Amarin Corp. plc - der absolute Hit!

Du hast null Ahnung, Lovaza von GSK macht 1 Milliarde Umsatz und Vascepa von Amarin ist deutlich überlegen, keine Erhöhung des LDL, wahrscheinlich weißt Du gar nicht was das ist!

FUD wird gestreut, auch bei einem negativen Panel zu Anchor ist Amarin ca 10 US Dollar wert!

Recherche lohnt, auch wenn Drecksbasher wie Du das Gegenteil behaupten, Kloopapier eben......  

Wenn die Fischölpille völlig ohne wirkung ist ,dann gibt es natürlich auch kein LDL Erhöhung,klar ? Du scheinst nicht mal zu ahnen wie weit es mit AMRN noch runtergehen könnte ! Wenn Vascepa nicht zugelassen wird,macht AMRN null (0) Umsatz,keine Pipeline ,nix ! Kursziel 0,50 dollar !!!!!!  

Amarin falls after FDA panel says fish oil pill benefits may be over-estimated

Shares of drug maker Amarin (AMRN) are falling after briefing documents were posted for an FDA review meeting scheduled for October 16 to consider Vascepa, the company's lipid-lowering drug derived from fish oil. WHAT'S NEW: The company has submitted a request to the FDA to substantially expand the treatment population of the drug to include patients with mixed dyslipidemia who are at high risk for coronary heart disease and who are already being treated with statins, a popular class of cholesterol lowering drugs. Data from one pivotal efficacy trial, ANCHOR, was submitted to support the expanded treatment indication. In the documents to be used by the advisors expected to give their recommendation to the FDA, staff wrote that in the ANCHOR trial there were positive dose responses in the percentage of subjects with improvements in levels of certain triglyceride and cholesterol readings. The staff also noted that the median percentage changes in the 2g Vascepa dose group were generally small and in an increase direction that was not in the favor of the test drug at that dose. The conclusion of the document stated further that the observed beneficial treatment effects of Vascepa relative to placebo in the trial "may be over-estimated." PRICE ACTION: In afternoon trading following the documents being posted to the FDA's website, Amarin shares are down 9.7% to $5.75  

und Du weißt nicht einmal daß Amarin schon eine Zulassung hat, Kloopapier eben...  

bitte hat Dendreon die Zulassung für Provenge gebracht ? Die Aktie ist daraufhin von 50 dollar auf 2,50 gefallen. Selbst wenn Amarin die zulassung für snakeoil hat (hätte),kann das immer noch ein fetter FLOP werden !  

...kann es werden..... , Kloopapier  

Das sagt ein SA User:

The FDA only required REDUCE-IT to be substantally underway before they accepted the sNDA for ANCHOR. They obviously had meetings with their management and Amarins management and the terms of the ANCHOR trial were agreed upon. To move the goalposts and to delay approval for ANCHOR at this stage makes zero sense. The FDA are about approving drugs that are safe and efficacious. Vascepa is exactly that.

Read the question being asked again:

"Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the
completion of REDUCE-IT?"

Here's a summary of Vascepa's main effects:

"After 12 weeks of therapy, statistically significant differences were observed between placebo and AMR101 4g with respect to TG (-21.5%; p<0.0001) and with respect to secondary endpoints such as LDL-C (-6.2%; p=0.007) and non-HDL-C (-13.6%;
p=0.0001)."

A statistically significant reduction in TG's ALONE should be considered enough as that was the agreed upon primary endpoint of the ANCHOR trial. When combined with the secondary endpoint reductions in LDL-C and non-HDL-C along with all the other favourable lipid parameters, Vascepa clearly meets all the criteria necessary for it to be granted approval.

From Page 8 of the ADCOM document (and repeated word for word again on page 63):

"In considering the results of the ANCHOR trial, the presumption has been that improving various lipid parameters will translate into a reduction in cardiovascular risk. With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes."

REDUCE-IT, once complete, will finally back-up the assumptions but AT THIS TIME IS NOT REQUIRED FOR ANCHOR APPROVAL.

From page 87:

"The applicant-sponsored cardiovascular outcomes trial, REDUCE-IT, which is studying patients at high-risk for cardiovascular disease at LDL-C goal on statin therapy with residually high triglycerides (TG ≥200 mg/dL to <500mg/dL), intends to confirm this implied benefit."

Wake up people. Arent you tired of swallowing bear shit?  

Expanding the use of Amarin Corp.’s fish oil drug Vascepa, approved last year to treat “very high” triglycerides, may depend on the outcome of a study on heart risks, U.S. regulators said.

Amarin declined 20 percent after Food and Drug Administration workers today gave an assessment of the prescription-grade omega-3 fatty acid in a report. An FDA advisory panel is set to meet Oct. 16 to discuss expanded approval for the drug to people with only high triglycerides, a fat in the blood, who also are using a cholesterol-lowering statin therapy.

The company, based in Dublin and run from Bedminster, New Jersey, is studying Vascepa’s ability to reduce cardiovascular events, the results of which probably won’t be available until 2016, Steve Ketchum, president of research and development, said Aug. 8 on a conference call. Next week’s advisory panel discussion is likely to be heated and the vote close, said Akiva Felt, an analyst with Oppenheimer & Co. in San Francisco.

“The hope for the best-case scenario, that the panel is really a formality, is off the table,” Felt, who has a “market perform” rating on the stock, said by phone. “The FDA does appear to be a little more cautious on the drug’s efficacy.”

Vascepa is Amarin’s lone product. The FDA approved the drug in July 2012 for people with very high triglycerides, a measure of fat in the blood of at least 500 milligrams per deciliter. The agency was scheduled to decide by Dec. 20 whether to clear the drug for people with high triglycerides, a level of 200 milligrams to 500 milligrams per deciliter
 

morgen,denn amarin macht nur knapp 8 Mill. Umsatz mit Vascepca zur Zeit:

On Wednesday an FDA advisory  panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions with elevated triglycerides (>200 mg/dl) and existing CV disease or at high risk for CV disease. The NDA for this indication is based on the ANCHOR trial, which showed that Vascepa lowered triglycerides in the target patient population.

The FDA review (available here) raises 2 troubling issues. The first is fairly simple and relates to the performance of the placebo in ANCHOR.  In its briefing documents the FDA raises the disturbing and unusual possibility that the mineral oil placebo used in the trial may not have been biologically inert. LDL levels in the placebo group went up 9% in the placebo group and this will make it difficult to assess the true effect of Vascepa. It’s unlikely that this issue by itself will entirely derail the NDA, but it may well serve to undermine confidence in the trial and put the panel in a critical frame of mind.

More significant, to my mind, is the lack of any evidence for any important improvement in clinical outcomes that can be tied to Vascepa. Now some people believe that ANCHOR provides enough data to justify the expanded indication, as it technically met its primary endpoint and reduced triglycerides. The argument here is that improvements in lipid parameters have traditionally been accepted by the FDA, and that there is no current approved and effective treatment to treat high risk people with moderately elevated triglycerides.

The counter-argument against approval is made clearly and strongly in the FDA briefing documents. Although the FDA agreed to the ANCHOR protocol, it also specifically noted that the interpretation of the trial would clearly depend on the results of several large ongoing outcomes trials testing the hypothesis that non-statin therapies (nitrates, fibrates) would reduce residual risk. Since that time the results of these trials have been published and they have uniformly failed to demonstrate any clinical benefit. Although the FDA notes that these trials have been controversial and are subject to different interpretations, the burden of evidence now remains on those wishing to prove that reducing residual risk with non-statin therapies is beneficial.

An apparent contradiction to  this perspective is the fact that the FDA has actually approved a number of lipid and diabetes drugs in recent years based on surrogate outcomes. An example is the approval of 2 new drugs from Aegerion and ISIS to treat people with extremely high cholesterol levels due to homozygous familial hypercholesterolemia. Although these drugs raised all kinds of red flags over both safety and efficacy, the FDA advisory panel members and the FDA itself ultimately decided in favor of the new drugs.

The decisive argument in these cases was that physicians needed as many options as possible in treating patients. This principle trumped concerns about the lack of outcomes. But there’s an important reason why this argument may not work in the case of Vascepa.

No matter what the FDA decides now, Vascepa will be available as a treatment option to physicians. Since it is already approved, physicians will still be able to prescribe it for off-label usage. The main effect of a negative decision would be to prevent Amarin from marketing and promoting the drug for this off label usage.

The fact that Vascepa is already on the market provides cover to the panel members. They will be less likely to make a recommendation based on the emotional appeal of expanding physician options and more likely to take a strong stance in favor of outcomes trials. The most likely scenario is that they will withhold approval of an expanded indication until the results of  REDUCE-IT, Amarin’s outcome trial with Vascepa, become available in 2016
 

The official word from the FDA on Amarin's (AMRN) FDA's review of the supplemental New Drug Application (SNDA) seeking approval for the use of Vascepa(R) (icosapent ethyl) capsules in the proposed ANCHOR indication won't be known until at least Wednesday next week. FDA papers were released today that sparked a more-heated-than-ever debate between bulls and bears as the stock price slid down. What the FDA will officially decide and which side is correct remains to be seen. Most agree a thumbs up could turn Amarin from rags to riches, as the indication for the ANCHOR trial is estimated at 36 million compared to only 4 million for the current indication, increasing its market potential by tenfold. The purpose of this article is to explore the "what if" Amarin receives a thumbs down.

The short version:
Amarin is broke within 2 years without ANCHOR approval.

The longer version:
As of June 30, 2013 Amarin had $149.4 million in cash, plus it raised $121.1 million in July for a total of $270.5 million. It had net cash outflows of $52.8 million in Q2 and stated, "Amarin anticipates that it will experience continued reductions in quarterly net cash outflows from operations with future quarterly results below the results of the second quarter..."

How much of a reduction? Gross profit margins that last two quarters were 48% and 45%. If you assume with quantity that grows to 60% and assume the sales of last quarter triple (weekly script rate currently is double what it was last quarter) going forward, it comes out to $9.9 million in gross profit ($5.5 million*3*60%), an increase of $7.2 million over last quarter.

Cash R&D was around $17 million last quarter. If you cut that in half to $8.5 million and reduce the $30 million cash SG&A to $25 million, you get an overall reduction in cash burn discussed thus far of $20.7 million using the most optimistic of scenarios imaginable.

Amarin, even then, is still at a $32.1 million quarterly cash burn. While Q3 results aren't out yet, let's assume the $52.8 million burned last quarter comes down to $40 million. That leaves Amarin with $230.50 million left. $230.5 million divided by $32.1 million = less than 8 quarters. This time in two years, Amarin is broke.

Amarin gave no details in its most recent conference call to expect anywhere as rosy of a scenario of reduced cash costs as I presented. Of course, there's always the buyout possibility, especially if another company with better resources believes it can market Amarin's Vascepa better than Amarin did. If sales go up sixfold instead of my "optimistic" threefold, cash burn would go down another $7.2 million (at 60% margins). Still, even at a sixfold increase and all the other rosy scenarios, it only buys Amarin time, not success, of another two quarters. It really needs a massive sales increase to even break-even, one that has a great chance with ANCHOR approval. Short of a buyout, or severe dilution, or an angel lender, I'm afraid Amarin is broke fairly soon without ANCHOR approval. It's do or die time. Amarin has no other drugs in its pipeline. Good luck to all.

 

http://us.rd.yahoo.com/finance/external/pssa/...nvestors?source=yahoo  

Amarin (AMRN) FDA Panel Predicted 7-to-3 in Favor of Approval - Jefferies

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After analyzing the last 13 FDA endocrine panel meetings, Jefferies analyst Thomas Wei is confident the panel will support Amarin Corporation (NASDAQ: AMRN) Vascepa approval.

"We analyzed the last 13 FDA endocrine panel meetings, specifically the votes and relevant commentary from the 10 committee members on AMRN's Wed panel for Vascepa label expansion for the ANCHOR indication," Wei said. "We would predict a 7-3 vote in favor of approval. That said, many of our predicted votes are based on mixed evidence, which could lead to a close outcome on Wed."

Commenting on the seven potential 'Yes' votes, Wei says: "We count four likely Yes votes (Dr. Seely, Dr. Wilson, patient rep, consumer rep). Dr. Seely has the most positive voting record of any panelist in this division,and the reps have shown a natural bias to increased patient access to new drugs. We found comments from Dr. Wilson on the importance of TG as an important CV risk marker and support for surrogate endpoints. We favor a Yes vote for Dr. Hiatt following strong opinions on post-approval CV outcomes testing in other diseases, but we remain concerned about one negative comment on the utility of lipid endpoints for another TG-lowering drug. We are leaning to a Yes vote for Dr. Everett, although he has participated in only one prior panel and his commentary had limited relevance to AMRN's situation. The biostatistician is another tenuous Yes prediction, as he is new to FDA panel meetings, so we base our analysis from past biostatisticians who have generally voted in favor of drug approvals and post-approval CV outcomes testing."

On the three likely 'no' votes, Wei comments: "All three predicted No votes (Dr. Smith, Dr. Cooke, Dr. Gregg) were difficult to call, but we were influenced by commentary in all three cases indicating a bias against surrogate endpoints. That said, the actual votes from these three panelists were generally positive, and for the two panelists on an obesity drug panel, they both voted for approval on the basis of weight loss as a surrogate endpoint."

Wei maintained a Buy rating and $20 price target on AMRN.
 

Junge ! Ausgerechnet heute,wo es interessant wird und AMRNs Existenz auf dem spiel steht,kann man weder kaufen noch verkaufen,Sauerei !!

Viel Glück !!!!  

Das ist doch generell so, dass ein Trading Halt stattfindet bei einem FDA-Meeting  

Spätestens in 2 Jahren pleite,es gibt keine erweiterte zulassung,da abgelehnt ! Ich hatte dich gewarnt,Magnetfeldfredy und sage auch anderen immer wieder: Geht raus BEVOR die entscheidung kommt !! Ganz wichtig !! Denn wenn sie positiv ist (gewesen wäre) kann man immer noch,wenn auch deutlich teurer,einsteigen !

Gestern ist Savient Pharmaceuticals (SVNT) um 90% gefallen,nach chapter 11,völlig überraschend,so könnte ich mir die Eröffnung morgen bei Amarin auch in Etwa vorstellen,wenn ihr mit 2 blauen augen rauskommt,dann nix wie raus,die haben nix mehr in der Pipe,das schicksal ist besiegelt !

MFG
Chali  

 

9:2 Durchgefallen .....  verweisen auf Endgültigen Studien Ergebnisse 2014 oder 2015

FDA Entscheidung am 20.12. wird mit zeiemlicher Sicherheit negativ......  

Die FDA ist ein korrupter Sauhafen, trotz Erreichen aller Endpunkte und ohne Sicherheitslücken wollen die die outcome-Studie abwarten, ich würde Klage gegen die FDA einreichen, die Studie wurde unter einem SPA gemacht also von der FDA abgesegnet!

Na ja, man kann billigst nachkaufen, Amarin hat das best in class Präperat für hohe Tryclyeride und Lovaza mit dem schlechtern Produkt macht in diesem Label 1 Milliarde Umsatz im Jahr und wird generisch!

Amarin still halted; Leerink Swann slashes PT by two-thirds, Aegis downgrades • 6:05 PM

Amarin (AMRN +3.2%) shares remain halted in AH trading after an FDA panel voted 9-2 against recommending an expanded drug label for Vascepa.
The beginning among what is sure to be several changing analyst outlooks, Leerink Swann slashes its PT to $6 from $18 (after upgrading AMRN to Outperform on Monday) while Aegis Capital downgrades the stock to Hold from Buy.
After panelists noted that "more clinically relevant measures of efficacy (i.e., REDUCE-IT cardiovascular event data) are needed before exposing a much larger number of patients," Leerink analyst Joseph Schwartz thinks there is a "a 10% probability of 'ANCHOR' approval on the 12/20/13 PDUFA date, a 40% probability of approval in 2017 after REDUCE-IT data in 2016, and a 50% approval of no label expansion ever. We assume peak Vascepa sales in 2030 of $2.6bn/$2.1bn/$1.2bn in these three scenarios."
Aegis's Ram Selvaraju thinks AMRN shares could be "range-bound for a significant period of time." Particularly ominous: "The fact that the firm will have to find a way to reduce expenses and drive revenues with only a narrow label in hypertriglyceridemia for Vascepa negates any likelihood of an acquisition near-term, in our view. In addition, because of the company's envisaged operational burn rate, we anticipate that Amarin could be forced to raise additional capital multiple times before the REDUCE-IT data become available."
Read comments  

doch völlig übertrieben oder?  

Es ist möglich, dass dort noch tiefer gestartet wird...  

http://www.thestreet.com/_nasdaq/story/12072224/1/...EE&cm_ite=NA  

 

der FDA oder?  

http://www.nasdaq.com/symbol/amrn/premarket  

Hahaha ! Ich lach mich bald mal kaputt,überall wo ich warne oder gewarnt hab ist irgendwann auch rudini am Start ! Ich warne davor bei 2 dollar einzusteigen,denn es wird aller Warscheinlichkeit nach auch hier bei AMRN so enden wie bei SVNT ! AMarin ist selbst bei 2 dollar noch viel zu teuer,aber ab 50 Cent könnte man zumindest einen zock wagen,das stimmt schon ....

MFG
Chali