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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
  • All Eyes Now Focusing On Acquisition Of Amarin 92 comments
    May 28, 2013 9:27 AM | about stocks: OMTH, AZN, AMRN

    After Astra Zenaca's (NYSE:AZN) shocking announcement of offering more than 80% premium to buy Omthera (NASDAQ:OMTH), a free fatty acid Omega-3 therapy not yet approved for the very high triglyceride market and with no regulatory exclusivity or long-term patents, and with no development stage combining use with statins, all eyes now focus on Amarin (NASDAQ:AMRN). AZN's bid for OMTH seems to confirm that AMRN's management is doing the right thing by holding out for the very highest offer it can get for shareholders. It's now clear that offers were made to Amarin, but they were not high enough. I have stated multiple time the offer would need to be in the upper $20s range to excite management. Now, AZN and others should be scrambling to bid for AMRN. It's the likely catalyst needed to get serious bidders to the table now, vs. later in the year when FDA approves Vascepa for the wider high triglyceride indication.

    Ask yourself, if AZN is willing to pay an 88% premium for a fledgling company only showing clinical results similar to Lovaza's $1-2B market, but without FDA approval yet, and no IP or developed statin program -- what should big pharma pay for AMRN, a company with FDA approval for Lovaza's indication and FDA approval coming in December for a market 10X larger, plus a developed statin program, and more than 19 patents granted through 2030. That's why my target is near $30.

    Stocks: OMTH, AZN, AMRN
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Comments (92)
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  • Bruce Roseman
    , contributor
    Comments (6) | Send Message
     
    Steve,

     

    AMRN Reduce It Outcomes trial results will surprise the critics. The longer BP waits to make an offer will just increase the buy out share price.
    I recently read a review of a study from the Archives of Internal Medicine done in 2005, titled “Effect of Different Anti-lipidemic Agents and Diets on Mortality: A Systematic review,” that may change our mind about the importance of your cholesterol on your health.
    Key points from the study:
    • The study harvested the best available evidence from a total of 97 studies which evaluated the effect on mortality by lowering lipids with various methods.
    • 137,140 individuals received various intervention and 138,976 individuals were controls.
    • Omega-3 fats (fish oils) did the best job at reducing death from all causes (mean reduction of 23%) and death from heart problems (mean reduction 32%), but did the worst job at lowering blood cholesterol levels.
    • Statin drugs did the best at lowering blood cholesterol and were 10 times more effective than omega-3 fats, however omega-3 fats were 44% more effective than Statin drugs in reducing cardiac related deaths and 32% more effective in reducing death from all reasons.
    • “Omega-3 fatty acids lower cholesterol levels to a very small extent which indicates their beneficial effects are from some other means, such as their anti-rhythmic properties, their membrane stabilizing effects, as well as their anti-inflammatory properties” from Dr. Dan Murphy
    This study is extremely important because the results of this study question whether lowering cholesterol should be such a focus for overall health. Omega-3 fats anti-rhythmic, anti-inflammatory, and cell membrane stabilizing effects theoretically suggest that the main focus should not be on lowering cholesterol, but improving the overall environment of the body that the cholesterol operates through reduction of inflammation and improvement of overall health with proper lifestyle changes.
    28 May 2013, 10:08 AM Reply Like
  • Bruce Roseman
    , contributor
    Comments (6) | Send Message
     
    Here is the link to the 2005 Study. Click on PDF text.

     

    http://bit.ly/10zoQVt
    28 May 2013, 10:23 AM Reply Like
  • coopman98
    , contributor
    Comments (69) | Send Message
     
    agreed Steve, confirms Big Pharma interest but also makes us realize that BO of Amrn will require 4- 5 billion not 400 million. not too surprised that MM are keeping price below Friday close. frustrating doesnt give us longs justice on the sideways move on this stock. I just cant see us going from 6.80 to 30.
    28 May 2013, 10:09 AM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    It might require much less, if the stock keeps deflating and we go into next year. AZN passed on Amarin, and the big question is why is it that WS doesn't see the potential but we do?

     

    Who is wrong?
    28 May 2013, 05:20 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » We go to new highs on FDA approval for Anchor. You saw $19 with Marine, take a guess how high for anchor approval. The OMTH situation changes things dramatically though, in my view. Competitors need to get in now, and if they do, they beat AZN to market on both Anchor and combined with statins. It is actually a situation that potentially just up'd AMRNs takeout price, given marketing of Marine is late 2014 for AZZ and OMTH and Anchor would be 2017-2018 earliest, with combined statins being 2020-2022. AMRN is Anchor approved this year, marketed early 2104, and statins right after...
    28 May 2013, 10:20 AM Reply Like
  • Attm
    , contributor
    Comments (35) | Send Message
     
    Why does AZN bother to buy OMTH then? If what you have said are all right, it seems that OMTH is quite worthless. Am I missing something?
    28 May 2013, 10:28 AM Reply Like
  • Not_Quite_Pheidippides
    , contributor
    Comments (156) | Send Message
     
    It's all about Crestor; AZN is trying to use OMTH to extend Crestor's lifespan with a combo pill. Crestor is going generic soon, but if they can put together a combo with extended protection, it will save them big money. To put things in perspective, the buyout price of OMTH (including the contingent payouts) is LESS THAN 6 weeks worth of Crestor sales. If it even helps Crestor stay on top of the market one more quarter, it will have been a great investment.
    28 May 2013, 01:49 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    NQP,
    Which is why I am disturbed that AZN passed on us, as the combo pill could have started selling very shortly. The big question is why did AZN go with a company that doesn't have approved indications over us? Are we missing something or is Joey asking to much?
    28 May 2013, 05:22 PM Reply Like
  • Not_Quite_Pheidippides
    , contributor
    Comments (156) | Send Message
     
    I think they were just being cheap. End of story. CEOs make hundred-million dollar mistakes all the time, and they're not career-ending. Purchases in the billions, though... I think they didn't have the guts to pull the trigger. (Corporate debt is so cheap these days, though, you gotta believe GSK or PFE could afford to pony up. Only, it's hard to buy something when it might be even cheaper tomorrow...)
    29 May 2013, 10:33 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    "Summer Street says Amarin's Vascepa was downplayed by a company insider at a primary care conference held in Washington DC last week. The firm notes that a member of Amarin’s steering committee said in a lecture that there is no reason to give Vascepa to patients with triglyceride levels below 500 until the outcome trial is complete. Summer Street continues to believe the FDA will not approve Vascepa for triglycerides below 500 until the outcome study is complete"

     

    WTF? Anyone? Bueller?
    28 May 2013, 10:26 AM Reply Like
  • CarolinaCowboy
    , contributor
    Comments (29) | Send Message
     
    Didnt GSK get fined for promoting off-label use? AMRN too smart to openly do that. IF Summer Street is short as suggested below, this off-label use sounds like a set-up question to highlight something,anything, negative.
    So far though, AMRN has been a hard pill to swallow. Longs taking one heck of a beating. Hasnt been an easy hold, that's for sure.
    28 May 2013, 11:37 AM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Carolina,
    Why couldn't he have just replied that for 200-500 indication it isn't approved but preliminary data looks good. No, he said if I remember correctly that without outcome trials why would you prescribe it. Yikes.
    28 May 2013, 05:23 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    Are you sure he said that or are you believing a short with an agenda?
    28 May 2013, 10:01 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Jolk wrote, "Are you sure he said that or are you believing a short with an agenda?"

     

    Who knows, but this is where Amarin should issue a press release to correct as that would remove uncertainty. If it is true, fine.

     

    It would be nice if the SEC would go after analysts more than they do now if they misdirect on purpose. Look at Cramer on TV told viewers he used to misdirect and give bad information, how is that not illegal?
    28 May 2013, 10:41 PM Reply Like
  • onecardchuck
    , contributor
    Comments (40) | Send Message
     
    Steve,

     

    I agree with you. I take it as AZN got bumped out of the bid for Amarin but see's the value of a combo statin/EPA and bought second best just to lock down a piece of the huge pie that a combo drug can generate in this market. They must feel they can get it approved for Anchor indication but all this is a long way away.

     

    Question is who remains at the table with Amarin (those with deeper pockets) and will it be a partnership or a BO. Especially with all the supplier agreements in place. It will be interesting to say the least.

     

    I am still sticking with Pfizer as my guess and will go with your price target.
    28 May 2013, 10:35 AM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Onecard,
    It seems so many Amarin investors think they have the upperhand, all I have seen is disatrous stock performance, decent launch with the paltry salesforce.

     

    Joey in my view wants to stay in power and to do so he needs partnership.
    28 May 2013, 05:24 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Onecardchuck,
    We do have quite a few supplier agreements, to me AZN has experience in locking up the market as well, as they did years ago with ace inhibitors.
    28 May 2013, 10:42 PM Reply Like
  • onecardchuck
    , contributor
    Comments (40) | Send Message
     
    Iam,
    Not enjoying the roller coaster ride I take it. This is what happens when you buck the trend and set off on your own. WS hates it when a company does not conform to the norm, but it is not everyday a drug like Vascepa is born. Know the science and your investment and you won't mind the bumpy ride so much. Remember it is the science and medicine that will win out as what you are seeing is the early stages of people seeing great result and jumping on board and yet with a paltry salesforce as you put it.

     

    Hope this helps,
    29 May 2013, 09:41 AM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    One,
    I hope your right, it seems wit marketing efforts that the one with the most cash wins, in many cases whether we have science or not.
    29 May 2013, 03:21 PM Reply Like
  • onecardchuck
    , contributor
    Comments (40) | Send Message
     
    Iam,
    That point would be a valid one in many case with many drugs, but not here. Why you ask? Because we are competing against GSK which has a lot of cash but yet we are growing and they are shrinking. Hence, the better medicine will always win out and sell itself and by the time AZN/Omthera get on the scene we will be well established as the one to beat. I just don't see how Epanova could top Vascepa and by then my guess is it would be Lipitor/Vascepa combo. I get why AZN did what they did was to get in the combo drug market cheap and fast, which will take some market share from Liptor/Vascepa but not enough to matter.
    30 May 2013, 09:17 AM Reply Like
  • coopman98
    , contributor
    Comments (69) | Send Message
     
    Pirate, Summer Street has been a big short player of AMRN as long as I know so take their comments with a grain of salt. they want the stock down so do you think they will publish anything positive? re read steve's last instablog.
    28 May 2013, 10:36 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Regardless, if Summer Street asserts that an Amarin insider stated that Vascepa shouldn't be in play for the 200 - 500 mg/dl indication until REDUCE IT outcome is known, Amarin's management needs to respond to this NOW. If this is true, heads need to roll and management needs to clarify or end up in shareholder lawsuits.
    28 May 2013, 10:59 AM Reply Like
  • sts66
    , contributor
    Comments (1145) | Send Message
     
    SS insinuates that an AMRN insider made that statement, but it's not even close to being true - a "member of Amarin's steering committee" = one of the doctors who helped run one or more of the clinical trials. Anyone want to be this person will turn out to be none other than Dr. Nissin or someone else associated with the Cleveland clinic?
    28 May 2013, 11:30 AM Reply Like
  • Danburydude
    , contributor
    Comments (108) | Send Message
     
    Give that man a cigar.
    28 May 2013, 11:36 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    This smells like dirty pool to me. There is a concerted effort to crush the stock price. When you don't play ball like people want you to, things get nasty. It would be nice to hear from mgt.
    28 May 2013, 11:42 AM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Agree 100%, but as usual I haven't heard a thing from them:(.
    28 May 2013, 05:24 PM Reply Like
  • exp456
    , contributor
    Comments (31) | Send Message
     
    I'm done guys--this has been one year of hell!

     

    Sick of all this pumping--how is this going to be acquired for $30+ when it can't even stay at $7 this late in the game.

     

    Take care and Good Luck--I have lost ~50% of my investment. Hopefully can recuperate part of the investment in something else.
    28 May 2013, 12:30 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    exp456,
    I am thinking of selling as well, good luck to you. I like you get tired of hearing bad news after bad news and keep hearing how we are going to be alright.

     

    It is like being in war, you lose your arm and the doctor says hey it is okay, we stopped the bleeding, but you now lost your foot. Hey it is all good no infection, oh now an infection, oh no due to the infection you now lost your leg. Oh no, another infection now you lost your other leg. Things are going to get better soon, yikes.
    28 May 2013, 05:26 PM Reply Like
  • sts66
    , contributor
    Comments (1145) | Send Message
     
    If you are truly a "stock genius", have done your DD on Vascepa, you wouldn't even consider being panicked out of your AMRN shares by all the BS being spread around today - you'd just be joining the mindless lemmings jumping off the cliff (likely losing your $$ shirt) that are being prodded from behind by the shorts and manipulators - IOW, doing exactly what they want, scare retailers out on the cheap. Krammer calls it "fomenting" - I call it outright lying.

     

    Today's nonsense is nothing if you've been in the biotech sector for a while, relatively tame in comparison to the wild gyrations other stocks have gone thru over the last year or two. Did you even bother to look at today's moneyflow? Ratio is 1.23 - that means strong buying pressure, perhaps short covering. Bios are a bumpy ride, especially ones in early drug launch mode, need a strong stomach to be in this sector.
    28 May 2013, 06:06 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Sts66,
    I hope you are correct, it could be manipulation, but AZN did purchase another company and not us. That to me is bad, and today I imagine shorts enjoyed money :(.
    28 May 2013, 10:43 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Good luck EXP456. By the sound of your 1st post on AMRN back in January I am shocked you stayed in it so long as negative as you were. You wonder why someone would be so negative questioning everything and stay a long. Good luck to you. Maybe you can put your money in MNKD as you see patience pays off. All in on MNKD and AMRN here.
    28 May 2013, 12:42 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    He was correct so far in his earlier sentiments, just being long doesn't mean that you can't see both sides. He like me most likely is in the hole big time, and was hoping for this to come around.
    28 May 2013, 05:27 PM Reply Like
  • pwt750
    , contributor
    Comments (67) | Send Message
     
    exp , thanks for the wishes and good luck you too.
    Sure I speak unwillingly for The Folks behind edgx / phlx / arca, they are very pleased you got their messagipulation
    28 May 2013, 12:43 PM Reply Like
  • Deep.Blue
    , contributor
    Comments (131) | Send Message
     
    im sure the AMRN insider was careful not to market the drug for the Anchor population and then Summer Street conveniently misconstrued that information... that simple.
    28 May 2013, 12:43 PM Reply Like
  • sts66
    , contributor
    Comments (1145) | Send Message
     
    Here's the clues: It's one of these guys, perhaps Dr. Ballantyne?

     

    http://bit.ly/110moqa

     

    Houston, TX - A new analysis from the large Atherosclerosis Risk in Communities (ARIC) study appears to suggest that elevated levels of lipoprotein-associated phospholipase A2 (Lp-PLA2) and C-reactive protein (CRP) provide information beyond traditional risk factors for identifying middle-aged individuals at risk for ischemic stroke [1].

     

    Publishing their findings in the November 29, 2005 issue of the Archives of Internal Medicine, lead investigator Dr Christie Ballantyne (Baylor College of Medicine, Houston, TX) and colleagues report that while race, hypertension, diabetes, systolic and diastolic blood pressure, triglyceride levels, and HDL-cholesterol levels were each individually associated with stroke risk, higher Lp-PLA2 and CRP levels increased stroke risk in statistical models adjusting for these traditional risk factors. Ballantyne and colleagues suggest that these novel markers may "complement" traditional risk factors, although they add that further study will be needed to assess whether selectively inhibiting either Lp-PLA2 and CRP could reduce the risk of ischemic stroke.

     

    In an editorial accompanying the study, however, Drs Philip Greenland (Northwestern University Feinberg School of Medicine, Chicago, IL) and Patrick O'Malley (Walter Reed Army Medical Center, Washington, DC) point out that simply showing statistical independence is not adequate for demonstrating clinical utility [2]. It is unclear, write the editorialists, how useful CRP or Lp-PLA2 levels will be for predicting risk when compared with traditional risk factors alone.

     

    "Hazard ratios and p values are useful for demonstrating statistical associations, but they fail to show whether the new marker is truly capable of making a major impact on risk prediction or risk discrimination," write Greenland and O'Malley.

     

    Ballantyne is also working on a competing drug:

     

    http://bit.ly/13WZHIu

     

    Houston doctors are testing a cholesterol shot that acts on the genetic cause of cholesterol. And it's radically reducing cholesterol levels in their studies.

     

    "I kinda ignored it for a long time until I had a heart attack," Terry Lim said.

     

    Lim was 34. She had to have a triple bypass, then an artificial heart valve because of the heart attack's damage. What caused this at 34? Her cholesterol.

     

    "It has gone as high as mid-300s to maybe close to 400," she said.

     

    Lim's extremely high cholesterol is genetic. And though she eats right, and takes the maximum cholesterol medicine she can, her LDL, or bad cholesterol, stays around 110 to 130. That's made her feel uneasy.

     

    "Like a ticking time bomb," Lim said.

     

    Now Lim gives herself a shot twice a month. It's an experimental cholesterol shot, and it's dropped her LDL into the teens.

     

    This shot that Lim takes is one of several things they're testing that may be able to do what the statin drugs can't.

     

    Lim is in a study conducted by Dr. Christie Ballantyne.

     

    "Lowers LDL fairly dramatically. You can see 50 percent, 60 percent reductions so it's being looked at in people with genetic disorders, people with very high LDL's," Ballantyne said.

     

    And he was also involved in this study:

     

    http://bit.ly/110moGo[sViewPointer]=1

     

    HPS2-THRIVE trial: This study of whether adding niacin and laropiprant to statins is better than statins alone in preventing future myocardial infarction in patients with previous MI or heart disease failed to reach its primary endpoint, Merck announced in late 2012. But the data on more than 25,000 patients provides enough power for potentially useful subgroup analyses, ACC.13 cochair Dr. Christie M. Ballantyne said. The cohort as a whole had low LDL levels at the start of HPS2-THRIVE (Heart Protection Study 2–Treatment of HDL to Reduce the Incidence of Vascular Events, but U.S. adults tend to have high LDL levels. Subgroup analyses may or may not show a beneficial effect of niacin/laropiprant in some populations, though it will be impossible to say whether any effect is due to the niacin or to laropiprant, which is given to reduce the side effect of flushing caused by niacin, said Dr. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.
    28 May 2013, 12:47 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    Dr. Ballantyne was principal investigator of ANCHOR,

     

    "The design and execution of the ANCHOR trial were robust and the trial results were very clearly positive," said Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, and principal investigator of the ANCHOR trial. "I am very impressed with the performance of AMR101. In particular, whereas current triglyceride-lowering drugs may raise LDL-C and causes patient treatment concerns, AMR101 demonstrated a decrease in LDL-C beyond the decrease created by statin therapy. Furthermore, it is very encouraging for patient care that AMR101 caused reductions in significant markers of cardiovascular risk such as Apo B and non-HDL-C. The greater triglyceride reduction in patients with higher potency statin regimens is also very encouraging."
    28 May 2013, 02:37 PM Reply Like
  • sts66
    , contributor
    Comments (1145) | Send Message
     
    Okay, so maybe it was one of these guys?

     

    http://bit.ly/18xaqdU

     

    Meeting Overview Venue: Walter E. Washington Convention Center Primary Audience: Primary Care May 21-23

     

    3:30 PM-4:45 PM Tackling the Toughest Issues and Cases of Hypertriglyceridemia Learning Objectives:

     

    1. Discuss the role of elevated triglyceride levels in the assessment and diagnosis of dyslipidemia, including cardiovascular risk factors

     

    2. Apply best practices in the attainment of TG levels, including the role of fasting and nonfasting states in accurate evaluation

     

    3. Evaluate the management of hypertriglyceridemia through greater adherence to evidence-based practices and accepted guidelines

     

    4. Select potential new and emerging therapeutic approaches to manage TG-based dyslipidemia, mixed dyslipidemia, and associated cardiovascular risk

     

    ==>Eliot A. Brinton<== MD, FAHA , FNLA (Read Bio) Vice President, American Board of Clinical Lipidology, Jacksonville, FL, President, Utah Lipid Center, Salt Lake City, UT, Director, Atherometabolic Research, Utah Foundation for Biomedical Research, Salt Lake City, UT
    ==>Michael Miller<== MD Professor, Departments of Medicine, Epidemiology & Public Health, University of Maryland School of Medicine, Baltimore, MD, Director, Center for Preventive Cardiology, University of Maryland Medical Center, Baltimore, MDMichael Miller MD Professor, Departments of Medicine, E

     

    Both are members of AMRN's steering committee or paid consultants:

     

    http://bit.ly/11vOKhH

     

    CVD Risk Reduction and Lipid Management

     

    Also found this:

     

    http://bit.ly/18xcAKg

     

    Dyslipidemia Management:
    State of the Art 2013
    Cardiovascular Health Summit, 2013
    Crowne Plaza, Billings, MT
    April 12, 2013
    Eliot A. Brinton, MD, FAHA, FNLA
    Vice President, American Board of Clinical Lipidology;
    Director, Atherometabolic Research
    Utah Foundation for Biomedical Research;
    President, Utah Lipid Center;
    Salt Lake City
    eliot.brinton@utah.edu

     

    Speaker Disclosures

     

    Dr. Brinton has received:

     

    •Research funding: Amarin, Health Diagnostic Laboratory, Merck, Roche

     

    • Honoraria as consultant/advisor: Abbott, Aegerion, Amarin, Arisaph, Atherotech, Daiichi-Sankyo, Essentialis, Genzyme, Kowa, Merck, Novartis, Regeneron, Sanofi-Aventis, Takeda

     

    • Honoraria as speaker: : Abbott, Amarin, Daiichi-Sankyo, Janssen, Kowa, Merck, Takeda
    28 May 2013, 04:08 PM Reply Like
  • sts66
    , contributor
    Comments (1145) | Send Message
     
    Instead of editing (again), I now believe it was Michael Miller, MD, who made that controversial statement last week. He was at the DC conference last week co-presenting with Brinton last week mentioned above.

     

    From: http://bit.ly/12gjnt4

     

    Triglycerides and Cardiovascular Disease in the T2DM Patient and Understanding Key Elements of Residual Cardiovascular Risk in T2DM Patients

     

    Introduction Michael Miller, MD, FACC, FAHA: First and foremost, I want to thank all of you for attending this CME symposium, Clinical Consults: Addressing Dyslipidemia Management Challenges in T2DM Patients—Improving Outcomes Through Guided Patient Solutions (GPS). What you need to know is that the program is jointly sponsored by Medical Education Resources, and importantly, Consensus Medical Communications, supported through an educational grant from Genentech.

     

    <snip>

     

    The first question that I’m going to tackle, and give Steve a breather, is it better to use fish oil than a fibrate in hypotriglyceridemic states? So, let’s focus on clinical outcomes because, first of all we don’t have any specific clinical outcome studies that have evaluated a pure hypertriglyceridemic population. And looking at use of hypotriglyceridemic therapy above and beyond standard of care, there is a study, and I’m on the steering committee for full disclosure.

     

    It’s called REDUCE-IT (Reduction of Cardiovascular Events with EPA Intervention Trial), which is using an omega-3 EPA compound and asking this question so, we’ll hopefully have some answers in the near future, actually probably in about 4 or 5 years. But in the meantime, we have to rely on the current data as they stand. We do have data with fibrates, as I mentioned, from subanalysis or the pre-specified analysis from ACCORD in a hypertriglyceridemic low HDL group, that fibrates added to a statin may confer additional benefit. Also in the omega-3 arena, we have data from the GELA study—that was a study done in Japan that used low-dose statins and omega-3—and they found that in the subgroup with high TG and low HDL, they also benefited. So you do have a choice here until we get data that actually, specifically address this question.
    28 May 2013, 04:47 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    I don't see any specific mention of not wanting to sell to ANCHOR patients until outcomes... Lovaza sell NOW to ANCHOR population off-label.
    28 May 2013, 05:06 PM Reply Like
  • seb90266
    , contributor
    Comments (12) | Send Message
     
    Hi Steve,
    What do you think would be the impact on PPS and potential B/O price if reduce-It fail?
    Thank you
    28 May 2013, 12:53 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Wont matter, reduce it farther out than Anchor.
    28 May 2013, 01:12 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Steve,
    It will matter if we aren't BO and Anchor isn't selling well because the majority is waiting for outcome data. Of course, I love to be wrong.
    28 May 2013, 05:29 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    steve any thoughts on summer streets comments that their is no reason to prescribe vascepa to patients with less thn 500 trigs until the studies are complete?
    28 May 2013, 01:22 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    Look at the ANCHOR trial data. That should tell you that regardless of any cardiovascular events study, Vascepa is useful in that indication range.
    29 May 2013, 06:56 PM Reply Like
  • Danburydude
    , contributor
    Comments (108) | Send Message
     
    Let us look at the OMTH charts. Last Tuesday, the short percentage was almost 80% of the float. Then, last Wednesday, the short percentage of the float went to almost zero on very heavy volume. Hmmmm. Looks like this was an open secret late last week.
    That the brings us the the bash articles on Friday. Another preplanned attack. Must be a coincidence. Nothing like some stock manipulation after a three day weekend.
    By the way, I did notice how the statement that ANCHOR won't be approved is now being back tracked to ANCHOR sales will disappoint on the one in a million chance it is approved. I was waiting for that argument to pop up.
    28 May 2013, 01:43 PM Reply Like
  • sts66
    , contributor
    Comments (1145) | Send Message
     
    "Let us look at the OMTH charts. Last Tuesday, the short percentage was almost 80% of the float. Then, last Wednesday, the short percentage of the float went to almost zero on very heavy volume. Hmmmm. Looks like this was an open secret late last week."

     

    Huh? 80% short? NASDAQ.com shows only 338k short as of 4/15, and shortanalytics.com shows 404k shorted shares covered on 4/22 - absolutely a leak - wish I'd have been tracking that stock, a dead giveaway! And they'll get away with it too, SEC won't even bother to look at the obviousness.

     

    "By the way, I did notice how the statement that ANCHOR won't be approved is now being back tracked to ANCHOR sales will disappoint on the one in a million chance it is approved. "

     

    Sorta like how Fartstein goes from "No Lorcaserin approval" to "it won't sell"?
    28 May 2013, 03:50 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    Reasons why ANCHOR needs to be approved:
    http://seekingalpha.co...
    28 May 2013, 02:06 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Keep your eyes on PFE
    28 May 2013, 03:36 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Bought more $10 strikes today. I love pain! I sometimes wonder if there is a battle going on behind the scenes and AZN dropped out. OMTH went public recently and certainly they would have held off if buyout discussion were serious. So it seems AZN changed direction recently for a reason. Maybe its wishful thinking but the only thing that makes sense to me at this point.
    28 May 2013, 03:56 PM Reply Like
  • stephenhandal
    , contributor
    Comments (187) | Send Message
     
    Please, enough with the speculation. Absolutely NO ONE expected this AZN - OMTH buyout. Anything could happen. Just wait it out and see.
    28 May 2013, 08:52 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    http://bit.ly/144lBGy

     

    Looks like someone knew something early, May 22nd trades should all be checked out.
    28 May 2013, 08:59 PM Reply Like
  • studythosestocks
    , contributor
    Comments (28) | Send Message
     
    I've got to agree with you on PFE. AZN was first in line I have believed for some time but just weren't willing to pony up the money (or couldn't compete with current negotiations). Two interesting factors currently with Pfizer. 1) They announce planned split off of Zoetis which has treated them very well (shareholders of Pfizer can shift a negotiated amount of shares over to ZTS at a 7% discount thus cleaning up house and keeping them as they say "focused on its core business as an innovative biopharmaceutical company".

     

    2) 4Bill Cap raise announced to restructure debt and notes.

     

    An announcement will not come until at least after the June 17-19th settling period with Zoetis split off but if we get NCE on June as many are anticipating, and Pfizer is successful in their plans, things could get interesting very quickly in the next 3 to 4 weeks.

     

    I think AZN's activity may be forcing everyone's hands now. Time will tell.
    28 May 2013, 09:46 PM Reply Like
  • bravo33
    , contributor
    Comments (60) | Send Message
     
    Maybe, but it could also be AZN executing their bolt on strategy and OMTH playing "we'll go it alone" to try and drive price up. Who knows.
    29 May 2013, 06:23 AM Reply Like
  • sts66
    , contributor
    Comments (1145) | Send Message
     
    I doubt PFE floated those new notes to do anything other than retire the ones coming due in 2013/2014, $4B is a pittance compared to their current cash hoard ($35.41B) and debt levels ($40.40B).

     

    AZN has a similar debt/equity ratio (45), MRK's is 37, while GSK's is a whopping 254 (!?!) - $6B cash/$31B debt - count them out as a potential AMRN suitor.
    29 May 2013, 12:34 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Sts,
    PFE could buy us wi a check if they wanted rig now.
    29 May 2013, 09:53 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Steve,
    I am not so happy about this purchase of Omthera it tells me AZN walked away from us. I wish I knew the reason, if it was due to the fact that Joe wanted to much money this could be problematic.

     

    If this stock were purchased tomorrow for 100% more, it would be pathetic. Yet, to me if there is more and more pressure on us with the stock deflating Joey will have to drop the price or GIA.

     

    As for Anchor I am concerned as I am reading about cardiologists that are indicating they won't be prescribing V until outcomes study for less than 500 trigs.
    28 May 2013, 05:19 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    I can not emphasize how ridiculous it would be to not prescribe Vascepa to ANCHOR patients, sure some might say that, but who knows if there is a conflict of interest there...

     

    EPA has shown itself to be SUPERIOR to a statin in a one on one study at reducing MACE as well as altering the structure of plaques compared to absolutely ZERO altering of plaques by the statin.

     

    Vascepa lowers lpPLA2 and hs CRP, two markers, when elevated, increase the risk of adverse events 100%, Vascepa lowers these markers. This was a secondary endpoint to ANCHOR.

     

    If you have high lp-PLA2 you better not be foolish enough to wait till 2016 to make the decision to lower it.
    28 May 2013, 05:27 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    And if you aren't aware by now, shorts say a lot of things to try to scare the shares out of you, they expect you to react just like you are reacting.
    28 May 2013, 05:28 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Perhaps they did not walk away but got priced out by others. When OMTH went public weeks ago did that mean nobody was interested in them? No...For all we know there is a bidding war and azn got priced out.
    28 May 2013, 06:10 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Jolk,
    I respect you as you know. I haven't sold, but I do have concerns. As to me I know we won't know but love to know why AZN passed on us to purchase OMT.

     

    As far as I know Omthera has no patents, correct? Just the phase III study which it is completing?
    28 May 2013, 06:26 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    Why AZN passed on us to purchase OMTH? Only they can tell you, and they aren't going to be telling anyone... So should we assume the absolute worst, every time or should we try to be dispassionately objective when looking for that answer?
    28 May 2013, 06:30 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Jolk,
    I wonder and again it is total speculation. If Joey wants to much, or wants more than BP is willing to give. I think he needs to look at what it will take in the next two years to make this a BB, before OMTH gets out there.

     

    AZN saw value in OMTH when many of us did not, it looks to me like NCE will be a yes for them, again I am not the FDA.

     

    I do not believe either that a deal can't be structured based on NCE yes or no, as look what AZN did with OMTH. If they meet certain objectives after they are purchased, sales goals, indications shareholders can get additional monies.

     

    Thus it tells me that NCE or no could be priced in based on FDA. Either way it is bad for us. I don't appreciate AF attitude but his story today was a good one in the sense that perhaps BP is interested in fish oil, just don't want to pay alot for it.

     

    Best scenario we partner and scripts grow.
    28 May 2013, 07:40 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    Amarin will have more than a year under their belt before OMTH/AZN gets a sniff of sales.

     

    We will know about ANCHOR before their sales as well.

     

    AZN has to pay for the development toward PDUFA and any outcome trials, REDUCE-IT is more than half-way enrolled.

     

    OMTH was eager to sell cheaply, I guess they aren't too optimistic about their future, else they would go it alone as well... How would they have funded their development with their poor IPO? How would they have funded their Outcomes trial? They are a Lovaza upgrade with DHA that raises LDL-C.

     

    They have no patent protection. AZN got them on the cheap.

     

    If you have any doubts about Joe, Vascepa, ANCHOR, you should sell now and invest elsewhere.
    28 May 2013, 08:06 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    It is pretty much proven we are superior to all drugs in the marine indication and have many catalysts such as combo and anchor in the near future. This stock is worth a absolute minimum of $ 15 a share ( most likely double + that). It is a matter of time and it will happen. I admit it is frustrating but in the end I am confident we will all be happy jzand company held off on taking a low ball offer.
    28 May 2013, 06:01 PM Reply Like
  • jasonturbo
    , contributor
    Comments (6) | Send Message
     
    I think there isn't much use in discussing the OMTH purchase with relation to AMRN.

     

    Apples to Oranges in my eyes, a realistic means of comparison would be Blackberry to Apple. AZN has purchased has "Blackberry", though they obviously are getting an inferior product, they still managed to obtain a product that can be marketed to the same customers - a fraction of the cost of the superior product, "Apple" (AMRN).

     

    It's a tough position to be in for potential AMRN suitors, especially as the price of AMRN continues to slide. JZ will not take less than 20$/share, so how do you justify to your existing board and shareholders that you want to pay a 3x+ multiple for a company which is selling a product that has multiple competitors and isn't gaining "viral" traction? (Not bashing current sales, they are fairly in line with estimates, and on a personal level I am satisfied)

     

    I don't think AZN is walking away from AMRN, I just think they see opportunity to purchase a competitor for 300M+/-, when you compare the price paid for OMTH, it seems like a bargain compared to the price paid for Reliant (LOVAZA) @ 1.65B or the expected price to be paid for AMRN - likely north of 3-4B. With the price you pay for AMRN you assume more risk, you need big sales targets, where as with EPANOVA you need only a small sales target to recoup your investment and turn a profit.

     

    Having said that, I believe it's difficult to really "price-in" the Anchor indication as there currently is no treatment on the market like Vascepa and it's hard to know just how aggressively doctors plan to prescribe for high TG's. The cost of the medication may be too much for many people who don't have the right coverage and it's possible the MD would sooner allow them to fall into very high TG's before prescribing as it could be there difference in whether or not they are covered by their plan etc. I'm not familiar with the difference in frequency of cardiac events between the high and very high TG groups, this could be a major factor in how often MD's will issue scripts to the high TG crowd etc.

     

    Lot's of variables, the one safe bet is that at a market cap of 1B, AMRN is a complete bargain, with Anchor it would seem that 2-3B is still a very good deal. (Especially factoring in the REDUCE-IT, patents, suppy chain, etc.)

     

    It's cheap diversity, and I would say it was good decision on the part of AZN.
    28 May 2013, 07:17 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    Reliant and Amarin had/have FDA approved products on the market, Omthera is at least a year away from MARINE population, if they get it.
    28 May 2013, 07:25 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Jason,
    Very valid point and myunderstanding was Joe wouldn't take less an 30 which was nuts to me.
    29 May 2013, 03:25 PM Reply Like
  • cptbac
    , contributor
    Comment (1) | Send Message
     
    Amarin (AMRN -6.4%) trades lower on negative comments out of Summer Street this morning, saying that Vascepa might not be as key as previously thought. The firm notes that a member of AMRN's steering committee presented at a primary care conference last week, and said there was no reason to give Vascepa to patients with triglycerides <500 mg/dL until the outcome of current trials are completed, and, even if approval is granted early, sales are likely to disappoint.

     

    Key disclaimer:

     

    "and, even if approval is granted early, sales are likely to disappoint." Although negative coverage, even they are not ruling anything out in terms early approval or on time approval. At this point, much to do about nothing.
    28 May 2013, 07:17 PM Reply Like
  • Matt Bayer
    , contributor
    Comment (1) | Send Message
     
    Is it a buy at current levels around 6.26?? Also when do you think NCE outcome will be?
    28 May 2013, 07:17 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » To be clear: AZN did not pass on AMRN; they really were never in the game. Their CEO is on record stating their near-term acquisitions will be focused on small, under $500MM buyouts. It's a failed strategy that cannot be near-term accretive to their growth. For that, you need a company upand ready to go, like AMRN with approvals, patents and next steps already taken.

     

    PFE just structured $4B debt sales, a good structure, let's see where this goes...

     

    I've maintained $4-6B will get this done, anything less gives the company away. OMTH is no AMRN, they knew it, that's why they sold out so cheap, just after going public. Its a huge risk for AZN, no NCE, no approval, slim line of IP, no next stages done in development...they basically acquired a development stage company...but only paid a little bit.
    28 May 2013, 11:19 PM Reply Like
  • permann
    , contributor
    Comments (3) | Send Message
     
    PFE is also divesting its 80% stake in Zoetis, the deal to be closed by June 19. PFE received $2 billion for the first 20% it sold in the Feb. Zoetis IPO. It will be an exchange offer subject to certain restrictions, one of which is the exchange of a minimum of 160,394,000 shares, up to a total of 400,985,000 shares. That 40% minimum gives them at least $4 billion +, and if they divest all the shares upwards of $8-9 billion. They announced this on May 22. The AZN deal is announced 6 days later. So PFE has the money. The timing seems about right too.
    29 May 2013, 08:16 AM Reply Like
  • stephenhandal
    , contributor
    Comments (187) | Send Message
     
    Thanks for deleting my comment Steve. I appreciate it very much. I'm going to try to get that reposted by SA.
    29 May 2013, 06:59 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » New article coming soon BTW, will have lots of new info, possibly some straight from AMRN - will be major eye opener to many here on insights to what happens next and what has transpired to keep us down so low.
    28 May 2013, 11:22 PM Reply Like
  • kylebriz
    , contributor
    Comments (9) | Send Message
     
    A $20 bid with additional 5 for nce and 7 for anchor approval could happen tomorrow.
    29 May 2013, 09:37 AM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    15 is more an a fair price and assumption of all debt.
    29 May 2013, 03:27 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Ill take $17 with $4 for NCE and another $6 for anchor. It would be like 3 pay checks.
    29 May 2013, 10:59 AM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Marine worth $13, at least another $13 for anchor and $4 for nce with a future payout based on reduce it results of another 10 plus.....could be easily $40 plus payout by year 2016
    29 May 2013, 07:01 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Lets not forget combo and statins, that's got to add at least $ 5 to this deal
    29 May 2013, 07:05 PM Reply Like
  • drrc1949
    , contributor
    Comments (8) | Send Message
     
    Steve, I am a devoted acolyte of Vascepa.......Amarin???, not so much....

     

    I provided some information and posed several questions to the company through IR email and snail mail but received no feedback. I can understand that, they're a small company after all. Likewise I tried the message board route which generated some lively discussion but no clear answers. Late yesterday, I discovered that you had returned and I've just finished catching up on your blogs and comments .

     

    Although Omthera/AZN hold no Omega-3 patents directly, DD published elsewhere by Biobillionaire reveals that Omthera has one application for Epanova in enhancing the effects of Clopidgrel anti-platelet therapy. Additionally,Omthera has a license agreement with Chrysalis Pharma who has 4 EPA related patents. Two of these are for capsules and two are for treatment of Irritable Bowel Symptom, a major inflammatory condition.

     

    I concede that acquisition of Omthera by AZN might just be a play for a combo drug with Crestor. But I can't stop wondering if something more may be at play here. AMRN longs have been made aware of the EPA:AA ratio and its potential impact on overall health. It's the basis for the huge breadth of potential indications for Vascepa, specifically due to its anti-inflammatory effects.

     

    Is there a chance that AZN is initiating a formidable end run with the Omthera product, perhaps in a modified form, by focusing on securing patent protections not contemplated by Anchor? AMRN has done all the legwork but the target has been treatment of lipid disorders. If AZN becomes the first to file claims that laser focus on EPA anti-inflammatory benefits, does Vascepa lose out to the AZN Omega-3 product? Does the current or applied for Patent Wall protect AMRN/Vascepa from this direction of attack?

     

    Or maybe AZN did, in fact, just buy a bargain entry point into the lipid space. Thoughts?
    29 May 2013, 06:54 PM Reply Like
  • Jolk
    , contributor
    Comments (220) | Send Message
     
    I believe Reliant was working on EPA/AA stuff in their patents apps. Joe Z and crew must be familiar with it.
    29 May 2013, 07:04 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    Also, with Epanova containing a fair amount of DHA just as Lovaza does, I would assume it may very well get an A-Fib warning if it would make it to market.

     

    Doctors won't prescribe the inferior product. Vascepa does a better job and doesn't have a warning label.

     

    AZN may have purchased it solely for the combo drug possibilities.
    29 May 2013, 06:55 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Dallas,
    Lovaza is still a billion dollar drug wi Afib and DHA
    29 May 2013, 09:55 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    The crazy thing about this stock is the company would be able to sell itself in a heartbeat for $10-12 a share which is a 35 to almost 50percent increase to its current price. Us longs should be buying up as much as possible at these levels. Take advantage of it as it will pay off, how much is the question.
    29 May 2013, 07:23 PM Reply Like
  • Samuel-
    , contributor
    Comments (103) | Send Message
     
    you mean almost 100%.. [from 6.5 to 12]
    29 May 2013, 08:59 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Correct not sure what I was thinking
    30 May 2013, 09:03 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (68) | Send Message
     
    Elan Corp. is keeping an eye on Amarin as a possible acquisition.
    :)
    30 May 2013, 05:25 PM Reply Like
  • ajbrzoz
    , contributor
    Comments (45) | Send Message
     
    Top BO possibilities:

     

    1)Pfizer
    2)Teva
    3)Elan
    4)Merck
    5)GSK

     

    or a combination of two of the above.
    1 Jun 2013, 12:19 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Forrest Labs seems to be interested but not sure in what capacity
    8 Jun 2013, 04:54 PM Reply Like
  • Scientist on Stocks
    , contributor
    Comments (186) | Send Message
     
    hi Steve, what makes you say that? any public disclosure by Forrest/ your sources / guess ?

     

    TIA
    9 Jun 2013, 12:25 AM Reply Like
  • stephenhandal
    , contributor
    Comments (187) | Send Message
     
    Sorry but the Forrest Labs rumor is complete bull$hit. It originated from YMB and has since spread around to StockTwits, IHUB and other websites.

     

    If you have another source though, then let us know..
    10 Jun 2013, 02:20 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » FL has met w/ AMRN, we know that. What has or may be transpiring, we don't.
    13 Jun 2013, 10:44 PM Reply Like
  • Scientist on Stocks
    , contributor
    Comments (186) | Send Message
     
    no, we don't know that. Can you provide the source of information ?

     

    i m aware of Elan's interest in amarin and i have the source but when did FL disclose such thing?

     

    TIA
    18 Jun 2013, 02:15 PM Reply Like
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