On 12 July, Biogen announced that it had entered a license and collaboration agreement with InnoCare Pharma for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS). This collaboration will allow Biogen to expand its MS pipeline portfolio with a treatment that has a promising efficacy and safety profile, as well as the potential to cross the blood-brain barrier.

Bruton’s tyrosine kinase (BTK) is an important protein in B cells, and the inhibition of BTK is thought to lead to B cell depletion and reduced B cell-mediated immune attacks in relapsing-remitting multiple sclerosis (RRMS) patients. B cell depletion is a well-received mechanism of action (MOA) in the treatment of MS, with a good efficacy and safety profile. The key benefit of BTKis is the fact that they offer a new MOA in this space. Orelabrutinib is a small molecule that seems to have effects on the microglia and B cells. Its MOA is distinct from that of the anti-CD20 monoclonal antibodies (mAbs), Roche’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab), as the drugs in this class do not cross the blood-brain barrier. If orelabrutinib does cross the blood-brain barrier, it may have more effects on the innate immune system and microglial activation.

Over the past year, Biogen’s MS portfolio has been affected by the loss of patent protection and revenues for its blockbuster drug Tecfidera (dimethyl fumarate). Biogen reported sales of $3.84bn last year. GlobalData forecasts that Tecfidera will generate $1.12bn in 2026 due to generic competition. This decline in revenue is also due to the launch of second-generation sphingosine-1-phosphate (S1P) receptor modulators, specifically Novartis’ Mayzent (siponimod fumerate) in March 2019, Celgene’s Zeposia (ozanimod) last March, and Janssen’s Ponvory (ponesimod) this March. The launch of Biogen’s Vumerity (diroximel fumarate) alongside Roche’s Ocrevus, Novartis’ Kesimpta and other anti-CD20 mAb pipeline assets are expected to steal some of Tecfidera’s market share. This new collaboration agreement for orelabrutinib could once again establish Biogen as a strong player in the MS market.

Orelabrutinib is currently marketed for different types of cancer in the US and China, and it is in Phase II of development for RRMS. It will not, however, have a first-in-class status, as another BTKi, Merck’s evobrutinib, is currently in Phase III of development. Evobrutinib is expected to launch in the US in 2025 and the five major European markets, namely France, Germany, Italy, Spain and the UK, in 2026. It will represent an additional choice for patients on B cell depletion therapies through its oral formulation, as all the other currently available B cell depletion therapies are injectables.

GlobalData expects that evobrutinib will likely be positioned as a second-line treatment similar to other B cell depletion therapies such as Ocrevus and Kesympta. Orelabrutinib’s market share, however, could be limited due to its late entry in the MS market and its second-to-market status within its class. GlobalData expects evobrutinib to reach sales of $390m in 2028.

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