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European Commission approved Roche's new subcutaneous (SC) formulation of MabThera (rituximab)

Discussion in 'Rituximab: News and Research' started by deleder2k, May 17, 2014.

  1. deleder2k

    deleder2k Senior Member

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    http://online.wsj.com/article/PR-CO-20140512-912153.html

    If Rituximab phase 3 trial in Norway turns out positive, would this be the preferred way instead of injecting it? Could there be any obstacles that would require us to get the injection version of Mabthera instead?
     
    vli, ukxmrv, catly and 7 others like this.
  2. alex3619

    alex3619 Senior Member

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    Logan, Queensland, Australia
    I would think there might be two obstacles. The first is that this new form might need to be tested on us in a small study to convince the sceptics that it will work as well as the infused version. The second is that being a new version it will be far more expensive, and the patent wont be about to run out.
     
    Valentijn likes this.
  3. deleder2k

    deleder2k Senior Member

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    I guess thats true. I read that all of the major pharmaceutical companies are rushing to get their own Rituximab version on the market. Roche's patent in Europe expired a few months ago and as they all see Rituximab as a big revenue booster, they're all trying to rush their own version to the market.
    We can only hope that the cost of the drug will fall drastically. The Norwegians will soon publish their results from whats left of their phase 2 study on Rituximab. They have told that they results are the same as whats already published.

    Could it be realistic that other clinics/hospitals in Europe will treat people with the drug given that the results from the latest Rituximab study looks positive? I am sure they will give an update while phase 3 study once they start seeing some results. The timeframe of the study are 2 years, plus 1 additional year to complete and publish the study. I can't wait three more years...
     
    Last edited: May 17, 2014
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  4. Ninan

    Ninan Senior Member

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    Good thing though, if the patent isn't running out for some time, Roche might be interested in financing a study themselves. That would be a great leap for humanity.

    I heard, from people visiting some seminars, that Fluge and Mella already use subcutaneous rituximab in some cases where the standard procedure doesn't work. And seem to have good results. Can't confirm it's true of course since I've seen no papers for some time but I'd say my sources are pretty reliable.

    So looking forward to them publishing something. It's been a while and we've heard "soon" for a long time now.
     
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  5. deleder2k

    deleder2k Senior Member

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    The patent for Mabthera (Rituximab) has expired in Europe. I think it still has 3 more years in the U.S. Phase 3 of the study is almost financed. I think they are $200,000 short. I got news today that they are starting the study in August. Roche hasn't funded nothing... If they their patent was valid 10 more years I am sure they would have been more interested in the study.
     
  6. Ninan

    Ninan Senior Member

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    Ok, I figured they would need a new patent? From what Alex said.

    August? The Norwegian study? Where did you hear that?
     
  7. deleder2k

    deleder2k Senior Member

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    Ah, i was talking about the old version. I have no clue if theres a new patent involved for the new Mabthera.

    I heard it from the ME/CFS Centre at Aker University Hospital in Oslo.
     
  8. deleder2k

    deleder2k Senior Member

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    Rituximab project at the Regional Committees for Medical and Health Research Ethics site: https://helseforskning.etikkom.no/i...prosjektregister/prosjekt?_ikbLanguageCode=us
    (In Norwegian)

    Some of the highlights:
     

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