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Mr. Rosenman has nearly 15-years executive experience in the health and wellness sectors, including weight loss, cosmetics skincare and nutrition, both Rx and OTC. Expertise areas include strategic market and product planning and corporate development (evaluation, recommendation and execution of... More
  • SIGNIFICANT AMRN DEVELOPMENT--PT CHANGE 44 comments
    Jul 16, 2013 9:55 AM | about stocks: AMRN

    Amarin was given notice of allowance for a very important patent - 669 that protects the Anchor population against other Rx. It also would provide legal protection, should Amarin want it against OTC products. This determination comes far earlier than expected and without further back and forth with USPTO. The bottom line is that no formula containing more than 4% DHA can participate in Anchor - meaning no other Rx, including Epanova. Amarin will be the only one to address the market, and the patent goes out beyond the current 2030 date on AMRN's other IP.

    Because Anchor approval is around the corner, I am increasing my price target to $35, BD talks and BO should conclude before or shortly after FDA approval of Anchor.

    Stocks: AMRN
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Comments (44)
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  • Give me a break. $35? You mean more than $6B market cap, really?
    16 Jul 2013, 10:32 AM Reply Like
  • Does this bring AZN as a suitor back into play, or did you consider them never out of play?
    16 Jul 2013, 11:25 AM Reply Like
  • Author’s reply » REALLY, and that is conservative. Its a $8-11B company in 4 years.
    16 Jul 2013, 11:24 AM Reply Like
  • Author’s reply » They were never out of play for me, although more unlikely than others given CEOs goal to do acquisitions that are smaller and bolt-on <$1Billion
    16 Jul 2013, 11:35 AM Reply Like
  • Steve, any thoughts on rumblings that anchor may get delayed? nice to see you getting excited again and keeping us longs informed.
    16 Jul 2013, 11:45 AM Reply Like
  • steve, i still dont understand why with this strong patent getting allowance we are still down today. any thoughts?
    16 Jul 2013, 11:45 AM Reply Like
  • Here's the thing. In April 2011 when Anchor data was released the stock was $16 and everyone from Investors to WS saw the potential of the Anchor market and AMRN was valued as a $8-$10 Bill company in the future. Keep in mind we were 1 year away from Marine approval and 2 years away from Anchor at that time.
    So now when the company is selling scripts at a good rate, Has 25 patents, Tier 2 Ins, 190 m covered under MC and 5 months from entering the Anchor market etc etc, people all of a sudden DO NOT see the SAME THING.. HOW is that logical..
    Oh yeah I know, bc you chose to believe the AF's of the world, and get emotional over the stock price..
    It's about facts my friends.... And regardless of stock price, if you think AMRN has accomplished what they have in the last year and BP values them less or is just not interested anymore YOU can NOT BE MORE WRONG!!
    Just look at July 9th AGM Presentation Page #4. If you think that justifies a $5.60 stock and a $800 mill mkt cap, then you shouldn't be investing at all... NOt just in AMRN..
    Harsh maybe, but the truth... Sorry to those offended..
    16 Jul 2013, 12:07 PM Reply Like
  • Agree with most of your points and that Amarin is clearly a valuable asset. However, where does $35 PT come from and where is the analysis to support it? If it's worth more than $8B, is the PT > $50? Claims should be substantiated. Without supporting analysis, you're guessing...
    17 Jul 2013, 06:13 PM Reply Like
  • thanks for the follow up,,,, and I agree,, the pps has nothing to do with the real value of this company,, and most people here will probably have a heart attack when the 400% comes rolling in or mabey higher.. I just think to myself,, took a little time,, smiling all the way to the bank.. thanks mr pearson
    17 Jul 2013, 06:15 PM Reply Like
  • Author’s reply » read my prior articles and catch up...thanks
    17 Jul 2013, 08:03 PM Reply Like
  • Where can I find this AGM presentation?
    17 Jul 2013, 09:33 PM Reply Like
  • On AMRN website under IR Events and Presentations. At the bottom of that page you will find it.
    22 Jul 2013, 01:55 PM Reply Like
  • Steve, I will have my mouth open and hope we get into the double digits prior to Anchor pdufa date !
    16 Jul 2013, 05:03 PM Reply Like
  • July 9, 2013 commentary pertaining to Steve Rosenman's "It's All About ANCHOR" instablog:

     

    Maiwat Comments:

     

    "Steve, no disrespect intended, but please stop quoting your "sources" and please stop with the $28-32 BO. The info your "sources" have given you has yet to pan out. We've heard AZN, GSK, PFE, etc., etc. Maybe it's true but me thinks these companies will wait until AMRN is on its knees gasping it's final breath before they act. Either that or they will just purchase the patents from the mafia loan sharks when AMRN defaults.

     

    You do a good job discussing the drug and the market it serves. If you do this, you will go a long way in helping people see the potential. But please leave your prognostications out of your analysis."

     

    Pirateescapee Comments:

     

    "Unless you can verify the story, sources and facts, I wouldn't print stuff like this.......not even in a blog."

     

    Steve Rosenman Response:

     

    "Just like I've stopped guessing at NCE timing, Im going to stop guessing about what he heck mgt is up to...just sticking with fundamentals of drug and the market it serves."

     

    Thank you for the patent 669 update but It's been barely a week and you're back to your unsubstantiated price target and buyout talk. I'm long Amarin, see value in the Vascepa asset, and hope for significant price appreciation. However, could you please stick to the fundamentals and provide objective, balanced, and substantiated analysis!

     

    Thank you
    16 Jul 2013, 05:03 PM Reply Like
  • Author’s reply » hipfreejazz - you can do whatever you want on your blog, i'll do what I want on mine.
    16 Jul 2013, 09:26 PM Reply Like
  • Author’s reply » Anchor will not be delayed.
    16 Jul 2013, 05:03 PM Reply Like
  • Can someone please clarify this patent for me?

     

    The way I'm reading it, claim #1 of this patent covers a method for lowering trigs in the Anchor trig range, with a treatment comprising of EPA and no more than 4% DHA. In other words, I read this to mean if anyone else tries to serve this patient group with pure EPA and <4% DHA, it would infringe this patent, because that would contain "not more than" 4% DHA. However, if someone would be able to adequately serve this group with EPA and 5%+ DHA, then it would not infringe this patent. I think the "not more than" has confused some people, myself included. I don't recall specifics of many of Amarin's other patents, so maybe I'm focusing too closely on this one patent. Also could just be missing the bigger picture in general. Thanks.
    16 Jul 2013, 05:04 PM Reply Like
  • Author’s reply » It means no product can have more than 4% DHA (pure EPA). So if you have 5% you infringe, get it?
    16 Jul 2013, 09:25 PM Reply Like
  • Steve,

     

    That is how I originally read it, and hope that is what it means. I am by no means great with patent/law terminology, so my brain spins in circles sometimes when I try to fully grasp this stuff. But I keep thinking about it as "not more than" is essentially synonymous with "less than or equal to". In this case the patent would read, "...pharmaceutical composition comprising about 4g of ethyl-EPA and less than or equal to about 4% DHA or its esters, by weight of all fatty acids present." Therefore, 4g EPA (pure EPA) with less than or equal to 4% DHA is what they are patenting. For example, making 4g EPA with 5% DHA a non-infringing composition. Obviously in this instance, the treatment would still need to get past other Amarin patents and not raise LDL-C to stand a chance. Once again, maybe I am missing something by focusing too closely on that one sentence.
    17 Jul 2013, 02:22 AM Reply Like
  • "However, if someone would be able to adequately serve this group with EPA and 5%+ DHA, then it would not infringe this patent. I think the "not more than" has confused some people, myself included."

     

    Don't get stuck on that single claim - has to have > 4% DHA *and* not increase LDL-C.
    16 Jul 2013, 05:26 PM Reply Like
  • First this patent builds the "oblivious" wall. If you would like to patent you 2 Gram 50% EPA and 10% Epanova could you?

     

    No, it's obviously prior art.

     

    Second, could a product that has 50 % EPA and 10% DHA be sued if it sold to treat 200 to 500 levels?

     

    Yes

     

    2 grams of Epanova 50% EPA & 10% DHA is 200 mg of DHA

     

    4 gram dose of 5% DHA the rest EPA contains 200 mg of DHA. Epanova would infringe on this NEW patent in the Anchor indication. Kinda sucks for AZN, unless they end up with Amarin.

     

    Hope that sheads some light.

     

    Bio
    16 Jul 2013, 06:18 PM Reply Like
  • Gotcha. So even though the LDL-C language was amended (removed) from the allowed patent, it is still essentially in effect since not increasing LDL-C is an automatic FDA requirement for approval to serve this population? Basically, as long as 5%+ DHA is enough to negatively effect (increase) LDL-C, this patent essentially blocks all other O3 drugs from this indication. Is that the key takeaway? Is there any data that reassures us that a DHA concentration as low as 5% raises LDL-C (statistically significant)?

     

    If I remember correctly, Amarin has patents for 90%+ EPA. Therefore, if a drug happened to be 89% EPA, 5% DHA, and 6% filler and manages to not significantly increase LDL-C, would it circumvent this patent? Not trying to piss anyone off, but I'm just trying to play devil's advocate here to get a good grasp on significance/strength of this patent. Thanks.
    16 Jul 2013, 08:49 PM Reply Like
  • Amarin is at $5.53 as of today. Your price target of $35 is a 532% premium from today's price.

     

    You state "BO should conclude before or shortly after FDA approval of Anchor." Why do you continue to put out time-based predictions? They don't work, especially with this stock. I don't get it. You did the same thing last year after Vascepa was approved for the >500 TGs indication. You stated BO was going to happen within the next few months, and it would be as easy as printing money. Look what happened Steve. Went from $16 all the way down to $9 in December with the financing, which you were SURE wasn't going to happen, and then now we're at $5.

     

    Seriously, give me a reason as to why myself and everyone else should lend credibility to your assertions this time?

     

    Don't delete my comment. Let's have an actual discussion.
    17 Jul 2013, 12:24 AM Reply Like
  • At current levels even 19$ or 16$ sound crazy and theoretical, yet it did trade for that, not that long ago. so with BO, in this crazy sector... when you work out where to draw the line, your guess is as good as mine
    17 Jul 2013, 08:50 AM Reply Like
  • Seriously, everyone has an opinion. Some of them are right, some of them are wrong. They put out a guess and an estimate. Do they have to answer to everyone when it doesn't happen. As for giving a reason why anyone would lend credibility, is it not enough to tell you that if you don't like the guess or estimate, use your own?
    17 Jul 2013, 01:33 PM Reply Like
  • Shandal, BO will be at least $35, which should happen by the beginning of Q1'14. Too many big pharma's are in desparate need of a blockbuster like Vascepa to generate significant immediate and long-term revenues. Piss-ant bolt-on acquisitions, like AZN's BO of OMTH, do not fit the bill.

     

    Consider AMRN's assets:

     

    1) Vascepa 2) Patent Portfolio 2) MARINE 3) Probable ANCHOR indication 4) Combo Product in Dev't 5) Supplier Lock-up.

     

    What is the value of AMRN if REDUCE-IT results are positive? IMO, they will be.

     

    Are you arguing that AMRN isn't worth at least a $35 BO price?

     

    If BO doesn't happen, it's BP's loss, and our long-term gain.

     

    17 Jul 2013, 06:09 PM Reply Like
  • Author’s reply » If you need to ask me that, then your comment may be deleted...
    17 Jul 2013, 06:12 PM Reply Like
  • Steve, we are only talking about US market.

     

    Do you know if there is any kind of approach or interest to European market ? I suppose that they cannot going into alone to that market ( or others possible huge markets like Mexico or Brazil) , but I think AMRN has any patent granted so that can tell us something. After all Amarin is an Irish company.

     

    As european I am, I'm very interested in Vascepa and I hope we can see it in our pharmacies sooner than later.

     

    Thanks in advance
    17 Jul 2013, 06:23 AM Reply Like
  • the doc linked by certain tweets on the subject contains amendments to 13/403,699 application.

     

    http://bit.ly/12wkxeJ

     

    Covers compostions comprising about 4 gram ethyl-EPA and not more than about 4% DHA.

     

    repeat; protected Compositions NOT MORE than 4% DHA.

     

    Where is the 'OVER 4% DHA infringes ' argument coming from ?
    17 Jul 2013, 09:49 AM Reply Like
  • I see it the same way you do, PWT.....if it has more than 4% DHA it doesn't infringe....and nobody has focused on what might be the most important wording "by weight of all fatty acids present"...so it must contain ~ 4g ethyl EPA, < 4% DHA as % of all fatty acids present to infringe. Don't see how Epanova violates the patent:

     

    "Epanova contains EPA and DHA in their free fatty acid form at a total concentration of 50-60% EPA and 15-25% DHA along with other potentially active omega-3 fatty acids"
    17 Jul 2013, 04:36 PM Reply Like
  • That is how I see it. You have to have more than 4% DHA in order to treat it, it protects Vascepa from 96% EPA 4%DHA. e.g. Has to be 95% and 5%.
    17 Jul 2013, 06:00 PM Reply Like
  • Author’s reply » If you have 4 gram epa with 4.1% dha, you infringe.
    17 Jul 2013, 06:13 PM Reply Like
  • pwt750, my thoughts as well. See my above comments and others' responses for additional discussion. It would still be a good patent, just not as encompassing as blocking anything greater than 4% obviously.
    17 Jul 2013, 06:13 PM Reply Like
  • So, can you have 4 gram EPA with 3.9% DHA?
    17 Jul 2013, 07:11 PM Reply Like
  • I couldn't agree more mr. steve,, current pps as nothing to do with the value of this company,, its product,, or the market potential of this product,, when the pps pops up 500%,, 600%,, most people will have a heart attack,, not me,, ill pause,, and say that it took a little time,, and smile all the way to the bank,, retirement will come 2 years closer,, Mr. Rosenman thanks for your very insightful articles,, amrn, arna, long and strong
    17 Jul 2013, 06:15 PM Reply Like
  • Author’s reply » You are only referring to amendments. Body can be interpreted more broadly to include EPA preparation not using more then 4% DHA. So if you have a substance that is 50-60% EPA (around 4g or not) and >4% DHA, it can be argued for infringement.

     

    This is a composition patent, so it can be argued that an amount less than or more than 4g of EPA is subject, as it is not specified other than by listing 'around'. The general art of composition is the EPA treating the specified indication, with no presence DHA properly defined >4% limit. If you are interpreting this as 4g is a requirement and that would be the limit to AMRN, I do not believe you are interpreting this correctly. The amended wording is actually quite clever and allows for a broad interpretation. I know the law firm that constructed this, and its no surprise to me how crafty and smart this was worded.
    17 Jul 2013, 06:16 PM Reply Like
  • thanks , definitely still reading it all, I posted the above link since I wasn't able to link the whole file/docs available on

     

    http://1.usa.gov/XyzXN0

     

    but on the 7/16/13 Notice of Allowance, Fees Due > Detailed Actions (Examiner's Amendments) it seems pretty clear they are talking about ethyl-EPA with no more than 4% DHA, and the APO-B, LDL-C reduction at 4gm/day was the non-obvious (and clinically significant) result the allowed the pat issue.

     

    Appreciate anyone setting me back on course but where is the hole in that doc ? What is the better doc to read ?
    17 Jul 2013, 06:57 PM Reply Like
  • Interesting note by Jeerio on ST. His fund contact actually called him and discussed some info shared by sales rep. According to him, FDA is allowing AMRN to include the Anchor study and the Jelis study in their conversations with docs. They cannot of course encourage off label use but can at least include these studies in their presos now. Walking a fine line as sales rep but if true should mean A adcom should be a shoe in and preps the docs for the anchor launch even though A is primarily focused on Prim Physicians.
    18 Jul 2013, 10:47 PM Reply Like
  • Author’s reply » appreciate the info as I have not seen this, but I would be careful. not sure this makes sense to me, so would not trade based on it. if true, obviously would be positive. keep in mind, it is very different for fda to accept a courtesy letter for marketing communication intent, vs. give approval to allow other label use.
    19 Jul 2013, 09:25 AM Reply Like
  • The original poster is a little off on what was stated. The FDA OK'd mentioning Anchor data on label once REDUCE IT was 50% enrolled so that is nothing new as has been 50% enrolled since launch. The NEW info was that they could also mention JELIS Study dats starting in August in sales calls as this was prohibited before.
    There is NO mention of approval to sell to another indication but more related to marketing communication intent.
    Original note on this below:
    rec'd call from fund source with ++ co sales contact, FDA has approved company use of A + JELIS results for sales calls beginning in August this is potentially huge in relation to sales and the run to Anchor allows company to warm up the space well in advance. Also, word was that PFE definitely in the mix for a deal. but the FDA part was presented as hard fact. as was relayed to me, co can use A + JELIS data soon. whether that turns to off-label is docs choice i suppose. seems like a left-field out of blue thing, but trust me, this guy never calls me. i call him. so this was notable.
    19 Jul 2013, 10:25 AM Reply Like
  • Author’s reply » where is a new indication referenced? I would not count on 'fund source' information.
    19 Jul 2013, 11:27 AM Reply Like
  • I wish you could explain all this 4% EPA DHA to the market makers, so maybe they are kind enough to start a PPS runup instead of stabilizing it around 5.60...
    17 Jul 2013, 07:16 PM Reply Like
  • statement below was in the CDER Med Rev for Marine. I have been wondering where the results were, unless "at minimum" refers to more than enrollment, or if a Med Review had pull enough to effect this.

     

    "This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached."

     

    http://1.usa.gov/ZREP5j
    19 Jul 2013, 09:42 AM Reply Like
  • Author’s reply » If Anchor data is able to be included on Marine, what are the chances Anchor will be approved on time and as expected?

     

    WallStreet is so out to lunch sometimes it scares me...writing on the wall...
    19 Jul 2013, 10:39 AM Reply Like
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