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david22hughes

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  • Amarin: The Silence Of The Lamb [View article]
    How can the FDA have the cheek to "urge" Amarin to continue the R-IT study after rescinding the ANCHOR SPA and denying multiple appeals??

    How can Amarin then turn around and announce their full commitment to R-IT after being completely screwed over by the FDA??

    Amarin will likely have to spend every cent it has remaining just to get to Interim data. The whole point of getting R-IT 50% enrolled was so that ANCHOR would be approved, and Amarin could market that indication, and the increased revenue from the expanded indication would offset the remaining cost of R-IT.

    If the FDA are not going to approve ANCHOR they have got to offer some sort of incentive to Amarin to continue with R-IT. The incentive, as you say, may very well be the "ability to market" ANCHOR ie the FDA allowing the trial data on the label
    Dec 3, 2014. 09:54 AM | 1 Like Like |Link to Comment
  • Amarin's Value With Or Without REDUCE-IT And A Final Word On Management [View article]
    Cheers for the info.

    Yeah Royalty Pharma seem to have very close ties with big pharma. Check this out: http://bit.ly/1nMbt5b
    Its like a big pharma who's who. Very cosy indeed.

    "Over the years we have had a simple and consistent strategy – invest in leading therapeutics, typically billion dollar blockbuster products, addressing critical care indications or serious medical conditions and marketed by leading companies."

    Pharmakon seem to be a little sister - a bottom feeder, scavenger type operation that stand to make a lot of cash should Amarin go bankrupt as they effectively now own Vascepa and the IP that protects it out to 2030. The guys you mention all have major ties with the big investment banks. No surprise there.

    Are they benevolent? Well, im certain that they will do everything they can to maximize return on their $100M investment. Vascepa is a valuable asset. They stand to make $50M in interest payments as a bare minimum, potentially a hell of a lot more should Amarin go bankrupt. It's a win win investment for them.
    Oct 28, 2014. 05:36 AM | 1 Like Like |Link to Comment
  • Amarin's Value With Or Without REDUCE-IT And A Final Word On Management [View article]
    I know about the terms of the Amarin loan and im familiar with Pharmakons other loans. Im after specifics about the company itself, its management team, its history, that sort of thing. I dont have the time to go digging myself but I see the CEO Pedro Gonzalez de Cosio was VP at JP Morgan and Director at Deutsche Bank.

    http://linkd.in/10uE1Gd
    Oct 27, 2014. 01:11 AM | Likes Like |Link to Comment
  • Amarin's Value With Or Without REDUCE-IT And A Final Word On Management [View article]
    I do own stock and I plan on selling it hopefully post positive R-IT interim data. They have enough cash on hand to make it to then thaks to the $100M loan but I don't have enough faith in the FDA to continue holding the stock beyond that. I have my suspicions as to who Pharmakon aka Biopharma aka Biopharma Secured Debt Fund II Holdings Cayman LP represent based on their previous dealings, but I can't find any specific details, which is why i'm asking on the off chance someone could provide me with them.

    "To secure its obligations in connection with the agreement, Amarin granted Biopharma a security interest in its patents, trademarks, copyrights, know-how and regulatory filings, submissions and approvals related to Amarin’s lead product, Vascepa® (collectively, the “Collateral”)."

    http://1.usa.gov/1xqeGYb
    Oct 26, 2014. 01:57 AM | Likes Like |Link to Comment
  • Amarin's Value With Or Without REDUCE-IT And A Final Word On Management [View article]
    Who exactly is Pharmakon? Are they effectively running the company?
    Oct 25, 2014. 09:26 AM | Likes Like |Link to Comment
  • Amarin's Value With Or Without REDUCE-IT And A Final Word On Management [View article]
    Thanks for the reply. At the current share price a BO has no chance of happening but the company is significantly undervalued so the stock price should/could recover. Marine, ANCHOR, R-IT 87% enrolled and the 40 patents are effectively currently being valued at less than $50m (Mkt Cap $184M;Cash $137M). The company is currently easily worth $7/share.

    There is a way BP could get the drug on the cheap if they really want it before interim data. An activist hedge fund such as Camber Asset Management who already own 11,000,000 shares at last filing, purchased at around $1.75, could accumulate enough voting shares (5%) and put a vote to the shareholders to oust the current management and then hand pick a BP friendly management team that would then sell the company to them for around $7 a share. Stock prices are heavily manipulated by Wall Street so it wouldn't be any issue getting the stock back to around $5 before the BO. If that happens it will happen by the end of Q1 2015 at the latest. I dont think its as far fetched an idea as people might think. Buying the company now rather than post home run R-IT data makes perfect economic sense. If BP want it near term they WILL get it but maybe they are content to wait until interim data is known before making their move. The likes of Pfizer have no shortage of cash. $5B is pocket change to them.

    So that then makes R-IT the mother of all biotech binary events with upwards of $5B riding on it. Buy your tickets early folks and come along for the ride! (As an aside, Dendreons stock price absolutely rocketed from $4 to $56 after its outcomes study proved Provenge worked and was safe. Dont be surprised if Amarins stock price see's similar action. What happened after the highs is another story, and Vascepa may have a similar fate, but as a trade between now and the release of the outcomes study data I doubt there is any stock out there offering a more attractive risk/ reward).

    Cheers,enjoy the weekend.
    Oct 24, 2014. 01:20 AM | 4 Likes Like |Link to Comment
  • Amarin's Value With Or Without REDUCE-IT And A Final Word On Management [View article]
    Thanks for the article. One point of clarity - the collusion with Kowa is a co-promotion deal and not "a partnership" as you state. An opportunity for a partnership with BP is still a possibility albeit a slim one in my opinion.

    What are your thoughts on a buyout before R-IT interim data? That also remains a possibility. R-IT is where the big money is potentially and BP know this very well. By buying Amarin out within the next 6 months or so they would be getting Amarin on the cheap. The company would be worth a hell of a lot more with efficacy data anywhere near as good as JELIS.

    As you state, there is a high probability R-IT will be successful. There are countless studies relating to the benefits of EPA, not least the JELIS sub-group representing the R-IT patient population that demonstrated a massive 53% reduction in major adverse cardiovascular disease when compared to a statin alone. The control arm for that trial was a statin alone so it is highly probable that EPA supercharges statins.

    The control group for R-IT is a statin + 4g of mineral oil / day. Mineral oil is a waste product from the crude oil refinement industry. It is pure gunk and certainly not the kind of stuff patients with a high risk of heart failure should be taking 4g/day of every day for 4 - 6 years or until they drop dead. I dont see how taking 4g of mineral oil will do anything other than hasten their demise. Mineral oil is the stuff in Johnson's Baby Oil. I have a 125ml bottle beside me. Would you consume 1 bottle of that/month every month for up to 6 years??? The FDA approved it as a placebo. What a joke. Meanwhile, EPA will be doing the job in the other arm of the trial, reducing arterial plaque and inflammation, as patients begin dropping like flies in the control arm, and the trial will be stopped early due to efficacy and safety concerns with the control arm.

    Interim data is expected in H1 2016 but I suspect we will get it far earlier than that, maybe even by this time next year.

    However you slice it the stock is a steal at a $1 with massive upside if R-IT is a home run.
    Oct 23, 2014. 01:45 AM | 6 Likes Like |Link to Comment
  • Amarin: REDUCE-IT And Debt Analysis Confirm That The Current Share Price Is An Opportunity [View article]
    Thanks for the numbers. Makes a mockery of the current $1 share price and confirms beyond any doubt that the stock is very much undervalued. (Even your worst case scenario price target of $1.69 represents a very nice gain from the current price).

    My one criticism would be that you have failed to provide any realistic probabilities for the scenarios you mention actually playing out. The fact is that scenario 1 has an excellent chance of success - far higher than 50%. 50% represents a total crap shoot.

    As you mentioned, in the JELIS subgroup of patients that are currently being studied in the R-IT trial, major adverse cardiovascular events were reduced by a massive 53% - and that was on a 1.8g dose of EPA. Patients in the R-IT trial are on 4g/day - more than double the dose. 957 patients were studied and the p value was 0.043. You would have to conclude that R-IT has an excellent chance of success and will succeed just as MARINE and ANCHOR did. R-IT is where the real value in this company has always been. We are talking about a multi billion market opportunity here.

    Obviously what the company needs to do now is aggressively drive script growth so they have sufficient cash to make it to REDUCE-IT interim data in Q2 2016. I suspect they will be bought out on the cheap long before then.
    Oct 9, 2014. 09:28 PM | 1 Like Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    Right on cue.........http://bit.ly/1s6PdkT
    Jul 31, 2014. 09:53 AM | Likes Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    Thanks for the reply. Just to address a few of your points....

    "These four things should tell you without a doubt that no appeal will be granted by the agency."

    I wouldn't be so cock sure of yourself. Ive held stock in this company for 6 years and have personal emails with Thero dating back to 2010 when he was the CFO. I was just as cock sure of a vote for approval of the sNDA before that dog and pony ADCOM show as you are now. The FDA isn't bound to the ADCOM votes in any way shape or form. To quote that guy who was an FDA drug reviewer in CDER from 1998 to 2008 in the article i cited above:

    http://bit.ly/1jxvGo1

    "While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees."

    Jenkins is the CDER director as you are aware and it is he who will ultimately decide the future of Vascepa and ANCHOR.

    All im saying is this aint over til the fat lady sings. I see no good reason at all for the FDA NOT to approve ANCHOR as a treatment for lowering high trigs. That was the purpose of the trial in the first place. It had nothing whatsoever to do with reducing major adverse coronary events. That is the whole point of the REDUCE-IT SPA and is a completely separate issue.

    "Many people, probably including you say; wait till the appeals process has concluded (2016?) and then file a 1st Amendment appeal."

    As I said above, i dont see this ever making it to the courts. The whole thing is too farcical. In any event, the most recent guidance from Thero indicated that if they are unsuccessful at this level of appeal they would go straight to the courts and would expect a ruling by the end of this year. I have no idea where you are getting 2016 from.

    "And yes, the time for pessimism is already here but for you that time is coming my friend."

    That sentence is cocky and patronizing plain and simple. We'll know who's correct soon enough. One of us has this spectacularly wrong. I'm quietly confident.

    Anyone heard from Fueurstein lately by the way? His silence on all this is deafening. You couldnt shut him up from bashing Amarin for love nor money until the stock bottomed out recently.
    Jul 27, 2014. 08:45 AM | Likes Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    How am i saying 2 different things? A delay is not the same thing as an official rejection. Im a glass half full kind of a guy. Until i see an offical rejection of the ANCHOR sNDA i will remain positive on its chance of ultimately being approved in some form. The ANCHOR sNDA was never actually denied. In Dec 2013 the PDUFA date passed WITHOUT an FDA decision -if anyone needs a refresher on the sequence of events have a look at page 15 of this: http://bit.ly/1pgkdhn
    The irony of course is that the PDUFA process is supposed to speed up drug approval. "The FDA estimated that a delay of one month in a review’s completion cost its sponsor $10 million." http://bit.ly/1pgkDV1 7 months later and still we wait.

    The appeal process is coming to a head. If denied at this level of appeal (i cant see it happening for reasons cited above) then its time for pessimism and 1st amendment talk. The problem with a denial at this level of the appeal is that it bodes horribly for the chances of REDUCE-IT ever getting approved and that would have knock on effects for AZN and the massive outcomes trial they are undertaking for Epanova. Everybody loses. Amarin, any BP with aspirations of owning Vascepa, the FDA, AZN, the patients who are denied access to the drug....why on earth would you allow that to happen when everyone could be a winner so easily?
    Jul 25, 2014. 05:53 AM | Likes Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    The FDA is waaaaaaaaaaaaay beyond being influenced by articles on seeking alpha, believe me. Do you have any idea of how corrupt and connected the FDA is?

    I said nothing about the FDA not wanting Vascepa on the market. All im saying is that this delay (the ANCHOR trial results were released April 2011! http://bit.ly/wjlBMV) suits certain parties down to the ground. That cant be denied - the FDA Commissioner's husband is co-CEO of a company that runs 4 hedge funds! As corrupt as the whole thing is and these people are, they are not stupid. The aim of the game is to make boat loads of cash and they are very well versed on how to do it.

    I have to disagree with your statement about "large pharma profits lost to suddenly healthy people." That just simply isnt true. Vascepa CURES NOTHING. It is a treatment. It may reduce major adverse cardio events by say 15-30% but so what? That's hardly earth shattering stuff.

    People want pills for ills. The vast majority have no interest in taking responsibility for their health and leading more healthy lifestyles with plenty of exercise and a diet rich in fruit, veg, naturally sourced EPA etc. THAT is the key to reducing and eliminating heart disease but whisper it gently. Depending on what company you keep your audience may be very easily offended by statements like that.

    BP stand to make a killing with Vascepa and the way they will do it is simple.The ANCHOR indication and treatment for high trigs is Vascepa + a STATIN - IT IS NOT VASCEPA ALONE. People do not get this. This means statins, the best selling drugs in the world will get a new lease of life at a time when they are going generic. That is huge for BP such as Pfizer and AZN who already have leading statins. Why do you think AZN bought out Omthera? I remain adamant Pfizer will own Vascepa sooner rather than later.
    Jul 25, 2014. 03:45 AM | Likes Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    My 2 cents for what its worth....

    I cant help but feel you are being very premature with an article like this discussing the 1st amendment when there is still a VERY good chance some form of compromise will be reached at this level of appeal within the FDA. I personally wouldnt be surprised to see the sNDA approved in full but expect the FDA to meet Amarin in the middle and allow them to include the ANCHOR trial data on the prescription label so they can market the drug to patients with high trigs between 200-499mgs/dL. There will be a black box style warning pertaining to the REDUCE-IT outcomes study and how as of yet there is no definitive proof that lowering trigs leads to a meaningful reduction in major adverse cardiovascular events.

    The director of the Office of New Drugs is John Jenkins. This is a division of the Center for Drug Evaluation and Research (CDER) and is the level of appeal within the FDA that Amarin are currently at.

    http://1.usa.gov/WGECTq

    Listen to this interview with Jenkins: http://1.usa.gov/WGEBii

    "It’s very important for people to understand," says Jenkins, "that we don’t know everything about new drugs at the time we approve them…. [I]f we waited until we knew everything you could possibly know, then the wait would be too long, and patients would be denied access to important new treatments."

    Now, read this from a former CDER employee: http://bit.ly/1jxvGo1

    "While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees."

    It makes absolutely zero sense for the FDA to deny approval of this drug as anyone following the story knows full well.The drug met all primary and secondary endpoints and is as safe as a placebo.By having REDUCE-IT 50% enrolled the sponsor met all requirements necessary for the acceptance of the sNDA. It should have been approved, no questions asked.

    So why did Amarin get stone walled at the ADCOM with a bunch of nonsensical crap relating to 3 other outcome studies that have essentially no bearing on Vascepa whatsoever? Who did the delay benefit?

    The delay benefited GSK. It allowed them to reap the final few hundred million $'s from Lovaza as it went generic. Amarin simply dont have the sales force to compete with GSK.The deal with Kowa is about the best they could do and we will only see the full impact of that deal in late Q4, start Q1 2015.The delay prevented Amarin from ever really gaining much of Lovazas market share.

    The delay also benefited Peter Brown who is married to the FDA's Commisioner, Margaret Hamburg. Peter Brown is co-CEO of Renaissance Technologies.Renaissance Technologies runs four hedge funds.The Medallion Fund is their "private fund".The Medallion Fund FAR outperforms not only the other Renaissance funds, but most funds overall; in 2008, the Medallion Fund returned 80%, while the other funds struggled or crumbled.

    http://bit.ly/WGECTr

    This is NOT a conspiracy theory, these are facts.

    Amarins is a one drug company. Any delays were likely to have a significant impact on the share price. Hedge funds and market makers were very well placed to make a killing by shorting this company all the way down to where it is now at a $ and change. And with a surprise approval of ANCHOR they are very well placed to make a killing once again by going long. The collapse in share price also prevented Amarin raising additional cash by dilution and going this alone. This plays nicely into the hands of big pharma.

    I will be amazed if Vascepa doesnt get approved at this level of appeal. The FDA doesnt have a leg to stand on in court and aside from that, this drug is simply far too lucrative an opportunity for a BP like Pfizer or GSK to pass up - the combined market potential of Vascepa is estimated to be close to $80 Billion- in the U.S ALONE! Think about that for a minute........its Billions, not Millions we are talking about.

    We should all know within a couple of weeks what the deal is.
    Jul 24, 2014. 11:04 PM | 1 Like Like |Link to Comment
  • Amarin Scrapes The Bottom Of The Barrel [View article]
    I have found that the best ploy when presented with a Quoth the Raven article is to skip the whole thing and just scroll down to the comments section beneath. Far more wisdom contributed there than Quoth the Raven will ever contribute.

    I just stumbled upon this interview with Rick Harrison re Vascepa if anyone is interested: http://bit.ly/1pZc81q
    Jun 28, 2014. 12:43 AM | 4 Likes Like |Link to Comment
  • Opko: Ignore The Commentary And Focus On Numbers [View article]
    Does anyone know if Rayaldy is likely to qualify for NCE?

    I find it very difficult to bet against a self made billionaire. At worst I can see the share price doubling from current valuation. Not a bad buy and hold for a while methinks.
    Feb 19, 2014. 04:39 AM | 6 Likes Like |Link to Comment
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