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david22hughes

david22hughes
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  • FDA Rescinds Amarin's ANCHOR Study Special Protocol Assessment Agreement [View article]
    It's a god damn lock Amarin get it.
    Jan 16, 2014. 04:35 AM | Likes Like |Link to Comment
  • OPKO Health's Rayaldy And Fall Prevention In The Elderly [View article]
    "...vitamin D3 is available OTC only"

    That's not true. We can all get vitamin D3 from the sun, naturally. 15-20 minutes/day will give you a nice healthy dose.
    Jan 7, 2014. 11:08 PM | 2 Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    You are missing the point I think. Epanova is a poor man's Lovaza and is years away from being approved and sold. Lovaza is going generic and is a poor man's Vascepa. It raises LDL by nearly 50% and comes with an A-fib warning yet has still been pulling in around $1 billion/year. Vascepa has none of these issues.

    The bottom line is that Vascepa is best in class for lowering trigs in the >500mgs/DL range (MARINE) and is potentially the ONLY drug with FDA approval for treating trigs in the 200-499 mgs/DL range - an indication with an estimated patient population 8-10 times the size of the MARINE indication.

    "...adding a component to EPA or modifying it and then going through the studies would be cheaper than paying the prices you mention."

    That process would require Phase 2 and 3 trials and take a significant amount of time and cash. There's no guarantee it passes the trial endpoints either. Why take the risk and spend all that time when Vascepa is already baked and ready to serve?

    " ....why should they give you more than half of value upfront when they have leverage(cash) and you do not."

    Again, depends on how much they want a drug that has the potential to pull in multi billion $'s annually for many years to come.

    "There is competition it will get higher with Epanova entering, Lovaza(generic entry) comes eventually so there is your party crasher."

    Where are the generic companies going to get the API that Amarin have already locked up? How are generics going to avoid patent infringements? Epanova is many years away from entering this space and as already mentioned is a poor man's Lovaza, never mind Vascepa.

    I admit im not too hot with coming up with a valuation on this company. Would be nice if someone reading this could come up with some figures and write an article on valuation. I admit im pulling the valuation of $2-4 billion from the air but I am basing it on the buyout rumour price of $20 and the fact that the inferior Lovaza went for $1.7 billion in cash.

    Vascepa has extensive patent protection;
    The API supply is locked up;
    It has FDA approval for the MARINE indication and is best in class for that indication;
    Amarin have over $200M in cash;
    JZ is gone;
    ANCHOR is a hairs breath away from being approved;
    REDUCE-IT is already 75% enrolled;

    Can someone come up with a realistic valuation of Amarin with and without ANCHOR and write an article?

    With all the above that they have going for them this has surely got to be worth at least a billion $'s without ANCHOR and up to or even beyond $4 billion with it. The point im trying to get across is that this stock is significantly undervalued and is a screaming buy at $2.
    Jan 5, 2014. 11:09 PM | Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    "Why should those big firms pay for something this firm has no ability to deploy?"

    Kind of obvious really, they can provide the resources Amarin cant to maximize potential revenue. It depends on how badly they want the drug. FDA approved drugs with the safety profile this one has and its potential to pull in several billion $'s annually makes it pretty attractive wouldnt you say?

    "There won't be patent protection for this long term and the ability to actually roll-it out and get a recovery on that capital is very tough."

    That's simply not true. Ive lost track of how many patents they have now protecting it out to 2030 but last i recall it was around 30 and they have something like 30 more pending. They have also locked up the supply of the EPA API with 4 different suppliers. How exactly do you evisage generics crashing the party?
    Jan 5, 2014. 05:48 AM | Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    Yes but why wait another year or two to get your hands on this drug when there is so much potential revenue to be made now - its multi billion $s with the ANCHOR label that we are talking about here. Pfizer and GSK have no shortage of cash on hand to cough up a mere $2-4 Billion. If ANCHOR is not approved big pharma WILL get this for peanuts (about a billion $'s).

    Maybe im a dreamer but I have a strong feeling JZ was forced out and ANCHOR approval is now in the works with the main condition of approval being that the company is subsequently sold post approval. That will have been made crystal clear to the new CEO John Thero. There is definitly something fishy going on with the timing of JZ's departure and the postponement of the ANCHOR PDUFA.
    Jan 5, 2014. 12:14 AM | Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    The REDUCE-IT patient population is estimated to be twice the size of the MARINE and ANCHOR indications combined. It is obviously in big pharma's interests to continue that outcomes study which is already 75% enrolled.

    At $2 a share with insane near term upside potential this stock is a screaming buy. I admit I havent a clue what the buyout price would be, but if Lovaza went for $1.7, Vascepa has surely got to be worth at least $2 billion, and more if they get the ANCHOR label. I cant see how JZ's retirement in the week of the ANCHOR PDUFA and the FDA dilly dallying is anything but positive at this stage in the game. SOMETHING big is going on behind closed doors, im certain of it.

    A $2 billion buyout represents around $11/share with $4 billion then obviously being closer to the $20 buyout rumour price that was being bandied about post ANCHOR phase 3 data.
    Jan 4, 2014. 06:16 AM | 2 Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    Why is no one talking about a buyout? That is precisely where all this is headed.This is potentialy a multi billion $/annum drug in the U.S alone that we are talking about here and I dont think enough people fully appreciate that. The API supply is already locked up and the patent portfolio is staggering. The main stumbling block to big pharma getting their mitts on this drug was JZ. He's outta the picture now, tail between legs and will be lucky to stay out of prison. Anyone fobbing the whole thing off as a 'conspiracy' simply doesnt have a clue about how the medical racket works and how multi billion $ deals go down.

    I have a buddy who was involved with an energy related technology and the CEO was offered a billion $'s to sell it to a 'European Consortium'. He refused and the kangaroo courts subsequently put him in prison for failing to file a form that has a compliancy rate of 0.25% in California. The only other guy ever convicted of the offence had his convction overturned on appeal. JZ was offered a golden handshake to 'retire'. Recinding the SPA was his final warning and thankfully for Amarin longs he finally got the message. Big pharma work very closely with the FDA - they are the FDA. It will have been made very clear to John Thero about what happens next.

    The SPA gets reinstated, ANCHOR gets mysteriously approved with label restrictions about claims of CV benefit, Amarins share price rebounds significantly, hedge funds pour back in and then lo and behold they are bought out by GSK or Pfizer for somewhere between $2-4 billion. GSK bought Lovaza - an inferior drug soon going generic- for $1.7 billion cash and that has been generating about $1 billion in sales/annum for the so called MARINE indication alone (the ANCHOR indication is worth an estimated 8-10X the size of the MARINE indication). Anyone who says big pharma aint interested in Vascepa needs their head examined.

    Amarin will be bought out by the end of March.

    I may be wrong about the above predictions but I have serious doubts about that.
    Jan 4, 2014. 01:38 AM | 2 Likes Like |Link to Comment
  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    I read crap on these investment sites all the time about how big pharma have no interest in fish oil and Vascepa. That is pure nonsence. If it were the case then GSK would not have bought Lovaza and Astra Zeneca would not have bought Epanova. Vascepa is the creme de la creme of fish oil and Pfizer or whoever WILL get their hands on it.

    The fact is that there is zero reason for the FDA not to approve the ANCHOR indication and they know it. The phase 3 trial proved it lowers trigs without raising LDL while having a safety profile comparible to a placebo. The drug met all primary and secondary endpoints and should therefore be approved albeit with a restricted label about claims of CV benefit.
    Dec 22, 2013. 07:34 AM | 3 Likes Like |Link to Comment
  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    It goes beyond that. JZ was the main stumbling block to Pfizer or GSK grtting their hands on Amarin and their asset worth billons of $'s. Think about that - billions of $'s; annually; in the US alone. Big pharma are working closely with the FDA to get this drug just the way they want it, make no mistake about it. Anyone who says big pharma have no interest in a multi billion dollar drug needs their head examined.

    I am certain JZ was told it was in his best interest to leave the company or else the kangaroo courts would put him behind bars. I am not exagerating. He finally got the message and left. Now the doors are wide open for big pharma to get their hands on Amarin and they will work with the FDA to get the precise label they want. The ANCHOR indication WILL now be mysteriously approved but there will be a warning label about unsupported claims of CV benefit. This allows the FDA to cover their ass until results of REDUCE-IT are known. Big pharma will happily continue to fund that trial as it will cost them a mere pittance.

    A deal will be done within the next 3 months. Expect Amarin's share price to rocket from here as the smart money begins pouring back in. $2 is a steal. If Lovaza was worth $1.7 billion, Vascepa is easily worth $2 billion. If you factor in the extensive patent portfolio, the cheap API supply which has been locked up, and the potential to tag this on to a statin, one could argue that Amarin are worth closer to $4 billion with the expanded ANCHOR label. A buyout of $2 billion would give a share price of around $11. $4 billion is obviously double that and closer to the rumour buyout price of $20 that was being bandied about post ANCHOR phase 3 data. JZ wanted to hold out for $30, $40, $100 because he is greedy. He aint around anymore.

    Big pharma WILL get this drug. $2 a share is the best Christmas gift anyone could hope for.
    Dec 21, 2013. 12:38 AM | 3 Likes Like |Link to Comment
  • Amarin: Summarizing The Variables Involved In The Upcoming PDUFA [View article]
    Declan Doogan was the head of R&D at Pfizer before he joined Amarin and designed the clinical trials for AMR101 (Vascepa).

    Lets see what happens to Amarin over the next 3 months. Something tells me that with the announcement of JZ's 'retirement' on Monday that pretty soon we will be reading about a big pharma buyout of Amarin. This drug has the potential to be a multi billion $ drug in the US alone. There arent too many of those knokcing around currently. Big Pharma arent interested?! What are you smoking dude?
    Dec 17, 2013. 10:06 PM | 3 Likes Like |Link to Comment
  • Amarin's CEO Quits On Shareholders And Vascepa [View article]
    Does the timing of this strike anyone as being very odd? The week of the FDA ANCHOR decision? Really? There has to be more to this going on behind closed doors than the public are privy to.

    I say Amarin get label approval for ANCHOR but with restrictions about claims of CV benefit pending results of the REDUCE-IT trial. They will be finally bought out by either Pfizer or GSK within the next 3 months who will fund the completion of the trial and market the ANCHOR indication while they are waiting. JZ was the main stumbling block to a buyout and now he's gone.

    Anyone any idea about what this company is actually worth? When JZ left Reliant and GSK got their hands on Lovaza they paid $1.7 billion in cash. Amarin have to be worth at least $2 billion with Vascepa being best in class, the huge patent portfolio, API supply locked up, REDUCE-IT 75% already enrolled etc
    Dec 16, 2013. 11:18 PM | 2 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    "Anchor criteria were met as you said, but they were wrong."

    Who set the criteria? The FDA. It's their mistake, no-one elses. Why should Amarin and its shareholders suffer because of incompetency within the FDA? Amarin did EVERYTHING required of them with a substantial amount of cash and time invested.
    Nov 27, 2013. 11:39 PM | 2 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Dont be surprised if the ANCHOR indication is approved in December with the same 'WARNING AND PRECAUTIONS' label pertaining to the fact that "The effect of Vascepa on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established", just like it has been for Lupin's Antara fenofibrate drug.
    Nov 27, 2013. 11:36 PM | Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    So what changed between then and now? The ACCORD-Lipid, AIM-HIGH, and the HPS2-THRIVE studies have no bearing whatsoever here. The ONLY study of ANY relevance to this particular drug (Vascepa) and its mechanism of action is the JELIS study and even that has its shortcomings.

    The acceptance of the sNDA for ANCHOR was based on Vascepa meeting its predefined safety and efficacy endpoints and the REDUCE-IT outcomes study being 'substantially underway'. ALL CRITERIA WERE MET. It would be criminal to reject the ANCHOR indication at this stage.

    I completely agree that until REDUCE-IT is completed, if ever (it is insane to deny the company label expansion and deprive them of potential revenue which would help its continued funding and completion), claims of CV benefit cannot be included on the label. What the drug does is lower triglycerides without any side effects in the 200-499mgs/dL range. The FDA should approve the drug for the ANCHOR indication because its is safe and does what it is supposed to do. Whether or not it reduces serious CVE's has yet to be determined. There is 'inferred evidence' but nothing conclusive. REDUCE-IT will go a long way to clearing the whole thing up. For now, both MARINE and ANCHOR should be approved but with label restrictions about claims of CV benefit. That is fair all round.
    Nov 27, 2013. 05:17 AM | 1 Like Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Anyone care to enlighten me as to why the ANCHOR trial was conducted in the first place if lowering trigs in the 200-499mgs/dL range is deemed to be of no CV benefit?

    How can the goalposts be moved after the agreed upon safety and efficacy endpoints were met?

    Who reimburses Amarin for the millions of $'s and time they invested in performing the trial if the ANCHOR indication is not approved?

    I
    Nov 27, 2013. 02:00 AM | Likes Like |Link to Comment
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