Wednesday, 8 July 2015

Move over looks like Roche is coming to Town?

Who said 2015 was not a good year for MS?

Move-over Biogen, Novartis, Bayer, Merck Serono etc......It looks like Roche is here and getting ready for DMT prime time. At one point it seemed that Roche had a deal with Biogen for them to develop the ocrelizumab, then there was lots of rumours whizzing around about a sale

Following the announcement by Roche last week that ocrelizumab is better than beta interferon and they expect to launch by 2016 what could that mean?

So a lot of unhappy docs as their babies get the heave-ho and a few scientists how may need a rethink.


Ocrelizumab appears to inhibit RRMS to a rate that is as good as or better than Alemtuzumab and Natalizumab at least based on phase II data. How good has the Phase III worked? Remember the results with lemtrada took a nose dive in phase III. How good is it? 

We will have to wait until the results are presented/leaked

However, it clearly does not cause the autoimmunities of alemtuzumab, so it could soon be bye-bye Lemtrada and the monthly blood tests.

Could it be bye bye to the T cell hypothesis and the EAEers?
They have already made up a story that anti-CD20 is about killing a few T cells and it is all about inhibiting antigen presenting function so carry-on regardless 

Once every 6 months verses once every month infusion and possible reduced risk of PML so for JC+ MSers....so could it be bye-bye Natalizumab?

Is it going to be for life or will neuros use ocrelizumab as a induction treatment and then monitor NEDA?

It is high efficacy so maybe bye-bye Gilenya....bye-bye Tecfidera and maybe your time has come for the rest.

Ocreluzimab however will have a risk of infections, as this was a reason it was pulled from development in arthritis and Lupus

What will the trials show?

What will happen to Rituxan (rituximab) a Roche product?....Go out of production as its patent expires?

What will happen to Ofatumumab? This was was swapped from GSK to Novartis (for cancer indication only) and sold as Arzerra. However, it is being used for Cancer and so they are faced with the CAMPATH/Lemtrada issue and whether they can jack the price up for MS compared to Cancer cost. They are years behind Roche as they have not started their phase III quick enough. So will there be off-label use?

Will generic rituxan make in-roads

The key question is the cost.....who knows? But I will predict it will be expensive.

What will NICE say to that...Well they should say First line because it is safer than Alemtuzumab, but because of cost they'll ration it maybe... and how long will this take 2016, 2017, 2018..better not take too long as generic fingolimod will becoming

Then what will the FDA say...Roche Swiss Company verses Biogen US Company, but it was Genetech US that developed the antibody and a US PI was behind the story in MS

Who knows?  But Good news for 2015.

What will happen in PPMS? Will it be cherry on the cake as the trials finish at end of 2015?

Let's wait and see what the results bring and how the regulators treat the data....and the price

2016 will be a big year for pharma, will the generics make any impact 

CoI None 

ProfG: multiple

25 comments:

  1. Prof C is a legend - I and many others have benefitted from Campath. Getting a drug to market (with the help of pharma) distinguishes the men from the boys. Prog G (Rick Wakeman of MS research) got close.

    Could it be bye bye to the T cell hypothesis and the EAEers? Let's hope so. Misquoting Churchill "never for the cause of humans have so many mice died for so few (breakthroughs)".

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    1. Yes he did a fantastic job and in time i am sure people will be singing the praise of steve hauser too. It is great that we have medicines that work and ocreluzimab is not over the starting line yet. However i would like to point out that campath originated in our furry friends no fuŕy friends no lemtrada or ocreluzimab

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    2. You are mouse mad. You credit your vermin for every breakthrough. David Ike thought there were aliens among us - lizard people who take human form. He may be right - perhaps mice people who take human form. I suspect you might be one of them. I hope you are working hard on a picture of Prog G in a Rick Wakeman outfit.

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    3. Credit where credits due, Have you seen My big fat Greek Wedding?-The Greeks invente everything:-)

      Picture done:-)

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  2. The wait is killing me !!! The prospectus for a safe high efficacy DMD and maybe an induction therapy too is very exciting ! .. I will consider myself fortunate as I am early RRMS and this would be just in time .. Hope the results don't make a nose drive like alem !

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    1. Safe is relative....ocreluzimab is not completely safe as remember development in arthritis and lupus was stopped because it was killing people so as PML and fatal infections arrive we will see it has its safety issues. New ones may arrive as occurred with tysabri, although there is a wealth of experience with rituximab.

      This drug is not in the market place yet and may be sometime away so you have to plan for the now and whats available now.

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    2. yup it is all relative , but keep in mind that MS'ers are more healthy then lupus patients aside from their condition .I am now doing well on Fingo , but I am wondering if Ocre turns out to be more effective and safe compared to fingo and works as an induction therapy ..it sounds like a no-brainer to me as I don't want to stay under the mercy of my employer and insurance .. (no NHS where I live !) , lets hope for good news :)

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  3. Lemtrada and Tysabri both have a sell-by date on them. Sell before Ocrelizumab is licensed.

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  4. An interesting contrast of posts. I wonder if Roche will make ocrelizumab available for people with MS in Greece? The Greek crisis is a true test of how willing Pharma will be to help out their fellow humans.

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  5. Does ocrelizumab will make a "come here" in interferons and glatiramer too? It might come as a first line induction therapy? Does that ocrelizumab get control of relapses in RRMS fact (NEDA) efforts will now focus on progressive forms? CIS could also use it? Woooowwww so many questions, but I was very "happy" since I read this publication ... "Hope is the last to die" o//

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  6. I wouldn't be so quick to kill off Lemtrada and Tysabri yet; people said the same thing about those two killing off the CRAB drugs. That said, I am excited for the impending release of Ocrelizumab as well as Daclizumab. More choices for highly-effective DMTs can only help.

    I'm not as optimistic about prices dropping much in the meantime, though. I suspect that we'll have to wait for generic Fingolimod to finally pop the pharma market bubble.

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    1. Yes it will have fun in the marketing departments

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    2. CRAB copaxone rebib, avonex, betaferon.....companied up by any chance?
      Who uses CRAB?

      Someone said generic fingo by 2016 in Australia, is this correct?, 2019 in US

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    3. I believe there is a 6 year patent period in Oz for pharma.

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  7. MD,
    Any idea if Obinutuzumab (Gazyva) is being explored for use in MS treatment?
    Thanks

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    1. Doesn't look like it ATM. As it's also a Roche drug and also anti-CD20 they're probably concentrating on ocrelizumab, though given the mechanism of action, use in MS would be indicated.

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    2. This is the cancer version the MS version will be much more expensive. For alemtuzumab they had to give the cancer variant away so they could reprice the MS version about 30 times more expensive

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    3. Other than a better side-effect profile, or a simpler treatment regimen, what would be the point of another anti-CD20, if Ocrelizumab clears all the regulatory hurdles? I'm sure we probably wouldn't get any cost savings if, as you say, it's also Roche product.

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  8. Where do they pick the name for these things?!
    I get the mab bit, but who came up with ocrelizu? Not very catchy is it.
    How about "MSamab"! Simples.

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    1. I know that "lizu" means that the monoclonal antibody was humanized in its production, but I can't speak with authority on the "Ocre" part--I assume that the company has a little more poetic license to choose the first part of the name to differentiate it from competitors' formulations.

      Naming new medications sounds like a fun task. I have no idea how pharmacists and physicians can keep track of all the medications available.

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    2. There are things called STENS and these are beginnings or normally endings that tell you what the compound is,e.g. an antibody a chimeric antibody, a mouse, hamster antibody a toxin directed antibody etc. etc

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    3. lizu actually li is immune-related and zu is humanised andmab is monoclonal antibody

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    4. Let's simplify. How about Roche$MoneyMoneyMoney$mab? Simple, honest, and clearly a monoclonal antibody.

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