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Avanir Pharmaceuticals, Inc. Message Board

  • theefalcon theefalcon Jun 20, 2013 4:48 AM Flag

    Welcome to the NHS UK Medicines Information website.

    Just a little ditty to let my long friends across the pond know where my home country is at with Nuedexta.

    Additional information is available to accredited registered NHS users

    New Drugs Online Report for dextrometorphan + quinidine

    Developmental Status
    UK: Recommended for approval (Positive opinion)
    EU: Recommended for approval (Positive opinion)
    US: Launched

    UK launch Plans: Available only to registered users

    Category
    BNF Category: Central nervous system
    Pharmacology: Dextromethorphan (NMDA antagonist/sigma agonist) +quinidine (CYP2D6 inhibitor

    Epidemiology: Prevalence of pathological emotions (pseudobulbar affect) following stroke is 14.9%
    Indication: Pseudobulbar affect

    NICE Information
    In timetable: No

    Company Information
    Name: Jenson
    US Name: Avanir

    The UK NHS Health System have been tracking Nuedexta for a number of years.
    Access to trial data and all that has gone before would be available to the NHS users.

    The web page is updated regularly with new developments. In case you can not get to the web site I shall post any additional news as it comes out.

    Best regards to all.

    Sr Falconi

    Sentiment: Hold

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    • horcents@sbcglobal.net horcents Jun 27, 2013 4:15 PM Flag

      Sr Falconi....thanks, as always, for your work and sharing. Do you think the EU market is going to be better than anyone anticipates?

      • 1 Reply to horcents
      • Hi Horcents – you are welcome. I quickly read your note before I set out for dinner last night and thought Hmm good question and how do I answer it. Well after giving it much deliberation I can not find a simple answer. My comment reminds me of what Razor once said about me “ask him the time and he will tell you how to build a watch” lol.

        If you were/are only referring to N for PBA it would not be such a task to answer, however IMO there is much much more to it than that. You have often referred to us being in a marathon; well I still think that is the case and we are only a small way round.

        Tremendous opportunities await in the EU, it is blatantly clear to me that how this is approached will reflect on the share holder value, sorry to state the obvious. There have been several things in life that have looked simplistic to me at the outset. Then I realized how complex they actually were if one was to get the best from it, the situation for N in Europe is no different.

        I was going to take a brief look at the permutations of the some of the main runners. As you know generally the greater the number of entrants the greater the price, the thing is I just do not know right now the number of entrants/indications, however I’m more than certain it is greater than two. Would we want to partner the stable before knowing what we have in it?

        Sorry for the brief thinking out aloud and probably not answering your intial question exactly, however it can be.

        Best regards

        Sr Falconi

        Sentiment: Hold

    • Falconi, we have previously discussed the possibility of Avanir contracting on a fee for service agreement for the sales of Nuedexta in high potential countries in the UK and Europe. We know that Avanir relied on Jenson for their services in helping to secure the EU approval. Is the implication from this announcement that Jenson may market Nuedexta as well? If this is the case, this is a very strong and effective means of non-partnered sales and marketing following the EU approval.
      Rzr

      • 1 Reply to rzrbackrob
      • Good morning Razor – I have looked at Jenson a few times now, from what I have observed I do not think they would be a suitable means of non-partnered sales and marketing, as I have not seen much if any evidence that they do such a thing, I will have another look. By the way we ought to say well done Jenson and thank’s.

        You will recall ABPI as of yet I have not seen Avanir on the full members list, I think it would be prudent for them to do so now. Avanir can obtain a vast amount of information with respect to the EU by being a full member. They would have access to the same information as GSK, SanofI, Pfizer, Lilly & Co , Amgen etc. In the event Avanir are serious about becoming a major mid cap CNS company if it was me I would certainly want the same if not more information than my competitors, the likes of those mentioned above. That leads you on to think can a competitor as those mentioned also be a partner.

        Know doubt and hopefully we shall discuss further in due course.

        Sr Falconi

        Sentiment: Hold

    • Date June 13 - Approved in the EU (That is the bit I find interesting)

      Published by NHS Drugs on Line 26/06/2013 17:03:44

      Additional information is available to accredited registered NHS users

      New Drugs Online Report for dextrometorphan + quinidine

      Developmental Status
      UK * Approved (Licensed)* previous Recommended for approval (Positive opinion)
      EU * Approved (Licensed* previous Reommended for approval (Positive opinion)
      US: Launched

      UK launch Plans: Available only to registered users

      Category
      BNF Category: Central nervous system
      Pharmacology: Dextromethorphan (NMDA antagonist/sigma agonist) +quinidine (CYP2D6 inhibitor

      Epidemiology: Prevalence of pathological emotions (pseudobulbar affect) following stroke is 14.9%
      Indication: Pseudobulbar affect

      NICE Information
      In timetable: No

      Company Information
      Name: Jenson
      US Name: Avanir

      The web page is updated regularly with new developments. In case you can not get to the web site I shall post any additional news as it comes out.

      Best regards to all.

      Sr Falconi

      Sentiment: Hold

    • UP Date coming ;-) see separate thread.

      Give me a moment.

      Sr Falconi

      Sentiment: Hold

    • eu anyday

    • semiequipmentgodoftheyear semiequipmentgodoftheyear Jun 20, 2013 12:09 PM Flag

      thanks great info

    • greatdayforinvestments greatdayforinvestments Jun 20, 2013 11:31 AM Flag

      Thank you Sir Falconi for the update! How exciting to say Europe here we come!!!

      Sentiment: Strong Buy

    • Good afternoon Sr Falconi.
      Thank you posting this.
      1 question: Who or what is " Jensen " on the company information paragraph ?
      Thanks in advance.
      Fred.

      • 1 Reply to fredhercules
      • Hi Fred - No problem

        Jenson carried out the application on Avanir’s behalf.

        On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nuedexta, 15 mg / 9 mg, 23 mg / 9 mg hard capsule intended for the treatment of pseudobulbar affect, a medical condition in which patients experience sudden and uncontrollable bouts of laughing or crying unrelated or disproportionate to their emotional state. The applicant for this medicinal product is Jenson Pharmaceutical Services Ltd.

        Sr Falconi

        Sentiment: Hold

    • Sir F - thanks again for your great findings and please keep us posted as EU is a big part of AVNR business going forward.

      PS: i was watching the new Airport show Heathrow and how all the planes - air traffic control it was very interesting dam Heathrow is very busy..

      Thanks

      Sentiment: Strong Buy

      • 1 Reply to harryavnr
      • You are welcome Harry

        PS Yes Heathrow is a fascinating airport, terminal 5 is relatively new.

        I have been through Chicago (O'Hare) airport a number of times, I always need to make sure I have my maps at hand for all the different arms that come of the main terminal, especially when you change to the internal flights. Neat railway system running around it.

        Sr Falconi

        Sentiment: Hold

    • Sr Falconi - thanks for nice info to start the day!! Very optimistic !!
      glta longs

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