Biogen recently announced that it has entered into 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 new collaboration will enable Biogen to expand its MS pipeline portfolio, while also providing a potential treatment for MS patients given the potential efficacy and safety profile, plus a promising level of blood-brain barrier, says GlobalData, a leading data and analytics company.

Alessio Brunello, Managing Pharma Analyst at GlobalData, comments: “The key benefit of BTKi is a new mechanism of action. It’s a small molecule and appears to have effects on microglia and B-cells. It is distinct from anti-CD20 monoclonal antibodies (mAbs) Roche’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab) as the drugs in this class do not get into the blood-brain barrier. If orelabrutinib does cross the blood-brain barrier, then it may have more effects on the innate immune system and microglial activation.”

Biogen’s portfolio for MS has been affected in the past year due to loss of patent protection and in revenues of its blockbuster drug, Tecfidera (dimethyl fumarate). Biogen reported sales of $3.84bn in 2020 and GlobalData forecast that in 2026 Tecfidera will generate $1.12bn due to generic competition. The decline from 2019 is due also to the launch of second generation S1P receptor modulators, namely Novartis’ Mayzent (siponimod fumerate) in March 2019, Celgene’s Zeposia (ozanimod) in March 2020 and Janssen’s ponesimod in March 2021.

Brunello continues: “The launch of Biogen’s Vumerity (diroximel fumarate), alongside of Roche’s Ocrevus, Novartis’ Kesimpta and other anti-CD20 mAb pipeline assets are expected to steal some market share from Tecfidera. This new collaboration agreement of this potential new agent could establish once again the strong presence of Biogen 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 Relapsing Remitting Multiple Sclerosis (RRMS); however, it does not 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 5EU in 2026 and it will represent an additional choice for patients on B cell depletion therapies through its oral formulation, as the other currently available B cell depletion therapies are injectables.

Brunello adds: “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. However, orelabrutinib’s market share could be limited due to its late entry in the MS market and its status of second to market within its class. GlobalData expects evobrutinib to reach $390m in sales in 2028.”