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Insmed Incorporated Message Board

  • terry_insm terry_insm May 8, 2013 3:07 PM Flag

    Arikace and...

    A couple of points on Arikace
    Arikace offers the advantage of time(is money) over current regimes. Currently TOBI take 40 minutes and then additional time to clean the device, where Arikace takes 13 min to administer. Many patients take a couple of hours with therapy for CF.TOBI nebulizer is big bulky and a plug in, Arikaces nebulizer is battery powered and small. Compliance will be better with Arikaces regime The TOBI podhaler is better and will be able to compete even with 2 treatments.-dry powder and uses batteries, its effectiveness slightly worse than standard TOBI

    I don't know if Arikace will display superiority but there is competition from the above TOBI podhaler and generic TOBI in late 2014. Insmed will be up against pharma giants Gilead and Novartis (who may just take them out if superiority and acceptance eventually comes. A buyout would happen before market penetration would be seen. Either way big pharma would know before most anyone else
    more later .................

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    • rehdvm2004 •

      Wait until May 23 when WL ties a ribbon around the gift of his skill and drive to get this company moving. This would not have happened under any of the previous INSM management teams of the last 7 years. They did not know the science they were trying to sell and get through the regulatory process

    • terry_insm • May 8, 2013 3:07 PM
      Arikace and...

      A couple of points on Arikace
      Arikace offers the advantage of time(is money) over current regimes. Currently TOBI take 40 minutes and then additional time to clean the device, where Arikace takes 13 min to administer. Many patients take a couple of hours with therapy for CF.TOBI nebulizer is big bulky and a plug in, Arikaces nebulizer is battery powered and small. Compliance will be better with Arikaces regime The TOBI podhaler is better and will be able to compete even with 2 treatments.-dry powder and uses batteries, its effectiveness slightly worse than standard TOBI

      I don't know if Arikace will display superiority but there is competition from the above TOBI podhaler and generic TOBI in late 2014. Insmed will be up against pharma giants Gilead and Novartis (who may just take them out if superiority and acceptance eventually comes. A buyout would happen before market penetration would be seen. Either way big pharma would know before most anyone else
      more later

      • 2 Replies to insm_truth_teller
      • terry_insm • May 8, 2013 3:07 PM
        Arikace and...

        A couple of points on Arikace
        Arikace offers the advantage of time(is money) over current regimes. Currently TOBI take 40 minutes and then additional time to clean the device, where Arikace takes 13 min to administer. Many patients take a couple of hours with therapy for CF.TOBI nebulizer is big bulky and a plug in, Arikaces nebulizer is battery powered and small. Compliance will be better with Arikaces regime The TOBI podhaler is better and will be able to compete even with 2 treatments.-dry powder and uses batteries, its effectiveness slightly worse than standard TOBI

        I don't know if Arikace will display superiority but there is competition from the above TOBI podhaler and generic TOBI in late 2014. Insmed will be up against pharma giants Gilead and Novartis (who may just take them out if superiority and acceptance eventually comes. A buyout would happen before market penetration would be seen. Either way big pharma would know before most anyone else
        more later

      • terry_insm • May 11, 2013 9:51 PM
        Arikace and... Part 2

        Arikace showed the advantage over other therapies with the off treatment cycle with an initial drop in FEV of 1% but with recovery by the end of 56 day of treatment.
        Off label extension studies showed continued benefit but is clinically anecdotal
        The trial doe not have to show superiority, so the bar is lower than a limbo dancer. Arikace improvement over TOBI in Phase2 by a good margin (11 to 7%),as far as regulatory , superiority is what Lewis is calling "compelling" imho
        and therein is one of the risks , as this compelling data must be achieved to benefit NTM. imho I expect Arikace to show non-inferiority to TOBI

        The market potential beyond the nonsense here is Wedbushs and close Cannacords 25% -30% by 2018 for 75+ M worldwide
        It remains to be seen what market Arikace develops , Europe is relatively small and socialist controlled market (25M+),other countries will take time.
        Of note in the real world of cost per year is a full monetary measure that no one uses. Arikace in many cases will be part of a regime.

        Trail Risks and safety - moderate dysphonia was seen in a relatively low % 8-10% but Phase3 tials have a good way of showing therapy problems and risks.

    • Who cares about the TOBI podhaler and generic TOBI if the predominat strains of Ps aeroginosa are TOBI resistant, for which there is clear evidence, as mentioned by WL in conference calls? I would be wiling to bet that there will be clear superiority of Arikace over tobramycin in whatever form of delivery . What matters is antibiotic/pathogen interactions. Cost then becomes immaterial. Efficacy is what matters.

    • Arikace and... Part 2

      Arikace showed the advantage over other therapies with the off treatment cycle with an initial drop in FEV of 1% but with recovery by the end of 56 day of treatment.
      Off label extension studies showed continued benefit but is clinically anecdotal
      The trial doe not have to show superiority, so the bar is lower than a limbo dancer. Arikace improvement over TOBI in Phase2 by a good margin (11 to 7%),as far as regulatory , superiority is what Lewis is calling "compelling" imho
      and therein is one of the risks , as this compelling data must be achieved to benefit NTM. imho I expect Arikace to show non-inferiority to TOBI

      The market potential beyond the nonsense here is Wedbushs and close Cannacords 25% -30% by 2018 for 75+ M worldwide
      It remains to be seen what market Arikace develops , Europe is relatively small and socialist controlled market (25M+),other countries will take time.
      Of note in the real world of cost per year is a full monetary measure that no one uses. Arikace in many cases will be part of a regime.

      Trail Risks and safety - moderate dysphonia was seen in a relatively low % 8-10% but Phase3 tials have a good way of showing therapy problems and risks.

      aint puttin up my trades
      as far as other indications - years money dilutions delays disappointment competition takeover and simple science- investors should take with a grain of salt
      Good Luck

    • Generic and much cheaper TOBI will be on the market next year as the patent expires.
      I get your point about the formularies.

 
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