Friday, 21 August 2015

NewsSpeak: GSK bows out to leave Novartis in the game

I am very excited; ofatumumab is resurrected. #NewsSpeak #MSResearch #MSBlog

"If you follow this blog you will have read many times that I believe that anti-CD20, and possibly anti-CD19, therapies are the real game-changers. They are highly effective treatments with a very good safety profile and may turn-out to be induction, rather than maintenance, therapies. As these treatments target B-cells, by depletion, they are also anti-EBV treatments, which may be how they work. EBV, the virus I think causes MS, resides in the B cell."

"Did you know that rituximab, the original anti-CD20 therapy, is the only licensed anti-EBV treatment? It is licensed to treat post-transplantation lymphoproliferative disorder, and several EBV-related lymphomas, which are caused by EBV."

"I was very disappointed when GSK stopped their phase 3 programme of ofatumumab in MS and was becoming increasingly concerned that ofatumumab would never see the light of day as a treatment for MS. The ofatumumab phase 2 results are probably the best phase 2 results ever seen with a potential MS DMT. This is why I am so excited about the news that Novartis have bought the rights to develop ofatumumab for MS. Firstly, this means that MSers may get to use ofatumumab in  the future, and secondly Novartis has shown that it is committed to its MS franchise. We were all getting concerned about Novartis' prospects in MS after the negative fingolimod PPMS trial and the imminent patent expiry of fingolimod."


The following is an excerpt from Novartis' press release:

Novartis acquires all remaining rights to GSK's Ofatumumab to develop treatments for MS and other autoimmune indications

FRIDAY, 21 AUGUST 2015 - 8:25AM

Novartis strengthens multiple sclerosis focus with the addition of Ofatumumab to leading MS portfolio which includes Gilenya and investigational treatments BAF312 and CJM112.


Ofatumumab is a fully human monoclonal antibody for relapsing remitting multiple sclerosis (RRMS) which targets CD20 and is administered by subcutaneous injection. The novel treatment works by inducing depletion of B cells in the lymphatic tissues; B cells are known to play an important role in MS

Basel, August 21, 2015 - Novartis announced today that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline plc (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis (RRMS) and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra®.

RRMS is thought to be associated with activation of B cells, a type of white blood cell in the immune system. Ofatumumab works by binding to the CD20 molecule on the surface of B cells and depleting them in lymphatic tissues. Positive phase IIa results for subcutaneous Ofatumumab demonstrated significant reduction of up to 90% in the cumulative number of new brain lesions in patients with MS between weeks 4-12 in the study. No unexpected safety findings were reported in the study. Since this was a dose finding trial, Ofatumumab is ready to begin phase III pivotal studies.

"Novartis is pleased to further reinforce our commitment to neuroscience and to add an exciting new treatment to our strong MS portfolio," said David Epstein, Head of Novartis Pharmaceuticals. "Our vision for patients with MS is to develop treatments that improve on current standards of care, meeting patients' needs at every stage of their disease with innovative and targeted drugs."

Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain and spinal cord through inflammation and tissue loss. More than 2.3 million people worldwide are affected by MS, a disease that most often begins in early adulthood. The typical evolution of MS results in progressive loss of both physical and cognitive (e.g. memory) functions. People with MS can be diagnosed with relapsing forms of MS (RMS), which include relapsing remitting MS (RRMS) and secondary progressive MS (SPMS), or with primary progressive MS (PPMS).

Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300 million to GSK for the acquisition of the compound and a further payment of $200 million payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534 million may be made. Novartis will also pay royalties of up to 12 per cent to GSK on any future net sales of Ofatumumab in auto-immune conditions.


CoI: multiple

19 comments:

  1. Great!
    undoubtedly this is a very important decision for us !

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  2. In reality how long will it take for this to be avaliable to patients and will any of the trials be in the uk.

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  3. Can Novartis reuse data from previous trials?

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    1. I think there will need to be another trialppossibly trials

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  4. Will this mean a price hike like alemtuzumab?

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  5. Are the phase 2 results better than those for Rituximab?

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  6. But tell the truth--is this likely to be one more treatment my neuro will say I can't have because I'm not sick enough?

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    1. It is safer than some treatments, "is this the person saying there there we'll get you a nice wheelchair?"

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  7. That's indeed a great news !

    I was wondering what are the differences between Ofatumumab and Ocrelizumab. I know they both target CD20, so what makes Ofatumumab "the best phase 2 results ever seen with a potential MS DMT" ?
    (maybe it is too soon to ask ;)

    The recent results with treatments targeting CD20 tends to show you're on the right way (crossed fingers). Congratulations so far to all people involved and keep doing the great job !

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    1. Ofatumab is all human ocrelizumab is humanised so contains abit of mousse/rat.

      E

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    2. http://multiple-sclerosis-research.blogspot.com/2015/07/education-naming-drugs.html

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    3. Thanks for pointing this out MD. I missed this topic.
      "Would you want to take a a drug called Shitola?" made me laugh, really :D.

      So, the all human version could be more effective because of it's nature, providing a better bounding to B-Cells ?
      And less risk to develop anti-drug antibodies ?

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    4. Yep less potential for drug reactions and being subcutaneous rather than an infusion is is easy to give and hangs around longer and it may get into lymph glands better

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  8. That's good news !! ... It seemed to be more effective than Ocrelizumabe and Rituximab?

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  9. But still not as good as lemtrada or hsct

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    1. Wrong it is better..
      compared to Lemtrada there is a much better safety profile i.e no secondary autoimmunity its heal will be PML risk but based on rituximab this low even without risk mitigation. In terms of phase iii i am predicting as good or better. Rr r

      emember the drop in phase iii was 55% compared to 80% in phase ii in alemtuzumab compared to beta interferon, if they repeat phase ii data with anti cd20.

      Subcutaneous is more convenient although i suspect we will see sub cutaneous alemtuzumab soon.

      As to HSCT it will lack the danger of infection and is more convenient

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    2. How would subQ Lemtrada work? You'd still need the monitoring, because that safety profile is no joke.

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  10. If it's effective as you say I really hope they choose to trial it against an oral rather than a CRAB drug.

    If it's true that most newly diagnosed (who choose escalation) opt for Tecfidera as I did, it'll be a hard sell to get people to sign up for a trial. I'd be really interested in a trial but not if I risk ending up on a less effective injectable with greater side effects. It would be my brain at risk and I'm quite attached to it!

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    1. No company are going to trial their drug against the most effective drug, they select the lowest hanging fruit and if you were going against an oral you would chose Aubagio and it is no better than CRAB drugs.

      Now if I want to go up against Tec then you sell in terms of efficacy of relapse rate against placebo. Tec was less than 50% and you look at the atrophy and Tec failed in one of its trials and then it is maybe twice a year verses every day no flushing no gastrointestinal effects.

      Lets see what the data is with ocreluzimabsays only 6 weeks to wait. If it is good you will have people signing up to ofataumumab trial, if they can't afford drugs, because the data show that anti-CD20 can be an induction treatment and so even two doses may be enough

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