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Steve Rosenman
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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
  • Note From Aegis On AMRN Situation 12 comments
    Sep 13, 2013 9:39 AM | about stocks: AMRN, GSK, AZN
     

     

    Teva / Par Lovaza Win Is A Blip: Reiterate Buy

     
    • Generic Lovaza May Still Be Years Away. Yesterday, it was announced that Teva Pharmaceutical Industries (TEVA/NYSE, Not Rated) and Par Pharmaceutical Co. (Private) had won an appeal against Pronova BioPharma in the U.S. Court of Appeals in their ongoing battle to obtain the right to launch a generic version of Pronova's Lovaza (omega-3-acid ethyl esters) in the U.S. We believe that the negative reaction to this news by Amarin investors was both ill-considered and unwarranted. In anticipation of approval of Vascepa™ in mixed dyslipidemia in December 2013, we reiterate our Buy rating and 12-month price target of $30.00 on Amarin shares.
    • Teva / Par Victory Does Not Mean Curtains For Amarin. We believe that the Lovaza patent news yesterday is of minimal relevance for several reasons. First, this appeals court decision does not automatically allow Teva and Par to begin marketing a Lovaza generic in the U.S. The case was yesterday remanded back to the lower district court, which in 2012 ruled in favor of Pronova. Second, we believe that Teva may have problems accessing sufficient fish oil supply to even make a generic version of Lovaza at commercial scale. Third, even if Lovaza generics eventually appear in the U.S., we believe that Amarin's Vascepa will remain viable as a commercial franchise because we remain optimistic that the drug will be approved near-term for use in mixed dyslipidemia. As we have stated repeatedly in the past, Lovaza cannot secure a label in mixed dyslipidemia as it elevates LDL-cholesterol. Thus, if Vascepa receives a mixed dyslipidemia label it should effectively become immune to cheaper competitors like Lovaza generics.
    • No Free Ride For Generics. We would remind investors that overturning the Lovaza patent estate is not a particularly noteworthy achievement. One of the Pronova patents initially challenged by Teva and Par expired in March of this year, while the other (the '667 patent) expires in April 2017. Investors would be well-advised to remember that even if generic filers win on the litigation front, they still have to obtain FDA approval for their copycat drugs. Thus far, the FDA has yet to approve a single Lovaza generic. Again, even if generics of Lovaza were to appear, they would not have a label in mixed dyslipidemia and would not be usable in that indication as reimbursement agencies would not be able to pay for them.
    • FDA Advisory Panel Does Not Present Cause For Concern. A panel vote on the approvability of Vascepa in mixed dyslipidemia is taking place on October 16, 2013. There is substantial cardiac outcomes-based evidence, most notably from the well-powered GISSI-Prevenzione and JELIS studies, that prescription-grade omega-3 fatty acids like Vascepa improve cardiovascular outcomes and reduce deaths in mixed dyslipidemia patients.
    Stocks: AMRN, GSK, AZN
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Comments (13)
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  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Saw this post on yahoo-comment??

     

    "I've been long Amarin for over a year now. (You can check my previous, albeit few, posts) However, I am concerned about Klosterman's Seeking Alpha article referring to a new drug that's completed phase I trials, PRC-4016 by Pronova, that purportedly lowers trigs, LDL-C, but raises HDL-C. Can anybody comment?"
    13 Sep 2013, 01:02 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Sounds like combo drug. Smartest thing GSK could do is discontinue Lovaza due to its fib warning and raising cholestral. Buy Vascepa and market it properly as the new improved drug. By the time Generic Lovaza hits it would have such a bad name nobody would touch it.
    13 Sep 2013, 02:34 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » would be smart...
    13 Sep 2013, 06:42 PM Reply Like
  • Naeeve
    , contributor
    Comments (2) | Send Message
     
    That's it!
    13 Sep 2013, 06:42 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    $5 billion
    14 Sep 2013, 10:50 AM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    The biggest telltale sign that AMRN is going to GIA for Anchor, if it is approved, is the change in their 1st qtr CC communication that they plan to partner and not GIA to the 2nd qtr CC that they once again have their infamous "3 options".

     

    Unlike some people who believe the entire pharma industry is clamoring to buy this company and will spend untold billions for it, I think AMRN management is finding that BP is calling AMRN's bluff. BP is more than willing to wait, if they indeed do have any desire to purchase AMRN.

     

    If Anchor is delayed or rejected, then this company is toast.

     

    Disclosure: I am long shares but not very hopeful based on management's previous decisions and communication.
    14 Sep 2013, 12:34 PM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    It is hard for me to believe that people who come on a board and post such negative thoughts on a company, yet are long the stock, can't find another stock out of the thousands listed, that are a much safer play than AMRN.
    14 Sep 2013, 01:09 PM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    Rydad21, by no means is AMRN a safe play. It is bounced around daily like a ping pong ball. It has a management team that is hardly transparent and changes directions every couple of months. It's one thing to invest in a company for its promising product but another to realize that the management team in place makes one bad decision after another with regards to getting the product into the market.

     

    If Anchor is approved and management does another GIA, this stock will suffer. A solid partnership is required to give AMRN the working capital and resources to make Vascepa a success. So far, this GIA approach is failing. After 7 months, the product has finally broken over the 5k scripts a week.

     

    You and others may say the above is negative but I say it is realistic. It's all too easy to promote grand future events as so many people on this board do. When these future events do not occur, then excuses are made and new time lines created.
    14 Sep 2013, 02:14 PM Reply Like
  • jeerio2
    , contributor
    Comments (8) | Send Message
     
    There are always a number of issues in play with Amarin. One is the drug itself - the science - and others are the controversies surrounding the FDA, GSK, and thoughts about "collusion" to keep Vascepa under wraps.

     

    The AdComm is approaching. Given the terms of the SPA, with a clear focus on safety & efficacy, it should be a slam-dunk. With a logical follow-up for full approval come PDUFA come December 20th. So, the question is, what might de-rail those events?

     

    The Feuerstein idea is that the expert panel will vote to wait for Reduce-It to be completed to see if the CV event reduction is real with Vascepa/Anchor. As we all know, the JELIS study, using 1.8g/day was wildly successful, essentially reducing CVEs by 20% overall, and 53% in the sub-group that had more serious issues. And, Reduce-It has been designed to assess results with patients who have those more serious, pronounced issues already.

     

    What will a 4g/day dosage do to effect that outcome? One could believe it will only get better. Who would want to suppress such a result, or more importantly now, delay the realization of those kinds of results over the next 2.5 years until Reduce-It outcomes are reported?

     

    I can't answer those questions definitively, but somewhere in nthe Wall Street and Big Pharma community, there seems to be evidence of attempts to keep Amarin from succeeding. A novice can understand that based on safety & efficacy, Anchor approval should be a no-brainer. Yet even this week, the newest wrinkle arrived: the push for generic Lovaza. Making an inferior drug cheaper for a handful of people doesn't actually advance the cause of health improvement. Those with insurance will be able to get Vascepa at a perfectly good price, and while some docs may take their time, most will be be compelled to switch to Vascepa through both the science and the Tier 2 incentives.

     

    Everyone knows that Lovaza is inferior to Vascepa. It's had a great run, but it has important downsides that aren't going away. Vascepa eliminates those downsides, helps the patients reduce TG levels, and as many have noted, seems to have a positive effect on numerous other health elements including inflammation and important concerns to the diabetic community, among others.

     

    So, what's the FDA to do? Delay Vascepa because BP interests are at stake - aren't ready for actual competition? Make millions of potential patients wait until Reduce-It results are proven, when there's nary a shadow of a doubt that those results will meet or beat the outcomes from JELIS?

     

    At the end of the day, integrity matters. People's lives and health matters. Say what you want if you're a pundit proclaiming an Anchor delay until R-It is finished, but if you take that stance, please come forth with a cogent rationale that supports your view. No one has supported those predictions with any facts, or a reasonable rationale for that outcome of the upcoming AdComm.

     

    I stand in favor of the science, the SPA agreement between the FDA and Amarin, and the fact that the integrity of the decisions made by the expert panel and the FDA will rule the day. It's not something Wall Street and it's monetary influence has any place being the final arbiter.
    15 Sep 2013, 11:58 AM Reply Like
  • kylebriz
    , contributor
    Comments (9) | Send Message
     
    Thank you Jeerio2!! Well said. What would an SPA be worth if they didn't honor the one with AMRN? Plan your trade and trade your plan. Money will be made being long from here on out.
    15 Sep 2013, 06:52 PM Reply Like
  • david22hughes
    , contributor
    Comments (237) | Send Message
     
    From the most recent Q2 Conference Call.....

     

    CEO Joe Zakrzewski:

     

    ".......we believe that we are well-positioned for approval of the ANCHOR indication. While we appreciate that investors took the risk associated with approval of this indication, we believe that our likelihood of success is much, much higher than we appear to be given credit for by the Street. (Funny he should refer to the Street. Isnt that the same crowd Adam Fartstain works for?) We are proud of successes we have had during first half of, and we believe that sticking to the five-point of light, if you will, that we have been talking about everything else will take care of itself.

     

    Number one, get the launch right. Number two, get managed care which we have done quite well on. Number three, get the ANCHOR sNDA accepted and get the indication approved. Number four, drive IP, particularly ANCHOR. Number five, supply chain. We are also eager for the tremendous opportunity that exists in the ANCHOR indication.

     

    I look forward to the positive catalyst that we believe will be the advisory committee and the PDUFA date. We look forward to the launch of Vascepa for the ANCHOR indication. When we do so, compared to the MARINE launch, we will be doing so with the advantage of significant managed care coverage and significant brand recognition amongst the highest prescribing physicians of other lipid lowering therapies. We will also have a first-in-class label with a very strong safety and efficacy profile."

     

    From the Q&A:

     

    Thomas Wei - Jefferies
    And maybe just a second question. I am sorry I think I have been hoping back and forth between calls here. I missed a little bit of what you said in terms of partnership for ANCHOR. Have you more shifted now towards thinking that you have got that you could do it yourself? How should we think about the different possibilities and where things stand?

     

    Joe Zakrzewski - Chairman of the Board, Chief Executive Officer
    I think the possibilities are all the same. So, Thomas, I think if we continue to get to know this market pretty darn well. We are seeing that we have got the right reach and penetration as well as the decile 7 to 10 we are [reaching frequently.] I think we have not made any decisions. We continue to have dialog and we are spending a lot of time both, as a management team and as Board thinking about these. We have got time, we are trying to do the right thing. What we don't want to do is, get into something that doesn't provides the right value if we do that.

     

    For example, there are companies out there that are getting a small fraction of what the economics are. This is got to be the right thing for us and any potential partner. I think other than that, I will go back to, we are still working those five things. And if we do those right, everything else will take care of itself, including whether we end up with a partner or not, but we are still sort of thinking about that and working through it."

     

    As far as shareholders are concerned, the company couldn't be in better hands. JZ has been here before and knows the score.

     

    Fear and negativity towards Amarin and its management team stems from a basic lack of knowledge about what is going on. If you havent done your homework you have every right to fear and shittalk. If you have studied ALL the available information and have even half a brain capable of processing it, you will KNOW that there is nothing to fear.
    16 Sep 2013, 07:29 AM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Post on Yahoo MB:

     

    And the winner is ...Atorvastatin!!! I will translate... Lipitor!
    Yes, we finally have a patent application for Vascepa (EPA) with Atorvastain (Lipitor). This is the biggie. I would say that about 80% of the patients I see who are on a statin are on Lipitor instead of the other competitors, so if they get approved for a combo drug this will win big (very big!). Let's hope someone notices this today. Less
    16 Sep 2013, 10:08 AM Reply Like
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