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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Dec 9, 2012 9:04 AM Flag

    FaceTheFacts INSM Longs - Accelerated Approval

    The difference between Janssen Pharma and INSM is considerable. The former has been a subsidiary of Johnson and Johnson since 1961. The company was based in Belgium when J&J acquired their IP and facilities. It has been a strong association ever since with Janssen having sponsored more than 170 clinical trials since. But the recent accelerated approval is for TMC207 to become the "fifth wheel" among the already existing four primary drugs to treat TB disease: "isoniazid (INH), rifampin (RIF), ethambutol (EMB) and pyrazinamide (PZA)" according to the CDC. If one further looks at the clinical trials for TMC207, one will see that they are performing trials to make sure the antibiotic is compatable with concurrent HIV/AIDs treatment, works with at least 3 other antibiotics in rotation, and has a Phase III on TMC207 alone trial that was approved in April 2012. But Janssen is holding off starting this trial because of the possibility of accelerated review. The important aspect of this is that TMC207 antibiotic turns off a critical TB enzyme system needed for bacterial survival by a totally unique mechanism of action. Thus TMC207 fits perfectly into a multiple modality therapy by attacking the TB bacteria in a totally separate manner from the other four. So in medical terms, TMC207 has a unique action, is safe and was shown to be efficacious in a Phase IIb study.

    Lets look at Arikace. Amikacin is a "second tier" treatment for TB, but is not a new drug, nor does it have a unique mechanism of action against bacteria. It also is inhalational, has a pulmonary lipid accumulation problem that is under study and has had "top line" Phase IIb data available for about 2 years which has not cause the FDA to get excited. The one area the FDA is excited about is the inhalational use for NTM, which was a protocol they asked Transave to file. That one got set back to a Phase IIb (Phase III enabling) because of the rat carcinogenicity study. So is the FDA moving to "accelerate" the approval of Arikace for treatment of any bacterial infection? I do not believe this to be the case. INSM is going to plod through clinical trials, generate data, get an approval and go from there.

    In the meantime, further encouragement would be provided by:

    1. Announcing the hire of a top regulatory official who could facilitate approval on both sides of the pond (if it is a VP level hire it will be a big employment package).

    2. Have INSM announce that they have validated the production of Arikace at the CRO facility.

    3. Give some early indication of the results for the NTM study with (hopefully) eradication of the NTM within the 84 day period, but better yet, within 30 days. Remember, this is a captured, orphan antibiotic drug market.

    We shall see in the next 60 days.

    Sentiment: Buy

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    • Accelerated approval is based upon submission of an NDA, which is the final paperwork that an applicant must file anyway. This is why an experienced VP of regulatory affairs is critical. The last NDA filed by INSM was 2005, Iplex for short stature. The accelerated review process is not predicated on "skipping paperwork."

      Sentiment: Buy

    • by rehdvm2004.Dec 9, 2012 9:04 AM.The difference between Janssen Pharma and INSM is considerable. The former has been a subsidiary of Johnson and Johnson since 1961. The company was based in Belgium when J&J acquired their IP and facilities. It has been a strong association ever since with Janssen having sponsored more than 170 clinical trials since. But the recent accelerated approval is for TMC207 to become the "fifth wheel" among the already existing four primary drugs to treat TB disease: "isoniazid (INH), rifampin (RIF), ethambutol (EMB) and pyrazinamide (PZA)" according to the CDC. If one further looks at the clinical trials for TMC207, one will see that they are performing trials to make sure the antibiotic is compatable with concurrent HIV/AIDs treatment, works with at least 3 other antibiotics in rotation, and has a Phase III on TMC207 alone trial that was approved in April 2012. But Janssen is holding off starting this trial because of the possibility of accelerated review. The important aspect of this is that TMC207 antibiotic turns off a critical TB enzyme system needed for bacterial survival by a totally unique mechanism of action. Thus TMC207 fits perfectly into a multiple modality therapy by attacking the TB bacteria in a totally separate manner from the other four. So in medical terms, TMC207 has a unique action, is safe and was shown to be efficacious in a Phase IIb study.

      Lets look at Arikace. Amikacin is a "second tier" treatment for TB, but is not a new drug, nor does it have a unique mechanism of action against bacteria. It also is inhalational, has a pulmonary lipid accumulation problem that is under study and has had "top line" Phase IIb data available for about 2 years which has not cause the FDA to get excited. The one area the FDA is excited about is the inhalational use for NTM, which was a protocol they asked Transave to file. That one got set back to a Phase IIb (Phase III enabling) because of the rat carcinogenicity study. So is the FDA moving to "accelerate" the approval of Arikace for treatment of any bacterial infection? I do not believe this to be the case. INSM is going to plod through clinical trials, generate data, get an approval and go from there.

      In the meantime, further encouragement would be provided by:

      1. Announcing the hire of a top regulatory official who could facilitate approval on both sides of the pond (if it is a VP level hire it will be a big employment package).

      2. Have INSM announce that they have validated the production of Arikace at the CRO facility.

      3. Give some early indication of the results for the NTM study with (hopefully) eradication of the NTM within the 84 day period, but better yet, within 30 days. Remember, this is a captured, orphan antibiotic drug market.

      We shall see in the next 60 days

    • The difference between Janssen Pharma and INSM is considerable. The former has been a subsidiary of Johnson and Johnson since 1961. The company was based in Belgium when J&J acquired their IP and facilities. It has been a strong association ever since with Janssen having sponsored more than 170 clinical trials since. But the recent accelerated approval is for TMC207 to become the "fifth wheel" among the already existing four primary drugs to treat TB disease: "isoniazid (INH), rifampin (RIF), ethambutol (EMB) and pyrazinamide (PZA)" according to the CDC. If one further looks at the clinical trials for TMC207, one will see that they are performing trials to make sure the antibiotic is compatable with concurrent HIV/AIDs treatment, works with at least 3 other antibiotics in rotation, and has a Phase III on TMC207 alone trial that was approved in April 2012. But Janssen is holding off starting this trial because of the possibility of accelerated review. The important aspect of this is that TMC207 antibiotic turns off a critical TB enzyme system needed for bacterial survival by a totally unique mechanism of action. Thus TMC207 fits perfectly into a multiple modality therapy by attacking the TB bacteria in a totally separate manner from the other four. So in medical terms, TMC207 has a unique action, is safe and was shown to be efficacious in a Phase IIb study.

      Lets look at Arikace. Amikacin is a "second tier" treatment for TB, but is not a new drug, nor does it have a unique mechanism of action against bacteria. It also is inhalational, has a pulmonary lipid accumulation problem that is under study and has had "top line" Phase IIb data available for about 2 years which has not cause the FDA to get excited. The one area the FDA is excited about is the inhalational use for NTM, which was a protocol they asked Transave to file. That one got set back to a Phase IIb (Phase III enabling) because of the rat carcinogenicity study. So is the FDA moving to "accelerate" the approval of Arikace for treatment of any bacterial infection? I do not believe this to be the case. INSM is going to plod through clinical trials, generate data, get an approval and go from there.

      In the meantime, further encouragement would be provided by:

      1. Announcing the hire of a top regulatory official who could facilitate approval on both sides of the pond (if it is a VP level hire it will be a big employment package).

      2. Have INSM announce that they have validated the production of Arikace at the CRO facility.

      3. Give some early indication of the results for the NTM study with (hopefully) eradication of the NTM within the 84 day period, but better yet, within 30 days. Remember, this is a captured, orphan antibiotic drug market.

 
INSM
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