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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
  • New FDA Document Could Mean NCE For Amarin 15 comments
    Apr 9, 2013 12:30 PM | about stocks: AMRN, GSK

    A new guideline document for generic Vascepa issued by FDA (they opine by issuing these type of documents for all new and approved drugs) suggests two things:

    1) They may be ready and willing to issue NCE, as the document specifies the active ingredient in a technically different way than on Lovaza's generic guideline document

    2) Amarin's stated supplier/manufacturing barriers to entry may play a huge role in thwarting generics, as the FDA document includes specific API directives.

    Stocks: AMRN, GSK
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Comments (15)
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  • bravo33
    , contributor
    Comments (61) | Send Message
     
    Steve,

     

    Good comments on a document that has been discussed just recently on a limited number of other sites. One question I'm not clear on - is there any 'effective date' associated with this document or are its findings applicable, binding and enforceable now? Your second point regarding API directives sounds very significant. I take from your comments that you think this could translate into NCE yes very soon.

     

    Thanks!
    9 Apr 2013, 01:49 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » FDA issues the document as a general guideline when new drugs come to market, and can provide this type of document to would-be generic manufacturers - making no observation, determination or designation to any IP that the drug may have. In this case, the document is moot to generics, as AMRN's patents will not allow them to infringe (at least not without risk and liability).

     

    Side note - I know of two generics (one top in the market and one a rather small player) that were looking to knock off Vascepa more than 1 year ago, they both have since abandoned their attempts and desire to go after Vascepa due to supply barriers causing the material to cost too much and due to AMRNs IP position. Forgetting the BS uncertainty talked about on Wall Street and in general, I am very confident AMRN will be the only Vascepa player for quite some time... The stock is only at this price b/c the big money is betting that there is more time to play with before the next leg up on AMRN begins again. This history has played out time and time again with AMRN and the big money supporters - just look at the charts relative to catalysts and news announcements. My take is we get a new multi-year high before Anchor approval.
    9 Apr 2013, 02:28 PM Reply Like
  • BiotechBillionair
    , contributor
    Comments (60) | Send Message
     
    I Agee 100% Steve. The wording between Icosapent Ethyl and Omega 3 Ethyl Esters has many key differences both in API and inactive ingrediates. A generic Icosapent Ethyl is required by the FDA to have both the same API and Inactive ingrediates...infringing on the 24 NOA or issued patents currently.

     

    New MAPP documents are being posted still by the FDA so timing the FDA is impossible. (4-10-13 http://1.usa.gov/12HuV88)
    10 Apr 2013, 08:18 AM Reply Like
  • kylebriz
    , contributor
    Comments (9) | Send Message
     
    Thank you Steve for your comment on the guidance document. Plesse continue to keep us informed as things are starting to heat up.
    9 Apr 2013, 07:36 PM Reply Like
  • mowadeeb1
    , contributor
    Comments (6) | Send Message
     
    Thanks Steve!! AF is already tweeting about it saying that the FDA guidelines makes it very easy for a generic version to come to market. He says that they will have to rely on patents to defend.
    9 Apr 2013, 07:36 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Mowadeeb1 : The FDA guidelines are supposed to make it easy (or at least clear) for any drug to come to market, that's why they have the guidelines, to enable generic competition per federal act put in place some time ago. That is why drugs need IP, supply barriers to entry, regulatory protection also obviously helps for a period of time. AMRN has what it needs to protect them. You can take it from someone who actually knows and talks to the generic companies that would look to go generic, or you can take it from someone who probably can't explain the difference between EPA and DHA, and FDA.
    10 Apr 2013, 08:55 AM Reply Like
  • sts66
    , contributor
    Comments (1725) | Send Message
     
    There's been a good discussion on IHUB about the FDA doc and what it means to AMRN - general consensus is that the "identical inactive ingredients" clause is that one of their patents is for being able to manufacturer stable EPA that has a shelf life of 36 months, and one or more of the inactive ingredients is responsible for keeping the oil from oxidizing or going "rotten' - that patent and the others should create a massive wall preventing any competition from entering this space until 2025-2030, NCE or not.
    11 Apr 2013, 02:17 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » I highlighted this recently, its a favorable inclusion for AMRN by FDA
    11 Apr 2013, 03:09 PM Reply Like
  • nader1022
    , contributor
    Comments (5) | Send Message
     
    does the FDA update this Orange Book tomorrow or next friday?
    11 Apr 2013, 06:49 PM Reply Like
  • bravo33
    , contributor
    Comments (61) | Send Message
     
    Tomorrow, April 12, is the target day this month. They can always vary by a day here or there as they proved last month. Stay tuned and good luck!
    11 Apr 2013, 07:37 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » They should update it tomorrow, by 2pm or so...
    11 Apr 2013, 10:50 PM Reply Like
  • jasonturbo
    , contributor
    Comments (6) | Send Message
     
    I usually never post here, have been following AMRN for the better part of 2 years, just added to my position today. In my opinion, the run up to approval should start very soon, possibly with a decision on NCE tomorrow, I'm probably stating the obvious but it's logical to assume today's trading activity is tightly linked to speculation on the next OB update.

     

    It's only a matter of time.. :)
    11 Apr 2013, 11:31 PM Reply Like
  • Not_Quite_Pheidippides
    , contributor
    Comments (209) | Send Message
     
    Delayed again. Next month, I hope.
    12 Apr 2013, 10:38 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Looks that way
    12 Apr 2013, 11:52 AM Reply Like
  • snelson203
    , contributor
    Comment (1) | Send Message
     
    Steve-

     

    What's your take on NCE this month- May 2013??
    14 May 2013, 09:23 PM Reply Like
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