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Insmed Incorporated Message Board

  • fudfighter3 fudfighter3 Feb 11, 2014 10:52 AM Flag

    Blatant scam of investors unaware of valuation

    A valuation of $7 a share would equate to a market cap of approx $280 million.

    2,700 of the 35,000 with Cystic Fibrosis in Europe using Arikace two years from now, at $32,500 per year, would warrant that current valuation -

    2,700 x $32,500 x 5 x 0.8 x 0.8 = $280.8 million.

    And there would have to be ZERO off-label use of Arikace in the following patient populations -

    30,000 with Cystic Fibrosis in the US

    110,000 patients in the US/Europe/Japan with NTM each year

    630,000 patients World-wide with MDR-TB each year.

    Amikacin injection is routinely used off-label to treat mycobacterial lung infections. How could Arikace fail to have a far better risk/benefit profile than amikacin injection in the treatment of pulmonary infections?

    When it's on sale in Europe for Cystic Fibrosis there WILL be substantial off-label use due to the far superior safety profile to amikacin injection.

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    • The likelihood of widespread off-label use can reasonably be inferred from the comments of a leading pulmonologist during the FDA-sponsored workshop on Non-CF Bronchiectasis in 2012 -

      [ In the unit - in the hospital - we frequently double coverage people with pseudomonal pneumonia, for example, or gram-negative pneumonia, or just empirically before we know what anything is.

      And a patient with a ventilator-associated pneumonia, or just a rip-roaring severe pseudomonal pneumonia, often gets two drugs of a different class ]

      [ There's a lot more adverse events when you use two drugs versus one. I think in the end, probably you should use two drugs if someone's really sick, because it improves the chances that you're going to actually have one of them working ]

      We don't know how many of the 50,000 Americans who die from pneumonia each year are critically ill with an amikacin-susceptible infection, but amikacin most certainly is a top-ranked therapy for the 150,000 World-wide who die from pneumonia caused by MDR-TB each year.

      The likelihood of emergency use of Arikace is well worth noting for anybody who fears the Arikace NTM data may not satisfy the key criterion for accelerated approval under the new legislation of being "reasonably likely to predict clinical benefit".

      The EMA now has evidence of both efficacy and safety in Cystic Fibrosis to support a European marketing authorisation.

      An estimated 44,000 in Europe have Cystic Fibrosis. And if 50,000 Americans die from pneumonia each year, how many Europeans suffer that fate?

      So how many Europeans are critically ill (as opposed to fatally-ill) with bacterial pneumonia each year, for whom Arikace would be far and away the fastest-acting emergency antibiotic?

    • Copied the following from the just-updated Company presentation.

      The guidance for the launch of Arikace for NTM is UNCHANGED - anywhere from 2015 to 2018 or later, i.e. not taking it for granted the FDA will approve on the basis of the Phase II data.

      Q1: FEBRUARY

      Received Orphan Designation for NTM from EMA

      Expect to provide interim update from two-year extension study in CF patients

      Analysis of data from first ~75 patients that have completed the first year under the two year extension study

      Q1: MARCH

      Announce 2013 financial results and file 10K

      Announce NTM data from double blind phase -

      ..... Top line data in press release

      ..... Analysis of data by lead investigators on investor conference call

      Q2: Continued dialogue with EMA and FDA regarding NTM regulatory path

      Q2: First patient first visit in NTM open label study

      File eCTD for CF Pseudomonas with EMA

      Exact timing dependent on NTM data and EMA regulatory dialogue

      Two Near-Term Commercial Opportunities

      U.S.: ARIKACE Phase 2 NTM data Q1 2014 and FDA dialog

      Europe: ARIKACE EMA Filing for CF in 1H 2014

    • I personally am still expecting FDA and EMA approval of Arikace for the treatment of serious pulmonary infection by amikacin-susceptible pathogens - supported by the totality of the data from the Arikace studies to date.

      But on the subject of off-label use, any guesses as to how much health authorities would save were they able to reduce the period a patient spends in intensive care for pneumonia by a couple of days?

      ECCMID April 2012 -

      [ The addition of a short-course of high-dose aminoglycoside to initial antipseudomonal beta-lactam therapy can improve the treatment of healthcare-associated pneumonia by shortening the length of hospital stay, researchers said here at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

      Limited treatment options and delays in empiric therapy for multidrug resistant gram-negative organisms (MDR-Gn) are said to be largely to blame for the unsettling rise in such infections, causing increased lengths of stay, costs, and mortality resulting with infections.

      Healthcare-associated pneumonia has been shown to be associated with particularly resistant pathogens, and a combination therapy in which aminoglycoside is added to antipseudomonal beta-lactam has been suggested to improve treatment and resolve symptoms faster than monotherapy.

      In testing the efficacy of the combination therapy, researchers evaluated a group of 227 geriatric patients with nursing home acquired pneumonia, in which 104 patients received a combination therapy of antipseudomonal beta-lactam plus aminoglycoside and 123 received beta-lactam therapy without an aminoglycoside between 2009 and 2010.

      The results showed that the combination aminoglycoside therapy group had a mean length of stay that was 1.83 days shorter than the non-combination therapy group, resulting in lower overall inpatient costs. ]

      Build a better mousetrap .....

 
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