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Insmed Incorporated Message Board

  • fud.fighter2 fud.fighter2 Mar 31, 2014 1:30 PM Flag

    Potential competition for Arikace

    The lungs evolved their present structure because in essence they incorporate a large surface area via which oxygen is able to diffuse into the bloodstream, with carbon dioxide coming the other way.

    But where oxygen can go so can any other minute particles - which has actually given birth to inhaled therapies which use the lungs as a route to the bloodstream.

    The Bayer-Nektar inhaled amikacin therapy currently in Phase III incorporates nothing to prevent the amikacin going straight through the lungs. Less efficacy, more toxicity.

    Aradigm is developing an inhaled liposome therapy for Non-CF Bronchiectasis - but the liposomes are far tinier than Arikace liposomes.

    Somebody from the Nektar board visited us in January and opined as follows -

    "I think that ARDM's leading drug is as effective as this one."

    When I challenged him he explained he was relying upon information posted on the Nektar board by a knowledgeable contributor - Motormouth Rehdvm of all people.

    Par for the course for that clown was the inane drivel he posted here yesterday - asking us to believe that the potential for liposomes to break up the mucus in Cystic Fibrosis explains the efficacy seen in the Comparator arm of the NTM study.

    I suggested to our visitor he ask Rehdvm these four questions -

    1. What info is Rehdvm aware of which would help in predicting the pharmacodynamic effect of the Aradigm liposomes - particularly concerning the potential for systemic toxicity?

    2. What is known about the safety studies in animals - particularly the two-year rat study one assumes the FDA will require?

    3. Can Rehdvm think of a reason for the FDA not to approve Arikace (assuming the NTM data due this quarter is supportive) for the treatment of serious pulmonary infections caused by amikacin-susceptible pathogens?

    4. If the FDA does indeed issue such a label for Arikace, what are the implications for competition with the Aradigm drug in the treatment of Non-CF Bronchiectasis?

    He didn't bother.

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