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Amarin Corporation plc Message Board

  • livinlifeveryday livinlifeveryday Oct 26, 2012 12:29 PM Flag

    Why PTO is quandry for FDA on NCE

    The recent 889 and 153 patents issued present a quandry for the FDA on the issuance of NCE
    The reason is simple.

    Although its clear that icosapent ethyl is already contained in Lovaza and hence disqualified from being awarded NCE status , the PTO in fact ruled that the results were BOTH surprising and unexpected. So much so, the PTO and because of the extensive analysis, studies , data, testitmony etc. Vascepa was warranted a patent for method of use; treatment for Reduction of Triglyceride over 500 TGs

    So, if youre the FDA, the logic that a prior approved chemical enity cannot qualify for NCE is a quandry when theraputic benefit is improved so much - how in the world can SAME chemcial entity produce surprising and unexpected results ? Unless its not the same?

    Hence the importance of 889 / 153

    Sentiment: Strong Buy

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    • At the moment I don't think Nce will be granted because - for what we know - Vascepa is NOT nce.
      But you hit the point:
      "How in the world can SAME chemcial entity produce surprising and unexpected results ? Unless its not the same?".

      Who knows. Is FDA taking time while achieving more tests on real chemical composition? Maybe in few weeks will FDA will release "Nce granted after late chemical investigation"?

      Otherwise - if there's not chemical difference - I don't think FDA is going to create another status (beside NCE and NME) after investigating on "allotropy" (check on wiki).
      But the doubt you raised does remain.

    • Dear Live for the day , Do you or friend know who or whom makes the final decision ? Do we have a panel ? Is there a vote ? If so , back to how many vote ? I don't know and if panel on NCE.... does simple majority rule . This issue is complex . I'm of the opinion that its in the hands of legal folks that represent AMRN , GSK , and FDA . Perhaps congress needs to make changes to current guidelines . Lol on congress doing something .

      • 1 Reply to drivethelane2001
      • The science is approved in committee, IMO this is a "yes" for NCE, otherwise we wouldn't be waiting.

        Then the decision must pass legal for final designation of NCE. This is the stage we're stuck on. '885 in the OB may trigger a decision, this should happen Tuesday 10-30. The FDA doesn't have to wait for the OB to be released in November to communicate the decision to Amarin.

        Sentiment: Strong Buy

    • Like some one said before, saying icosapent ethyl is already contained in Lovaza and so Vascepa can't have the NCE is like saying since CARBON is in all virtually all molecular objects that life is built on, that anything that has CARBON in it can't be new, once someone had patented a molecule with Carbon in it.... you see the ridiculousness of such an argument...

      Question:

      WHAT is the FORMAL DEFINITION, by the FDA, for what "an active moiety" is?

      Answer:

      the "MOLECULE OR ION responsible for the physiological or pharmacological action of the drug substance."

      Either THAT definition is TRUE or NOT TRUE (as a statement of a certain formality, used by scientists and institutions: I have no problem one way or the other...).

      The "molecule or ion" in Lovaza --- that is, PER THE FDA, "responsible for the physiological or pharmacological action of the drug substance --- is NOT just the EPA (46.5%), or the DHA (37.5%), or the Omega 6, 7, & 9 (10%).

      It is ALL OF THOSE.

      In AMRN's Vascepa, on the other hand..... it is JUST THE EPA alone that is "responsible for the physiological or pharmacological action of the drug substance."

      Again, my belabored point is not to argue over overlapping molecular structural entities... rather, it is to argue that, as a scientific body, ONCE you established a certain BASIC definition or criteria (arbitrary or not.... such as P value of 0.05 or lower is FDA approvable; higher is not... etc), YOU NEED TO STICK TO IT.

      You shouldn't gather a whole bunch of lawyers, from different sides, and haggle over SEMANTICS.

      If the definition is too vague, too complex, or not scientific enough... YOU FREAKIN' CHANGE IT, formally, before you go on using it as a guide post for granting or denying petitioners the various rights and statuses....

      • 1 Reply to laujhawj
      • LOL
        "You shouldn't gather a whole bunch of lawyers, from different sides, and haggle over SEMANTICS."

        There you go again.... appling reasonible person law and common sense. Dam....I liked that!

        That's why AMRN hired technical skilled in this realm and lawyers to overcome objections. the test applys BUT you can challenge.

        PTO justs want AMRN to give them the answer so they can tell GSK you can't file generic challenge

        Sentiment: Strong Buy

    • Liv

      Talked to CDER ombudsman VB, after our conversation I'm leaning towards the new patents having an effect on a timely decision. We discussed what the indecisiveness, especially with small companies, influences the success of Vascepa launch. She referred to the NCE as a legal decision, obviously the scientist have ruled yes to NCE, otherwise we would have given the "no".

      Sentiment: Strong Buy

    • Unfortunately lawyers never have a quandry with any stated positon and my guess is this whole thing is a big legal semantics battle.

    • Livin, I had saved these from the FDA website and I keep coming back to them. It seems as though reason #1 allows the exception for reason #2 and in keeping with the quandry in your post would give them their allowance to grant NCE.

      1." Exclusivity is available for new chemical entities (NCEs), which by definition are innovative, and for significant changes in already approved drug products, such as a new use"

      2. "A 5-year period of exclusivity is granted to new drug applications for products containing chemical entities never previously approved by FDA either alone or in combination. "

    • - how in the world can SAME chemcial entity produce surprising and unexpected results ? Unless its not the same?
      Hence them asking Amarin to conduct Reduce-It study...hopefully '885 stable pharmaceutical composition puts us over the top.

    • livin...important fact your missing, this is a GOVERNMENT entity, reasoning and logic aren't used here =)

 
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