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  • FDA Rescinds Amarin's ANCHOR Study Special Protocol Assessment Agreement [View article]
    The whole point of conducting the REDUCE-IT trial was so that ANCHOR would get approval for the expanded indication, allowing Amarin to continue its future funding by tapping into a multi billion $ market. Why waste everyones time and money agreeing to an SPA that you had no intention of adhering to? Why tell a company they need to have an outcomes study 50% enrolled before acceptance of the sNDA only then later, subsequent to a farcical ADCOM, to tell them to go stuff themselves? It's a total shit show.

    Prescriptions? Everything Amarin had been doing up until now was in preparation for the expanded label in January. Why you think they only had 275 reps and took out that $100m loan that starts looking horrible after Q1 2014 without ANCHOR?

    Shenanigans I tells ya. Pfizer or GSK buy this in Q1 2014 for mere buttons.
    Oct 30, 2013. 06:29 AM | 7 Likes Like |Link to Comment
  • FDA Rescinds Amarin's ANCHOR Study Special Protocol Assessment Agreement [View article]
    The FDA previously denied GSK's application for Lovaza to expand into the estimated 36 million patient population with high triglycerides in the 200-499 mg/DL range citing concerns about the fact it raised LDL by 49%. That was a legitimate reason. Lovaza has an a-fib warning in addition to that. Vascepa works just as well as Lovaza at lowering triglyerides but actually reduces LDL cholesterol and has no a-fib safety concerns. Vascepa met all primary, secondary and safety endpoints as per the agreed upon SPA set by the FDA. The FDA has now officially binned the SPA.

    The question is why, what is their reasoning? Anyone who thinks it has anything to do with results from the ACCORD-Lipid and AIM-HIGH and the HPS2-THRIVE outcome trials is seriously deluded. That's just the cover story.

    There has been obvious manipulation of the Amarin share price going on. This may be an outright attempt to try and bury the company as the FDA, hedge funds and GSK collude together to wipe Amarin out, or, it may be because big pharma want to get this drug on the cheap by returning the big fat finger JZ showed to them. Something is going on behind the scenes that we are not privy to and Amarin have clearly been warned about keeping stum.

    There is huge potential for this drug but NOT when marketed as a fish oil alone. The FDA are making that clear based on their ridiculous logic. It could still be prescribed and marketed in combo with a statin like Lipitor but only big pharma would be allowed do that which means Amarin will have to sell up shop post ANCHOR denial. The writing is on the wall.

    The next conference call on November 7th will be amusing.
    Oct 30, 2013. 03:19 AM | 8 Likes Like |Link to Comment
  • Amarin: Potentially Worth $3 To $4 Without Expanded Approval [View article]
    The problem with Vascepa is that it is touted as being just another fish oil. If the FDA approve ANCHOR they are essentially encouraging people to take more fish oil - OTC grade, Lovaza, Vascepa, whatever - all fish oil is the same irespective of DHA/EPA content and dose. Anyone who has looked at the science can clearly see that Vacepa is the creme de la creme of fish oil at a 4g dose but the science is being ignored.

    I strongly believe that the only chance this drug has of ever making it big is if it is marketed and prescribed as a combo drug with a statin. A powerful 1 2 punch against trigs and cholesterol. It has to be made clear to the public that Vascepa is far superior to OTC grade fish oil and that people are wasting their time taking it. Take ONLY Vascepa and a statin has to be the clear message. I think Pfizer would be a perfect fit. The have a leading statin Lipitor and the marketing power to pull it off.

    There has been an obvious witch hunt against fish oil going on but Amarin and big pharma now could use that to their advantage and clearly differentiate this drug from all the other fish oil out there. The fact remains that it IS the best fish oil out there - now go market that fact. Its the combination of cholesterol and trig lowering and may have CV benefit. REDUCE-IT aims to prove it. Would be pure madness to stop that trial but also pure madness to expect Amarin to fund it without ANCHOR approval. I say this gets sold to Pfizer in the new year. It would also inject a new lease of life into Lipitor.
    Oct 26, 2013. 02:39 AM | 2 Likes Like |Link to Comment
  • Amarin Could Still Turn Profitable [View article]
    I can read fine thanks. Your missing the point of what im saying, my fault for not being clear, but no need to get your knickers in a twist. im entitled to my opinion, take it or leave it.

    That ADCOM made it pretty clear the ANCHOR indication wont be approved. They basically said you cant market this to the high trig population in the 200-499 range claiming CV benefit because we dont have sufficient evidence yet that it does have benefit. Yes, it reduces trigs significantly without raising LDL level and go ahead and prescribe it off label to the 200-499 range and to patients in the very high >500 range but we are not going to give our official stamp of approval for the 200-499 range. That obviously will have a big impact on future potential sales.

    The only way this drug will be approved for the ANCHOR population and allowed to be marketed with claims of CV benefit is if big pharma do it marketing Vascepa and a statin as a combo drug, OR post a successful REDUCE-IT trial. Ideally you would need a 1 pill statin Vascepa combo drug which is what Amarin have been working on. I say Pfizer buy this company and work on that while waiting for the REDUCE-IT results.
    Oct 25, 2013. 03:51 AM | Likes Like |Link to Comment
  • Amarin Could Still Turn Profitable [View article]
    statins lower total cholesterol, NOT LDL cholesterol....does anyone have a clue whats going on here? you can potentially market vascepa and a statin for lowering heart disease but the FDA have made it clear you cant market a drug based on lowering trigs alone....vascepa is a combo drug at best for the ANCHOR indication....Amarin dont own a statin of their own...thats the problem....they need Pfizer and Lipitor or some other leading statin to tap in to the market....and so it will be sold
    Oct 24, 2013. 11:54 AM | Likes Like |Link to Comment
  • FDA Reviewing Panel Comments In 9-2 Vote [View instapost]
    "A 50% reduction in staff doesnt suggest they have any expansion plans imminent does it?"

    That was a rhetorical question, didnt need answering because the answer was obvious. The ANCHOR patient population is an estimated 10X the size of MARINE for which they had about 275 sales reps. You dont cut that number to save on a few millon $'s if you are confident of ANCHOR approval. You maintain it and announce how you plan on substantially increasing the sales force post ANCHOR approval.

    Here's a question for all the Amarin bears out there who have magically appeared out of the woods in support of the FDA and the farcical ADCOM and vote. When you go for a medical check up, blood samples are taken and tested for your total Cholesterol level, your LDL level and your Triglyceride level. Why do doctors bother to do this if high triglycerides are not a problem and not correlated with heart disease? Are the FDA now saying that only triglycerides >500mg/dL are of any importance? Don't bother treating high trigs because we have no concrete evidence and hard data to support the claim that lowering high trigs has any CV benefit until the REDUCE-IT study is completed. Your trigs are 502mgs/dL and holy smokes you need meds to reduce them but 402mgs/dL, 499mgs/dL, no, no worries there, you'll be fine! That JELIS study may as well have been conducted on rats its of so little relevance apparently.

    The whole thing is a joke.
    Oct 23, 2013. 11:23 PM | 4 Likes Like |Link to Comment
  • FDA Reviewing Panel Comments In 9-2 Vote [View instapost]
    JZ's biggest mistake was that quote when he said that if there was an offer of $30, $40, $100 we can talk. He basically announced to the world that a) he could be bought out and b) he's greedy. He and Amarin shareholders are now learning the hard way that Big Pharma determine the buyout price and nobody else. They will use the FDA, market manipulators, dodgy Caymen Island loan sharks etc to get this drug one way or the other.

    Because JZ can be bought out and is greedy all is probably not lost for the shareholders. Some kind of deal will be brokered over the next few weeks and months. A 50% reduction in staff doesnt suggest they have any expansion plans imminent does it? It's a move of a company and a CEO that has accepted its fate. Remember that JZ and the board still hold a substantial amount of shares and greedy Joe will go to Big Pharma with tail between legs and try and get as much as he can knowing that he now has ZERO chance of going this alone.

    I still say ANCHOR gets rejected and they are sold somewhere between $5-10/share. There is a very slim possibility that if he agrees to a deal whereby whatever happens with the ANCHOR PDUFA he agrees to sell, ANCHOR mysteriously then gets approved and Pfizer or whoever get their drug but at a higher premium obviously. Amarin may be in negotiations now as to what that premium will be. That theory is a long shot but you never know whats going on behind closed doors. Huge blocks of shares are currently being bought up.

    Steve, I know you bought more shares at $8 or thereabouts and you obviously still believe all is not lost. Simple question, the share price is now $2 and change, are you buying more?
    Oct 22, 2013. 11:53 PM | 2 Likes Like |Link to Comment
  • Is Amarin Going Belly-Up? [View article]
    The fact that you have an anonymous user name and havent replied to a single comment tells me you have an agenda and its fairly obvious what that is.

    Can Amarin go belly up? Absolutely. That was the whole point of that ADCOM in my opinion. Scare Amarin and JZ shitless, let them know who is the real boss, and disabuse them of any notions they had of going this alone. The ADCOM and the stock price collapse to $2 was basically a stone cold threat.

    I expect Pfizer are behind it all. AMRN has already named Pfizer's Lipitor as the statin agent to be patented with Vascepa. There are no shortage of links between Pfizer and Amarin. Declan Doogan was the head of R&D at Pfizer before joining Amarin. He designed the ANCHOR trial. Pfizer have the statin, Amarin have the triglyceride lowering fish oil. AZN would not have aquired Omthera if prescription grade fish oil in combo with statins had no potential. Omthera were aquired for $323 million with additional specified milestones worth $120million bringing the total cost of the aquisition to $443 million.

    Pascal Soriot, Chief Executive Officer of AstraZeneca said: “The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas.”

    So at the very least AZN are definitely interested in the space but with the ADCOM strongly suggesting the REDUCE-IT outcomes study needs to be completed before approval of ANCHOR, Vacepa's clear superiority over Epanova (in terms of safety, efficacy, and the fact they havent even started an outcomes study yet) means it is lagging far behind Vascepa. The Lovaza generic ruling pretty much cancels out Omthera completely.Vascepa also has extensive patent protection and Amarin have already locked up supply of the API. If the plan was to destroy the company I am certain that Amarin would NOT have been granted the 30 or so patents they have been granted thus far. AZN recently had an outright rejection for one of their recent composition patent applications for Epanova. That was very telling.

    Now the question is how much is Amarin worth? That cant be determined without knowing the FDA's decision on the ANCHOR indication.I am pretty sure Pfizer are now negotiating with Amarin about what happens next but one thing is now certain - they go this alone and the company is dead.

    Its a possibility that if JZ agrees to a buyout before the PDUFA date, ANCHOR will be mysteriously approved and then marketed by Pfizer to the expanded patient population with label restrictions. Goodnight Lovaza. The buyout price would be north of $20 - less than $30,$40,$100 but alot more than the Goldman Sachs $6.80 valuation. I accept that that scenario is more than likely rooted in fantasy land but stranger things have happened.

    More likely is that Amarin agree to a buyout but only after the ANCHOR PDUFA decision is known. It will then be denied in December, and the buyout price will be in the region of the Goldman Sachs $6.80 valuation.

    One of those 3 scenarios WILL play out between now and the end of Q1 2014.
    Place your bets.

    For the record, I am long Amarin and have been for years.
    Oct 22, 2013. 12:55 AM | 2 Likes Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    Why accept the sNDA? Hell, why even agree to conduct the Phase 3 trial in the first place?! Would have saved everyone a whole lot of time and money. This is not over yet though. I say that ADCOM was a deliberate attempt to scare Amarin and JZ shitless and disabuse them of any notions they had of trying to go this alone. The drug has huge potential, thats the bottom line. It's not in Pfizers interests to destroy the company but ADCOM made it clear that unless they sell, the FDA and market manipulators will make damn sure they go bankrupt.
    Oct 22, 2013. 12:29 AM | 1 Like Like |Link to Comment
  • New Study: EPA Reduces Cardiovascular Events - Enough For Amarin Approval? [View article]
    Big time shenanigans going on. This authors first article under an anonymous name too. Slam it down to $2 and now the pre PDUFA pump begins.
    Oct 21, 2013. 12:47 PM | 2 Likes Like |Link to Comment
  • Clock Ticks For Amarin As Outcomes Awaited [View article]
    Niacin is a completely different drug with its own distinct metabolic effects. It has zero relevance to EPA and its mode of action. The FDA can base their desision to deny ANCHOR approval on whatever they like, they make the rules. They can decide to deny it because JZ isnt wearing a pink frilly knickers if they want but better to keep their reasons somewhat science based so the racket remains intact.

    Come up with financing? Forget it. That ship has sailed.

    I expect Pfizer to make one final offer before year end and Amarin would be wise to accept it. AMRN has already named Pfizer's Lipitor as the statin agent to be patented with Vascepa. There are no shortage of links between Pfizer and Amarin. Declan Doogan was the head of R&D at Pfizer before joining Amarin. Pfizer have the statin, Amarin have the triglyceride lowering EPA. AZN would not have aquired Omthera if prescription grade fish oil had no potential. Omthera were aquired for $323 million with additional specified milestones worth $120 million bringing the total cost of the aquisition to $443 million.

    Pascal Soriot, Chief Executive Officer of AstraZeneca said: “The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas.”

    So at the very least AZN are definitely interested in the space but with the ADCOM strongly suggesting the REDUCE-IT outcomes study needs to be completed before approval of ANCHOR, Vacepa's clear superiority over Epanova (in terms of safety, efficacy, and the fact they havent even started an outcomes study yet) means it is lagging far behind Vascepa. The Lovaza generic ruling pretty much cancels out Omthera completely.Vascepa also has extensive patent protection and Amarin have already locked up supply of the API. So what is Vacsepa currently worth if Epanova was worth $443 million? There is clearly big potential for a statin Vacsepa combo drug but the only way it will ever realize its potential is with big pharmas help.

    A buyout of Amarin was always on the table. With the ANCHOR indication approved it is obviously worth alot more than it is without. With its approval Amarin could continue to go it alone but with the odds of ANCHOR approval in December having dropped dramatically after that ADCOM, the only real course of action now available is to sell the company. Dumb longs to believe the SPA actually meant anything. The fact REDUCE-IT is already 75% enrolled is Amarin's saving grace. That's worth potentially a hell of a lot to big pharma down the line. It has a great chance of producing positive data largely because Vascepa is a natural product with no side effects and they are using a 4g dose. Doogan and co have optimized that trial design so it has the best possible chance of being a success.

    Amarin have shot themselves in the foot with that financing deal to raise $100 million last December. The Company has agreed to repay Biopharma up to $150 million of future revenue and receivables. The first repayment under the agreement is a repayment of $2.5 million of interest due to Biopharma in November 2013, subject to the limitation described below. Additional quarterly repayments are due thereafter in accordance with the following schedule: $2.5 million of interest in the first quarter of 2014; $8.0 million per quarter in each of the next four quarters, $10.0 million per quarter in each of the next four quarters, $15.0 million per quarter in each of the next four quarters and a final payment of $13.0 million due in May 2017. The quarterly repayments through the third quarter of September 2014 represent interest only.

    Except upon a change of control in Amarin, the agreement does not expire until $150 million has been repaid. Under the agreement, upon a change of control, we would be required to pay $140 million, less any previously repaid amount, if the change of control occurs on or before December 31, 2013, or required to repay $150 million, less any previously repaid amount, if the change of control event occurs after December 31, 2013. The Company can prepay after October 1, 2013, an amount equal to $150 million less any previously repaid amount.

    http://bit.ly/H4wsMq

    So what is that telling you? Anyone care to join the dots? The writing is on the wall, the fix is in. This is how big pharma do business when small fry biotech refuse to play ball. Without ANCHOR approval Amarin are as good as dead. They are going to have a very hard time paying that loan back without ANCHOR revenue. The current share price totally rules out raising cash by dilution as an option.

    The deal will be done by year end or by the end of the first quarter of next year and Pfizer will be unmasked as the mastermind behind it all. You dont get to become the biggest pharmaceutical company on the planet by accident.

    So what is Amarin actually worth? Somewhere in the region of Goldmans Sachs $6.80 price target id say. $7 a share is alot better than the stock price will be next year if JZ continues harbouring fantasies of going this alone.

    Im long this stock by the way and have been for years. I hope im 100% wrong and they get ANCHOR approval in December but that ADCOM farce was the final straw for me.
    Oct 20, 2013. 11:40 AM | 3 Likes Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    I expect Pfizer to make one final offer before year end and Amarin would be wise to accept it. AMRN has already named Pfizer's Lipitor as the statin agent to be patented with Vascepa. There are no shortage of links between Pfizer and Amarin. Declan Doogan was the head of R&D at Pfizer before joining Amarin. Pfizer have the statin, Amarin have the triglyceride lowering fish oil. AZN would not have aquired Omthera if prescription grade fish had no potential. Omthera were aquired for $323 million with additional specified milestones worth $120million bringing the total cost of the aquisition to $443 million.

    Pascal Soriot, Chief Executive Officer of AstraZeneca said: “The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas.”

    So at the very least AZN are definitely interested in the space but with the ADCOM strongly suggesting the REDUCE-IT outcomes study needs to be completed before approval of ANCHOR, Vacepa's clear superiority over Epanova (in terms of safety, efficacy, and the fact they havent even started an outcomes study yet) means it is lagging far behind Vascepa. The Lovaza generic ruling pretty much cancels out Omthera completely.Vascepa also has extensive patent protection and Amarin have already locked up supply of the API. So what is Vacsepa currently worth if Epanova was worth $443 million? There is clearly big potential for a statin Vacsepa combo drug but the only way I can see it realizing its potential is with big pharmas help.

    A buyout of Amarin was always on the table. With the ANCHOR indication approved it is obviously worth alot more than it is without. With its approval Amarin could continue to go it alone but with the odds of ANCHOR approval in December having dropped dramatically after that ADCOM, the only real course of action now available is to sell the company. Dumb longs to believe the SPA actually meant anything. The fact REDUCE-IT is already 75% enrolled is Amarin's saving grace. That's worth potentially a hell of a lot to big pharma down the line.

    Amarin have also shot themselves in the foot with that financing deal to raise $100 million last December. The Company has agreed to repay Biopharma up to $150 million of future revenue and receivables. The first repayment under the agreement is a repayment of $2.5 million of interest due to Biopharma in November 2013, subject to the limitation described below. Additional quarterly repayments are due thereafter in accordance with the following schedule: $2.5 million of interest in the first quarter of 2014; $8.0 million per quarter in each of the next four quarters, $10.0 million per quarter in each of the next four quarters, $15.0 million per quarter in each of the next four quarters and a final payment of $13.0 million due in May 2017. The quarterly repayments through the third quarter of September 2014 represent interest only.

    Except upon a change of control in Amarin, the agreement does not expire until $150 million has been repaid. Under the agreement, upon a change of control, we would be required to pay $140 million, less any previously repaid amount, if the change of control occurs on or before December 31, 2013, or required to repay $150 million, less any previously repaid amount, if the change of control event occurs after December 31, 2013. The Company can prepay after October 1, 2013, an amount equal to $150 million less any previously repaid amount.

    http://bit.ly/H4wsMq

    So what is that telling you? Anyone care to join the dots? The writing is on the wall, the fix is in. This is how big pharma do business. Without ANCHOR approval Amarin are as good as dead. They are going to have a very hard time paying that loan back without ANCHOR revenue. The current share price totally rules out raising cash by dilution as an option.

    The deal will be done by year end or by the end of the first quarter of next year and Pfizer will be unmasked as the mastermind behind it all. You dont get to become the biggest pharmaceutical company on the planet by accident.

    So what is Amarin actually worth? Somewhere in the region of Goldmans Sachs $6.80 price target id say. $7 a share is alot better than the stock price will be next year if JZ continues harbouring fantasies of going this alone.
    Oct 20, 2013. 07:06 AM | Likes Like |Link to Comment
  • Clock Ticks For Amarin As Outcomes Awaited [View article]
    There's no doubt this stock is being manipulated and the market manipulation is facilitated by guys like "PU" - i prefer the letter combination FU or even AF. The first major red flag i saw regarding market manipulation was the day it was announced the FDA had accepted the ANCHOR sNDA for review. The stock should have popped on that news but it actually closed DOWN for the day ( I may be wrong but im almost certain it traded at $6.66 on the news - pretty symbolic number). Patents kept getting issued, zero effect on stock price. BASF and other API suppliers confirmed, stock closes down for the day.

    What is this company worth with just MARINE, the patents, API, cash balance, REDUCE-IT 75% enrolled etc considering OMTHERA went for $550 million? Amarin have to sell the company now. Dont they have some clause in the loan contract that says if they are bought out by Dec 31st 2013 and the loan is paid back in full they dont have to pay the huge interest repayments? I cant remember the specifics.
    Oct 20, 2013. 12:26 AM | Likes Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    The voting question was phrased in such a way that Amarin loses. There was no mistake made. This is a drug worth potentially >$10 Billion annually in the hands of big pharma - NOT in Amarins. Look at the evidence and think about it -the joke that was the ADCOM, the witch hunt against fish oil, the manipulation downward of the share price, no NCE etc has made that clear for all to see. Think about that figure for a minute - $10 Billion. Thats big business and Amarin are going to be denied a free pass and run at it. The fix is in. I hope JZ realizes it sooner rather than later.

    There's a slim chance of course that im wrong and ANCHOR will still be approved in December but based on all the evidence would you bet on it? You'd be mad to. All Amarin have ever been doing is the big pharmas donkey work. Sell it to them and they potentially turn it into a blockbuster. Go alone and the FDA et al will bury it.
    Oct 19, 2013. 10:57 AM | 1 Like Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    Goldman Sachs are clearly in on this big time, no surprise there. The other analysts are a joke and have no clue about whats really going on. Goldman came out with a price target of an insanely low $6.80 pre ADCOM which all longs myself included laughed and jeered about. Thats in and around the region Amarin will be bought out for if JZ finally bites the bullet and decides to play ball with the big boys. With the share price now at $2, a buyout around $7 is all of a sudden a very attractive propostion. JZ continues being stubborn and they will send it down to a $ or under.
    Oct 19, 2013. 09:10 AM | Likes Like |Link to Comment
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