Novartis’s Ocrevus me-too on track for filing

Novartis’s plan to turn Arzerra from an underwhelming blood cancer drug into a less underwhelming one for multiple sclerosis is on track to deliver a US filing this year. This follows positive readouts today of Asclepios I and II, pivotal studies of Arzerra’s active ingredient, ofatumumab, showing reductions in annualised relapse rate versus Sanofi’s Aubagio in relapsing-remitting MS. Full data will be presented at next month’s Ectrims meeting, but Aubagio is a low bar to beat, having shown a 32% reduction in annual relapses. This has been blown out of the water by Roche’s blockbuster Ocrevus, which with an 80% reduction is Novartis’s real competitor. Ocrevus validated the anti-CD20 approach to treating MS, but ofatumumab is one of only three other MS projects using this mechanism. A second, TG Therapeutics’ ublituximab, is in the pivotal Ultimate-1 and 2 studies, which read out in 2021, and long-term follow-up from phase II will feature at Ectrims. Novartis has distinguished ofatumumab for MS from Arzerra by formulating it as a monthly SC injection, currently coded OMB157; 2024 forecast sales of OMB157 should easily beat Arzerra, according to EvaluatePharma, but will come nowhere close to those of Ocrevus.

Anti-CD20 antibodies in development for MS
Project Company Status in MS 2024e sales in MS Trial ID
Ocrevus Roche Approved for relapsing or PP MS $6.7bn NCT01194570
OMB157 Novartis/Genmab Phase III in relapsing MS $940m NCT02792231
NCT02792218
Ublituximab TG Therapeutics Phase III in relapsing MS $188m NCT03277261
NCT03277248
BCD-132 Biocad Phase I study in Russia NA NCT03551275
Rituxan Roche Failed Olympus trial in PP MS Zero NCT00087529
Source: EvaluatePharma; PP=primary progressive.

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