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