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

[deleder2k]

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

MabThera SC approved by the European Commission: In March 2014, the
European Commission approved Roche's new subcutaneous (SC) formulation of
MabThera (rituximab) using Halozyme's recombinant human hyaluronidase
(rHuPH20) for the treatment of patients with follicular lymphoma and
diffuse large B-cell lymphoma. The previously approved formulation of
MabThera is delivered by an intravenous infusion which takes
approximately 2.5 hours. The new MabThera SC formulation can be
administered subcutaneously in approximately 5 minutes and comes as a
ready-to-use, fixed dose, 1,400 mg solution, which shortens pharmacy
preparation time and reduces the overall impact on hospital resources.

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?

 

[alex3619]

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.

 

[deleder2k]

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...

 

[Ninan]

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.

 

[deleder2k]

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.

 

[Ninan]

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

August? The Norwegian study? Where did you hear that?

 

[deleder2k]

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.

 

[deleder2k]

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:

In a randomized phase II study of rituximab two infusions two weeks apart versus placebo in 30 patients with chronic fatigue syndrome, we then completed an open-label phase II study 28 patients with rituximab induction and maintenance therapy, a total of 6 infusions over 15 months. 21 patients (72%) had response to defined criteria, 18 patients (64%) had clinical significant improvement in most CFS symptoms. Duration of response within 36-month study period, with a mean of 108 weeks for 14 major responders and 68 weeks for 4 moderate responders, 11 are still in response after 36 months of follow-up.