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Insmed Incorporated Message Board

blank2thisone 34 posts  |  Last Activity: Jan 27, 2015 3:57 PM Member since: Jul 18, 2010
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  • Reply to

    Time line MAA review process

    by blank2thisone Dec 3, 2014 4:10 PM
    blank2thisone blank2thisone Dec 21, 2014 3:14 PM Flag

    Why do u say a year now?....August it is!!

    Sentiment: Strong Buy

  • Opinion
    1.
    The Paediatric Committee, having assessed the application in accordance with Article 22 of
    Regulation (EC) No 1901/2006 as amended, recommends as set out in the appended summary
    report:
    •toagree to changes to the paediatric investigation plan and to the deferral
    and to the waiver in
    the scope set out in the Annex I of this opinion
    .
    The Norwegian Paediatric Committee member agrees with the above
    - mentioned recommendation of the Paediatric Committee.

    2.
    The measures and timelines of the paediatric investigation plan
    and the subset(s) of the paediatric
    population
    and condition(s) covered by the waiver
    are set out in the Annex I.
    This opinion is forwarded to the applicant and the Executive Director of the European Medicines
    Agency, together with its annex and appendix.

    Sentiment: Strong Buy

  • blank2thisone by blank2thisone Dec 3, 2014 4:10 PM Flag

    http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/10/WC500004235.pdf

    Sentiment: Strong Buy

  • Reply to

    November deck on Insmed's website Page/slide 9

    by justarook04 Dec 2, 2014 8:20 AM
    blank2thisone blank2thisone Dec 2, 2014 9:00 AM Flag

    EU: MAA filing with the EMA by
    end of 2014

    US: Initiate trial in NTM patients
    that have failed prior treatment

    Tick in the box!!!

    Sentiment: Strong Buy

  • ...Would be great to elaborate on the filing during investor conferences

    Sentiment: Strong Buy

  • Reply to

    Arikayce Patent Portfolio = Expiration 2029

    by blank2thisone Nov 19, 2014 8:46 AM
    blank2thisone blank2thisone Nov 23, 2014 2:26 PM Flag

    Thanks Mr.Fein!

  • ARIKAYCE Patent Portfolio – Eight Orange Book Listable Patents

    U.S. 7,544,369
    : Method of treating
    Pseudomonas aeruginosa
    infection (
    liposome size
    ). “First
    Patent”, Expires June 6, 2025

    U.S. 7,718,189
    : Formulation of liposomal aminoglycoside.
    “Formulation Patent”, Expires June 6,
    2025

    U.S. 8,226,975
    : System comprising a liposomal aminoglycoside formulation and an inhalation
    device. “Free and Bound Patent”, Expires August 15, 2028

    U.S. 8,632,804
    : Method of treating cystic fibrosis patient with aerosolized composition comprising
    free aminoglycoside and encapsulated aminoglycoside (liposome consisting of electrically neutral
    lipids).*

    U.S. 8,679,532
    : Method of treating patient for mycobacterial infection comprising administering
    aerosolized comp. comprising free aminoglycoside and encapsulated aminoglycoside (liposome
    consisting of electrically neutral lipids).*

    U.S. 8,642,075
    : Aerosolized composition comprising free and encapsulated aminoglycoside.*

    U.S. 8,673,348
    : Method of treating patient for
    Pseudomonas
    infection comprising administering
    aerosolized comp. comprising free aminoglycoside and encapsulated aminoglycoside*

    U.S. 8,802,137
    : Liposome comprising encapsulated aminoglycoside, lipid bilayer comprises a
    neutral phospholipid and sterol, L/D weight ratio is 2:1
    or less, mean diameter of 0.1 to 0.5 microns.
    Nebulized spray comprising the same. Expires June 6, 2025

    Sentiment: Strong Buy

  • Reply to

    November Investor Presentation.....

    by insmhistorian Nov 10, 2014 5:02 PM
    blank2thisone blank2thisone Nov 10, 2014 5:11 PM Flag

    Funny! r we aware of any upcomin investor presntation?

    Sentiment: Strong Buy

  • Reply to

    October 31 Short Interest Report.....

    by insmhistorian Nov 10, 2014 4:54 PM
    blank2thisone blank2thisone Nov 10, 2014 4:58 PM Flag

    jad did fly on the wall

    Sentiment: Strong Buy

  • Reply to

    CC Comments - Pricing Premium For Arikace

    by jad9000 Nov 8, 2014 5:18 PM
    blank2thisone blank2thisone Nov 10, 2014 9:07 AM Flag

    Thanks for posting!...Great remarks of WL!!

    Sentiment: Strong Buy

  • blank2thisone blank2thisone Nov 6, 2014 8:52 AM Flag

    Our current priorities are as follows:



    · Continue generating additional clinical data from studies showing the effects of ARIKAYCE to treat NTM lung infections and Pseudomonas lung infections in CF patients;

    · Actively pursue new drug filings to secure approval for ARIKAYCE to treat NTM lung infections in the US, Europe, Canada, Japan and certain other countries;

    · Actively pursue new drug filings to secure approval for ARIKAYCE to treat Pseudomonas lung infections in CF patients in Europe and Canada;

    · Expand our product supply chain in support of clinical development and if approved, commercialization;

    · Prepare for commercial launch in the NTM indication in the US, Europe, Canada and eventually Japan and certain other countries;

    · Prepare for commercial launch in Pseudomonas lung infections in CF patients indication in Europe and Canada;

    · Attempt to develop, acquire, in-license or co-promote promising late stage or commercial products that we believe are complementary to ARIKAYCE and our core competencies; and

    · Continue to develop novel formulations of existing therapies, where such reformulation could materially improve the treatment paradigm for the underlying disease or to enable pursuit of a new indication.



    In support of these priorities, we completed our registrational phase 3 clinical study of ARIKAYCE in CF patients with Pseudomonas lung infections in Europe and Canada. We plan to submit regulatory marketing applications for the CF and NTM indications in Europe by the end of 2014 and in Canada in the first half of 2015. In the first half of 2014, we completed our US and Canadian phase 2 clinical study of ARIKAYCE for the treatment of NTM lung infections in treatment refractory patients. Following recent discussions with the FDA, we plan to initiate a global phase 3 clinical trial of ARIKAYCE in NTM which will be a confirmatory study for patients with NTM lung infections that failed prior standard of care treatment. We plan to scale up manufacturing, we are identifying second source suppliers, and we plan to implement supply and quality agreements in preparation for commercialization of ARIKAYCE. In February 2014, we entered into a contract manufacturing agreement with Therapure Biopharma Inc. (Therapure) for the manufacture of ARIKAYCE at the larger scales necessary to support commercialization. In July 2014, we entered into a commercialization agreement with PARI Pharma GmbH (PARI), the manufacturer of our drug delivery nebulizer, to address our commercial supply needs. We have commenced the build-out of our commercial infrastructure in preparation for potential commercial launches in Europe, Canada and the US. We will continue to evaluate opportunities for additional products through various business development channels.

    Sentiment: Strong Buy

  • NTM:
    We intend to file a MAA with the EMA by the end of 2014 and in Canada during the first half of 2015 for the treatment of NTM lung infections, as well as for Pseudomonas lung infections in CF patients.

    · We are proceeding with a phase 3 study which will be designed to confirm the positive culture conversion results seen in our phase 2 clinical trial. This confirmatory study will primarily investigate ARIKAYCE for use in the non-CF, treatment failure population with MAC NTM lung infections.

    · If approved, we expect ARIKAYCE would be the first approved inhaled antibiotic treatment in the US, Canada and Europe for NTM lung infections.

    · We are developing plans to commercialize ARIKAYCE, if approved, in certain countries in Europe, in the US, and Canada, and eventually Japan and certain other countries.

    CF:
    We intend to file a MAA with the EMA by the end of 2014 and in Canada during the first half of 2015.

    · We are developing plans to commercialize ARIKAYCE, if approved, in certain countries in Europe and Canada where we expect it would be the only once-a-day treatment for Pseudomonas lung infections in CF patients.

    · We will initiate new studies in pediatric patients, however we currently do not plan to initiate any further studies in adult CF patients with Pseudomonas lung infections.

    Sentiment: Strong Buy

  • blank2thisone blank2thisone Oct 30, 2014 2:59 PM Flag

    Patentbaristasdotcom search for insmed

    Sentiment: Strong Buy

  • blank2thisone blank2thisone Oct 30, 2014 10:14 AM Flag

    February 16, 1993 United States Patent 5,187,151
    June 5, 1995 United States Patent 6,331,414
    Jun 18, 1996 US Patent No: 5,528,287

    Furthermore, the parties will form a joint-development committee to guide the development and commercialization of Iplex in non-Tercica/Genentech indications. The Settlement, License and Development Agreement is in effect until the later of 2018 or the expiration of any subsequent Tercica/Genentech issued patents that cover IPLEX or its indications.

    Sentiment: Strong Buy

INSM
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