AMARIN CORP. PLC REG.SHS(SP.ADRS NEW)/1 LS-,50 (WK

https://www.kardiologie.org/...-bringt-vielleicht-doch-etwas/16153248

Call:
https://seekingalpha.com/article/...-results-earnings-call-transcript


https://www.fool.com/investing/2019/07/31/...marins-strong-q2-re.aspx

 

 

FDA will nun doch einen Panel durchführen (14.11.19)

https://www.fiercepharma.com/pharma/...-cardiovascular-benefits-label

 

...ich habe schon lange auf diesen Einstieg hier noch gewartet...
1.Tranche zu 15 Dollar...bei weiterem Nachgeben der Kurse würde ich weiter nachkaufen.
Den Panel Termin erachte ich als absolut unproblematisch außer einer gewissen Verzögerung jetzt um einige Wochen oder Monate.

 

Biologic Basis of EPA to Reduce Atherosclerosis Burden:

https://reachmd.com/programs/video-library/...sclerosis-burden/10541/  

AHA, American Heart Associaton, empfiehlt Vascepa für Triglyceridsenkung und Reduktion und von Herzinfarkt, Schlaganfällen und herzbedingten Todesfällen, super Meldung für die Patienten und Amarin mit Vascepa:

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.


 

Wohin mit Amarin?  

Toller unabhängiger Bericht bestätigt, dass Vascepa nicht nur Herzinfarkt, Schlaganfall und Herztod um bis zu 30 % reduziert, sondern auch Kosten-Effektiv ist und dem Gesundheitssystem Milliarden spart, hoffentlich bald auch in Europa:

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

“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.

 

Ein heißer Monat steht bevor, 14.11.2019 Adcom, zahlreiche Publikationen und Late Brake Abstract am 18.11.2019 mit Riesenpotential:

Seven Data Presentations Relevant to Vascepa® (Icosapent Ethyl) Capsules and Persistent Cardiovascular Risk to be Presented at American Heart Association’s 2019 Scientific Sessions, November 16 – 18
GlobeNewswire•November 4, 2019

Amarin to Webcast Discussion of Presented Data November 18, 4:30 - 5:30 p.m., Eastern Time

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, announced that two independently conducted studies, two moderated poster sessions and three presentations based on research supported by Amarin will be presented at the American Heart Association’s (AHA) 2019 Scientific Sessions, November 16-18, in Philadelphia, PA.

“Cardiovascular disease is the leading cause of death and the costliest chronic disease in the U.S. today,”1 said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer, Amarin. “It is imperative that we conduct and share scientific research that may help address the often devastating, debilitating and deadly conditions that now affect almost half of Americans.2 Several of the scheduled presentations at AHA focus on Amarin’s REDUCE-IT® study and provide further context on the potential clinical and economic value of Vascepa® (icosapent ethyl) as a treatment for people who have statin-controlled cholesterol levels, yet have elevated triglyceride levels and are otherwise still at high risk of cardiovascular events.”

Upcoming Featured Presentations

   Session FS.AOS.01 – Featured Science Population Science, November 16, 7:30 – 7:40 a.m., Eastern U.S. Time
   “Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT,” – presented by William S. Weintraub, M.D., MedStar Washington Hospital.

   Session FS.MDP.05 – Follow-up of Landmark Trials, Moderated Science Poster, November 17, 4:20 – 4:25 p.m., Eastern U.S. Time
   MDP479, “REDUCE-IT USA: Results from the 3,146 Patients Randomized in the United States,” – presented by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital and Harvard Medical School.

   Session LBS.06 – Late Breaking Science VI: New Frontiers in Lipid Therapy, November 18, 9:00 – 9:10 a.m., Eastern U.S. Time
   “Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides (200 – 499 mg/dL) on Statin Therapy (EVAPORATE study),” – presented by Matthew J. Budoff, M.D., Los Angeles Biomedical Research.

Other Upcoming Data Presentations

   Presentation Sa1056, “Purified Eicosapentaenoic Acid Ameliorates Cardiac Fibrosis and Tissue Inflammation on Spontaneously Hypertensive Rats,” – Giselle C. Meléndez, M.D., Danielle Medina-Hernandez, Adam Pflum, M.D., Vivian Xu, David M. Herrington, M.D., presented Saturday, November 16., 1:30 – 2 p.m., Eastern U.S. Time.
   
   Presentation Su3237, “Improving Appropriate Use Of Omega-3 Fatty Acids In Primary Care: Success Of Online CME,” – Jelena Spyropoulos, Medscape Education, New York, NY; George Boutsalis, David Anderson – presented Sunday, November 17, 12:30 – 1 p.m., Eastern U.S. Time.
   
   Presentation Mo1016, “Influence of Eicosapentaenoic and Arachidonic Acid on Cholesterol Crystal Formation in Membranes under Hyperglycemic Conditions,” – Samuel C.R. Sherratt, B.S., R. Preston Mason, Ph.D. -- presented Monday, November 18, 11:30 a.m. – noon, Eastern U.S. Time.
   
   Moderated Poster Presentation MDP414, “Many Statin Treated Persons with Borderline Triglyceride Levels are at Risk of ASCVD,” – Nathan D. Wong, Wenjun Fan, Sephy Philip, Peter P. Toth, and Craig Granowitz – presented Monday, November 18, 1:20 -1:25 p.m., Eastern U.S. Time.

As will be disclosed in the presentations listed above, much of this independent research was funded by Amarin.

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.

Investor Webcast on November 18, 4:30 p.m., Eastern U.S. Time
Amarin will host a webcast at 4:30 p.m. Eastern U.S. Time, November 18, 2019. The webcast will be accessible through the investor relations section of the company’s website at www.amarincorp.com. The webcast can also be heard via telephone by dialing 877-407-8033. A replay of the webcast will be available for two weeks following the webcast. To hear a replay of the webcast, dial 877-481-4010 (inside the United States) or 919-882-2331 (outside the United States). A replay of the webcast will also be available through the company's website shortly after the webcast. For both dial-in numbers please use conference ID 55923.

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-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 proportion 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.6,7,8,9

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.

The FDA has not completed its review and made a final determination 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 are expected to 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 time 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 is anticipated to 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. More detailed presentation of such considerations is set forth in the risk factors section of Amarin’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission. 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 further 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.

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.

Amarin Contact Information

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

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

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

References

1 American Heart Association. 2017. Cardiovascular Disease: A Costly Burden for America Projections Through 2035
2 The American Heart Association's "Heart Disease and Stroke Statistics-2019 Update"
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.

Contact:

 

Auf ein Neues...  

FDA Dokumente geben Auftrieb vor dem Panel

https://www.fda.gov/advisory-committees/...ittee-meeting-announcement

 

Panel stimmt mit 16-0 für die Ausweitung der Zulassung

Damit dürfte Amarin zu einem Übernahmekandidaten werden, wenn die Zulassung erfolgt und das Label positiv ausfällt (ohne Black-Box-Warning).

https://www.fiercepharma.com/pharma/...animous-nod-from-fda-committee

 

Buyout imminent:

What's Next for Amarin's Stock?
Amarin's days could be numbered after a positive adcom vote.
George Budwell
George Budwell
(TMFGBudwell)
Nov 15, 2019 at 9:00AM
Author Bio

Yesterday, Amarin (NASDAQ:AMRN) scored a major win. All 16 panelists on Vascepa's advisory committee voted in favor of the drug's cardioprotective benefit based on the unprecedented results of the cardiovascular outcomes study Reduce-It.

Wall Street, for its part, immediately chimed in on the potential impact of this favorable outcome. Analysts quickly noted that this label expansion could broaden the drug's target market to anywhere between 5 million to 15 million patients in the United States, depending on how broad of a label the FDA chooses to go with.
Wooden blocks that spell out "buy-out".

Image Source: Getty Images.

The quirky part of the story is that these same analysts suggested that Vascepa's peak sales could vary from a low of $1.5 billion to a high of $4 billion following this positive advisory committee vote -- again, reflecting the huge discrepancy in the drug's potential target market based on the uncertainty of its final label.
What the Street is really saying

What's odd about these peak sales figures is that they simply don't make mathematical sense. To square this circle, we have to assume that Wall Street is either predicting that Amarin will significantly lower Vascepa's net selling price (it won't), or that the company will have a hard time servicing this massive target market (it might).

Breaking this down further, most industry insiders agree that Vascepa's Reduce-It indication should cover at least around 10 million people in the United States (i.e., patients presently on statin therapy but who still have trouble controlling their triglyceride levels). A $4 billion peak sales estimate thus implies a 25% penetration rate.

That's crazy low for a drug aimed at patients with an elevated risk of heart attack or stoke, and that are already receiving care in the form of statin therapy. Stated plainly, pharma reps aren't going to have to beat the bushes to identify the vast majority of these patients.

What gives? Wall Street is basically saying that Amarin won't be able to handle the volume associated with this market -- and there's good reason to believe that a bottleneck effect could come into play.
What's next?

To remedy this situation, Amarin has three clear choices to maximize shareholder value in the near-term:

   Aggressively build out its commercial infrastructure. Amarin has announced a doubling of its sales force, but it still has a long ways to go before it can fully cover this enormous patient population. This option also runs the risk of jacking up expenses well before the surge in demand fully materializes. That's not exactly prudent for a company finally on the cusp of becoming cash flow positive.  
   Enter into a co-promotional partnership with a big pharma like Pfizer (NYSE:PFE). Pfizer has the connections and commercial bandwidth to transform Vascepa into a juggernaut within a very short period of time. A co-promotional deal might also involve a significant equity stake from the likes of Pfizer or perhaps a large up-front cash infusion. Either way, Amarin's shareholders would benefit immensely from a partnering deal.
   Put the company up for sale. Amgen, Pfizer, and Novartis have all been rumored to have interest in Amarin. An outright sale eliminates the inherent commercialization risk associated with a go-it-alone strategy, and it would almost certainly come at a healthy premium.

What's the most likely outcome? A buyout. These types of megablockbuster drugs do not come around often, and there's just no way big pharma is going to let this opportunity pass them by. In fact, Pfizer has a Vascepa-sized hole in its product portfolio right now with the loss of exclusivity for its nerve pain medication Lyrica. Pfizer's management has also openly admitted to an interest in pursuing more bolt-on acquisitions. Amarin, in many ways, would be an ideal pick-up for Pfizer, especially with the big pharma's ongoing metamorphosis into a growth-oriented company.    
 

https://www.sharedeals.de/...0-kantersieg-beim-gestrigen-fda-meeting/  

Wir haben einen Mega Winner:

Amarin Highlights Key REDUCE-IT®-Related Data Presented at American Heart Association 2019 Scientific Sessions
[GlobeNewswire]
GlobeNewswire•November 18, 2019

REDUCE-IT USA results, in prespecified subgroup analyses, showed cardiovascular risk reductions across all endpoints, including 30% relative risk reduction  in all-cause mortality

New analysis determined icosapent ethyl (Vascepa®) is highly cost-effective in patients from the REDUCE-IT study and, as is rarely found, may result in net healthcare cost-savings to patients, payers and society

Data showed prevalence of elevated risk of major cardiovascular events (mean 10-year ASCVD risk score greater than 20%) in more than 20% of patients on statins with triglycerides below 150 mg/dL

Interim EVAPORATE study provides important mechanistic data with relevance to the reduction in cardiovascular events seen in the REDUCE-IT clinical trial; final study results likely in early 2020

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, hosted a webcast today to discuss important data with study authors who presented at the American Heart Association 2019 Scientific Sessions, November 16-18. The data covered related to Vascepa® (icosapent ethyl) capsules, the landmark clinical outcomes study REDUCE-IT®[1] , as well as the cardiovascular risk of patients with elevated triglycerides, a type of fat in the blood.

“The more we study the REDUCE-IT data and the at-risk conditions of the patients studied in this important clinical trial, the better we understand the nature and extent of persistent cardiovascular risk among patients on statins and with elevated triglycerides, and how to address it,” said Craig Granowitz, M.D., Ph.D., chief medical officer, Amarin. “At Amarin, we are proud to have played a role in supporting and sharing data with the scientific and medical communities that could make a major difference in cardiovascular care, an area where the need for new and innovative treatment options is urgent and growing.”

About Cardiovascular Risk
The number of deaths in the United States attributed to cardiovascular disease continues to rise.2,[3] There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are similar, accounting for 1 of every 19 U.S. deaths (approximately 1 every 40 seconds).4

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with high triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35% – but that still leaves 65-75% risk remaining.5 People with high triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.6,[7],[8]

Key Data Presented at AHA and Reviewed During Amarin’s Webcast

   “REDUCE-IT USA: Results from the 3,146 Patients Randomized in the United States,” – presented by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital and Harvard Medical School.

   Highlights: This prespecified REDUCE-IT subgroup analysis showed substantial risk reductions in the USA patients treated with icosapent ethyl 4 g/day versus placebo across all prespecified composite and individual primary and secondary endpoints, including 31% relative risk reduction and 6.5% absolute risk reduction in first occurrence of 5-point major adverse cardiovascular events (MACE), corresponding to a number needed to treat of 15 (NNT=15), and a significant 30% relative and 2.6% absolute risk reduction (NNT=39) in all-cause mortality in the USA subgroup.

   Additional prespecified cardiovascular endpoints in which the REDUCE-IT USA subgroup showed significant relative risk reduction included myocardial infarction, cardiovascular death, and stroke, similar to the full cohort in the overall REDUCE-IT global results. These results were incremental to the cardiovascular risk reduction achieved by conventional therapy administered to the high-risk patients studied, including incremental to statin therapy.

   The REDUCE-IT USA subgroup consisted of 3,146 patients (nearly 40%) of the previously reported full trial cohort. REDUCE-IT was not specifically powered to examine individual subgroups. P-values presented for the USA subgroup are nominal and exploratory with no adjustment for multiple comparisons. Differences in efficacy outcomes for the USA patients are best viewed as qualitative and not quantitative; nevertheless, the data are useful and provide reassurance that the results in the USA are at least as strong as the results seen outside the USA and in the trial overall.

   The REDUCE-IT USA study results were also published in Circulation, AHA’s official scientific journal.9

   “Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT,” – presented by William S. Weintraub, M.D., MedStar Washington Hospital.

   Highlights: In this combined patient-level and simulation lifetime cost-effectiveness analysis, icosapent ethyl in high cardiovascular risk patients shows exceptional benefit with cardiovascular event reduction as well as cost-savings in-trial and over patients’ lifetime in many simulations. Findings of potential cost effectiveness of a medical therapy are rare. This analysis considered the current market cost for Vascepa and the potential savings from avoiding major adverse cardiovascular events, such as strokes and heart attacks, the cost of which can be high. This cost-effectiveness analysis was conducted by MedStar. As is typical, the cost-effectiveness analyses were not prespecified as part of the REDUCE-IT clinical trial design but did rely on the results of this landmark outcomes study.

   “Many Statin Treated Persons with Borderline Triglyceride Levels are at Risk of ASCVD,” – presented by Nathan D. Wong, Ph.D., M.P.H, University of California, Irvine.  

   Highlights: This study showed prevalence of elevated risk of major cardiovascular events (a mean 10-year atherosclerotic cardiovascular disease (ASCVD) risk score greater than 20%) in more than 20% of patients on statins with triglycerides below 150 mg/dL. This suggests the need for greater lifestyle and other therapies to address remaining residual ASCVD risk.
   
   “Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides (200 – 499 mg/dL) on Statin Therapy (EVAPORATE) study,” – presented by Matthew J. Budoff, M.D., Los Angeles Biomedical Research.

   Highlights: At the prespecified 9-month interim analysis, there was slowing of total non-calcified plaque (sum of LAP, fibrofatty, and fibrous plaque) (35% v. 43%, p=0.010), total plaque (non-calcified + calcified plaque) (p=0.0004), fibrous plaque (15% v. 26%, p=0.011) and calcified plaque (-1% v. 9%, p=0.001), after adjustment by baseline plaque, age, sex, diabetes status, baseline triglyceride levels, and statin use. However, there was no significant change in the primary endpoint of low attenuation plaque between active and placebo groups (74% vs 94%, p=0.469) at this 9-month interim look. This investigator-initiated study is continuing to its designed completion of an 18-month review.

   EVAPORATE is the first study in the United States, which enrolled a total of 80 patients, to use multidetector computed tomography (MDCT) to evaluate the effects of icosapent ethyl as an adjunct to statin therapy on plaque characteristics in a high cardiovascular-risk population with persistent high triglyceride levels. Patients underwent interim scans at 9 months and are currently being followed for an additional 9 months with MDCT. Final results from this study are anticipated in early 2020.

   Arterial plaque and coronary atherosclerosis are key factors leading to significant increases in the probability of acute obstructions and angina or other coronary artery disease signs and symptoms.

All of the analyses highlighted above were funded by Amarin.

A replay of the webcast will be available for two weeks following the webcast. To hear a replay of the webcast, dial 877-481-4010 (inside the United States) or 919-882-2331 (outside the United States). A replay of the webcast is also be available through the company's website, Amarincorp.com, in the Investor section. For both dial-in numbers please use conference ID 55923.

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-IT, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the cardioprotective effect of icosapent ethyl, a unique prescription therapy, as an add-on to statins in patients with high cardiovascular risk. As defined in the published results of the study, the high cardiovascular risk patients, despite stable statin therapy, had elevated triglyceride levels (lower enrollment target of TG >135 mg/dL). As per the study’s design, approximately 71% of the enrolled patients had established cardiovascular disease and the other patients were diagnosed, as per trial enrollment requirements, as having diabetes and other cardiovascular risk factors.

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

About Vascepa® (icosapent ethyl) Capsules
Vascepa (icosapent ethyl) capsules are a single-molecule prescription product which has been developed and studied for more than a decade and has been prescribed more than 8 million times in the United States. Vascepa, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has been issued multiple patents in the United States and 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 its review or made a final determination 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 are expected to 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 time 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 is anticipated to 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. More detailed presentation of such considerations is set forth in the risk factors section of Amarin’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission. 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 further 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.

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.

Amarin Contact Information

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

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

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

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 American Heart Association. Heart Disease and Stroke Statistics – 2019 Update: A Report from the American Heart Association. Published January 31, 2019.

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

4 American Heart Association: Heart Disease and Stroke Statistics -- 2019 At-a-Glance.

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 Bhatt DL, Miller M, Brinton EA, et al. REDUCE-IT USA: Results from the 3,146 Patients Randomized in the United States. Circulation 2019. DOI: 10.1161/CIRCULATIONAHA.119.044440.


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falls sich einer fragt, wieso die aktie heute um mindestens 10 % gefallen ist. dies könnte vielleicht ein grund sein:


Amarin Stock Is Sinking After a Bearish Assessment of Its Heart Drug

By Josh Nathan-Kazis
Updated Nov. 20, 2019 10:12 am ET / Original Nov. 20, 2019 9:39 am ET

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Amarin has asked the FDA to approve Vascepa to reduce the risk of cardiovascular events, including heart attack and stroke. Photograph by Louis Reed

Shares of the biotech firm Amarin was down more than 4% shortly after the market opened on Wednesday as an analyst at Oppenheimer published a particularly bearish take, arguing that the stock, which closed Tuesday at $22.73, will fall to $7 within 18 months.

In the past two weeks, Amarin shares (ticker: AMRN) gained more than 40% before falling slightly. The stock is up 38.4% this month through Tuesday’s close. The gain came before and after a meeting of an advisory committee of the Food and Drug Administration that voted to recommend an expanded label for Vascepa, Amarin’s fish-derived cardiovascular drug.

“We forecast sales growth to underwhelm and heavy selling costs to impede profitability,” Oppenheimer analyst Leland Gershell said in a Tuesday afternoon note initiating coverage of Amarin. Gershell rates the stock Underperform and set a price target of $7.
Editor's Choice

“We believe that a [roughly] 12-month stream of late stage competitor data starting next month will increasingly weigh on shares as these products, which we believe offer superior profiles, are factored into models,” Gershell wrote. “While some may regard AMRN as a probable M&A target, we see the likelihood of this outcome as only shrinking with time.”

Amarin pushed back on the Oppenheimer report. “We are confident in our ability to significantly grow Vascepa with an expanded label,” the company said in a statement. “It’s also important to understand that many products have failed to demonstrate the positive results shown in REDUCE-IT and that it will take a decade or more and considerable funding for companies that have not yet started an outcomes study to potentially show benefit with products that have different mechanistic effects than Vascepa.”

The back story. Shares of Amarin are up 67% this year as of Tuesday. Vascepa is approved to reduce triglycerides in certain patients, but the company has asked the FDA to approve it to reduce the risk of cardiovascular events, including heart attack and stroke, which could add billions of dollars to its sales. Last week, an FDA advisory panel voted unanimously to recommend that the FDA approve the drug for the new indication, although questions remain about how broad the new label will be.

What’s new. In his note Tuesday, Gershell warned that the hype over Vascepa may be overblown. He wrote that the price of Amarin shares assumes that sales of Vascepa will rise more than $2 billion by 2023 or 2024, and that the company’s operating margins will improve. But Gershell warned that the increase in sales may disappoint, arguing that there is already significant off-label use of Vascepa, which will bite into any growth when the new indication is officially approved.

Gershell also wrote that Vascepa will remain an expensive drug to sell. “We anticipate selling expense escalation above Street projections as AMRN struggles to meet revenue estimates in a category fraught with omega-3 generics, dietary supplements, and foreseeable competition,” he wrote.

He also warned that other companies are working toward competitors to Vascepa, and that Amarin is increasingly unlikely as an acquisition target. “We believe the ripest time for [acquisition] has already passed,” he wrote. “From here, we increasingly discount this outcome as emerging competition layers onto a murky intellectual property position.”

The stock fell 4.4% to 21.74. The S&P 500 was down 0.1%.

Looking forward. The FDA is set to announce its decision on Vascepa by Dec. 28.  

Is Amarin Really a $7 Stock?
Amarin's shares got walloped yesterday by a bearish analyst report.
George Budwell
George Budwell
(TMFGBudwell)
Nov 21, 2019 at 9:25AM
Author Bio

Yesterday, Amarin (NASDAQ:AMRN) lost over 10% of its value in response to a rather harsh report by Oppenheimer analyst Leland Gershell. The key issue that triggered this double-digit sell-off appears to be Gershell's uberbearish prediction that Amarin's stock could drop by as much as 70% to a lowly $7 per share over the next year.

The analyst's reasoning is based on two underlying assumptions:

   Vascepa's sales will fall well short of expectations following its label expansion for patients at risk of cardiovascular disease. Amarin's stock has recently been trading at a price-to-sales ratio north of 20, so it's definitely fair to say that the market expects Vascepa's sales to grow by leaps and bounds soon. The current consensus estimate stands at $2.2 billion, according to EvaluatePharma. However, a broad label could easily double -- or perhaps quadruple -- this figure, given the sheer size of the market.
   Amarin's prospects as a buyout candidate will quickly fade due to the emergence of competition in the space from AstraZeneca's Epanova, Acasti Pharma's CaPre, Matinas BioPharma's MAT9001, among others.

Here's why investors shouldn't get overly worked up by this bearish analyst report.
Woman staring at an open laptop computer with a look of shock on her face.

Image source: Getty Images.
Amarin: King of the omega-3 hill

While Gershell's take is certainly audacious, it simply doesn't line up with the facts on the ground. First off, Vascepa is the only omega-3 treatment in history to show a statistically significant cardiovascular benefit in a large, placebo-controlled trial. So while it's easy to point to the emergence of "superior competition" as a potential risk factor, the reality of the situation is that most -- if not all -- of these rival candidates could very well flop in terms of conveying a cardiovascular benefit. In fact, it would be rather surprising if any of these putative competitors emerged as a direct rival to Vascepa during the drug's prime years.

Keeping with this theme, the candidate with the best chance of knocking off Vascepa -- Acasti's CaPre -- probably wouldn't get through a full-on cardiovascular trial until Vascepa was in its twilight years from a patent protection standpoint. That's important because doctors aren't going to readily prescribe a medicine off-label for a wide swath of Americans just because it seems to stack up well against the standard of care. Eyeball tests don't fly when it comes to patient care. CaPre will have to complete a time-consuming cardiovascular outcomes trial before it will ever be prescribed in lieu of Vascepa, and that won't happen until almost the end of the next decade.

The take-home point is that Vascepa should easily grab the lion's share of the omega-3 treatment space for the whole of the next decade, thanks to its highly anticipated label expansion as an add-on to statin therapy in patients with elevated triglyceride levels.
Is Amarin still a strong buyout candidate?

On the buyout front, Amarin's prospects haven't changed whatsoever since Vascepa's positive adcom vote. Long story short, there is no logical reason to believe that Astra's Epanova is going to perform any better than its mixed fish oil predecessors, much less upstage Vascepa's unprecedented Reduce-It results. Moreover, the biggest competitive threats to Vascepa are upwards of a decade from truly materializing.

So, given the fact that there isn't a single product with a proven cardiovascular benefit currently being marketed by a small biopharma, it's more than reasonable to assume that Amarin does indeed have a huge target on its back right now. In other words, Amarin's shares have a much better chance of rocketing to $70 than crashing to $7 over the next 12 months.  

Does Amarin Have a Dark Horse Suitor?
Gilead's decision to add Vascepa to an ongoing NASH study failed to grab much attention last week. But this development is quite intriguing for several reasons.
George Budwell
George Budwell
(TMFGBudwell)
Nov 24, 2019 at 6:38PM
Author Bio

Amarin (NASDAQ:AMRN), a mid-cap pharma company, has long been rumored to be a buyout candidate. The core reason is that the company's prescription omega-3 treatment, Vascepa (icosapent ethyl), hit the mark in a large, placebo-controlled cardiovascular outcomes trial -- a feat no other omega-3 therapy has ever accomplished. In fact, GlaxoSmithKline's competing omega-3 treatment, Lovaza, failed to show a similar cardiovascular benefit in its Ascend trial.

This novel, orally administered omega-3 pill could thus end up as a key component in the standard of care for patients at risk of cardiovascular disease, despite being on statin therapy. The big deal is that this target market is believed to encompass almost 10 million Americans at present. Even so, this already large patient population could grow significantly over the next decade because of the out-of-control obesity epidemic. So, conservatively speaking, Vascepa should rack up at least $2 billion in annual sales, depending on the scope of the drug's as-of-yet to be determined label for this indication.  
Two men shaking hands over a table.

Image Source: Getty Images.
Buyout rumors aplenty

Amarin has repeatedly been linked to three pharma heavyweights as a possible takeover target. These not-so-secret names are Amgen, Pfizer, and Novartis (NYSE:NVS), and they have bubbled to the top of the M&A rumor mill because each company has an abiding interest in cardiovascular care, as well as the financial flexibility to pay top dollar for Amarin's hand.  

This weekend, however, news broke that Novartis has decided to acquire The Medicines Company mainly for its experimental lipid-lowering treatment inclisiran. This $7 billion deal, in turn, probably spells the end of Novartis' long-rumored interest in Amarin.

Nonetheless, a new challenger may have quietly emerged from the shadows. Approximately two weeks ago, Gilead Sciences (NASDAQ:GILD) added Vascepa to an ongoing phase 2 study for patients with nonalcoholic steatohepatitis (NASH). The drug will be assessed as part of a triplet therapy that includes the biotech's non-steroidal farnesoid X receptor agonist cilofexor and the acetyl-CoA carboxylase inhibitor firsocostat. Top-line data from this ongoing trial is due out next May, according to clinicaltrials.gov.  
Why would Gilead buy Amarin?

The lowdown is that Gilead is attempting to develop a top shelf combination treatment for NASH. By doing so, the biotech would be able to leap frog the first-generation of monotherapies set to hit the market as soon as 2020. And it might even be able to establish a competitive moat against the army of big pharmas and big biotechs racing to bring their own combo NASH treatments to market. Vascepa could be Gilead's ticket to unlocking the wide-open $65 billion NASH market.

Why might Vascepa be the missing ingredient in Gilead's NASH quest? Back in April, Gilead unleashed some promising data for the doublet therapy of cilofexor and firsocostat in NASH patients at the International Liver Congress. The drawback was that some of the patients evaluated in the trial exhibited a severe spike in triglyceride levels -- a known side-effect of firsocostat. Presumably, Gilead decided to add a Vascepa arm to explore the drug's ability to combat this potentially serious side effect.

What's more, Vascepa might also provide an all-important cardioprotective benefit in this at-risk patient population. And this second clinical benefit could be a game-changer for the therapy from a commercial standpoint. There is a well-established link between NASH and cardiovascular disease, after all.

What's the key takeaway? While this clinical trial news might turn out to be a big, fat nothingburger, it may also be the first sign that Gilead is considering an Amarin partnership, or perhaps a full-on buyout. The fact is that Gilead is one of the few biopharmas that could buy Amarin in cash without batting an eye. Moreover, Vascepa's potential dual purpose as an add-on to statin-therapy in patients with cardiovascular disease, and as part of a top-selling NASH cocktail, easily justifies the premium a buyout would entail.      

https://www.finanznachrichten.de/...gen-von-amarins-icosapent-382.htm

https://investorplace.com/2019/12/...tion-rumors-moving-amarin-stock/

etwas kritischere news:

https://www.nasdaq.com/articles/...-gamble-on-fda-approval-2019-12-04  

Die Daten sehen gut aus, sollte Bewegung in den Kurs bringen. 87% der Patienten bei UNITY PFS sprechen an - 1. Quartal 2020 UNITY-CLL Daten, dann könnte/sollte die Aktie explodieren.  

FDA erteilt  erweiterte Zulassung (restricted Label) für Vascepa

https://www.fiercepharma.com/pharma/...or-fish-oil-derivative-vascepa

 

dass der kurs wieder so gefallen ist?  

Sell on good news und Spielchen der Shortseller...Wird die nächsten paar Tage bestimmt noch weiter nachgeben. Mittel-/langfristig gesehen, ist das aktuelle Marktgeschehen aber uninteressant  

Geil, nach USA Zulassung, nun auch in Kanada, Amarins Vascepa wird Millionen Menschen helfen:

VASCEPA® Approved in Canada to Reduce the Risk of Cardiovascular Events
[GlobeNewswire]
GlobeNewswire•January 2, 2020

   VASCEPA becomes the first and only Health Canada approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients approved for treatment

   Commercial launch expected in mid-February 2020 by Amarin’s commercial partner for Canada

   VASCEPA approval was supported by clinical results from the REDUCE-IT® trial which included a 25% placebo-controlled relative risk reduction in the first occurrence of major adverse cardiovascular events such as heart attack and stroke

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN) is pleased to announce that Health Canada has approved the use of VASCEPA® (icosapent ethyl) to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. This is the first and only approval by Health Canada of any drug for this important indication. The approval was achieved through Amarin’s commercial licensee for VASCEPA in Canada, HLS Therapeutics, Inc. (“HLS”). Pursuant to an agreement announced in 2017, HLS has exclusive commercial rights to VASCEPA in the Canadian market.  

“We congratulate HLS on securing this important approval of VASCEPA.  We are confident that HLS will work to educate healthcare professionals across Canada on the life-saving and risk-reducing effects of VASCEPA. HLS is managed by an experienced and capable team of pharmaceutical industry professionals and we look forward to witnessing their progress,” stated John F. Thero, president and chief executive officer of Amarin.

The approval of VASCEPA by Health Canada positions this important drug to address a large unmet medical need. In clinical study of VASCEPA over approximately five years of patient follow-up, approximately 28 percent of patients treated with statins and other contemporary therapy but not treated with VASCEPA experienced a major adverse cardiovascular event (MACE), defined as the first occurrence of either myocardial infarction (heart attack), stroke, coronary revascularization, unstable angina requiring hospitalization or cardiovascular death.1 As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have persistent high cardiovascular risk. As reflected in the Health Canada approved label, VASCEPA demonstrated a 25% relative risk reduction in the first occurrence of MACE in these high-risk patients. More information regarding clinical studies of VASCEPA can be found at www.amarincorp.com.

The approval of VASCEPA by Health Canada follows the recent approval of a similar indication for VASCEPA in the United States. On December 13, 2019, the United States Food and Drug Administration (FDA) expanded the indicated use of VASCEPA to include use “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.”

Under the previously announced terms of the Amarin-HLS’s agreement, in 2017 HLS paid Amarin $5.0 million to in-license the exclusive Canadian rights to VASCEPA and in 2018 paid an additional $2.5 million following reporting of successful clinical outcomes study (REDUCE-IT) results for VASCEPA. Furthermore, under the terms of this agreement, Amarin will receive $2.5 million as a result of today's approval by Health Canada and is eligible to receive more than $50.0 million in additional milestone payments, most of which are sales-based milestones.  Amarin is responsible for supplying VASCEPA for sale in Canada on a cost-plus basis. In addition to milestone and supply payments, the agreement for commercialization in Canada provides for payment to Amarin of double-digit royalties on VASCEPA net sales in Canada.  HLS currently expects Canadian sales of VASCEPA to reach between CAD $150 and $250 million per year.

Pricing of VASCEPA in Canada will be jointly established by the parties. In the United States, two separate health economic studies presented in recent months conclude that VASCEPA is cost-effective. Such analyses suggested that the price of VASCEPA in the United States could be considerably higher and still remain cost-effective. These findings reflect the affordable pricing of VASCEPA in the United States and the relatively high costs of MACE, such as heart attacks and stroke, which VASCEPA helps avoid.

Vascepa is the subject of numerous Canadian issued patents and pending patents with expiration dates which could extend to 2039.  The eligible patents will be added to Health Canada’s Patent Register following receipt of NOC and in accordance with Health Canada’s process.

Pursuant to this approval, VASCEPA is now approved in three countries in addition to the United States, Canada, United Arab Emirates and Lebanon. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union, the Middle East and North Africa, and is evaluating other regions for potential regulatory filings.  

https://www.astrazeneca.com/media-centre/...slipidaemia-13012020.html