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Amarin Corporation plc Message Board

  • doctorevensen doctorevensen Nov 14, 2012 12:37 PM Flag

    Chiral Switch and the NCE

    Joe Z was trying to use the 'Chiral Switch' to get the NCE. This was used previously by Nuvigil to get NCE when Provigil was out there and Nexium and though prilosec was out there. Basically they isolated an isomer from a previous racemic mixture and got NCE status. FDARA 264 contains the governing law with relation to isomers being aproved (like vascepa) if a previous racemic mixture has already been approved (like loveza). Unfortunately, to get approved you need a new indication, and vascepa's is the same as it doesn't qualify for NCE......But here is the reason for the NCE delay, the FDARA 264 law expired Oct 1st so now the rules can be bent since the FDA knows new indications are on the way with ANCHOR. This is the reason for the delay, since the FDA needs to follow continuity and precedence from previous NCE decisions, it couldn't give the NCE prior to Oct 1st.

    Sentiment: Strong Buy

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    • As I mentioned in a different post, This information is wrong. I have a PhD in organic chemistry from a top 10 institution so hear me out. The structure of EPA or DHA do not contain a chiral center. Therefore, any isomers that exist are structural isomers not stereoisomers. What that mean is there are no enantiomers to separate. Sorry guys, these are facts.

      Having said that, I do think we have a chance of getting NCE. The only way is if the FDA decides to make an exception to its own rule and grant NCE in the spirit of supporting innovation given the unexpected and superior clinical profile of pure EPA. If they don't make this exception, we will not get NCE. Period.

      Sentiment: Hold

    • Per the approval letter from the FDA, AMRN filed a 505(b)(2). YMB won't let me link it, but it's on the FDA website. I copied and pasted below:
      "Dear Ms. Berry:
      Please refer to your New Drug Application (NDA) dated September 25, 2011, received
      September 26, 2011, submitted pursuant to 505(b)(2) of the Federal Food, Drug, and Cosmetic
      Act for VASCEPA (icosapent ethyl) Capsules, 1 gram.
      We acknowledge receipt of your amendments dated September 26 and 28, October 7,
      December 30, 2011; and January 27 and 30, February 2, 6, 9, and 28, March 5 and 22, April 5,
      11, 19, and 30, May 4 (2), 16, and 29, June 15 and 27, July 13 and 18, 2012. We also
      acknowledge receipt of your email dated July 25, 2012, stating your agreement to the labeling
      revisions that we communicated to you by email on July 25, 2012."

      Sentiment: Strong Buy

    • krafalski Nov 14, 2012 4:39 PM Flag

      fascinating!! best post ive read in 6 months on this board!! thank you for the clarification

      Sentiment: Strong Buy

    • AMRN filed a 505(b)(2), not a 505(b); therefore the Chiral Switch argument does not apply.

      Sentiment: Strong Buy

    • Interesting. Thx for posting

    • interesting perspective. however based on the omega 3 (fish oil) purification processes for both Lovaza and Vascepa, I don't think these processes can distinguish enantiomers which are identical in formula but different in chirality. That means that Vasccep and Lovaza are both mixtures of different enantiomers. I doubt that either company has gone down the path to analysis the exact composition of enantiomers in their API. If so, they would put it in their patents too. That analysis is pretty challenging to do considering both are natural ingredients. So ...

      Personally, I think the prolonged delays are due to the uniqueness of this case and FDA's caution of setting an exception or precedent case.

      Sentiment: Hold

      • 3 Replies to dbssanfran
      • look up loveza patents through the uspto. the patents are all filed as look at vascepa, it is all cis-epa. I don't know the chemical modalities to seperate or create them but the proof is in the pudding.

        Sentiment: Strong Buy

      • remember, they are fabricating the isomer not separating it form existing fish oil.....
        just check the patents for loveza.....they are listed as 'all-z' omega 3....epa......look it up. it appears that vascepa has distinguished itself as an isomer because it is the cis (E). and loveza is trans (Z). The label for vascepa lists it as 'epa esters'....however the patents for loveza list it as the trans isomer....very interesting!!!!!!!

        Sentiment: Strong Buy

      • Disagree, read the labels for both drugs. Vascepa is labeled as cis isomer only!!!!! this is the key!!!! I have posted several times under investor hub in the amrn sec. look for DrEPE posts....and give me your feedback. I believe I hit the nail on the head with this DD. I think we have similar knowledge on the subject, and appreciate any intelligent feedback. I tried to post it here in the past but you can't cut and paste to this board and i type too slow .

        Sentiment: Strong Buy

    • well thats an interesting argument ive never read before, thanks for sharing

    • The EPA isomer argument for NCE is a great one and should support a positive NCE decision. GLTA!!! $$$

      Sentiment: Strong Buy

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