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Amarin Corporation plc Message Board

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  • jesse.livermore jesse.livermore Nov 14, 2012 6:57 PM Flag

    Exclusivity, NCEs patents, generics..


    So the stated H-W exclusivity periods are actually shorter than the real times required for a generic to launch...In reality the listing of a drug in the Orange Book (It was originally Orange, because it first came out around Halloween...true) usually results in about seven and a half years of exclusivity even without the NCE.

    But AMRN has more going for it than the defense of lawyers and agencies...Generics' main strategy revolves around the fact they can sell the drug for a substantially lower price than the brand can, because for the most part there actions are mainly on paper...So commonly generics sell for 50-70% the price of the brand...This is not likely to work in the case of Vascepa, a lot of the drugs generics attack are drugs with limited sales volumes, the type that the brand has to mark up to cover the seven or so years of research and FDA costs...Vascepa with a potential 40mil plus patient pool will and should employ a strategy of thin profit margins which will still provde huge earnings because of the volume, but destroy the incentive of the me toos...

    Then there is the the requirement for supply...we are talking about tonnes of reined product..No generic can afford to tie up suppliers for the years of exclusivity which puts AMRN squarely in the driver's seat...And catching up after AMRN has five or so years of garnering refiners is not going to be feasable..

    IMHO...the NCE simply fades to black in this scenario

    ": ) JL

    Sentiment: Strong Buy

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    • cont...

      The REDUCE-IT study and the NCE are only tangentially related. The NCE effects the H-W exclusivity period and REDUCE-IT' being "substantially underway" is an FDA requirement for the sNDA allowing Vascepa to be FDA approved for the dyslipidemia clinical indication. An indication that is over ten times the size of the FDA indication for which the drug is approved at present...So the answer is, of course you continue REDUCE-IT....

      ": ) JL

      Sentiment: Strong Buy

    • Thanks JL
      Appreciate the well reasoned analysis.

      Sentiment: Buy

    • Any examples of a market being large enough that a drug company charged a low enough price to dissuade competitors? Thank you.

      • 1 Reply to coumery
      • coumery...

        If they successfully thwarted the competition, how would we know?...Put yourself in the position of being a generic...Does it sound more logical to market and sell a product with limited volume and a high profit margin...or have to get all those refineries and realise if you don't capture a substantial portion of the market quickly, you might be in financial trouble.. limited drugs with high profit margins, the price drops of 50% or more by generics currently result in conversions (switching to the generic) of 80% within two to three months...due to 3rd party coverers and co pays...

        This will not happen in AMRN's case...

        ": ) JL

        Sentiment: Strong Buy

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