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Amarin Corporation plc Message Board

  • mtdsus mtdsus Sep 20, 2012 11:48 AM Flag

    NCE is NOT as important as Patents--See Astra Zeneca fight with Generics in 2007--2010

    NCE is not as important as Patents. Take a look at Crestor by Astra Zeneca.
    FDA lifted its protection of Crestor in 2007-followed by Generics like Apotex etc. filing applications with FDA in 2007.
    Astra Zeneca sued them--and WON. Generics argued that Patents were fraudently obtained.The judge dismmised and Apotex had to pay penalities for selling.
    Also note--Astra Zeneca initiated JUPITER trials--which were to take 4-6 years like Amarin's OUTCOME trials also called REDUCE-IT. But in 2009 (2 years into trials--Astra reported the early data to FDA panel for Review. The panel favored the Jupiter results with a big majority.Finally in 2010-FDA approved Crestor for Reducing Cardiac events--even though many questioned Why people with C-RP below 2 were excluded.
    Anyhow CRESTOR sales jumped from 4.5 billin$ in 2009 to 6.5 bill.$ in 2011.
    Crestor patent expires in 2014.
    So if OUTCOME STUDY results are GREAT--as JELIS study for Epadel in Japan were(1999-2005)--then AMARIN may ask FDA for additional LABELING APPROVAL in 2013 or 2014.
    SO AMARIN's Value could shoot up in 2013 or 2014.
    WATCH OUTCOME TRIALS closely in 2013/2014.
    Don't worry about NCE !!!

    Sentiment: Strong Buy

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    • In the long run Patents could prevent generics for at least the 8 year time frame the NCE gives them exclusivity.
      However, as your post shows not having it means uncertainty to whether a lawsuit would be won, time and money defending the lawsuit, AND in other cases the generic company has won the lawsuit and defeated the patents so that leads to a lot of questions that are unanswered and thus not good for the stock price.

      Nobody on this board is a patent attorney and could tell you the odds of the patents standing up.

      Since BO is the #1 likely option there is a value placed on NCE, I've seen $6 by one analyst. Whether the reality becomes that NCE was not needed because patents were so strong it prevented generics anyways is moot. NCE is a guarantee. Patents are not. Simple as that and there is quite a bit of value in that guarantee.

      So you MIGHT be 100% accurate in your assessment....but NCE still matters.

    • You make the same common mistake as others on here. You compare PATENTS VS NCE. It is NOT about which has better protection, it is about what NCE does for the patents. In short, it protects against patent lawsuits and the VERY expensive patent fights that result. It does not matter how many patents you have, there will be patent lawsuits, and the bigger the prize the more likely there will be expensive lawsuits.

      The other issue is no matter what you, me or anyone else on this board thinks or believes, the MARKET and any acquiring BP has a value set on what Amarin is worth with NCE and without. PERIOD. The market and BP could care less what you set forth above. Need proof? Look at the PPS since the last announcement that the NCE status was going to be delayed again. Everyone and his uncle is staying on the sideline waiting for the other shoe to drop on NCE status. The only action on AMRN is the shorts working it lower since they know they have until October 8 (next OB) to work this down. Furhter proof? Check the spreads in options trading at the popular strike prices. There is about a $5 spread being bet on NCE.

      So tell me again NCE does not matter. Well you may not care, but others (the market and BP) who have a big influence on what the PPS is (and what we get) do care.......and that makes me care as well.

      Sentiment: Strong Buy

      • 1 Reply to ucamjf
      • u-cam..

        You know what they say about opinions...

        MO..Do not think the the NCE is a big deal one way or the other...In point of fact the FDA approval is more vital than any of the patents, because you can not sell one pill without the FDA's sanction. From an exclusivity standpoint both the NCE and the new clinical investigation exclusions are actually longer than the statutes indicate, because although a generic can file at the end of the term, the FDA on average takes about 19months after the filing to grant the approval to the generic. If AMRN does not get the FDA NCE, they will four and a half years of FDA exclusivity from the new clinical investigation exclusion, before a generic enters the market.

        IMHO...There is a very good chance no generics will decide to take AMRN on...What you say!!
        AMRN's business plan is not going to favor copy cats..Ideally generics cash in on the high mark ups over cost on brand name drugs..That is their strat...undercut the price. Vascepa is a different kind of drug..Due to the huge patient population addressed by Vascepa, and that it will be used long term on a daily basis, AMRN will able to cut the profit margins to razor edge and still make hug money off the volume. In essence leave no room for generics to cut the price.

        The "first in" premium on this drug will be enormous. Talk about lawsuits coming 3-4 years from now...they won't see the courtroom for years. By that time AMRN should be enjoying a land rush business...As far as BP..Well you know I personally hope they never sell to BP, so you might get the idea I really do not care what BP thinks about the NCE or anything else...

        Have a nice day...

        ": ) JL

        Sentiment: Strong Buy

    • todhale Sep 20, 2012 11:57 AM Flag

      Good post. I have always thought that early data from REDUCE-IT, combined with the safety profile, would be a no brainer for the FDA to fast track additional labeling. I actually think this is the "negotiating point" regarding a BO as this will dramatically increase the market for Vescepa.

      Sentiment: Strong Buy

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