Amarin - The Science Of Lipid Therapy - Älteste Beiträge zuerst (Seite 60)

[Magnetfeldfredy]

Große Hoffnung für diesen Late Braker:

[Magnetfeldfredy]

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.

[bernie55]

Antwort auf Beitrag Nr.: 61.712.266 von Magnetfeldfredy am 17.10.19 15:57:36

Cantor 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

[Magnetfeldfredy]

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.

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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.

[bernie55]

Antwort auf Beitrag Nr.: 61.570.521 von Magnetfeldfredy am 26.09.19 07:44:03

Zitat von Magnetfeldfredy: Große Hoffnung für diesen Late Braker:

[bernie55]

In den USA Foren erscheinen immer wieder sehr positive Experten-Kommentare zu AMRN, VASCEPA und zu der REDUCE IT Studie.

Hier mal einige aktuelle Links:


ACC says Vascepa & not fish oil delays ASCVD

Oct 21, 2019
Lipid Management for Prevention of ASCVD
Melvyn Rubenfire, MD, FACC

Die kürzlich durchgeführte REDUCE-IT-Studie hat gezeigt, dass Personen mit hohem Risiko für ASCVD oder Diabetes mit einem zusätzlichen vaskulären Risikofaktor und einem Triglyceridspiegel von 135-500 mg / dl mit gut kontrolliertem LDL-C auf einem Statin, das 4 g Icosapent Ethyl erhielt, 4 g Icosapent erhielten hatten eine 25% ige Reduktion der wichtigsten CV-Ereignisse, die nichts mit der Wirkung auf Triglyceride zu tun hatten.

Icosapent Ethyl ist eine geschützte und hochgereinigte Form von EPA. Die Ergebnisse der REDUCE-IT-Studie sollten nicht verallgemeinert werden, um ein Nahrungsergänzungsmittel mit Fischöl zu empfehlen.

Es wird angenommen, dass der Wert von icosapent Ethyl mit anderen Mechanismen zusammenhängt, einschließlich entzündungshemmender und antithrombotischer Wirkstoff

https://www.investorvillage.com/smbd.asp?mb=2294&mn=5215&pt=…



Comment on the Food and Drug Administration (FDA) Notice: 

Oct 21, 2019
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

John R. Nelson MD,FACC,FNLA,FASNC
Director,California Cardiovascular Institute

Zusammenfassend lässt sich festhalten, dass die Hinzufügung des Etiketts von Vascepa zur Verringerung von kardiovaskulären Ereignissen, einschließlich des Todes durch CV bei Patienten mit CVD oder DM mit einem oder mehreren Risikofaktoren für eine Statintherapie mit Tg 135-499, Leben retten und die CV-Morbidität verringern sowie die Kosten senken wird.
Wie ich eingangs sagte, ist dies ein wahrer historischer Moment im Bereich der Reduzierung / Prävention von kardiovaskulären Risiken, und ich bedanke mich bei der FDA für all ihre Bemühungen und dafür, dass sie mir die Gelegenheit gibt, zu einem so wichtigen Thema Stellung zu beziehen.

https://www.regulations.gov/document?D=FDA-2019-N-3936-0030

[kmastra]

Einige Bilder, die den Effekt seit Reduce-it nochmal schön illustrieren.

[Magnetfeldfredy]

Good news vom Patentstreit:

Roth reiterates $31 target.

Comments on patent litigation:


AMRN scores another win in its battle against Vascepa imitators. In its ongoing litigation with potential generic competitor drugs to Vascepa (named in the court docket as West-Ward Pharma, Hikma Pharma, and Dr. Reddy's Labs), yesterday's news brought a summary judgment that we see as ruling favorably for AMRN. Let's break down the litigation update piece-by-piece: 1) First, remember that AMRN (plaintiffs) and the generic drug developers (defendants) are engaged in a court dispute over ANDA patent litigation and what the generic developers are allowed IP-wise; 2) In this situation, the generic developers typically will try to get an early end to the litigation, known as a summary judgment, to limit the scope of the case and bring an early end to the trial; 3) However, in this update the Court ruled against the ANDA filers' (generics) summary judgment, and narrowed several potential lines of generic argument from the case, thus benefiting AMRN; and 4) As discussed in a press release on its website (see here), the ruling also brings the possibility of ANDA case settlement with generics, should the option be in AMRN's best interest. We see this litigation news, which limits the scope of IP the case will focus on, as reaffirming the robust patent protection (100+) for Vascepa and confirming the strength of its Orange Book patents, which don't expire until 2030. In our view, AMRN is set up to achieve a dominant market position as a CV-risk reducing drug for the long-term vs. the horde of generic EPA drug developers.

[Magnetfeldfredy]

Cantor Fitzgerald Positive on Amarin (AMRN) As Generics Lose On Summary Judgement
October 29, 2019 3:04 PM EDT Send to a Friend
Cantor Fitzgerald analyst Louise Chen raised the price target on Amarin Corporation (NASDAQ: AMRN) to $35.00 while maintaining an Overweight ...

[bernie55]