® (icosapent ethyl) is larger than previously believed. These revised plans follow estimated record revenues for the quarter ended June 30, 2019 and assume expanded FDA labelling for Vascepa.

sNDA Update

As previously announced, Amarin submitted an sNDA to the U.S. Food and Drug Administration (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 expected 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.

The FDA grants Priority Review designation to applications for drugs that, if approved, have the potential to offer significant improvements in the effectiveness and safety of the treatment of serious conditions when compared to standard applications. Assuming the FDA approves this sNDA, Vascepa is anticipated to be the first drug with an indication to reduce residual cardiovascular risk in patients with statin-managed LDL-cholesterol, but persistent elevated triglyceride (TG) levels, an important indicator of cardiovascular disease.

The results of the REDUCE-IT study were published in The New England Journal of Medicine in November 2018.1 Additional results and analysis of total recurrent events observed in REDUCE-IT were published in the Journal of American College of Cardiology in March 2019.2

Vascepa is currently indicated as an adjunct to diet to reduce TG levels in adults with severe (TG ≥500 mg/dL) hypertriglyceridemia, an important but much smaller patient population than can be addressed with an approval of this sNDA.

To date, the FDA has not informed Amarin as to whether it plans to convene an Advisory Committee meeting (AdCom) to review the sNDA. As previously disclosed, Amarin continues to prepare in the event that an AdCom is convened. If Amarin is informed definitively that there will or will not be an AdCom, the company plans to update investors accordingly.

Preliminary (Unaudited) First Half 2019 Financial Results

Record Revenue Levels Achieved: Net total revenue for the three and six months ended June 30, 2019 are estimated to have reached between $97 and $101 million and between $170 and $174 million, respectively. Both the second quarter and first half of 2019 results represent record revenue levels for Amarin. These results, which are subject to auditor review, represent an increase of approximately $44 to $48 million (approximately 84% to 92%) for the second quarter of 2019 over the corresponding period of 2018 and an increase of approximately $73 to $77 million (approximately 76% to 80%) for the first half of 2019 over the corresponding period of 2018. These results consist predominantly of U.S. sales-driven increases in prescriptions for Vascepa. Wholesaler inventory levels of Vascepa were within normal industry ranges at the end June 2019.

Current Assets: Amarin ended June 2019 with cash and cash equivalents of approximately $221 million (compared to $211 million at March 31, 2019), approximately $94 million in net accounts receivable and approximately $47 million in inventory.

No Debt, Except Remaining Balance of Royalty Bearing Instrument: Amarin ended June 2019 with no debt except the remaining balance on its royalty bearing instrument which is repaid at a rate of 10% of Vascepa revenues; aggregate repayment of less than $74 million remains until this royalty-like obligation is fully extinguished.

2019 Financial and Operational Guidance

Amarin initially provided guidance for 2019 in its press release dated January 4, 2019. Amarin now makes the following updates to that guidance:

2019 Revenue Guidance: Forecasting Vascepa revenue levels at this early stage remains difficult. Based on estimated total revenue results for the first half of 2019 which exceeded prior expectations, Amarin increases its guidance for 2019 net total revenue to a range of $380 to $420 million. While Amarin remains optimistic that Vascepa will generate billions of dollars in revenue in the years to come, the history of other therapies for chronic conditions suggests that growth builds over multiple years, and thus, the company is not prepared to provide quantified guidance regarding revenue levels beyond 2019.

Commercial Expansion in United States: Amarin has accelerated and further expanded its commercialization plans for Vascepa in the United States. Amarin intends to increase the size of its U.S. sales force to approximately 800 sales representatives with the aim of having its expanded team hired, trained and deployed by October 2019. This increase would represent a doubling of the size of Amarin’s current sales force.

The timing of such expansion had been accelerated in part due to the priority review designation of the sNDA for Vascepa. Assuming label expansion for Vascepa on the September 28, 2019 PDUFA date, Amarin expects to have educational and promotional materials available by early October 2019 to promote Vascepa based on the new label.

The size of the planned expansion reflects the result of evaluations involving multiple contributing factors. Previously Amarin had estimated the potential expansion of its sales force to reach between 600 and 800 sales representatives and for the expansion to potentially occur in phases. The decision to expand the sales force to approximately 800 sales representatives by October 2019 was based on new information including the encouraging progress being made by sales representatives hired at the start of 2019, positive feedback from physicians with deep understanding of the REDUCE-IT data, additional data on the commercial opportunity that exists in detailing physicians who have not yet been educated about Vascepa and data suggesting that education of healthcare professionals regarding Vascepa will be improved if our sales representatives call on physicians with greater frequency.

As a reminder, in late 2018, Amarin hired, trained and deployed 265 new and qualified sales representatives within approximately three months after learning the results of REDUCE-IT. At the time, more than 20,000 applications were received for the 265 open sales positions. Based on this track record and the robust results of Vascepa clinical trials, Amarin is confident it can double its sales force to 800 sales representatives by October 2019.

While Amarin is confident that expanding its sales force will result in meaningful revenue growth beyond 2019, the company’s revenue guidance for 2019 as described above anticipates little incremental contribution in 2019 from these newly hired sales representatives. Based on available data, it typically requires multiple months for newly hired sales representatives to become meaningfully productive particularly if they are calling on healthcare professionals who also are new to Vascepa, which will be the case for a large part of such sales force expansion.

Amarin intends to support its expanded U.S. sales team with multiple promotional and educational programs. All such initiatives will be aimed at providing truthful and non-misleading information to lead to improved patient care. Included in Amarin’s promotion plans is a direct-to-consumer advertising campaign, subject to review by the FDA’s Office of Prescription Drug Promotion (OPDP). The company anticipates submitting proposed Vascepa advertisements to OPDP in October 2019. Based on the timeline for other companies getting consumer advertising reviewed by FDA following new labelling, assuming new Vascepa labelling, launch of such branded advertising is anticipated in the second quarter of 2020.

Plans for commercialization of Vascepa outside of the United States remain unchanged, including intentions to submit for regulatory approval of Vascepa in the European Union near the end of 2019.

Comment from Amarin’s President and CEO

“We are pleased with the progress made to date, including the significant revenue growth we’ve achieved for Vascepa,” commented John Thero, president and chief executive officer of Amarin. “We anticipate Vascepa revenue growth to accelerate further after label expansion approval and with a larger sales team, and then again after we commence promotion of Vascepa for cardiovascular risk reduction on television and through other media. We are preparing for a robust launch of REDUCE-IT data with the aim of helping physicians improve patient care for millions of patients with residual cardiovascular risk after their cholesterol is controlled, as identified by elevated triglycerides.”

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.

About REDUCE-IT™

REDUCE-IT1 was an 8,179-patient multinational cardiovascular outcomes study completed in 2018. REDUCE-IT 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.3, 4

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.5

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.6-9

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.

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 Medicine1 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.

Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. FDA has not reviewed and opined on a supplemental new drug application related to REDUCE-IT. FDA has not reviewed the information herein or determined whether to approve Vascepa for use to reduce the risk of MACE. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

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 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.

Recurrent event analyses for the total primary endpoint events and for the total key secondary endpoint in REDUCE-IT as published in the Journal of the American College of Cardiology were conducted using a series of statistical models. These analyses were tertiary or exploratory endpoints; most of the models used were prespecified and one was post hoc. Each recurrent event statistical model has inherent strengths and weaknesses, with no single model considered definitive or outperforming the other models, and this is an evolving field of science. Nonetheless, results from the total primary and total key secondary endpoint events analyses are consistent across the various recurrent event statistical models and are also consistent with the original primary and secondary endpoint results. Together, the REDUCE-IT recurrent event analyses and the original primary and key secondary endpoint analyses support the robustness of the clinical benefit of Vascepa therapy in reducing cardiovascular risk.

Forward-Looking Statements

This press release contains forward-looking statements, including expectations regarding revenue and prescription growth, including updated revenue guidance for 2019; sales force expansion and marketing initiatives expected in 2019 and beyond; FDA regulatory review, including the timing and outcome of such review; the applicability and reliability of REDUCE-IT results; and the expected outcome and timing of review elements and market dynamics for Vascepa. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition, Amarin's ability to effectively commercialize Vascepa will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to gain regulatory approvals, create market demand for Vascepa through education, marketing and sales activities, to achieve market acceptance of Vascepa, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the Vascepa franchise. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
References
Amarin | 19,20 €
Hier nochmal die wichtigsten Eckdaten im Überblick:

Amarin Provides Mid-2019 Update

> Record Revenue Achieved in 1H19 Primarily Due to Increased Demand for Vascepa

> Guidance for Total 2019 Revenue Increased to a Range of $380 to $420 Million from $350 Million Following Unaudited Second Quarter Results Estimated Between $97 and $101 Million, or Between $170 and $174 Million for the First Half of 2019

> U.S. Sales Force to Double in Size; Recruiting Commenced

> Vascepa sNDA PDUFA Goal Date On-Track for September 28, 2019; Potential for Therapy to Become First Prescription Product Available for Cardiovascular Risk Reduction in Patients with Elevated Triglyceride Levels, Despite Statin Therapy
Amarin | 19,20 €
Sogar Adam Feuerstein schreibt nichts Negatives:

Amarin raises sales guidance for heart drug Vascepa, hires more sales reps for larger marketing push

By Adam Feuerstein @adamfeuerstein

July 2, 2019

Vascepa pill handout
Amarin

Amarin (AMRN) pre-announced record quarterly sales of its heart drug Vascepa on Tuesday and raised its financial guidance for the remainder of the year, citing strong patient demand for the drug, derived from fish oil, now that it has been shown to significantly lower the risk of death and other adverse cardiovascular events.

The Bedminster, New Jersey-based drug maker is also doubling the size of its commercial salesforce to prepare for the highly expected expansion of Vascepa’s label by the Food and Drug Administration in late September, the company said.

Sales of Vascepa in the just-ended second quarter reached a record range of $97 million to $101 million, Amarin said. The final sales tally will be announced after the company’s auditors review the results.

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At the $99 million midpoint, Vascepa sales in the second quarter nearly doubled sales from the year-ago period. Sell-side analysts, on average, were expecting Vascepa sales of $91 million in the third quarter, according to Koyfin.
Related:
The biotech scorecard for the third quarter: 12 stock-moving events to watch

Amarin attributes the accelerated sales growth of Vascepa to the publication last year of results from the REDUCE-IT clinical trial, which found that Vascepa provides significant cardiovascular benefits to a much broader swath of people than previously believed.

Based on surging demand for Vascepa prescriptions, Amarin now expects 2019 sales in the range of $380 to $420 million, the company said. Its previous Vascepa sales guidance, offered last January, was $350 million.

The current analyst consensus has Vascepa sales reaching $390 million in 2019, so investors, to some extent, were already anticipating Tuesday’s guidance hike.

The FDA is expected to rule by Sept. 28 on Amarin’s request to expand the Vascepa label to include the heart benefit claims resulting from the REDUCE-IT clinical trial. So far, the FDA has still not informed Amarin about any plans to convene an outside advisory committee meeting to review the Vascepa data, the company said Tuesday.

Typically, the FDA gives a drugmaker 60 days advance notice to prepare for an advisory committee meeting. With the calendar turning over to July, the odds that the FDA will schedule a Vascepa meeting are growing smaller, which in turn, makes it more likely that the agency will approve the Vascepa label expansion without delay.

Doctors are already prescribing more Vascepa based on the publication of the heart benefits seen in the REDUCE-IT study. Amarin’s marketing efforts, however, must wait for an official green light from the FDA. In anticipation of that happening, the company said Tuesday it has begun hiring new salespeople to market Vascepa. Once fully hired, Amarin’s commercial team will total 800 people, double its current size.

Amarin also intends to submit a marketing application for Vascepa in Europe by the end of the year.

Shares of Amarin rose 9% to $21 in early trading.
Amarin | 18,70 €
Eigentlich nur noch eine Frage der Zeit, bis Big Pharma hier zugreift, oder was meint ihr?!

Revolutionäres Produkt/Medi ohne Nebenwirkungen, Topp-Wachstumschancen etc.
Amarin | 18,70 €
Glaub ich auch, der Preis muss stimmen, unter US$ 50 wird John Thero nicht verkaufen, hoffentlich!
Amarin | 18,70 €
Bloomberg:

Amarin Surges After Drugmaker Says Heart Pill Sales Are Booming
[Bloomberg]
Myah Ward
,Bloomberg•July 2, 2019

(Bloomberg) -- Amarin Corp.’s American depositary receipts surged to their highest intraday price since March 12 after the drugmaker said that its new heart pill was selling faster than projected and that it plans to double the size of its sales force.

The company now expects 2019 revenue to be $380 million to $420 million, up from a May 1 prediction of $350 million. Amarin will also increase its sales force to approximately 800 people, it said in a statement Tuesday.

The success of the heart drug, called Vascepa, had at one time made the Dublin-based company the subject of takeover speculation.

“We have great confidence in our ability to successfully market and sell Vascepa in the U.S. on our own,” Chief Executive Officer John Thero said in an email to Bloomberg.

The depositary receipts were up 13% to $21.79 at 1:01 p.m. in New York, after rising as much as 14%.

Vascepa is approved for sale in the U.S. to lower patients’ triglyceride levels. Triglycerides are a type of fat in the blood, and too high a level can increase the risk of heart disease and stroke.

The company has asked the U.S. Food and Drug Administration to let it market Vascepa as helping reduce the risk of cardiovascular events, following a successful clinical trial. The FDA’s decision is expected by late September.

To contact the reporter on this story: Myah Ward in New York at mward174@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

For more articles like this, please visit us at bloomberg.com

©2019 Bloomberg L.P.
Amarin | 22,26 $
Amarin guidance highlights continued Vascepa traction, says H.C. Wainwright Amarin's updated revenue guidance yesterday highlights the continued U.S. prescription traction of Vascepa, H.C. Wainwright analyst Andrew Fein tells investors in a research note. The analyst finds the guidance updates in line with his 100 physician survey, which suggests Amarin "remains in the early stages of Vascepa launch with significant upside ahead coinciding with growing physician awareness." Fein reiterates a Buy rating on the shares with a $51 price target.

Read more at:
https://thefly.com/landingPageNews.php?id=2929191
Amarin | 23,63 $
Amarin guidance highlights continued Vascepa traction, says H.C. Wainwright Amarin's updated revenue guidance yesterday highlights the continued U.S. prescription traction of Vascepa, H.C. Wainwright analyst Andrew Fein tells investors in a research note. The analyst finds the guidance updates in line with his 100 physician survey, which suggests Amarin "remains in the early stages of Vascepa launch with significant upside ahead coinciding with growing physician awareness." Fein reiterates a Buy rating on the shares with a $51:eek::D price target.

Read more at:
https://thefly.com/landingPageNews.php?id=2929191
Amarin | 23,60 $
Überblick zu wichtigen Fakten, Visionen und Zitate aus den letzten Wochen.

- Amarin hat die Zulassung zum Verkauf des Medikaments Vascepa
in den USA erhalten. Vascepa ist in der Lage, den Triglyceridspiegel von Patienten zu senken. Die Triglyceride sind eine Art Fett im Blut - ein zu hoher T.Spiegel kann das Risiko für Herzkrankheiten und Schlaganfälle erhöhen.

- Amarin hat nach einer „erfolgreichen“ klinischen Studie ( Ergebnisse der REDUCE-IT-Studie wurden im November 2018 und im März 2019 veröffentlicht) bei der FDA einen Antrag auf Erweiterung des Vascepa-Labels zur möglichen Risikominderung von kardiovaskulären Ereignissen gestellt.

- Ob vor der FDA Entscheidung eine Sitzung des Advisory Committee (AdCom) einberufen wird , um die NDA zu überprüfen, bleibt abzuwarten. Zumindest hat die FDA bisher Amarin noch nichts mitgeteilt.
In diesem Zusammenhang sagt Adam Feuerstein:
Normalerweise teilt die FDA einem Arzneimittelhersteller 60 Tage im voraus mit, dass er sich auf eine Sitzung des Beratungsausschusses vorbereiten soll. Mit der Umstellung des Kalenders auf Juli sinken die Chancen, dass die FDA ein Vascepa-Meeting einberufen wird, was wiederum die Wahrscheinlichkeit erhöht, dass die Agentur die Erweiterung des Vascepa-Labels unverzüglich genehmigt.

Die Entscheidung der FDA wird am 28.09.19 erwartet.

Nach der Bekanntgabe ( 02.07.19 ) der Steigerung der Umsatzzahlen von Vascepa sagte CEO John Thero:
“We have great confidence in our ability to successfully market and sell Vascepa in the U.S. on our own”

Ende 2018 stellte Amarin nach Bekanntgabe der ersten Ergebnisse von REDUCE-IT bereits 265 neu-geschulte und qualifizierte Vertriebsmitarbeiter ein. Basierend auf dieser Erfolgsbilanz und den guten Ergebnissen der klinischen Studien mit Vascepa ist Amarin zuversichtlich, dass das Verkaufsteam bis Oktober 2019 auf 800 Vertriebsmitarbeiter verdoppelt werden kann.

Das zeugt von einer klaren, überzeugenden Strategie , das Verkaufs-Procedere selbst managen zu können - und damit vielleicht ersten Buyoutgerüchten entgegen zu treten.


https://www.statnews.com/2019/07/02/amarin-raises-sales-guid…" target="_blank" rel="nofollow">https://www.statnews.com/2019/07/02/amarin-raises-sales-guid…


https://finance.yahoo.com/news/amarin-provides-mid-2019-incl…

https://finance.yahoo.com/news/amarin-surges-drugmaker-says-…
Amarin | 23,48 $
Antwort auf Beitrag Nr.: 58.247.820 von Cyberhexe am 18.07.18 22:09:58
Zitat von Cyberhexe:
Zitat von lobberland: Ich hoffe auf Sekt... bisherigen Ergebnisse lassen es zumindest erhoffen



ich bin ebenfalls vorsichtig optimistisch , dass REDUCE-IT den Beweis liefern wird, dass hochdosiertes Fischöl in Form von Vascepa kardiovaskuläre Erkrankungen gegenüber Plazebo stat. signifikant um 15% senkt!

Ich habe deswegen heute eine erste Position aufgebaut, die möglicherweise in den nächsten Wochen noch aufgestockt wird - Ergebnisbekanntgabe von REDUCE-IT ist auf Ende 3q2018 angekündigt.

Ich würde meinen: Sekt, je nach Ergebnis vielleicht sogar Champagner!



...am 28.9.2019 wird VASCEPA spätestens von der FDA zugelassen --> Prescription Drug User Fee Act (PDUFA). Dann gibts nicht nur Sekt!
Amarin | 22,73 $
Gibt es hier Meinungen zu ACST? Dort stehen später im Jahr noch P3 Daten zum Krillöl Projekt an. Logischerweise kein CVOT aber sie könnten sowohl von AMRN profitieren als auch in Antizipation der P3 Ergebnisse weiter steigen. Marktkapitalisierung liegt bei 100 Mio.
Amarin | 23,06 $
Why Amarin Stock Is Up 63% So Far in 2019
[Motley Fool]
Beth McKenna, The Motley Fool
,Motley Fool•July 10, 2019
What happened

Shares of Irish biotech Amarin (NASDAQ: AMRN) are up 14.2% so far this month, through Tuesday, July 9.

This rise follows the stock's 42.5% gain in the first half of 2019, according to data from S&P Global Market Intelligence. The S&P 500 returned 18.4% over this period.

Amarin's year-to-date gain is a hearty 62.7% through July 9, versus the broader market's 20.2% return.
A pile of six see-through, light-gold capsules on a flat surface.
A pile of six see-through, light-gold capsules on a flat surface.

Image source: Getty Images.
So what

July

On July 2, Amarin shares surged 16.3% following the company increasing its full-year 2019 revenue guidance to a midpoint of $400 million, up from $350 million. The raise was driven by strong demand for Vascepa, its omega-3 fatty-acid drug derived from fish oil that's currently approved to treat patients with high triglyceride levels.

This demand could be only a start, however, as Amarin and its investors are eagerly anticipating the U.S. Food and Drug Administration's decision on a huge label expansion. In late September, investors should learn whether the FDA has given the green light to Vascepa for the treatment of patients at risk for major adverse cardiovascular events, including heart attacks or strokes.

As background: Amarin stock skyrocketed last September after the company released robust results of its Reduce-It cardiovascular outcomes study. As I previously wrote, "The study showed that Vascepa ... reduced the risk of major adverse cardiovascular events by 25% in patients already taking statin drugs compared to those receiving a placebo, which is a highly statistically significant result."

AMRN Chart
AMRN Chart

Data by YCharts.

First Half of 2019

Amarin stock likely got a tailwind in the first half of the year from the strong overall market. That said, we can attribute its outperformance of the market to several catalysts, including:

Jan. 9: Shares popped 8.1% following the company's optimistic presentation at the J.P. Morgan Healthcare Conference.
Jan. 10: Shares soared 22.1% on market chatter about pharmaceutical giant Pfizer being interested in making a bid for Amarin.
Feb. 22-27: Shares gained 21.5% in the four market days leading up to and including the company's release of its fourth-quarter and full-year 2018 results, driven by investor optimism about Vascepa sales on the heels of the Reduce-It study. Indeed, investors were right to be hopeful, as Vascepa's Q4 revenue rose 44% year over year to $77.3 million.
May 29: Shares surged 11.6% after Amarin announced that the FDA had granted an expedited review of Vascepa for patients at risk of major adverse cardiovascular events. This moved the timetable for the agency's decision to six months after the application submission rather than the more usual 10 months.

Now what

Take heart, investors: The FDA's decision on Vascepa's label expansion should be less than three months away, in late September. Look for Amarin stock to react accordingly.
Amarin | 19,60 €
Planet Fitness, Allergan, Amarin: 'Mad Money' Lightning Round
Jim Cramer weighs in on Planet Fitness, Allergan, Amarin, MPLX, Zynerba Pharmaceuticals, Schnieder National, United Parcel Service and more.
Scott Rutt
Jul 10, 2019 8:40 PM EDT
Portfolio Advice: Apple & Walmart

Here's what Jim Cramer had to say about some of the stocks during the Mad Money Lightning Round:

Planet Fitness (PLNT - Get Report) : "I think Planet Fitness is terrific and they're winners."

Allergan (AGN - Get Report) : "This one has gotten a takeover bid. It's done."

Amarin (AMRN - Get Report) : "This is pretty good. It's a buy."

MPLX (MPLX - Get Report) : "I'll say it's OK to own, but pipelines have been a tough place. "

Zynerba Pharmaceuticals (ZYNE - Get Report) : "Very interesting, but I'll stick with GW Pharmaceuticals (GWPH) ."

Schneider National (SNDR - Get Report) : "Let's go with United Parcel Service (UPS - Get Report) ."

Cramer and the AAP team are redeploying some cash to one of their recent initiations, Caterpillar (CAT - Get Report) . Find out what they're telling their investment club members and get in on the conversation with a free trial subscription to Action Alerts Plus.

On Real Money, Cramer says it looks like America is overrun with denim right now. Get more of his insights with a free trial subscription to Real Money.

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Search Jim Cramer's "Mad Money" trading recommendations using our exclusive "Mad Money" Stock Screener.

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At the time of publication, Cramer's Action Alerts PLUS had a position in CAT.
Amarin | 21,98 $
Antwort auf Beitrag Nr.: 60.947.566 von bernie55 am 03.07.19 17:02:19
Zitat von bernie55: - Ob vor der FDA Entscheidung eine Sitzung des Advisory Committee (AdCom) einberufen wird , um die sNDA zu überprüfen, bleibt abzuwarten. Zumindest hat die FDA bisher Amarin noch nichts mitgeteilt.

In diesem Zusammenhang sagt Adam Feuerstein:
Normalerweise teilt die FDA einem Arzneimittelhersteller 60 Tage im voraus mit, dass er sich auf eine Sitzung des Beratungsausschusses vorbereiten soll. Mit der Umstellung des Kalenders auf Juli sinken die Chancen, dass die FDA ein Vascepa-Meeting einberufen wird, was wiederum die Wahrscheinlichkeit erhöht, dass die Agentur die Erweiterung des Vascepa-Labels unverzüglich genehmigt.


Auf dem Advisory Committee Calendar ist für Juli 2019 soweit nichts angekündigt

https://www.fda.gov/advisory-committees/advisory-committee-c…
Amarin | 20,80 €
Verschreibungen von VASCEPA von Februar 2015 - Juli 2019 ( CaptBeer auf stocktwits.com )

Amarin | 20,40 €
Wichtiger Schwerpunkt der 36. Tagung für die Prävention von Herz-Kreislauf-Erkrankungen -
die Ergebnisse von REDUCE-IT werden vorgestellt und diskutiert


ASPC 2019 (The American Society for Preventive Cardiology)

July 19-21, 2019

La Cantera Resort & Spa
San Antonio, TX

https://www.aspconline.org/congress2019/


CONGRESS OVERVIEW
Important advances in prevention and treatment of cardiovascular disease continue to emerge, and these advances must be consistently incorporated into clinical practice to provide the best care for patients.

Opening day Agenda

19.07.19


3:30–3:40 PM Welcoming Remarks

3:50–4:30 PM
Keynote Lecture: REDUCE-IT and Treating Beyond LDL-C Lowering Deepak Bhatt, MD

Seite 3 auf https://www.aspconline.org/wp-content/uploads/2019/05/ASPC-…
Amarin | 19,70 €
Antwort auf Beitrag Nr.: 61.051.915 von lobberland am 18.07.19 08:54:43Guten Morgen,

das liegt an 2 Dingen (meiner Meinung nach)

einmal das hier:
https://investor.amarincorp.com/news-releases/news-release-d…

das führt dazu sich die Frage zu stellen warum Amarin 54 Tage vor spätester FDA Bekanntgabe ob zugelassen oder nicht bis zu 460 Mio in Cash umwandelt und mit diesem Schritt nicht erst das Ergebnis abgewartet hat. Daher "psychologischer Nebeneffekt" denken jetzt viele, Amarin vergoldet sich den zuletzt hingelegten Höhenflug der Aktie um für "härtere Zeiten" Cash zu haben, sprich härtere Zeiten bedeutet Sie sind selbst nicht vollkommen überzeugt davon das Sie diesmal durchkommen. Da Amarin ausschliesslich auf das eine Medikament setzt hängt eben extrem viel von dieser anstehenden Entscheidung ab..

Andere Interpretationen sind, Amarin glaubt dass sie "sicher" die Zulassung erhalten und will mit dem Cash wirklich schon die Markterweiterung angehen so dass Sie sofort im grösseren Masstab loslegen können.

Ein kleiner negativer Effekt zusätzlich aus dieser zunächst positiven Erkenntnis ist, Sie machen ernst damit alles alleine weiter stemmen zu wollen, sprich sind nicht an Übernahmeangeboten interessiert... Sprich kurzfristige Kurssprünge da Übernahme ansteht bleibt somit aus..

Zum anderen ist auch die Zwischenprüfung die immer noch nicht vom FDA an- oder abgekündigt wurde, vor "finalem" Entscheid weiter im Spiel. Eigentlich gehört das zum normalen Prozedere und keine durchzuführen wäre aus meiner Sicht absolut einzigartig, aber wenn sie kommt wäre das absolut normal und kein negatives Zeichen...

Naja all diese Punkte geben den Skeptikern kräftig Aufwind und ein weiteres Absinken des Kurses ist wahrscheinlich...

Jetzt heisst entweder daran glauben und am besten die nächsten Wochen einfach nicht so genau auf den Kurs achten ;) oder alles raus mit Verlusten so schnell wie möglich...

Einige spielen auch das Spiel so, jetzt raus und wenn die Aktie noch weiter unten ist wieder alles rein, mit entsprechendem Geld also mit mehr Anteilen dann bis zum Finale dabei sein...

Die FDA Finalentscheidung kann aber "jederzeit" kommen dass heisst man spielt egal wie nicht "sicher" und kann bestimmte Kursbewegungen egal wie man sich entscheidet verpassen.

Ich gehe für meinen Teil auf Risiko da mich das Medikament die Studie und die Aussage der Fachärzte als auch Patienten sehr überzeugt haben. Ich glaube an einen Gamechanger, aber eines ist sicher die Aktie braucht insgesamt Zeit um sich auch später in sehr profitable Höhen zu schwingen, da Amarin das nun selbst ankurbelt und nicht die Ressourcen eines Grosskonzerns besitzt...

Hoffe diese Einschätzung hat Dir etwas geholfen ? :)
Amarin | 17,40 €
Antwort auf Beitrag Nr.: 61.052.095 von flyingbeef am 18.07.19 09:16:34Danke für deine ausführliche Einschätzung
Dabei bleibe ich auch auf jeden Fall, bin mir sicher das hier das eine Pferd auch ins Ziel läuft. 🙋‍♂️
Amarin | 17,40 €
Amarin ist höchstseriös und treibt die Markteinführung mit der Kapitalerhöhung voran, für mich ist die Zulassung in trockenen Tüchern, 31 % weniger Herzinfarkte, 28 % weniger Schlaganfälle und 20 % weniger Todesfälle beim Reduce-It Trial, sensationell und so gut wie ohne Nebenwirkungen!

Amarin stockt auf 800 Reps auf und macht Vascepa zum Megablockbuster, Nachkaufchance!

Wir wissen ja noch nicht den Ausgabekurs, ich tipppe um die 20 US Dollar und die Fonds die kaufen wollen ja auch Ihren Gewinn machen!;)
Amarin | 17,30 €
Antwort auf Beitrag Nr.: 61.052.953 von Magnetfeldfredy am 18.07.19 10:28:25Hi sehe ich auch so.

Amarin steht für preiswerte Medikamente, keine Gewinnmaximierung, die haben auch meiner Meinung nach Anstand. Daher sehe ich diesen Cash-Move auch in keinster Weise als Bereicherung, dass würde einfach nicht passen, weder zu Ihrem Chef noch zur Firma selbst.

Ich denke auch dass Sie wissen das Sie in der Zielgeraden stehen. Dass Sie die Unabhängigkeit von raffgierigen Übernahmefirmen weiter bewahren wollen finde ich im Gegenteil auch sehr sympatisch.

Ich hab gerne in diese Aktie investiert, es fühlt sich einfach "gut" an und ist im Idealfall auch eine echte Bereicherung für die Menschheit. Da dann ein wenig mit Anteil gehabt zu haben und wenn es auch nur ein bischen Geld ist why not :)
Amarin | 17,30 €
@flyingbee
@Magnetfeldfredy

Euren Ausführungen ist nichts mehr hinzuzufügen.

:kiss: Super vielen Dank , klasse gemacht !:kiss:

Die dargestellten möglichen Szenarien und Hypothesen decken sich soweit auch mit den Beiträgen in den amerikanischen Foren ( stocktwits, yahoo).



> ...sobald die Anteile von den Instituten gekauft wurden, werden die großen Namen gezwungen sein, mit der Berichterstattung zu beginnen.

> ...sobald die FDA-Zulassung vorliegt, wird Amarin in viele Investmentfonds mit Biotech-Beteiligungen aufgenommen.

> Amarins Plan ….dass Kapital verwendet wird, um strategische Vermögenswerte zu erwerben und das kommerzielle Angebot von Vascepa zu erhöhen..... Amarin muss viele Fischfarmen besitzen und möglicherweise sogar EPA-produzierende Mikroalgenfirmen oder -produkte kaufen.

> ..einem möglichen Buyout entgegenwirken...

> ….FDA-Nachrichten können jetzt jeden Tag sein!

> J. P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC und Cantor Fitzgerald & Co. agieren als gemeinsame Book-Running-Manager im Angebot.Diese „Institute“ werden die „Angebots-Anteile“ in Rekordzeit verschlingen

> ....geht davon aus, dass der Kurs zwischen 19 und 20 US-Dollar liegen wird.


Let´s hope the best....so time will tell
Amarin | 19,37 $
Amarin Prices Public Offering of American Depositary Shares

GlobeNewswire•July 19, 2019

BEDMINSTER, N.J. and DUBLIN, Ireland, July 18, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN) today announced the pricing of the underwritten public offering of 22,222,223 American Depositary Shares ("ADSs") at a price to the public of $18.00 per ADS.

The gross proceeds of this offering are expected to be approximately $400.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Amarin. The offering is expected to close on or about July 23, 2019, subject to customary closing conditions.

https://finance.yahoo.com/news/amarin-prices-public-offering…
Amarin | 16,90 €
Reduce-IT
Hallo zusammen,

würde gerne eure Meinung dazu hören. Ich habe Interviews von Fachärzten die sich die Studie angesehen haben gelesen.

Fazit: Grundtenor war positiv = tolles Potential

Aber: Natürlich gibt es auch immer die andere Seite der Medallie.

Negative Aspekte waren:
- Placebo war Mineralölbasierend, es könnte also sein dass die sehr positiven Ergebnisse im Vergleich zur Placebogruppe auf negativen Gesundheitseffekten beruhen die das Placebo ausgelöst haben könnte. (Dazu muss msn wissen das FDA hat explizit ein mineralölbasiertes Placebo für die Studie akzeptiert)
Hier geben Experten zu dass mutmasslich wenn das einen Effekt hat aber nicht so sehr ins Gewicht fällt so dass Vascepa keine Wirkung mehr hätte. Aber eben keine 25% mehr...
- Ein anderer Aspekt war das die ausgewählten Testpersonen mit nicht genug Zufall zu den Gruppen zugeteilt wurden und somit ebenfalls evtl. eine positivere Darstellung der Ergebnisse möglich waren als wenn das Verfahren mehr Zufall gehabt hätte
- Letzter Aspekt war dass zwar eine positive Wirkung statistisch nachvollziehbar nachgewiesen wurde, aber andere Fischölbasierte Produkttest nie eine auch nur annähernd vergleichbare Wirkung erzielt hätten. Dazu wurde angemerkt dass man viel zu wenig darüber weiss warum Vascepa wirkt und das noch genauer untersucht werden müsste.

Das sind alles Dinge die auch heute wohl auf dem Kongress wieder Thema sein werden. Kennt sich jemand von euch mit Pharma aus und kann das einschätzen ob diese Argumente Roadblocker sind oder das zwar valide Anmerkungen sind dass aber eine Zulassung nicht gefährden dürfte ? Auch würde mich interessieren ob diese Argumente trotz Zulassung den Marktantritt und die Geschwindigkeit der Medikamentenverschreibung weiter hemmen könnte ? Wäre an euren Meinungen sehr interessiert.
Amarin | 16,80 €
Einschätzung zur aktuellen Situation
Hallo,

evtl. helfen diese Gedanken anderen auch ein wenig, die vom Kurssturz etwas mitgenkommen sind... :keks: (Ich selbst habe aktuell ordentlich Verluste...)

Ich hatte mir überlegt wenn ich John Thero wäre und so handeln würde wie er es getan hat, warum hätte ich das getan.

Eigentlich sind diese ganzen Spekulationen, bald kommt die FDA Entscheidung oder Amarin selsbt hat nun große Zweifel (sie wissen was...) totaler Blödsinn.

JT weiss genausowenig wie wir wie sich das FDA entscheiden wird und hofft das beste für sich und die Firma. Ganz sicher glaubt er an Ihr jahrelang erprobtes Produkt und die Studie besätigt Sie ja auch immens.

Also warum dann nochmal so eine Finanzspritze ?

Ganz einfach, es ist eine klare Entscheidung für seine Leute / seine Firma. Er hat wie viele andere Firmen die überleben wollen die Möglichkeit gesehen zu einem aktuell ganz guten Preis neue finanzielle Mittel zu erhalten.

Wozu ?

Naja für 2 Dinge:

1. Egal ob die FDA Entscheidung jetzt kommt später oder gar nicht, seine Firma kann erst mal ein paar Jahre weiter machen und gegebenenfalls auch ein neues Produkt / neue Anwendungen testen. Sprich er sichert erst mal die mittelfristige Zukunft ab, ganz unabhängig davon ob er an einen Erfolg glaubt (wovon ich überzeugt bin das er es glaubt) oder nicht. Ganz nüchterne Entscheidung eben. Und es ist besser 600 Mio auf der Hohen Kante zu haben als 200 Mio würdet ihr ähnlich sehen wenn es eure Firma wäre ;)

2. Wie im Aktienverkaufsvohrhaben beschrieben können die zusätzlichen Finanzen wirklich helfen schneller zu expandieren. Er wird aber mit grösseren Ausgaben warten bis die Entscheidung da ist. Er bekommt keine Insidertips vom FDA usw. hier ist keine Verschwörung im Gange weder im positiven noch im negativen Sinne.... Siehe Stellenanzeigen sind aktuell immer noch die knapp 40 Stellen drin. Trotzdem kann man mit dem nun gewonnen Finanzmitteln schneller den Markt bedienen und auch dem FDA gegenüber besser zusichern auf benötigte Kapazitäten in absehbarer Zeit für den Markt upgraden zu können. Hilft also dem ganzen Prozess nur und ist evtl. sogar ein wichtiger Baustein, da Amarin ja plant erst mal alleine loszulegen und dass FDA eine gesunde finanzielle Basis sehen muss um den Markt der dieses Medikament erfordert auch schnellstmöglich dieses liefern zu können.

Was hat sich nun durch dieses nochmalige Geldholen verändert ?

Nichts, rein gar nichts... Die Chancen sind genauso hoch oder niedrig wie Sie vor der Finanzspritze waren, die Aktion hat "nichts" mit irgendwelchen bösen Vorahnungen das alles schief geht zu tun oder ähnliches... JT handelt absolut rational im Sinne seiner Firma.. und dessen weiterer Zukunft.

Das er da dann wissentlich bei Berufs-Skeptikern usw. unter den Aktionären (naja manche haben ja auch Grund dazu es gibt auch wirklich kriminelle Firmen oder Chefs...) den Kurs ins Trudeln bringt kann ihm egal sein. Die Firma wäre sowieso innerhalb kürzester Zeit extrem viel oder nicht sonderlich viel wert, ganz nachdem wie die FDA Entscheidung eben ausfällt.

Ja es ist keine Entscheidung wo wir als Anleger gehätschelt werden.. Er scheint sich zu sagen, die die überzeugt sind wie Amarin selbst die bleiben und wissen nun dass es um den Zieleinlauf geht, dass er seine Beweggründe wie hier beschrieben nicht klar und offen formulieren kann ist natürlich selbsterklärend :cool:
Amarin | 16,10 €
Antwort auf Beitrag Nr.: 61.070.479 von flyingbeef am 20.07.19 13:35:21
Zitat von flyingbeef: Und es ist besser 600 Mio auf der Hohen Kante zu haben als 200 Mio.....

Trotzdem kann man mit dem nun gewonnenen Finanzmitteln schneller den Markt bedienen …...

…...da Amarin ja plant erst mal alleine loszulegen und dass die FDA eine gesunde finanzielle Basis sehen muss, zur Vermarktung des Produktes...


Das Unternehmen beabsichtigt, die finanziellen Mittel von 400 Mio. USD zu verwenden, um

- die Größe der vorhandenen Vertriebsmitarbeiter zu verdoppeln,
- die Marketinginfrastruktur zu verbessern ( u.a. mehr Werbung) und
- das Produktionspotential auszuweiten.


Amarin hat derzeit eine NCE-Exklusivität für die Vermarktung von Vascepa - diese läuft bis zum 20 Januar 2020.
Es ist also nur eine begrenzte Zeit vorhanden, bis die FDA mit dem Zulassungsverfahren für alternative Arzneimittel / generische Namen beginnen kann.

Amarin steht derzeit auf eigenen Füßen und verfügt noch nicht über die Maschinenproduktion, die die größere mögliche Konkurrenz sofort einsetzen könnte.

Amarin hat keine ZEIT zu verlieren.
ZEIT ist GELD – spielt eine sehr wichtige Rolle.

Amarin muss die aktuelle Situation somit ausnutzen, um Vascepa an die Verbraucher zu bringen und sich zugleich einen Markennamen aufzubauen.


https://seekingalpha.com/article/4276637-amarin-valuations-s…

https://www.fiercepharma.com/pharma/after-460m-cash-raise-am…
Amarin | 17,75 $
Antwort auf Beitrag Nr.: 61.089.148 von bernie55 am 23.07.19 18:07:48Hallo,

Danke sehr interessant und hilfreich !

Über diese Exklusivität wusste ich nichts. Soweit ich weiss gibt es ein paar Marktbegleiter die sich auch auf Basis der erfolgreichen Reduce-IT Studie erhoffen schnell eigene Daseinsberechtigungen zu erhalten.

Insbesondere wird hier ja ständig in den amerikanischen Foren ja z.B. über Acasti Pharma und deren krill oil-derived mixture diskutiert.

Ich kann dass nicht richtig einschätzen ob eine große Chance (nach Erfolg Vascepa) besteht das dass FDA deren CaPre wirklich auch bis Anfang 2021 zulassen würden.

Halte das im Moment eher für Hype Propaganda...

Ich kann auch nicht einschätzen ob deren Medikament wirklich vergleichbar ist mit Vascepa, die beziehen sich ja, schlau wie sie sind, nur auf vermeintlich vergleichbare Teilaspekte in Ihrer Präsentation und behaupten natürlich Marketing-tauglich Sie können das auch nur "besser" ;)

Außerdem kann ich zuletzt nicht sagen ob Sie das Krill basierte Öl auch in den benötigten Mengen und Zeitumfängen herstellen können, da habe ich eher meine Zweifel + mögliche Umwelteffekte.

Meines Wissens nach kann man Krill nicht effizient und umweltverträglich züchten, wie es weitestgehend eben mit Fischen funktioniert, zumindest ist mir keine Methode bekannt.

Außerdem ist Krill "die" Grundlage für das Leben im Meer schlechthin, keine Ahnung welche Mengen sie dann für Medikamente umwandeln müssten, daher die Idee ist nett aber die Umsetzung könnte alles andere als nett werden.

Zurück zum Thema:

Ich finde die Argumentation dass Amarin sich darüber bewusst ist Gas geben zu müssen, um möglichst ein großes Stück vom Kuchen sich sichern zu können schlüssig. Um aber das derart aus eigener Kraft weiter vorantreiben zu können, müssen die evtl. ab Mitte 2020 wieder Kapital abgreifen um deren Expansionskurs weiter voranzutreiben, für wie wahrscheinlich hältst du dass ?
Amarin | 16,30 €
Amarin to Report Second Quarter 2019 Results and Host Conference Call on July 31, 2019


BEDMINSTER, N.J., and DUBLIN, Ireland, July 24, 2019 (GLOBE NEWSWIRE) --
Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that it will host a conference call with members of Amarin senior management to discuss the company's second quarter 2019 financial results and provide an operational update on Wednesday, July 31, 2019 at 7:30 a.m. ET. The conference call will follow the anticipated release of the company's financial results earlier that day.

Event Details:
The conference call can be heard 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 or 201-689-8033 from outside the United States. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010, PIN: 51652. A replay of the call will also be available through the company's website shortly after the call.

https://finance.yahoo.com/news/amarin-report-second-quarter…
Amarin | 16,10 €
Amarin up 3% premarket on draft ICER report confirming Vascepa value
Jul. 24, 2019 9:07 AM ET|About: Amarin Corporation plc (AMRN)|By: Douglas W. House, SA News Editor

Amarin (NASDAQ:AMRN) perks up 3% premarket on light volume on the heels of a draft report from the non-profit Institute for Clinical and Economic Review (ICER) concluding that Vascepa (icosapent ethyl) and Johnson & Johnson's (NYSE:JNJ) blood thinner Xarelto (rivaroxaban) provide clinical benefit, reduce cardiovascular risk and "fall below commonly cited thresholds for cost-effectiveness." In other words, the products are priced appropriately for the value delivered.:D

JNJ is off a fraction premarket.

See all stocks on the move »
Amarin | 16,30 €
Amarin Is Just Running Up That Hill; Peak Sales Could Reach $10B:eek:, Says Analyst
[TipRanks]
TipRanks
,TipRanks•July 24, 2019

Biotech Amarin (AMRN) is one of Wall Street’s biggest standouts, with shares skyrocketing 566% in just the last year. Its fish-oil derivative drug Vascepa is already clinically proven to lower very high triglycerides without raising bad cholesterol. What’s more, recent trials revealed it could also cut cardiovascular risks by 25% in patients with abnormally high triglyceride levels. The FDA will either approve or reject this potentially very lucrative label expansion on September 28, and approval should send shares soaring.

An approval would make Vascepa the first therapy, as an adjunct to diet, proven to reduce cardiovascular events when used to treat patients with persistent elevated triglyceride levels and other cardiovascular risk factors. It is this large, unmet medical need for potentially tens of millions of patients which Vascepa has been targeting for many years.

Ahead of this key date, Cantor Fitzgerald analyst Louise Chen has just released a very bullish report on Amarin. She made the call following the company's recent equity raise. “The proceeds should help accelerate the growth of Vascepa, and we think the peak sales potential of this drug could be $5B-$10B” writes Chen. FactSet forecasts $2.1B of sales by 2024.

Indeed Amarin currently shows a ‘Strong Buy’ Street consensus with all six analysts covering the stock bullish. Meanwhile the average analyst price target of $33 suggests shares can surge over 80% from current levels.

On July 18, AMRN announced the pricing of the underwritten public offering of 22.2 million shares at a price of $18 per shares. The gross proceeds of this offering are expected to be ~$400 million, before deducting expenses. Note that Amarin has also granted the underwriters a 30-day option to purchase up to an aggregate of 3.3 million additional shares.

As the company’s press release reveals, AMRN intends to use the net proceeds from the offering for multiple purposes. These include: (1) doubling its existing sales force for Vascepa to 800, increasing advertising, and supporting expanded commercial operations; (2) increasing the commercial supply of Vascepa from third-party drug product suppliers; and (3) for general corporate purposes.

“Amarin also may use a portion of the net proceeds to acquire strategic assets, although it currently has no agreements or commitments in this regard” the statement says.

Looking ahead the next catalysts to keep an eye on are as follows: 1) as you would expect, the potential FDA approval AMRN's supplemental new drug application (sNDA) seeking an expanded indication for Vascepa in the US based on the positive results of AMRN's REDUCE-IT study, 2) pick up in sales from expanded label as well as increased sales and promotional efforts, and 3) Amarin becoming profitable by 2020 (according to the analyst’s estimate).

Net-net, Chen reiterates her buy rating with a $35 price target (93% upside potential). “We continue to think that AMRN is an interesting asset in a consolidating space” she says.
Amarin | 18,21 $
Amarin's Recent Negative News And Why It Doesn't Matter
We have a well-disguised short attack basing ....... just read :)

https://seekingalpha.com/article/4277525-amarins-recent-nega…
Amarin | 18,52 $
Antwort auf Beitrag Nr.: 60.965.512 von kmastra am 05.07.19 22:03:13
Zitat von kmastra: Gibt es hier Meinungen zu ACST? Dort stehen später im Jahr noch P3 Daten zum Krillöl Projekt an. Logischerweise kein CVOT aber sie könnten sowohl von AMRN profitieren als auch in Antizipation der P3 Ergebnisse weiter steigen. Marktkapitalisierung liegt bei 100 Mio.





ACST ist jetzt sehr gut gelaufen. Von daher habe ich mal die Häfte verkauft. Ich denke aber nach wie vor, dass sie sehr von der erweiterten Zulassung von VASCEPA profitieren könnten...
Amarin | 18,53 $
Antwort auf Beitrag Nr.: 61.107.949 von kmastra am 25.07.19 21:56:07Hallo, wegen Acasti, ich denke dass es zwar einen kleinen Push Effekt nochmal geben könnte wenn es hier eine erweiterte Zulassung gibt, aber eigentlich realistisch betrachtet mehr als psychologischen Wert hat dass ja sonst nicht für deren Medikament.

Die müssen sich erst einmal auch über eine mehrere Jahre lange Studie beweisen ob Ihre Mischung / Medikament wirklich eine Wirkung erzielt usw. das FDA wird die nicht einfach durchwinken. d.h. meine Meinung ist, der Kurs wird sich jetzt normalisieren evtl. so auf etwas über einem Dollar einpendeln und kann im Glücksfall dann nochmals über 2 Dollar nach positivem Ergebnis steigen.

Aber man weiss nie wir die Börse reagiert, richtig ;) ? Zumindest ist jetzt ein guter Zeitpunkt um erst mal rauszugehen würde ich sagen...
Amarin | 16,80 €
Was du für einen Blödsinn schreibst. Die reduce it Studie ging über fast 5 Jahre.
Amarin | 16,50 €
Eine Outcome Studie ala Reduce It kostet ca. 500 Millionen US Dollar mit 8000 Probanden weltweit, dann die genialen Ergebnisse, kaum zu toppen, vielleicht bald eine Übernahme für 50 US Dollar?
Amarin | 16,50 €
Antwort auf Beitrag Nr.: 61.111.432 von Optimist73 am 26.07.19 12:59:13@Optimist73

Meinst du damit meine Antwort ?

Es ist sicher kein Blödsinn zu sagen die brauchen schon mehr als nur "Trittbrettfahrerargumente" um sich ebenfalls am Markt mit Ihrem Wirkstoff erfolgreich platzieren zu können. Ergo sie müssten eine eigene Studie anstreben und ja die dauert... siehe Amarin... habe ja von "jahrelang" geschrieben.

Es ist im Gegenteil Blödsinn zu glauben dass Sie dadurch beim FDA auch gleich einen erweiterten Zulassungsspielraum bekämen, dass passiert 100% nicht...

Wo jetzt der zitierte Blödsinn deiner Meinung nach sein soll darfst du gerne mit entsprechenden Argumenten erläutern oder war es nur ein Missverständnis meiner Worte ? 🙃
Amarin | 16,50 €
Antwort auf Beitrag Nr.: 61.112.482 von flyingbeef am 26.07.19 15:01:48Geht es bei dir um Amarin?
Amarin | 16,80 €
Ich will hier doch gar nicht AMRN schlecht reden! AMRN hat definitiv ein sehr gutes Produkt und vor allem eines der wenigen Produkte, das ziemlich sicher ein Blockbuster wird.

ACST wird Ende des Jahres Ergebnisse der P3 veröffentlichen. Da geht es um Biomarker Daten. Einen CVOT werden sie nie und nimmer machen - richtig. Ein solches Label wie (hoffentlich demnächst) AMRN auch dann nicht bekommen, wenn die P3 überhaupt erstmal erfolgreich ist und das Produkt zugelassen wird. Trotzdem könnten sie vom Erfolg AMRNs durchaus am Markt profitieren. Bei einer Bewertung von 100 Mio. fand ich es eine Kauf und einen Hinweis in diesem Forum Wert...
Amarin | 18,43 $
Antwort auf Beitrag Nr.: 61.112.824 von Optimist73 am 26.07.19 15:43:35Hallo , siehste dacht ich es mir doch es war ein Missverständniss, nein es ging um eine andere Aktie da gab es eine Rückfrage und dazu meine Antwort....

Zum Thema Acasti nochmal, nein hatte nicht den Eindruck das du hier Amarin schlecht machen wolltest keineswegs...

Es gibt nicht wenige die Aktien bei beiden haben eben wegen von vielen vermuteten Effekten die aus dem potentiellen Erfolg von Amarin resultieren werden. Was die Aktie für spekulierende „longs“ noch interessanter macht ist das ein grosser Pharmariese die als Konkurrenzprodukt zu Amarin aufkaufen könnte. Das ist aktuell der Hauptgrund warum die so steigt. PS ich habe mich wohl geirrt da geht noch was die Aktie steigt wieder kein Downgrade in Sicht.... wenn du Zeit hast würde ich bis Ende des Jahres abwarten wenn deren weitere Studienergebnisse vorliegen, sollten die positiv ausfallen und Amarin inzwuschen rocken dann sxhiesst die Aktie auch nochmal deutlich hoch... Daher viel Glück 😀
Amarin | 18,34 $
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 €
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 €
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 €
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 €
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 $
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 $
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.: 61.141.730 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 €
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.: 61.211.336 von kmastra am 08.08.19 22:41:32Korrupte Drecks FDA!
Amarin | 17,81 $
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 $
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 23:53:37
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 €
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.: 61.213.283 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 €
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.: 61.180.032 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 €
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 €
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 €
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 $
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 $
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 $
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 $
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.: 61.400.003 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 $
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.: 61.404.386 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 $
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 €
$AMRN Dr. Budoff confirmed that EVAPORATE stopped at 9 months. Now AMRN confirms interim. Why is that important? Interim had an efficacy readout that had EVAPORATE stopping at 9 months if it hit endpoints (P value of ≤0.006). *ht to eightisenough at ST
Amarin | 16,83 $
Antwort auf Beitrag Nr.: 61.549.263 von Magnetfeldfredy am 23.09.19 19:03:46@Magnetfeldfredy
Würdest Du bitte zukünftig entsprechende Quellenangaben posten damit der geneigte Leser
derartige Aussagen nachvollziehen kann? Betrifft z. B. die Beiträge Nr. 585 und 586.

Danke und Gruß,
holgi-w
Amarin | 15,20 €
INVESTOR RELATIONS

AMARIN TO PARTICIPATE IN THE CANTOR GLOBAL HEALTHCARE CONFERENCE

Sep 23, 2019
DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 23, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present a general company update at the Cantor Global Healthcare Conference on

Thursday, October 3, 2019 from 10:05-10:35 a.m. Eastern Time
in New York City.

A live audio webcast of the presentation will be available at: http://www.amarincorp.com, and will be accessible at the same link for 30 days.

https://investor.amarincorp.com/news-releases/news-release-d…
Amarin | 15,20 €
Große Hoffnung für diesen Late Braker:

Amarin | 15,89 $
Independent Drug-Pricing Assessment Finds Vascepa® (icosapent ethyl) Cost-Effective as an Adjunct to Statins in Treating Patients at High Risk of Cardiovascular Events, such as Heart Attack, Stroke and Cardiac Death
GlobeNewswire•October 17, 2019


DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that an independent organization that evaluates pricing of prescription drugs has issued its final report assessing the cost-effectiveness of Vascepa® (icosapent ethyl) capsules. The final assessment confirms the cost-effectiveness of Vascepa across all the non-profit organization’s analyses, including its most stringent criteria.1

The review was derived from results of the landmark phase 3 clinical trial REDUCE-IT®2, focusing on the clinical benefit-risk profile of Vascepa and its value as an additive therapy for cardiovascular disease. The conclusion from the report is that Vascepa easily meets “commonly cited thresholds for cost-effectiveness and therefore represent a high long-term value for money,” based on the organization’s value assessment framework.3:D

“We are proud to have priced Vascepa to be cost-effective, and we appreciate this positioning being recognized by third-parties,” said Craig Granowitz, M.D., Ph.D., chief medical officer, Amarin. “However, despite the report’s positive conclusion that Vascepa is cost-effective, we believe that it understates the true value of Vascepa. For example, the report’s base-case analyses reflect only the costs of heart attack, stroke and cardiovascular death and exclude other high costs associated with other cardiovascular events demonstrated to be lowered by Vascepa in the REDUCE-IT cardiovascular outcomes study (e.g., revascularization procedures and hospitalization for unstable angina) as well as lower rates of recurring cardiovascular events in patients treated with Vascepa during the study.”

Another Cost-Effectiveness Analysis of Vascepa to Be Presented at AHA

A separate independent, academic cost-effectiveness analysis of Vascepa based on patient-specific data from the REDUCE-IT study will be presented at the American Heart Association Scientific Sessions 2019 on November 16 by William S. Weintraub, M.D., Director of Outcomes Research, MedStar Cardiovascular Research Network. Amarin provided an unrestricted grant for this academically driven analysis, titled “Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT.”

Cardiovascular Disease, an Urgent Public Health Issue

“There is no doubt that cardiovascular disease is an urgent and growing public health issue, with more than half of U.S. adults impacted,” Dr. Granowitz added. “The U.S. spends approximately $555 billion on cardiovascular disease each year, and it is projected that these direct and indirect costs could increase to more than $1.1 trillion by 2035.4 Amarin has worked for over a decade to develop and test Vascepa to create a new preventative care solution that will potentially help many of our family, friends and neighbors within this population. Our goal is to make Vascepa accessible to as many patients as possible who can benefit.”

Vascepa is currently approved in the United States 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 a label expansion based on the REDUCE-IT study results showing reduction of cardiovascular events in high-risk patients. The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA to act on the sNDA is December 28, 2019. Assuming FDA approval, Vascepa is positioned to become the first drug indicated to reduce persistent residual cardiovascular risk in statin-managed patients with elevated triglycerides (135 mg/dL or greater) and other risk factors for cardiovascular disease. The approval of such label expansion and the wording of the indication statement is under regulatory review.

Today, many insurance plans, or payers, already broadly cover Vascepa. Upon assumed FDA label expansion, Amarin plans to use the results of the REDUCE-IT study, further objective health-economic analyses, and other medical information and data in negotiations with payers to seek expanded Vascepa insurance coverage.

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.5,6

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.7

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.8,9,10,11

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 completed review and opined on a supplemental new drug application related to REDUCE IT. FDA has 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 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.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the use of Vascepa to potentially help millions of patients. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals; the risk that data interpretations or other information from third parties, the regulatory review process, regulatory authorities and in connection with an advisory committee could be made public that are negative or may delay approval or limit Vascepa’s marketability; the risk that special protocol assessment (SPA) agreements with the FDA are not a guarantee that FDA will approve a product candidate; the risk associated with the FDA's rescinding the REDUCE-IT SPA agreement; the risk related to FDA advisory committee meetings; and the risk that the FDA may not complete its review of the REDUCE-IT sNDA within the timing expected. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Amarin | 16,20 $
Antwort auf Beitrag Nr.: 61.712.266 von Magnetfeldfredy am 17.10.19 15:57:36Cantor Fitzgerald analyst Louise Chen reiterated an Overweight rating and $35.00 price target on Amarin Corporation (NASDAQ: AMRN) after the company announced that an independent organization that evaluates pricing of prescription drugs, ICER, has issued its final report assessing the cost-effectiveness of Vascepa.

The final assessment confirms the cost-effectiveness of Vascepa across all the non-profit organization’s analyses, including its most stringent criteria, the analyst notes.

https://www.streetinsider.com/dr/news.php?id=16020750
Amarin | 16,31 $
2 Stocks That Could Double Your Money Money20
These two biotech stocks are poised for big gains next year.
George Budwell
Oct 19, 2019 at 3:49PM

Buying growth stocks in an election year is generally ill-advised. During the last presidential election cycle in 2016, growth stocks, on balance, dramatically underperformed the broader markets, whereas value stocks as a whole produced market-beating returns on capital. Going one step further, some growth-oriented subsectors such as biotech were flat out taken to the woodshed over the course of 2016, thanks to the economic and regulatory uncertainties stirred up by the rancor of presidential politics.

The point is that investors arguably shouldn't initiate a new position in a growth-heavy equity in the midst of a politically charged market, without a well-defined major catalyst firmly etched into the calendar. This group of equities, after all, comes with the inherent disadvantage of having to swim against the current of presidential politics and all that comes with it.
A hand arranging wooden blocks with upward pointing arrows in stair-step fashion.

Image Source: Getty Images.

Fortunately, there are a select few growth plays that meet this rather high bar. The biotech stocks Amarin (NASDAQ:AMRN) and Heron Therapeutics (NASDAQ:HRTX) both have a strong chance of doubling in value in 2020, regardless of how the political landscape evolves in the meantime. Here's a brief rundown of the essential points investors need to consider about each of these promising growth plays.
Amarin: One last hurdle

Wall Street's current consensus 2020 price target for Amarin has its shares rising by an astounding 86% over the next 12 months. However, this stately price target might still be missing the mark by a country mile. Underscoring this point, investment banking firm H.C. Wainwright has significantly deviated from its peers on this equity by issuing a gob-smacking $51 price target on Amarin's shares. For those of you keeping score at home, Wainwright is basically calling for the biotech's shares to more than quadruple in value in 2020.

What's all the fuss about? Amarin is slated to do battle with the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee on Nov. 14. The question at hand is whether the company's prescription omega-3 treatment, Vascepa, is truly a quantum leap forward in the treatment of patients at risk of cardiovascular disease, despite being on statin therapy. The FDA is expected to hand down its final ruling on the matter by Dec. 28, according to a recent investor presentation.

While the FDA is unpredictable by its very nature, Vascepa seems to have an excellent shot at grabbing this high-dollar indication based on its unprecedented cardiovascular outcome trial results. The big deal is that lipid-lowering medications -- especially those aimed at treating underlying cardiovascular disease -- are some of the best-selling pharmaceutical products of all time. Pfizer's Lipitor, for instance, has racked up well over $100 billion in cumulative sales over its life cycle. Vascepa, for its part, may even surpass Lipitor from a total sales standpoint.

Stated bluntly, Amarin's shares will surely be off to the races in 2020 if Vascepa clears this last regulatory hurdle.

Heron: A small-cap stock with mid-cap potential

Every year there's a biotech stock that mounts a furious comeback. Heron Therapeutics is poised to be that stock in 2020.

The lowdown is that Heron's shares crumbled this year in response to the FDA rejecting its experimental pain medication HTX-011. On Oct. 1, Heron reported that it successfully refiled the drug's regulatory application with the FDA and that it is slated for a truncated six-month review cycle. In short, HTX-011 could be on the market by the third quarter of 2020.

Why should investors stand up and take notice? Although Heron's anti-nausea medications have started to show signs of life after a sluggish start, HTX-011 is the drug that should put the company on the map. Novel pain medications are worth their weight in gold because of their long commercial shelf lives and the well-documented need for non-opioid painkillers in the acute setting. At a minimum, HTX-011 should be able to generate several hundred million in sales per year and might even achieve blockbuster states late in the next decade.

Wall Street, in turn, expects Heron's shares to more than double in value over the next year, with some analysts even calling for the biotech's stock to rise by a jaw-dropping 306% from current levels. While naysayers may call these price targets unrealistic, the fact is that Heron will almost certainly turn into a buyout target if HTX-011 gets the green light from regulators next year. There is a huge demand for these types of drugs in the world of big pharma, and it's no easy feat to development one on your own. It's far easier to simply pay up to acquire one that's already on the market.

10 stocks we like better than Heron Therapeutics

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David and Tom just revealed what they believe are the ten best stocks for investors to buy right now… and Heron Therapeutics wasn't one of them! That's right -- they think these 10 stocks are even better buys.
Amarin | 14,50 €


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