Toujeo PI

Discussion in 'Sanofi' started by Anonymous, Feb 26, 2015 at 7:18 AM.

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  1. Anonymous

    Anonymous Guest

    Does anyone see the discrepancies in the pi versus our modules?
     

  2. Anonymous

    Anonymous Guest

    Such as what? My oral boards are coming up and I am concerned.

    Pls be specific.

    Thanks
     
  3. Anonymous

    Anonymous Guest

    The hypoglycemia data came from a combined review of three Phase III studies sponsored by Sanofi. The studies also showed that Toujeo and Lantus were similarly effective in controlling overall blood sugar and are the basis for Sanofi's recently filed U.S. marketing application for Toujeo.
     
  4. Anonymous

    Anonymous Guest

    Pi no mention of hypo, several mentions of 10-20% more units, open pen use days.
    Not what we were trained on.
     
  5. Anonymous

    Anonymous Guest

    PI section on Sanofi Hypoglycemia

    -TYPE 1 patients: FDA states there were no clinically important differences in hypoglycemia control between TOUJEO and LANTUS int Type 1.

    -TYPE 2 patients: Does not mention any comparison of TOUJEO to LANTUS like they did for type 1.
     
  6. Anonymous

    Anonymous Guest

    We are fucked.
     
  7. Anonymous

    Anonymous Guest

    We are fu*^ed.
     
  8. Anonymous

    Anonymous Guest

    Not if they price it right.
     
  9. Anonymous

    Anonymous Guest

    Do not fear Joe Balzer and Greg are still here
     
  10. Anonymous

    Anonymous Guest

    Think about it. This industry is about growth. If the goal here is to convert Lantus patients to Toujeo, it's going to have to cost more. Period.
     
  11. Anonymous

    Anonymous Guest


    Lantus was already priced at a premium through a 160% market up over the last couple of years. This common prctice when frug is near the end of its patented life. Toufeo will be priced the same, which will be a premium compare to generic lantus and levemir.
     
  12. Anonymous

    Anonymous Guest

    Please do not put Levemir as a comparison to Lantus, generic Lantus (not even a thing yet stupid) or Toujeo. That shit has limited efficacy thus its lack luster SOM. Lantus will still kick Levemirs a$$ 10 years from now. Don't be jealous Novo, remember you guys are the best reps in pharma
     
  13. Anonymous

    Anonymous Guest

    http://www.bloomberg.com/news/articles/2015-02-05/sanofi-revamps-diabetes-unit-to-gain-ground-against-novo

    I'm not even sure what point you're trying to make here - is it that Sanofi reps are terrible? Your CEO was fired, along with 1/3 of your managers, because Lantus has been losing market share to Levemir for the past 3 years. If Novo has done that with a terrible product, what does that say about those of you selling Lantus? The past several years have simply shown that Lantus has a higher market share because it came out first. No other reason. When you actually have to sell, you can't even hang on to the business you already have.

    But, don't be jealous. I'm sure you're awesome.
     
  14. Anonymous

    Anonymous Guest

    The approval on Wednesday was the PDUFA date. Now the negotiations begin for updating the label and claims. The PI is only the first version. This is why the launch will only be with a PI MVA and the promo materials with claims will be submitted to OPDP agency at the end of next week for release by end of April or early May.
     
  15. Anonymous

    Anonymous Guest

    obviously you are unfamiliar with the process. There was no committee meeting. What you see is what you get. That is why the stock tanked and the analysts unimpressed. I wish you were right.
     
  16. Anonymous

    Anonymous Guest

    Agree...the PI is the PI. Will the FDA require a REMs strategy too?
     
  17. Anonymous

    Anonymous Guest

    It is to bad you do not understand a drugs patent life cycle. novo reps rock!!!
     
  18. Anonymous

    Anonymous Guest

    If you know so much then answer this simple question:

    How many promotional pieces for a drug can be submitted at one time for review by OPDP at the FDA?
     
  19. Anonymous

    Anonymous Guest

    So, your CEO was fired because of a patent life cycle? Interesting....
     
  20. Anonymous

    Anonymous Guest

    Insulin is insulin is insulin. The mechanism of action is the same; it is the protraction which is different. Even NPH, for all its insane variability lowers blood sugar at a relatively similar rate as Lantus or Levemir. just like aspirin is aspirin. If ou were to say you will have diff clinical results between analogs to a savvy, evidence based clinician, I would like to be there to see you get schooled.