Biogen has agreed to pay InnoCare Pharma $125 million upfront for exclusive rights to the oral BTK inhibitor orelabrutinib for the potential treatment of multiple sclerosis (MS) worldwide and certain autoimmune diseases outside of China, including Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China, the companies announced Monday. InnoCare is also eligible for up to $812.5 million in additional payments if certain development and commercial milestones, as well as sales targets, are achieved.

According to the companies, orelabrutinib's ability to cross the blood-brain barrier means it has the potential to inhibit B-cell and myeloid cell effector functions in the central nervous system (CNS), and could potentially help slow disease progression in all forms of MS. It is currently being investigated in a global Phase II trial of about 160 patients with relapsing-remitting MS in the US and Europe.

Setting itself apart from other BTKs

"Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTK inhibitor programmes," remarked Biogen R&D chief Alfred Sandrock. He noted that Biogen, whose MS portfolio currently includes Tecfidera (dimethyl fumarate), Tysabri (natalizumab), Vumerity (diroximel fumarate), Pledgridy (peginterferon beta-1a) and Avonex (interferon beta 1a), is "focused on developing next-generation approaches" for patients with progressive and relapsing forms of MS.

As part of the deal, InnoCare will also be able to pocket tiered royalties in the low to high teens on potential future net sales of any product stemming from the collaboration. The Beijing-based drugmaker has already obtained Chinese approval of orelabrutinib to treat relapsed/refractory patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma, and patients with relapsed/refractory mantle cell lymphoma (MCL). It has also been cleared in China to treat MCL in the first-line setting.