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Insmed Incorporated Message Board

  • liv4ucf liv4ucf Feb 26, 2013 2:58 PM Flag

    !!Lewis extremely positive yesterday!!

    1. Lewis suggests the data will meet the endpoint of "non-inferiority" for CF/Pa and was very optimistic that the data will demonstrate superiority by virtue of superior kill of Pa.

    2. He went on to explain the importance of the 28 day on 28 day off treatment equivalency with TOBI in terms of developing mutant strains that might become resistant. He then linked this treatment regimen with two important clinical facts and alluded to two others:

    a. The once per day treatment regimen is more easily scheduled for patients than BID for TOBI, or TID for Cayston.

    b. That once patients experience the single dose regimen, they will be reluctant to switch to a different BID or TID antibiotic regimen unless their is a life threatening change.

    c. Lewis alluded to an important point that is currently not emphasized, which is the concurrent therapy with other agents would be prescriptively allowable for patients. Using certain adjunctive agents (e.g., Pulmozyme) was pretty much precluded in the Clear-108 trial. That is between the physician and the patient.

    d. He also alluded to the fact that because of antibiotic resistance and non-penetration of macrophages, other antibiotic formulations could be developed in the future.

    3. He went on to suggest that the Extension Trial could be pivotal and allow use of Arikace for much longer periods than the 6 cycles in the Clear-108 Phase III.

    4. The NTM trial was referenced well by re-iterating the "captured market" for Arikace if the bacterial kill endpoint can be achieved. Relative to this use, Lewis stated:

    a. INSM believes their endpoints are achievable and will show a statistically significant therapeutic effect.

    b. If a. is achieved they will file with the FDA for expedited review by year end.

    c. If they achieve b., they will cross file in Europe, Japan and with other regulatory agencies.

    5. The most important part of the presentation, I believe, was the understanding that INSM now has of the regulatory process on an international scale. They know there is extensive regulatory filings to be submitted in order to enter and capture market(s).

    6. Lewis said that INSM would market and not look for a partner.

    7. Lewis went on to outline the IP supporting the exclusivity of the liposome for 2029 and beyond, which is the key to future drug development. The key to this IP is the fact that the liposome composition is similar to the natural lipid coat inside the lungs.

    In all, I heard the facts stated well, a good understanding of the clinical signs and endpoints, a realistic grasp of the regulatory situation and a good understanding of the market for inhalational antibiotics. It is a vast improvement from the previous administration, regulatory approach and presentation of the clinical science. Congratulations, INSM.

    Sentiment: Strong Buy

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