Seeking Alpha

Steve Rosenman's  Instablog

Steve Rosenman
Send Message
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
  • A Stock That May Rally $20 In 3-Months 66 comments
    Sep 30, 2013 7:17 AM | about stocks: AZN, PFE, AMRN

    Amarin Pharma, Inc. (AMRN) has not been loved by Wall Street over the past 12-months. It all started when the CEO announced a go-it-alone strategy for their first approved FDA indication after he elected not to go the initial route of securing a strategic partner or selling the company. Despite a rise over the past month, the stock has disappointed, especially given strengthening fundamentals and mainly positive news along the way. (click to enlarge)12-Month Chart for Amarin

    In fact, the stock is trading at nearly the levels it traded prior to releasing positive data on its first phase-3 trial years ago (called Marine trial)--no less, trading at levels lower than the 2012 FDA approval of that indication!

    I'll be clear though: AMRN is currently the most risk-mitigated biotech opportunity with extremely high return potential in a relatively short amount of time. I will explain factors that lead to my continued and building sentiment below, but one factor that is hard to ignore is that the stock is trading at levels that discount the company's IP, ignore the pending Anchor trial indication and suggest complete failure of the approved Marine indication. There are presently no analyst financial models that support the stock's current low levels. So, let's look into whether the stock should continue trading at under $10 or rise to over $20.

    The Science: AMRN's drug is not the fish oil you can purchase in drug stores, online or even consume through food sources. It is also unlike any other FDA approved (Lovaza) or developmental (Epanova) Omega-3 class drug known to science. Vascepa, (known as AMR-101 by medical journals and the scientific community) is derived from a highly purified form of fish oil, and lab modified to ethyl esters in order to concentrate out the active ingredient. This ingredient is specifically identified by AMRN and confirmed by FDA as EPA, icosapent ethyl. This very much technically, and on its face, is unlike GlaxoSmithKline's (GSK) Lovaza, which is an uncharacterized combination of Omega-3 Ethyl Esters--so says FDA and GSK.

    EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and enhances TG clearance from circulating VLDL particles. While Omega-3s are generally known to be anti-inflammatory in nature, EPA can also help inhibit acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decrease lipogenesis in the liver; and increase plasma lipoprotein lipase activity. Yes, it's a mouthful but know that preparations with DHA and other Omega-3 fatty acids have not clinically demonstrated all these potential actions. In addition, Niacin therapies work very differently by only limiting your liver's ability to produce LDL and VLDL cholesterol. It's a different drug class altogether. Prescription and over-the-counter niacin is available, but prescription niacin is used by doctors and patients because it has the least side effects. Dietary supplements containing niacin that are available over-the-counter are not proven effective for lowering triglycerides, and may damage your liver. Niacin outcomes study suggests these therapies do not reduce CV risk. On the contrary, the Japanese JELIS study suggests EPA has statistically significant positive effects on CV outcomes. Note that JELIS was done on a population already on a high level fish diet. So, AMRN's massive Reduce-It study on western subjects should demonstrate clear and significantly higher benefits.

    The Regulatory Environment: The FDA approved Vascepa based on a randomized, placebo controlled, double-blind, parallel-group study in 151 subjects with severe hypertriglyceridemia. Baseline TG levels were between 500 and 2,000 mg/dL. The subjects received Vascepa 4mg per day for 12 weeks. Vascepa significantly reduced median TG (p< 0.001), VLDL-C (p< 0.05) and Apo B (p< 0.05) levels from baseline relative to placebo. Bottom line, it blew expectations out of the water, as it was effective and completely safe, unlike prior drugs. This indication serves a market of $1-2 billion annually.

    AMRN is now up for regulatory evaluation on their next drug application for Vascepa in the expanded 'Anchor' indication, the treatment of patients with high triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia. The Prescription Drug User Fee Act (PDUFA) date is December 20, 2013 and a FDA decision should be expected on that date.

    The importance of this decision cannot be under-stated or over-looked. The Anchor population comprises no less than 1/3 of the American public, likely far more, with market values 10x that of the Marine indication.

    Like Marine, the anchor phase-3 trials were a major success. Best of all, the trial was done under SPA, or special protocol assessment agreed to in writing by the FDA. You can learn more about that topic in a recent AMRN press release here. This SPA, along with the safety and efficacy profile of the drug should be a home run at the advisory panel prior to the PDFU decision. I remind readers that this panel is required by FDA due to the first-in-class status of Vascepa in a new patient population. I also point out that these panels primarily focus on safety, only go outside of the scope of the indicated use if safety is a concern (read into this that Reduce-It outcomes not a factor), and that FDA has not informed AMRN about any topics that would be out of the realm related to their sNDA marketing claims (record of 'clean' communication by FDA to AMRN) on the advisory panel. I further call out that if weight loss drugs with serious harmful and life threatening side effects like Vivus's (VVUS) Qsymia and Orexigan's (OREX) Contrave can be approved for marketing without concluded outcomes studies than it's best you be on the side of AMRN come panel-time

    The Legal/Intellectual Property/Exclusivity Situation: This is where we touch on patents and regulatory exclusivity (NCE/NME). AMRN has an astonishing amount of granted IP related to composition of matter, and methods of treating, both broad and narrow. FDA recognizes 19 granted AMRN patents. In contrast, Lovaza has three patents, only one which really affords any level of regulatory protection, and it was quite broad. So broad in fact that a recent appeals court opinion reverses a prior ruling about the ability of generic firms to produce Lovaza. That story can be found here. Long and short is that this decision should come as no surprise. It was actually a surprise within the industry (I'm in the industry) that the patents were not thrown out in the past as being too broad. Still, Lovaza prevailed all this time and the fight is not over. Consider, by the time generics can even source the material (if they can even get it) and conduct their studies and documentation, Lovaza IP protection would have been over anyway. This turn of events gives AMRN investors much reason to get excited, as Teva, AZN and GSK now have vested interests in the Omega-3 drug class space. More later on that.

    Nobody saw a 12-month plus delay on NCE decision, including me. I have always maintained AMRN will achieve NCE and I still do. I have evaluated (with 3rd party sources) the science side, the regulatory side and the legal side and my conclusion is the delay is related to FDA process. The topic is moot now with all the patents, but still would provide a psychological thumbs up and additional upside to the stock (probably $2-3 worth).

    The Continued Momentum Of Marine Indication: No new drug launch to the medical community comes out of the gate to be a blockbuster overnight. That's not the way it works and is the reason stockbrokers and Street.com writers don't need to go to medical school to get their series 7s, if you catch my drift. In retail alone, we need a good 3-6 months of clean POS data, meaning data that comes 3 months after initial launch (6-9 months total). For Rx, double that, even triple it with a smaller sales force. AMRN is steadily increasing scripts by 3-5% incrementally per week and has achieved over 6,000 (not including 20% under-reporting) on weeklies as of the time I am writing this article. IMS data indicates it's coming at the share loss of its prime competitor, Lovaza.

    As far as health insurance coverage, Amarin looks to be doing quite well. At the end of the first quarter, management stated that it had secured formulary access for the drug in plans covering more than 190 million people. At first, none of those plans included Vascepa in their tier 2 category. However, during April and May, Amarin said that health plans covering 40 million individuals switched the drug to tier 2. By the end of the second quarter, Amarin announced that 72 million people had access to Vascepa as a tier 2 drug -- more than twice the amount at the end of the first quarter. We are now observing sales increases really starting to respond to the additional coverage.

    Anchor and Reduce-It Indications: Simply stated, Vascepa can be the blockbuster of blockbusters when Anchor is approved late this year. The future potential of Reduce-It doubles that market again, if outcomes prove positive later in the 2016 timeframe.

    (click to enlarge)Populations served by Vascepa in USA alone

    What we are looking at is a high-multi-billion-dollar company in the making. And you ask yourself why there has not been a partnership or acquisition yet at the $15-20 level...

    (click to enlarge)Sell for $15...Really?

    (click to enlarge)

    Past Trading Patterns By Majority Holders: Wall Street has a funny way of returning kindness. AMRN is not really too different. If you evaluate the movements and actions of the big money funds around catalyst events for AMRN, you see sudden spikes, followed by some upward momentum. Healthcare investors are risk adverse and will not go in until reasonably sure that a return can be made. Time is money and it's not to be wasted waiting around. Catalysts are coming, and so is the money.

    (click to enlarge)News-driven performance

    A Major Development That Adds Substantial Weight To Strategic Importance of Vascepa to "Big-Pharma": Adding additional perspective and credence to my consistent view that an acquisition is the end game for AMRN is the recent generic ruling buzz on Lovaza. Many people have been asking if this will negatively effect AMRN. Let me be clear: There are only two companies that it will negatively impact, GSK and AstraZeneca (AZN). If the court ruling stands (and regardless, in the future when Lovaza IP expires), Lovaza will become meaningless as there will be generic options. Not so with AMRN's Vascepa. As a best-in-class therapy for Marine indication, it will be the one that docs prescribe and insurance companies will pay for. Therefore, if GSK wants to be in the game, it needs to offer Vascepa as soon as possible.

    AZN purchased Epanova primarily for use with their statin, but probably thought it could pay for the trial expenses with sales of Epanova in the very high triglyceride market. Big mistake and big lesson learned. Epanova, even if approved by FDA is unlikely to be prescribed by doctors (given side effects similar to Lovaza), and will not be covered by health insurance now that Vascepa is on the market and generics will be an option in the future. Great case study and acquisition 101 class for CEOs that look to do transactions on the cheap. You get what you pay for. So, given the Epanova drug is a complete waste of time and money as a primary and adjunct triglyceride therapy, AZN is likely back in the market, and if not, they should be. Finally, if you believe in the generics story for Lovaza, you have to believe Teva would be interested in making a play for AMRN in order to own the entire space and control pricing (for brands and generics). Admittedly, this is not my preferred or most logical way things play out. Would be brilliant for Teva, and I know a bunch of brilliant people there... AMRN's supply agreements prevent access by other companies and provide price protection over generic companies, which is a major reason Teva would need to own the whole deal.

    Finally, there is Pfizer (PFE), the company with the most executive ties back to AMRN, the company with deep pockets and a wanting pipeline for its flagship cardio segment, and the company with the most popular statin, the statin named in AMRN's combination trial...Lipitor.

    So, it has been established and now is hopefully very transparent that Rx Vascepa is not standard fish oil; is building sales revenue and scripts consistently; is ahead of the game on health insurance tier coverage; will emerge the winner in the Marine indication space; faces likely approval in the Anchor indication within months, where there will be no direct competition until at least 2021; has additional multi-billion indication trials underway; and presents itself as a serious strategic asset to nearly every major pharmaceutical company playing in the cardiovascular space.

    The catalysts will come steady and quickly throughout the rest of 2013. AMRN has corrected more than 100% in the past on binary events, and I would expect a similar correction through December well up into the teens, with additional payoffs coming dependent on Anchor launch strategy and strategic dealings. A double or triple on the December stock price (should Anchor receive favorable approval) is fair and reasonable for a biotech asset covering this many potential lives.

    Disclosure: I am long AMRN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    Themes: quick-picks-lists Stocks: AZN, PFE, AMRN
Back To Steve Rosenman's Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Comments (66)
Track new comments
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    fantastic article steve, thanks!

     

    Factual, logical, and a good explanation of the market and AMRN's potential.
    30 Sep 2013, 10:19 AM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    It's just a compilation of what we know already. Looks like he is making good money using seeking alpha by writing substandard articles which are nothing but predictions which never came true.
    30 Sep 2013, 05:31 PM Reply Like
  • User 52619
    , contributor
    Comments (8) | Send Message
     
    In your article you say: "I remind readers that this panel is required by FDA due to the first-in-class status of Vascepa in a new patient population".
    Can anyone confirm that ? There's any FDA regulation about it?
    You see, we have been discussing ( someone being concerned) about "why did FDA need an ADCom panel" for Anchor ? and "What's the real reason behind it - given they could avoid it".
    Yet I didn't succeed to get clear about it - do the FDA need an AdCom in this situation (the first-in-class status of Vascepa in a new patient population) due to some FDA regulatory or customary rule (which one?) or neither...nor?
    1 Oct 2013, 08:31 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » General FDA language about approval on NDAs and advisory panels:
    http://bit.ly/16ExMBy, footnote 16/17

     

    Historical advisory panels showing all drugs asking for new indications being approved under adcoms, also note that all the panels that did not have outcome studies; the drugs were still given thumbs up, but panel simply asked for study in the future, while drug is being marketed (example: Trilipix combo therapy):
    http://bit.ly/16ExMBz

     

    Gosh, why doesn't AF do his homework.
    1 Oct 2013, 09:35 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » That's funny, as I elect not to get paid a cent from SA. I do this on my own. Don't need the money if you catch my drift.
    1 Oct 2013, 07:15 PM Reply Like
  • User 52619
    , contributor
    Comments (8) | Send Message
     
    Thank you for your reply, but i'm no way near to AF, both geographically (I'm italian and live in Italy, and still had no chance to visit US), and ethically speaking. I'm disgusted of that man).
    Forgive me I didn't tell you before, but I've always appreciated your contribution, although, from my point of view, you seem to me to be too much an all black/all white man. Maybe it comes from your being much more aknowledged than me when dealing with farma stocks. On the other hand considering english is not my language, being confused with some native english speaking fellow sounds pretty nice to me.
    Thanks a lot
    1 Oct 2013, 07:16 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (297) | Send Message
     
    Vertex's Kalydeco -- first-in-class cystic fibrosis drug, no panel.

     

    I can name more, if you want.
    4 Oct 2013, 06:26 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Cystic Fibrosis potential patient population in the US = 30,000
    ANCHOR potential population 36,000,000

     

    Average lifespan of a cystic fibrosis patient 37.4 years.

     

    I can see why the FDA might waive a panel in this situation.
    4 Oct 2013, 01:27 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (66) | Send Message
     
    very good answer Pirate
    4 Oct 2013, 03:57 PM Reply Like
  • pwt750
    , contributor
    Comments (65) | Send Message
     
    "The FDA reviewed and approved Kalydeco in approximately three months under the agency’s priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.

     

    Kalydeco was approved ahead of the drug’s April 18, 2012 prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.

     

    Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient’s mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

     

    CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population.

     

    About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation."
    7 Oct 2013, 03:14 AM Reply Like
  • winnachickendinna
    , contributor
    Comments (34) | Send Message
     
    Being a Greek American I respect Italians. Italians can live FDA proof.
    1) They drink a red wine a meal
    2) They eat pkenty of tomatoes
    3) Olive oil
    4) They don't drink a lot of pop
    5) not much suger in their coffee
    6) a bit of baking soda at night
    7) they can have a PHD they will still do physical work with pride

     

    So on and so forth...

     

    8)
    24 Oct 2013, 10:35 PM Reply Like
  • KCSVEN
    , contributor
    Comments (35) | Send Message
     
    You lay out the bullish position really well(Which I agree with 100%). I've been thinking lately the company is in its best position ever. Exponentially increasing scripts, increasing Tier 2, coupons going away 2014 means more to bottom line, little real competition for many years, over 30 patents, Anchor approval coming and cash position solid thanks to recent raise..

     

    I'd say the things to temper the bullish side is
    1) GIA for Anchor means another 6 month+ wait to see if they can get Anchor sales to rapidly grow
    2) They give up too much in a partnership
    3) Launching to Anchor indication all out GIA would involve large costs that may bring the need for one more raise of cash.

     

    I think the BEST scenario is to partner with a BP with a plan that reduces partner take at Reduce It success, build Anchor sales rapidly, partner buys AMRN in late 2014 for nice premium.

     

    A non-partner approach can still lead to late 2014 BO but could be the one scenario where AMRN holds out until Reduce IT since a positive result in 2016-17 blows current valuations out of the water.

     

    If they cannot get something done with BP for Anchor, then we may not see the doubling of price until mid-2014 assuming they can successfully sell the indication on their own.
    30 Sep 2013, 10:38 AM Reply Like
  • chunk713
    , contributor
    Comments (41) | Send Message
     
    Great article Steve. Very well presented and finally puts to rest all the "what if" comments being thrown around by certain sources. I still believe that PFE is the company that will get them and will win the bid. They have much to gain by doing so! Thanks again for writing this article and making clear the FACTS about Amarin and Vascepa!
    30 Sep 2013, 10:51 AM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    Great Article
    30 Sep 2013, 11:06 AM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Excellent article on Amrn to some up the current situation. At least someone here can explain their thesis with facts vs. a bunch on nonsense.
    30 Sep 2013, 11:34 AM Reply Like
  • CarolinaCowboy
    , contributor
    Comments (28) | Send Message
     
    Great article. Thank you.
    30 Sep 2013, 11:50 AM Reply Like
  • coopman98
    , contributor
    Comments (69) | Send Message
     
    great job as always, we just need WS to buy in, analyts to raise PT and BP get out their checkbooks.
    30 Sep 2013, 12:19 PM Reply Like
  • Attm
    , contributor
    Comments (35) | Send Message
     
    Prediction with timing hasn't worked so well, Steve.
    30 Sep 2013, 12:43 PM Reply Like
  • region
    , contributor
    Comments (4) | Send Message
     
    going to have my dad sell ALL of his BP and buy AMRN..
    30 Sep 2013, 12:52 PM Reply Like
  • labner
    , contributor
    Comment (1) | Send Message
     
    Steve, can you post this blog as an article so that more readers have access? Thank you for addressing the science, best article on Vascepa yet.
    30 Sep 2013, 12:52 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » KCSVEN, I don't disagree.
    30 Sep 2013, 12:52 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Note, on the Vascepa dose I say 4mg in the instablog, should be 4g.
    30 Sep 2013, 12:52 PM Reply Like
  • rml360
    , contributor
    Comments (25) | Send Message
     
    you hear anything about the ATP4 guidelines getting published by year end? and if so, how does it impact Amarin? I know biobill put in his 2 cents
    30 Sep 2013, 01:18 PM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    Great article. That is the entire AMRN picture as clear as it gets! Nothing more needs to be said.

     

    Great job Steve.
    30 Sep 2013, 03:02 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    If the adcom vote is positive, and I believe it will be, that should be a key to offers from BP. They will at that point know the numbers they can plug in for projections with Anchor included, and have a candidate to take over that is basically instant revenue for them. All the work has been done. They just buy it out and run with it. It doesn't get any easier. Patents are all done, approvals done or all but done, tier 2 done on many levels... just buy out amrn and rake in money. That has got to be something BP has to be thinking about.
    30 Sep 2013, 03:18 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » ATP4 has no bearing on Adcom panel. NIH is not FDA. It has been established scientifically that high trigylcerides are a medical concern and a therapeutic area that is approved for drug use.

     

    CV is not the indication here, so while there may be some interest/questions in this area as to safety - it's not a topic that should prevent approval, and SPA supports this as well. Given AMR-101 is completely safe, there is very little risk.

     

    Still, the market believe the panel will say no, given current SP. The stock should be at $12-15 by now to be honest.
    30 Sep 2013, 06:12 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    The real question to be answered here is why does the market believe the panel will say no? I have my own theories, such as
    1. A lack of wide spread understanding of the difference between Vascepa and fish oil.
    2. A lack of knowledge as respects what Vascepa does in concert with lowering trigs, i.e lowering inflammation biomarkers etc.

     

    I think the panel meeting will shed light on these issues and clear up alot of things.

     

    How about you? What do you think?
    30 Sep 2013, 06:59 PM Reply Like
  • johnnybio
    , contributor
    Comments (23) | Send Message
     
    hahaha
    30 Sep 2013, 06:53 PM Reply Like
  • rml360
    , contributor
    Comments (25) | Send Message
     
    short interest is up again, I see, let them burn, including fraudstain and his cronies. Can't wait to see that live blog:

     

    AF: Here comes the vote:

     

    1 yes
    2 yes
    3 yes
    4 yes
    5 yes
    6 yes

     

    AF: Geez, not sure what the panel sees here? Its just fish oil

     

    7 yes
    8 yes

     

    AF: GSK stock sinking 1.5%, not sure why

     

    amrn_investor: shove it

     

    AF: $amrn stock up 25-30% after hours, not sure why
    30 Sep 2013, 07:11 PM Reply Like
  • bhorgan
    , contributor
    Comments (12) | Send Message
     
    I really do enjoy reading your articles Steve. I have a couple of questions

     

    1). Why do you think the company diluted so far in advance of Anchor PDUFA.
    2). Was it required that they issue an 8k with Reduce-it enrollment - At this point I don't understand why they did and I don't remember seeing previous 8k.
    3). Why do you think BP hasn't already purchased AMRN? Wouldn't it be better to acquire before anchor?
    4)Is it possible that the NCE delay could be linked to anchor and that AF may actually be correct and the FDA does want more data before approval. I understand they have a SPA but it kinda seems that the FDA does whatever the hell they want and when they want.

     

    Again thanks for your posts
    30 Sep 2013, 09:38 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » As to your other questions:
    2. Was not required. If I am correct, the PR was in conjunction with clarification statements on SPA. Probably intentional for positive spin.
    3. Risk, they are AMRN will need to be >$3B acquisition for company to agree.
    4. No chance of AF knowing anything about FDA
    1 Oct 2013, 03:00 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » 1. Apparently their were funds that wanted that overhang removed (the financing). Not sure I buy that. Either way, it was not smart timing and done from a position of weakness vs. strength. Mgt has done great things on the science side, not so much on the financial side.
    1 Oct 2013, 03:01 AM Reply Like
  • dbssanfran
    , contributor
    Comments (5) | Send Message
     
    For 2), yes one of the requirements for Anchor approval is ReduceIt is substantially underway. Not sure if 3/4 of the enrollment completion is considered substantial, but it surely supports it.
    1 Oct 2013, 07:17 PM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    "there" should be used instead of "their".

     

    I understand that non-English speaking people get confused, but there is no excuse for English speaking persons, esp. "professional" persons to not know how to use the English language.
    1 Oct 2013, 07:41 PM Reply Like
  • 5967241
    , contributor
    Comments (88) | Send Message
     
    I see a +ve no matter an ADCOM +ve or -ve. If ADCOM is +ve, they will have a higher offer, if ADCOM is -ve, there will still be an offer and AMRN will be forced to sell. So these current levels are a buy in any case.
    30 Sep 2013, 09:50 PM Reply Like
  • coopman98
    , contributor
    Comments (69) | Send Message
     
    Why do you think WS believes the panel will decline?
    1 Oct 2013, 12:07 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Wall Street knows it will get a positive outcome, but they intentionally bring the pps down so to get bigger gains right after approval. Called manipulation.
    1 Oct 2013, 01:16 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » B/C WallStreet has no clue what's is going on w/ AMRN, too many uncertainties created by FDA delays and circumstances they just don't understand.
    1 Oct 2013, 09:34 AM Reply Like
  • david22hughes
    , contributor
    Comments (232) | Send Message
     
    Correct - Goldman Sachs set the pre ADCOM price target at $6.80....i highly doubt the run-up between now and the ADCOM sees the share price go over that....here's some data from Arena based on their share price around last years ADCOM and PDUFA....

     

    Arena ADCOM scheduled Thursday, May 10th, 2012.

     

    One month before this date on April 10th, shares closed at $2.87.

     

    Monday, May 7th: $2.72
    Tuesday, May 8th: $3.42 (up 26% on 50 million volume)
    Wednesday, May 9th: $3.66 (up 7% on 42 million volume)

     

    Thursday, May 10th: Shares halted due to ADCOM. Press release issued announcing positive ADCOM vote

     

    Friday, May 11th: $6.36 (up 74% on 76 million volume)
    Monday, May 14th: $6.61 (up 4% on 25 million volume)
    $3.66-$6.61 = 81% gain
    Tuesday, May 15th: $6.06 (down 8%)

     

    Shares ran down from there 9% to a low of $5.52 on Friday, May 18th.

     

    FDA PDUFA date scheduled for June 27th, 2012.

     

    Thursday, June 21st: shares reached pre-PDUFA date high of $11.68 (up 219% from $3.66)
    Friday, June 22nd: $9.88 (down on 90 million volume)
    Monday, June 25th: $9.20
    Tuesday, June 26th: $8.85 (down 25% from $11.68 high)
    Wednesday, June 27th: FDA approval granted. Shares up 29% to $11.39 on 90 million volume.
    Thursday, June 28th: $10.23 (down 10%)
    Friday, June 29th: $9.98

     

    Read into all that what you will........do some more digging yourselves with other biotech companies and adcom/pdufa event related price action and you may notice something of a trend
    1 Oct 2013, 03:51 AM Reply Like
  • kokabu
    , contributor
    Comments (3) | Send Message
     
    Your comparing AMRN to ARNA. Would make more sense if u compared AMRN to AMRN. Or in other words Marine to Anchor. If I do recall Amrn jumped to $20 on marine indication alone and stayed steady around 14 upto and after FDA approval of marine. a ANCHOR = 4x population of Marine, u do the math. Anchor will huge for Amarin if aproved.
    1 Oct 2013, 07:17 PM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    "You're" instead of "Your". "You're" is a contraction for "You are". Ex: You are comparing AMRN to ARNA.

     

    Your is a pronoun showing possessive nature. Ex: Your AMRN stock is stuck in the mud!
    1 Oct 2013, 07:39 PM Reply Like
  • david22hughes
    , contributor
    Comments (232) | Send Message
     
    "Your comparing AMRN to ARNA."

     

    No, i'm not. You're missing the point entirely. I am analysing the share price action of ARNA around 2 crucial binary events that are just around the corner for AMRN. ARNA had a hell of a lot riding on last years PDUFA and ADCOM just as AMRN do. With ANCHOR and its massive potential AMRN's share price possibly stands to increase even more than ARNA's did. I've done my homework on other biotech companies and the share price action around their PDUFA and ADCOM dates and noticed a trend. You can do that yourself if you feel so inclined.

     

    ANCHOR is about 10x the size of the MARINE population by the way - not 4x. Your math is sloppy and your grammar is poor. Thanks ever so much for the comment though.
    1 Oct 2013, 10:14 PM Reply Like
  • kokabu
    , contributor
    Comments (3) | Send Message
     
    Wow I did not know ANCHOR was 10x the population of MARINE, I thought it was 4x. That's a huge difference and further solidifies the value of ANCHOR. Thanks for pointing that out.

     

    I do get your point, however I still don't like the comparison between ARNA and AMRN. A proper comparison would be between Marine and Anchor, same drug just a different target population. If we reached 20 on Marine alone pre FDA approval, can't imagine what ANCHOR will do for us. Like u said ANCHOR is 10x the population of MARINE.
    2 Oct 2013, 02:21 AM Reply Like
  • JohnCappello
    , contributor
    Comments (32) | Send Message
     
    Steve, thanks for the summary.
    It seems to me that most investors lack an appreciation for who benefits most by Vascepa being approved for the Mixed Dyslipidemia indication. 75 % of Diabetics die of cardiovascular disease. The development and progression of CVD is by far the most significant risk for Diabetics. While Vascepa is known as a cardiovascular drug, 28 million diabetics are potential beneficiaries of improved lipid markers, especially lower inflammation. This is why the Anchor trial was 70% diabetics and why the ADCOM panel is primarily Endochronologists. A placebo-like drug that improves key lipid panels of those with Mixed Dyslipidemia will be prescribed for millions of Diabetics in the US alone. In fact, it's already happening regardless of Anchor. Lastly, on Thursday October 3rd, Dr Bays, Dr. Bhatt (PI of Reduce it) and Dr. Ballantyne will deliver an Amarin sponsored lunch symposium on treating mixed Dyslipidemia. Interesting timing and venue.
    1 Oct 2013, 08:06 AM Reply Like
  • Deep.Blue
    , contributor
    Comments (131) | Send Message
     
    Seems very unlikely that a bunch of endocrinologists, who have seen hundreds and hundreds of patients die from CV disease will say, "lets wait for outcomes from a drug that does so well on lipid markers and where safety is placebo". Also, if Anchor adcom was about Reduce IT, it would be infront of a CV panel, not a diabetes panel. Remember that 70pct of Anchor patients were T2 Diabetics.
    1 Oct 2013, 04:10 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Did you see the new motley interview segment? I know people are skeptical of what they say, but the guy Max thinks that the FDA Anchor decision could be either yes or no-according to him it could go either way! I though most knowledgeable investors are expecting a resounding Yes.

     

    Maybe I'm being over optimistic about approval?
    7 Oct 2013, 10:20 AM Reply Like
  • sts66
    , contributor
    Comments (1017) | Send Message
     
    No way. From a SA instablog:

     

    http://seekingalpha.co...

     

    "under the new Performance Goals and Procedures for 2013 through 2017 the FDA cannot alter what was agreed to under the Special Protocol Assessment (SPA) Agreements. It states the following:

     

    The fundamental agreement here is that having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.

     

    What are the health concerns related to Vascepa? None. Side effect wise it is comparable to placebo in clinical data and thus far on the market. What are the health benefits of Vascepa? An arms length list of lowered biomarkers that signal the Reduce-It trial will be a success. It's a rather simple decision to make."
    7 Oct 2013, 10:56 AM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Saw this post on YMB--is what they say possible?

     

    BTW I think it will be a green light but in a worse case scenario for Adcom is it all or nothing or does the Adcom panel have some leeway ie they say look, we'll recommend giving you 350-499mg/dl for now instead of 200-499mg/dl, pending REDUCE-IT? Some folks on ST seem to think that carve-out might be possible? Is a modification such as that allowed? Less
    7 Oct 2013, 10:26 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    That is one of the most ridiculous ideas I've ever read. They won't adjust the indication of Anchor. They will get the indication they are after, no more, no less. It's not any more complicated than that.
    7 Oct 2013, 05:08 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Amarin ought to move on this study. Fresh in the news
    "Massive DNA study points to new heart drug targets and a key role for triglycerides"
    http://bit.ly/17QWqNh
    and
    "New study gets to heart of triglycerides’ role in coronary disease"
    http://bit.ly/17QWooy

     

    So who led the study? Sekar Kathiresan.
    Kathiresan is the current Director of Preventive Cardiology at the Massachusetts General Hospital (MGH) Heart Center and an Associate Professor of Medicine at Harvard Medical School. He received his B.A. in history summa cum laude from the University of Pennsylvania in 1992 and received his M.D. from Harvard Medical School in 1997. Kathiresan completed his clinical training in internal medicine and cardiology at MGH. He served as Chief Resident in Internal Medicine at MGH in 2002-2003

     

    I know I know..........you thought maybe Adam Feurstein led the study, but you were wrong.
    8 Oct 2013, 03:30 AM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    AF did not lead or participate in the study. However, he did report that there were two empty chairs in the room.
    8 Oct 2013, 08:54 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Steve-
    What do you think of the announcement of a conference call after the Adcom meeting on Wednesday the 16th? Isn't this weird considering we can listen in on the Adcom meeting? What are they going to say that we won't have heard already??
    9 Oct 2013, 10:49 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Guess we'll have to wait and see, lol. Given the bad rap Amarin has continually received for NOT communicating with shareholders, it is funny to see that the simple scheduling of a CC has everyone looking for hidden meaning. Despite access to the Adcom proceedings there will no doubt be much the company has to say and lots of questions from analysts and investors alike.
    9 Oct 2013, 11:49 AM Reply Like
  • xtradersdotnet
    , contributor
    Comments (23) | Send Message
     
    20? hard to believe with it down 21% today. NCE does not matter, today was the big catalyst and everyone who was bullish was WRONG..

     

    seems that the person who bought those 10000 5.5 puts Thursday is being paid a nice fat $300,000+ profit.

     

    hope this teaches people not to listen to others and do thier own DD..
    11 Oct 2013, 04:03 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Steve has left the bldg!
    11 Oct 2013, 06:40 PM Reply Like
  • Patrick Harrington
    , contributor
    Comments (24) | Send Message
     
    Looks like the game is over AMRN
    12 Oct 2013, 04:03 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    @xtra, ring , pat,,, you 3 are full of nonsense
    12 Oct 2013, 01:28 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Saw this post on ihub. Care to comment?

     

    I read the Briefing Documents, both from the FDA and those put out from Amarin. Lots of information to digest. I'm dead tired as I stayed up all night doing it (couldn't sleep anyway). It is obvious to me that the contents leaked to several parties way prior to the infamous Bloomberg article/headline. I might be missing something here but the FDA BD is pretty negative and Amarin's responses are pretty weak. The reviewer calls into question, numerous times, the results of the ANCHOR trial,based on the placebo numbers. A large portion of the BD encompasses running down previous outcome study results and crapping all over JELIS. Here is a gem from pages 81-82 under "Reviewers Comments"
    Reviewer comment: Following the release of ACCORD-Lipid results in 2010, the FDA held an
    advisory committee meeting to discuss the findings of the ACCORD-Lipid trial as they related to
    the indication granted to fenofibric acid (Trilipix) for coadministration with a statin. Since
    2008, Trilipix is FDA-approved for use in combination with a statin to reduce TG and increase
    HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on
    optimal statin therapy to achieve their LDL-C goal.
    EMDAC members were asked to comment on their interpretation of the two subgroup analyses
    with significant interaction terms suggesting a treatment effect according to gender and baseline
    lipid subgroups (TG=204 mg/dL, HDL-C=34 mg/dL), in the context of the negative ACCORDLipid
    MACE primary outcome. In response, members cautioned against the over or under
    interpretation of subgroups from clinical trials in general, but particularly with negative trials.
    Suggestions of benefit or harm from subgroup analyses were defined as hypothesis generating
    that should not alter clinical practice or regulatory decisions until properly validated, especially
    in the context of an overall null result.
    Members voted unanimously to require the conduct of a clinical trial designed to test the
    hypothesis that, in high-risk men and women at LDL-C goal on a statin with residually high TG and low HDL-C, add-on therapy with Trilipix versus placebo significantly lowers the risk for
    MACE. Furthermore, members commented that numerical benefits in lipid surrogate endpoints
    such as TG and HDL-C when added to statin therapy should not trump clinical outcome data.
    Finally EMDAC made recommendations to the FDA regarding what further actions to take
    regarding Trilipix’s current indication for coadministration with a statin including (a) continued
    marketing with or without revision to labeling or (b) withdraw approval of Trilipix’s indication
    for coadminstration with a statin. The majority of members voted to allow the indication to
    stand pending the results from a dedicated CVOT. Some members felt there was not enough
    evidence from the ACCORD-Lipid trial relevant to the specific Trilipix coadministration
    indication to warrant withdrawal of the indication. Others felt that with no additional relevant
    clinical evidence provided by ACCORD-Lipid, and because the indication had already been
    granted based on numerical improvements and supported by regulatory standards of the time,
    this should be honored until further information on clinical outcomes were available. However,
    several members recommended that the FDA consider requiring a different level of evidence for
    future lipid altering drugs, transitioning away from surrogate endpoints to relevant clinical
    cardiovascular outcomes especially for indications for add-on therapy to statins.

     

    I'm a long time "long" on AMRN but I have to say that the FDA BD was a real shit sandwich. Amarins core argument in their BD was that lowering Trigs in effect lowers Non HDL-C which IS considered an accepted risk factor for CVD. However in the ACCORD trial trigs were lowered 22.2%,LDL-C was lowered 18.9% and HDL went up 8.4%. I could go on and on and on about the reviewer shredding the basic core Amarin argument based on failed outcome studies.Amarin does a good job of dissecting previous Omega 3 studies but fails to explain (by ommision) why other outcome studies which were better at lowering trigs than Vascepa failed to show an outcome. The JELIS results were explained by the reviewer by pointing out that the baseline LDL-C levels were high because participants were not on optimized statin therapy but were on low dose statins and that LDL-C dropped when combined with EPA by 25% while trigs merely dropped by 9%.
    13 Oct 2013, 11:11 AM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    It's kind of funny that Steve is nowhere to be found. One would think he would debate/dissect the iHub post if he TRULY IS QUALIFIED. It is also possible that Steve agrees with it and knows his days of pumping AMRN are gone.
    13 Oct 2013, 02:28 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Redacre analysis on AMRN:

     

    Amarin Corporation PL/C (NASDAQ:AMRN)
    Last week we gave our readers a head's up that AMRN's briefing documents would be out on Friday October 11th instead of Monday the 14th due to Columbus day being a federal holiday. Sure enough, AMRN;d briefing documents were released around 1:30 pm on Friday. There are only two questions for the advisory committee (AD COMM) to consider.

     

    The gist of question 1 is:

     

    Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population.

     

    this is a non-voting question meant to solicit discussion from the AD COMM members.

     

    Question 2 is the voting question:

     

    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? Please provide the rationale underlying your recommendation.

     

    The FDA briefing documents themselves were a mixed bag. While the documents acknowledged that Vascepa demonstrated a statistically significant reduction in Triglycerides compared to placebo, they also questioned whether or not the placebo used in the MARINE and ANCHOR trial was truly inert. Indeed, placebo patients in both of these trials saw marked increases in lipid parameters. Such increases were not observed in other placebo controlled trials that used other oils (corn oil, olive oil etc.) as the placebo agent.

     

    AMRN has consistently stated that the most relevant study to compare the effects of Vascepa would be the JELIS study. However, in the briefing documents, the FDA points out several factors that make the applicability of the JELIS results uncertain. First, patients in the JELIS trial were NOT already on optimum statin therapy. Next, since JELIS was open label, the patient and provider bias factors cannot be ruled out. Next, the mean triglyceride levels in JELIS were considerably lower than those of the ANCHOR population. While there was a subgroup that had mean triglycerides >200 mg/dl, this population was not pre-specified, and was only 5% of the JELIS study population. In other words, the population closest to the ANCHOR population in JELIS was both post-hoc and only a small percentage of the overall study population.

     

    The FDA reviewer's comments suggest that, while JELIS indicated a positive effect on CV outcomes, more recent trials (ACCORD, AIM HIGH) do not support the idea that lowering lipid parameters leads to benefits in terms of CV outcomes.

     

    On Wednesday, investors should pay careful attention to the FDA's comments with respect to the mineral oil placebo. We believe that this is currently the biggest risk for AMRN. If FDA strongly makes that case that the mineral oil placebo is not biologically inert, this has strong implications for the REDUCE-IT trial. If the biological inertness of the placebo is strongly questioned by FDA, the results of the REDUCE-IT trial may also be brought into question. This is risk has far-reaching implications for the AMRN investment thesis.

     

    While some longs like to argue that the Special protocol assessment (SPA) for the ANCHOR trial is, in some way, a "contract" between AMRN and FDA regarding the conditions under which the ANCHOR indication would be approved; this is far from the case. In reality, the SPA is merely a statement of whether clinical trial protocols are adequate to meet the scientific and regulatory requirements identified by the sponsor.

     

    In AMRN's case, the company has often stated that their agreement with the FDA required that the REDUCE-IT trial be substantially underway prior to submitting the ANCHOR sNDA. This is 100% accurate; however, this does NOT imply that once RECUDE-IT was substantially underway that the ANCHOR sNDA would be APPROVED; merely that it could be submitted for review.

     

    The briefing documents do contain some apparent inconsistencies with prior SPA agreements. To wit, according to the NDA review documents for Vascepa in the MARINE indication:

     

    It was agreed that a non-inferiority test for percent change from baseline in LDL-C would be performed between AMR101 and placebo using a non-inferiority margin of 6% and a significance level at 0.05.

     

    Compare this to what the Briefing documents state (page 103/115):

     

    The sponsor performed non-inferiority tests for percent change from baseline in LDL-C between each of the AMR101 doses and placebo using a non-inferiority (NI) margin of 6% and a 1-sided significance level of 0.025. This reviewer thinks that the non-inferiority test was not suitable in this setting [for an efficacy claim] because the study was a placebo-controlled trial.

     

    The reviewer's comments appear to directly contradict the FDA's own description of what was agreed in the SPA. Since the AD COMM members already have the FDA briefing documents in hand, it will be up to the company to properly point out that FDA had agreed to the non-inferiority test as part of the SPA. This is in fact one of the very things that a special protocol assessment is designed to avoid - a moving of the goal posts after the fact.

     

    All in all, the briefing documents are a real toss-up. While Vascepa undoubtedly reduces triglycerides, the mineral oil placebo is a confounding factor, and more recent studies indicate that lowering triglycerides, once a patient is on optimal statin therapy, is of questionable value. At least on the the FDA reviewers seems to be leaning strongly in the direction of wanting to wait for the results of REDUCE-IT prior to allowing the expanded label for Vascepa. However, practicing clinicians will have their own views on whether or not the lipid lowering results demonstrated by Vascepa would be meaningful for their patients.

     

    AMRN has two more trading days prior to the AD COMM. Expect the stock to be halted all day on Wednesday the 16th as the AD COMM deliberates. Our view is that the FDA briefing documents reading slightly negative for AMRN's chances given the strong sway that the FDA can have over its panel members. Investors on the long side would do well to consider some put protection; however options premiums are quite high at this point. We would not recommend increasing long exposure on the basis of these briefing documents despite AMRN's recent price drop.

     

    We are long AMRN (via calls).
    13 Oct 2013, 10:01 PM Reply Like
  • butters301
    , contributor
    Comments (12) | Send Message
     
    Thank you Steve for sharing your insights as always. As a healthcare practitioner, I'd like to share this page from the American Heart Association. Total cholesterol score is calculated by adding HDL + LDL + 20% triglyceride level. I cannot support our FDA's new position that lowering triglyceride does not help prevent CVD. http://bit.ly/1hnEdO2
    7 Nov 2013, 05:31 PM Reply Like
  • sts66
    , contributor
    Comments (1017) | Send Message
     
    "Total cholesterol score is calculated by adding HDL + LDL + 20% triglyceride level"

     

    I know you know this, but the layman may not - typical (cheap) cholesterol tests actually measure TC, HDL, and TG (not LDL), so the real formula is:

     

    TG - HDL - 1/5*TG = LDL

     

    ergo, LDL is a derived, not measured, number. Of course the more extensive/expensive tests that measure all sorts of particles do directly get LDL-C, but that's not the sort of test most normal screenings use.
    8 Nov 2013, 02:10 PM Reply Like
  • butters301
    , contributor
    Comments (12) | Send Message
     
    Thank you sts66 for the clarification. The primary mission as a clinician is "do no harm" to patients. Just a reminder to our FDA. The American Heart Association clearly provided treatment guideline and recommendation to both clinicians and the public that lowering cholesterol and triglycerides are equally important in the prevention of CVD with supportive studies. Vascepa in my opinion, has the best safety profile in high triglyceride reduction. In essence, this factor alone makes it the drug of choice as it causes "the least harm" to patients as CVD is a chronic and progressive condition which requires not only intensive lifestyle and diet modifications but "prolonged exposure" to its treating drug.
    10 Nov 2013, 10:16 AM Reply Like
  • butters301
    , contributor
    Comments (12) | Send Message
     
    I hope you find these helpful as well. TG 200-499 mg/dL requires treatment (see Step 9) by NIH guideline. http://1.usa.gov/HPc1nC
    And also please look under Figure 9-2 Dyslipidemia where omega-3 therapy is listed in patients TG 200-499 mg/dL. http://1.usa.gov/HPc0jz
    10 Nov 2013, 10:10 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    a must read,, fda's laws, regulations and guidance,,, ymb, invalidating oct16 adcom...
    9 Nov 2013, 05:51 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    This is a must-read. Things were not in order during the Adcom and misconstrued. Amarin should be all over the rules of the meeting and should explain this at their A-meeting. Hopefully they can get some kind of label expansion. This has been their plan all along. Without a label-expansion, it will be years before most of us can get our investment back to black.
    9 Nov 2013, 07:00 PM Reply Like
Full index of posts »
Latest Followers

StockTalks

More »

Latest Comments


Posts by Themes
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.