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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Feb 7, 2013 8:23 AM Flag

    Approximatelytwo years ago . . .

    One of the famous pumpers on this MB posted a reference to the following:

    "Novartis Vaccines & Diagnostics to Pay More Than $72 Million to Resolve False Claims Act Allegations Concerning TOBI"

    Novartis salespeople were suggesting to physicians that inhalational tobramycin solution could be used outside the prescriptive label copy for other types of respiratory infections. The physicians actually responded to these suggestions and Novartis took the hit. The Justice Department reference is easily accessed from the above title. Now we are to believe the Justice Department, with this precedent, would ignore Arikace for unlimited inhalational antibiotic use blathered by the poster of the above information. If INSM even remotely attempted to go this route, they could not take a $72 million impairment charge the way that Novartis did.

    Arikace will succeed on a step-by-step basis towards one, two, three and maybe more label copy indications. But it will not leap-frog into "the only inhalational antibiotic on Earth" category in any Longs lifetime . . . or in any pumpers.

    Sentiment: Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • downbythewater@ymail.com downbythewater Feb 11, 2013 1:55 PM Flag

      If Arikace makes it to market in a few years it will be old science and new antibiotics will be coming on the scene.
      Tedizolid will provide a useful addition to the antimicrobial armamentarium, particularly in complicated skin and skin structure infections, due to its high oral bioavailability and once-daily dosing.
      Arikace is a machine
      rpt:
      What is interesting and brought me here to this abortion,,since I am invested in a company dealing with antibiotics is that there is a rising resistance to antibiotics, mostly coming out of China. There are no new antibiotics. More advanced antibiotic companies are creating antibiotics a different way - eliminating an enzyme that the bacteria needs to sustain and grow or they die. The bacteria is not attacked and thus can't mutate. Therefore no resistance.

      Last month Trius received the QIDP designation(created by the Generating Antibiotic Incentives Now (GAIN) Act,because Trius's development of new antibiotics.
      Insmed is on a completely different path and does not qualify for GAIN
      Trius Phase3 results initiated the ruling because of the inovation of the antibiotic
      Insmed will grind along thru the regulatory process.NTM is in phase2B.

    • Ever wonder why biopharmas produce 150% of the specific types of drugs that are needed on an annu to basis? Because the sales forces for each drug company will go out and and compete with each other to sell 5-10% more of their product. You cannot sell it if it is not produced and ready for sale. There are sales people who operate under the impetus of increasing product sale everyday. Just like other sales people. If the durg that is produce goes past label copy, it is recalled, retested, relabeled and shipped overseas. Ever wonder why 1 or 20 sidewalk businesses in Mexico is a "Pharmacia?" Lets put that one into perspective on this MB. What poster has been spouting for years that Arikace will displace TOBI for all uses. Not just CF/Pa.

      As for one antibiotic alone being the "cure-all, end all, be-a;;" selection, multiple scientific groups are investigating the rational rotation of antibiotics, including the hospital that participated in the Euro CF/Pa study of Arikace (this was the earliest reference article for combination therapy, but the authors cite even earlier scientific papers):

      "Antibiotic resistance in Pseudomonas aeruginosa: mechanisms and impact on treatment

      in Drug Resistance Updates (2000) 3, 247–255

      Robert E.W. Hancock,1 David P. Speert2

      Departments of Microbiology and Immunology,1,2 Pediatrics,2 University of British
      Columbia,Vancouver, British Columbia, Canada

      STRATEGIES FOR PREVENTION OF EMERGENCE OF
      RESISTANCE

      Combination therapy

      Since cross-resistance between major classes of anti-Pseudomonal antibiotics is unlikely to develop, it is common practice to treat serious infections with a combination of a b-lactam and an aminoglycoside. Not only do the drugs appear to exert a synergistic antibacterial effect, but they may also delay or prevent the emergence of resistance during therapy. There are a few novel approaches under development in
      which the combination of agents would include an antibacterial agent and an inhibitor of a major resistance mechanism.The best example of this would be the use of a combination of b-lactamase inhibitor and b-lactam, although the b-lactamase inhibitors currently available in the clinic do not work well and a specific inhibitor of class C enzymes should be used.26 Another approach, being pursued by
      Microcide Pharmaceuticals (US) is the development of inhibitors of efflux pumps (e.g. MC-207, 110) as a method of potentiating the activity of fluoroquinolones, and possible other drugs.68 Similarly, the use of antimicrobial peptides that are able to break down the outer-membrane permeability barrier, but have little intrinsic antibiotic activity has been proposed as an approach to overcoming this type of intrinsic
      insusceptibility."

      This article also talks about inhalational antibiotics, biofilms, and other topics related to Pa. But the point is that physicians realize one antibiotic does not treat all. Including the physicians that are collaborating in the clinical trial of Arikace.

      Also, ClinicalTrialsDOTgov has various references (depending upon keywords used in the search) including:

      Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)

      A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies (a collaborative study by Gilead to test the effect of rotating between Cayston and TOBI).

      Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients - somewhere during the discussions on this MB Mpex Pharma completed the Phase III on inhalation levofloxacin v. TOBI, so they are probably filing an NDA or EMEA application.

      Talk is cheap when you have no research to present to substantiate your opinions and just try to denegrate someone who does their research and tries to provide some accurate info to investors. I am way-Long on INSM (I wish I had bought and sold in the past) but Clones 1, 2 and 3 can call me all the names they wish, but the method stays the same and like James Stewart says in "Mister Smith Goes To Washington" . . . "Somebody out there will listen."

      Sentiment: Buy

      • 6 Replies to rehdvm2004
      • You could see the setup yesterday with the sentiment.....

        Someones buying!! ............... short interest is down!

        Traders know these setups are not the instant gratification of Huge move !from the obvious clownsbut take time,especially with such a thinly traded stock.

        Today 90% of the volume is selling ...but but ..INSM up ! 13 cents.... OTAY!

        YD - short since 7.81
        Good Luck

        by terry_insm.Feb 11, 2013 2:38 PM.
        The short interest is adding here imho
        Good Luck

      • Mpex was bought out by Aptalis Pharma, whic is proceeding with the NDA because, while the primary endpoint was not statistically significant in:

        "In Study 207, the placebo-controlled single-cycle study, the differences between Aeroquin and placebo groups in the predefined primary endpoint of time to first pulmonary exacerbation were not statistically significant, however efficacy among certain secondary endpoints (lung function, reduction in Pseudomonas aeruginosa from sputum) in Aeroquin treated patients was demonstrated."

        The secondary endpoints were significant including "lung function." That is FEV-1. That secondary endpoint with Aeroquin is the primary endpoint for Arikace. And they did lower Pseudomonas aeruginosa counts in sputum, which is a secondary Arikace endpoint. So on a comparative basis (and as we who follow the inhalational antibiotic parade to new NDA drugs) Aeroquin might well have competed with Arikace. Anyway the debate goes on.

        And fud is quoting Estonia for justifying treating TB with Arikace instead of looking at the joint CDC and NIH recommendations for treating pulmonary TB. TB does leave the lungs and go systemically to the liver, other abdominal organs and, as recently mentioned in the scientific literature, sequesters in the bone marrow.

        Lets put it this way, the new drugs for treating pulmonary TB will include the mycobacterial metabolic and enzyme inhibitors before they will fall back on any antibiotic, like Arikace. Just read the CDC and NIH statements.

        Arikace is a buy mainly because of NTM. Not because it will displace systemic amikacin, or other inhalational antibiotics. It should capture a share of the "rotational treatment of chronic Pa" but that will be a percentage of less than 100%.

        Let's see who is more correct.

        Sentiment: Buy

      • Rest assured,the vast majority here appreciate your posts...
        ===========================================
        by rehdvm2004

        Ever wonder why biopharmas produce 150% of the specific types of drugs that are needed on an annu to basis? Because the sales forces for each drug company will go out and and compete with each other to sell 5-10% more of their product. You cannot sell it if it is not produced and ready for sale. There are sales people who operate under the impetus of increasing product sale everyday. Just like other sales people. If the durg that is produce goes past label copy, it is recalled, retested, relabeled and shipped overseas. Ever wonder why 1 or 20 sidewalk businesses in Mexico is a "Pharmacia?" Lets put that one into perspective on this MB. What poster has been spouting for years that Arikace will displace TOBI for all uses. Not just CF/Pa.

        As for one antibiotic alone being the "cure-all, end all, be-a;;" selection, multiple scientific groups are investigating the rational rotation of antibiotics, including the hospital that participated in the Euro CF/Pa study of Arikace (this was the earliest reference article for combination therapy, but the authors cite even earlier scientific papers):

        "Antibiotic resistance in Pseudomonas aeruginosa: mechanisms and impact on treatment

        in Drug Resistance Updates (2000) 3, 247–255

        Robert E.W. Hancock,1 David P. Speert2

        Departments of Microbiology and Immunology,1,2 Pediatrics,2 University of British
        Columbia,Vancouver, British Columbia, Canada

        STRATEGIES FOR PREVENTION OF EMERGENCE OF
        RESISTANCE

        Combination therapy

        Since cross-resistance between major classes of anti-Pseudomonal antibiotics is unlikely to develop, it is common practice to treat serious infections with a combination of a b-lactam and an aminoglycoside. Not only do the drugs appear to exert a synergistic antibacterial effect, but they may also delay or prevent the emergence of resistance during therapy. There are a few novel approaches under development in
        which the combination of agents would include an antibacterial agent and an inhibitor of a major resistance mechanism.The best example of this would be the use of a combination of b-lactamase inhibitor and b-lactam, although the b-lactamase inhibitors currently available in the clinic do not work well and a specific inhibitor of class C enzymes should be used.26 Another approach, being pursued by
        Microcide Pharmaceuticals (US) is the development of inhibitors of efflux pumps (e.g. MC-207, 110) as a method of potentiating the activity of fluoroquinolones, and possible other drugs.68 Similarly, the use of antimicrobial peptides that are able to break down the outer-membrane permeability barrier, but have little intrinsic antibiotic activity has been proposed as an approach to overcoming this type of intrinsic
        insusceptibility."

        This article also talks about inhalational antibiotics, biofilms, and other topics related to Pa. But the point is that physicians realize one antibiotic does not treat all. Including the physicians that are collaborating in the clinical trial of Arikace.

        Also, ClinicalTrialsDOTgov has various references (depending upon keywords used in the search) including:

        Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)

        A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies (a collaborative study by Gilead to test the effect of rotating between Cayston and TOBI).

        Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients - somewhere during the discussions on this MB Mpex Pharma completed the Phase III on inhalation levofloxacin v. TOBI, so they are probably filing an NDA or EMEA application.

        Talk is cheap when you have no research to present to substantiate your opinions and just try to denegrate someone who does their research and tries to provide some accurate info to investors. I am way-Long on INSM (I wish I had bought and sold in the past) but Clones 1, 2 and 3 can call me all the names they wish, but the method stays the same and like James Stewart says in "Mister Smith Goes To Washington" . . . "Somebody out there will listen."

        Sentiment: Buy

      • rehvdm,

        You are correct, the aeroquin phase III studies are over, and the results are in.

        Mpex actually ran two phase III studies, and while the first did show non-inferiority against TIS, the second vs. placebo did not show a statistically significant change. Usually that makes filing and approval a tough chore.

        Here is a copy and paste of the release: In Study 207, the placebo-controlled single-cycle study, the differences between Aeroquin and placebo groups in the predefined primary endpoint of time to first pulmonary exacerbation were not statistically significant, however efficacy among certain secondary endpoints (lung function, reduction in Pseudomonas aeruginosa from sputum) in Aeroquin treated patients was demonstrated.

      • excellent post

      • Red,,,,,,,,,,,,,Good post.

    • it will be at least 4 years till Insmed gets an approval in the US

    • Robert, I'm going to assume we will be reading a lot of you on the board the next couple days what with the 2-feet of snow coming into Boston. Stay warm and safe.

    • Rummy, I hope you were sober as Kenneth has complimented you for when you posted - The physicians actually responded to these suggestions and Novartis took the hit. It scares me to imagine how ridiculous your posts would be if you were drunk. Why in the world do you think "the physicians actually responded"???????

      Because it makes so darned much sense!!!!!

      A salesman could not get a physician to respond to Tobramycin Inhalation for lung cancer, but for another lung infection........well, that's very different.

      The GAIN act only passed last May. Read it. You may well gain some valuable knowledge regarding how serious the FDA is about widening the number and types of available antibiotics.

      By the way, I'm sure no salesperson could have ever caused you to act to use a proven antibiotic on an infection - you would see right through that type of convoluted logic!!!!!

      Sentiment: Strong Buy

    • Rummy, regarding:

      The physicians actually responded to these suggestions and Novartis took the hit.

      Thanks for making Fud's argument that the GAIN act could make it considerably easier for Arikace to win wider approvals! Why do you think that physicians "actually responded to the suggestions"????? Because it makes so darned much sense - that's why!

      If a salesman suggested a physician use Tobramycin Inhalation to fight lung cancer, he would be laughed at. Using Tobramycin Inhalation to treat other pulmonary infections, however, must have seemed perfectly logical or the physicians would not have responded to the suggestions. It is perfectly logical.

      Please actually read the act. The FDA is very, very serious about substantially widening the number and types of available antibiotics.

      Sentiment: Strong Buy

    • Red, Thank you for your continued sober contributions to this board.

 
INSM
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