Amarin - The Science Of Lipid Therapy (Seite 119)

[asthmamoah]

Antwort auf Beitrag Nr.: 61.927.859 von bernie55 am 14.11.19 23:15:43

👍👍👍 Sehr, sehr geiles Ergebnis. Mit solch einer Deutlichkeit hätte ich das nie erwartet😀😀

[Rastelly]

Amarin erhält FDA-Nominierung zur Erweiterung des Labels von Heart Drug Vascepa, von Blomberg

https://finance.yahoo.com/news/amarin-wins-fda-panel-nod-213…


Auszug:

Alle 16 Diskussionsteilnehmer stimmten zu, dass das Medikament als Medikament verkauft werden sollte, um das Risiko für kardiovaskuläre Ereignisse wie Schlaganfall und Herzinfarkt zu verringern, und stimmten darin überein, dass das Medikament sowohl sicher als auch wirksam ist. Die Zulassung könnte die potenzielle Patientenpopulation von derzeit 600.000 auf 10 Millionen erhöhen, schätzte SVB Leerink Anfang dieses Monats.

Der Diskussionsteilnehmer James de Lemos äußerte sich skeptischer und sagte, Vascepa sollte "nur für die Sekundärprävention zugelassen werden", wobei das Unternehmen Vascepa gegen ein Placebo bei diesen Patienten mit geringerem Risiko untersuchen musste.

Jefferies Analytiker Michael Yee schrieb am Donnerstag zuvor, dass die potenzielle Patientenpopulation in den USA fünf bis 15 Millionen erreichen könnte, obwohl nur eine Million Patienten, die das Medikament einnehmen, es noch zu einem Medikament von 2,5 Milliarden Dollar machen würden.

Es wird erwartet, dass die US-Aufsichtsbehörden bis zum 28. Dezember eine endgültige Entscheidung treffen. Die Agentur befolgt in der Regel den Rat ihrer Expertengremien, ist jedoch nicht dazu verpflichtet. Die Aktien des Drogenkonsumenten wurden am Donnerstag während des Panels gestoppt, beendeten den Mittwoch jedoch mit einem 4-Monats-Hoch.

Gruss RS😎

[bernie55]

Antwort auf Beitrag Nr.: 61.927.859 von bernie55 am 14.11.19 23:15:43

Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT® Outcomes Trial

•November 14, 2019
Cardiovascular disease events like heart attacks, stroke and death affect millions of patients in the United States and are estimated to cost $500 billion annually

Millions of high-risk patients with cardiovascular disease could benefit from this cost-effective therapy if expanded label receives FDA approval; PDUFA date is December 28

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa® (icosapent ethyl) capsules to reduce the risk of cardiovascular events in high-risk patients based on results from the landmark REDUCE-IT®1 cardiovascular outcomes trial.

The FDA is not bound by the recommendations of an advisory committee. Amarin plans to work with the agency as it completes its review of the company’s application seeking an appropriate label expansion for Vascepa to reflect REDUCE-IT results.

Cardiovascular disease is the number one cause of death for men and women in the United States and the nation’s costliest disease, with direct and indirect expenses in excess of $500 billion each year.2 An independent drug pricing watchdog group concluded that Vascepa is cost effective for cardiovascular risk reduction as demonstrated in REDUCE-IT even under the most stringent standards of that group, a result rarely achieved in its analyses.3

“Today we moved an important step closer to potentially helping millions of patients who are at risk for cardiovascular events despite being on standard-of-care statin therapy,” said John F. Thero, president and chief executive officer of Amarin. “Vascepa is positioned to be the first approved treatment to reduce cardiovascular events in the group of at-risk patients studied in the landmark REDUCE-IT clinical trial. We appreciate both the opportunity to present these results and the committee’s strong vote of confidence. We look forward to anticipated labeling discussions with the FDA, and we continue to prepare for the launch of Vascepa assuming FDA approval of our sNDA on or before the target PDUFA date of December 28.”

Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart and Vascular Center, and professor of medicine at Harvard Medical School, said: “The REDUCE-IT results are quite remarkable and illustrate how icosapent ethyl could transform the treatment of cardiovascular disease in the United States and worldwide. From my perspective as not only a researcher but also a practicing physician, icosapent ethyl represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins and, if FDA approved, will be a critical tool for physicians to use to help prevent cardiovascular events such as heart attack and stroke, including fatal ones, in high-risk patients.”

“Amarin thanks the patients, advocacy groups, physicians, researchers, and others who expressed overwhelming support for Vascepa through their written and in person comments at the advisory committee meeting,” Thero said. “We also recognize the contributions of the 8,179 patients who participated in REDUCE-IT, some for over six years. Thousands of patients and professionals contributed to the REDUCE-IT results. We look forward to having their sacrifices and contributions reflected in an expanded indication for Vascepa that has the potential to benefit millions of patients.”

https://finance.yahoo.com/news/amarin-announced-fda-advisory…

[bernie55]

Antwort auf Beitrag Nr.: 61.927.334 von asthmamoah am 14.11.19 22:09:19

Zitat von asthmamoah: Approved, 16 - 0 Voting for yes

[bernie55]

Antwort auf Beitrag Nr.: 61.923.179 von Cyberhexe am 14.11.19 15:45:47

Zitat von Cyberhexe: Hi Bernie - sitzen wir wieder einmal im selben Boot?

Ich glaube nicht, dass wir absaufen!
wie immer: TIME WILL TELL!

YES - you know - you`ll never walk alone..
...sorry.... you `ll never sail alone.

[Magnetfeldfredy]

Amazing stuff, jetzt noch positive Evaporate am Montag als Late braker und wir könnten US Dollar 50 erreichen:

Amarin's Stock Could Reach $50 Per Share Soon
Here's where a de-risked Amarin could be headed over the next few months.
George Budwell
George Budwell
(TMFGBudwell)
Nov 13, 2019 at 9:37AM
Author Bio

Yesterday, Amarin's (NASDAQ:AMRN) shares jumped by a whopping 20.9% during normal trading hours. The spark behind this eye-catching move northward was the release of the U.S. Food and Drug Administration's (FDA) briefing materials for the company's upcoming advisory-committee meeting set for this Thursday.

Come Thursday, Amarin and the FDA's panel of experts will mull over the putative cardioprotective benefits of the company's prescription omega-3 treatment known as Vascepa. The big deal is that Vascepa's addressable market would expand to upwards of around 9.5 million Americans who are currently on statin therapy but still suffer from elevated triglyceride levels.
Businessman holding risk and rewards blocks.

Image Source: Getty Images.

That's a $15 billion per-year commercial opportunity right now -- based on the drug's estimated annual net price of $1,625, per the cost-effectiveness watchdog ICER. Future price hikes, combined with the continued growth of this target market as a whole, though, could push Vascepa's sales into truly rarefied air.

Keeping with this theme, Vascepa has the potential to generate annual sales larger than those of Pfizer's (NYSE:PFE) megablockbuster cholesterol medicine Lipitor, as well as AbbVie's anti-inflammatory behemoth Humira. For those new to the world of biopharma, Lipitor and Humira are the two bestselling pharmaceutical products of all time. That's just how big of a deal Vascepa's proposed cardioprotective indication is from a commercial standpoint.

With this background in mind, it's arguably the perfect time to consider if Amarin's stock can climb even higher in the days and weeks ahead. Here's a look at Amarin's potential risks and rewards in light of yesterday's market-moving event.
Amarin: The risks and rewards

Amarin's stock sports two clear-cut risk factors: the regulatory risk associated with Vascepa's proposed label expansion and the company's real world ability to fully capitalize on this ginormous commercial opportunity, post-approval.

Now, the risk emanating from the upcoming label-expansion decision appears to be minimal in the wake of yesterday's briefing-document release. The most critical issue heading into this advisory-committee meeting was the potentially confounding effect of the mineral oil placebo on the magnitude of Vascepa's observed cardioprotective benefit in the Reduce-It trial. However, the FDA's own reviewers admitted that they couldn't explain away Vascepa's cardioprotective benefit simply as a function of a non-inert placebo.

Two key statements in the briefing documents made this point crystal clear:

FDA analyses attempting to differentiate whether increases in LDL-C and other biomarkers were due to the mineral oil placebo are inconclusive...

FDA's exploratory analyses to assess the effect of these markers suggested that the difference in LDLC between the study groups could not account for the positive CV outcomes.

So, unless something truly extraordinary happens at Thursday's meeting, the FDA will more than likely approve Vascepa's label expansion.

Amarin's key risk thus boils down to the company's ability to maximize Vascepa's commercial potential. Although Amarin is planning on significantly beefing up its sales force once the FDA formally approves this label expansion, the reality of the situation is that the company simply cannot tackle this vast market by itself.

Amarin doesn't have the commercial infrastructure or the marketing clout to cover all the bases, so to speak. There's an inherent structure reason, after all, why all the bestselling drugs in the world are either marketed directly by a pharma titan or at least partnered with one of the industry's biggest names.

What this means is that Vascepa's peak sales would probably top out at the $2 billion mark under a go-it-alone approach and could take several years to reach this high-water mark. In that case, Amarin's shares would arguably be fairly valued at something along the lines of $27.8 per share (five times peak sales), representing a 33% upside potential from current levels.

For the uber-bulls out there, the plain truth is that Amarin's shares would almost certainly be trading at much higher levels if the market thought the company could realistically push Vascepa's sales significantly beyond the $2 billion mark within the next four years. So $2 billion does appear to be the market's working peak sales estimate -- at least as things stand now.
The wildcard

There is a wildcard at play here, however. Amarin's management hasn't even attempted to build out a broader clinical pipeline to complement Vascepa, and that's a big tell in regards to the company's value-creation strategy. Cutting to the chase, Amarin has probably already fielded a few tender offers in the event the FDA greenlights Vascepa's Reduce-It indication.

Amgen (NASDAQ:AMGN) and Pfizer have both been rumored to have interest in Amarin in the recent past, after all. Making this situation even more intriguing is that both Amgen and Pfizer have been been gobbling up high-value assets of late in order to finally move beyond the patent cliff. Vascepa, for its part, could turn into a crown jewel of the pharma industry under the umbrella of either Amgen or Pfizer, making it a highly desirable asset for these titans of the industry.

How much could Amarin fetch in a buyout? With two gold-star players vying for Vascepa, Amarin's buyout price could easily range from $36 to $42 per share (assuming a tender offer in the range of $13 billion to $15 billion). Now, if a bidding war broke out -- a scenario that played out when AbbVie had to pay top dollar to acquire Imbruvica, the low $50s might even be possible.

When would a buyout most likely occur? Big pharma has a tendency to announce needle-moving business development moves early in the year -- frequently in January around the time of the J.P. Morgan Healthcare Conference. The reason is that these early-year announcements help to set the stage for investors' expectations for the full year.
Final thoughts

The big picture is that investors shouldn't be surprised if Amarin indeed gets this all-important label expansion for Vascepa before the end of the year, and this regulatory win, in turn, leads to a buyout at a healthy premium within the first quarter of 2020. From a more conservative viewpoint, Amarin's shares should at least appreciate by another 10% to 20% before the end of 2019, especially with its biggest risk factor -- a complete response letter -- seemingly off the table.

[lobberland]

Antwort auf Beitrag Nr.: 61.927.400 von Magnetfeldfredy am 14.11.19 22:16:02

😮😮😮 wow...

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 61.927.334 von asthmamoah am 14.11.19 22:09:19

Amarin

Wie geil👍👍👍👍👍💪💵💵💵💵

[asthmamoah]

Approved, 16 - 0 Voting for yes

[Cyberhexe]

Antwort auf Beitrag Nr.: 61.925.390 von Cyberhexe am 14.11.19 18:43:23

Ich bin mir nahezu sicher, dass die Anwendung vin VASCEPA heute erheblich erweitert wird. Die Frage ist jedoch, wie weit?

Der größte Teil der Patienten in der REDUCE-IT-Studie ist für die sogenannte Sekundärprävention bestimmt. Dies bedeutet, dass diese Patienten bereits einen Herzinfarkt oder Schlaganfall hatten. Die Erweiterung um diese Indikation halte ich für sehr wahrscheinlich.

Die Frage ist jedoch, gibt es eine Erweiterung um Risikopatienten, die bisher noch kein kardiovaskuläres Ereignis hatten (Herzinfarkt, Schlaganfall, Stent).

Amarin schlug auf der Grundlage neuer Post-hoc-Analysen vor, diese Patienten mit einem Risiko-Score auszuwählen, der das kardiovaskuläre Gesamtrisiko des Patienten berechnet. Marvin Konstam von Tufts protestierte, dass eine Risikobewertung hier möglicherweise nicht angemessen sei.

Hier könnten auch Probleme wie die Sorgen um das Mineralöl-Placebo eine Rolle spielen. Die FDA rechnet damit, dass nur etwa 3% der insgesamt um 25% verringerten Ereignisse mit REDUCE-IT von Bedeutung sein könnten. Das Gremium arbeitet sehr hart daran, die Daten auf eine übersichtliche Tabelle mit Vor- und Nachteilen für diese Gruppen zu reduzieren, und bittet um Informationen zu Nebenwirkungen, die gegen die geringere Wirksamkeit in der Primärprävention abgewogen werden können. Thomas Weber von der Duke University bat um Einzelheiten für seine eigene Analyse, die darauf hindeutete, dass 33 Patienten behandelt werden müssten, nicht 22, wie zuvor vorgeschlagen.

Folgende Empfehlungen sind denkbar:

1.) das Gremium empfiehlt, Vascepa nur bei Patienten mit bereits bestehenden Herz-Kreislauf-Erkrankungen zu verschreiben

2.) es empfiehlt, dass Patienten einen höheren Triglyceridspiegel als die 135 Milligramm pro Deziliter haben, die Amarin vor der Verschreibung von Vascepa vorschlägt,

3.) allen von Amarin beantragten Indikationen wird zugestimmt

Alle Varianten sind denkbar und keines dieser Szenarien ist eine Katastrophe. Einige werden sogar argumentieren, dass, wenn es um die Größe des Marktes geht, nichts davon zählt. In einer Mitteilung an die Anleger argumentierte Michael Yee von Jefferies, dass die Beschränkung des Marktes auf sekundäre und nicht primäre Patienten immer noch einen Markt von mindestens 5 Millionen Patienten in den USA darstelle und Amarin nur 1 Million Patienten erreichen müsse für 2,5 Milliarden US-Dollar Umsatz.

Not too bad!