InnoCare is expected to receive a $125m upfront payment in addition to potential milestone payments and tiered royalties


Biogen will obtain exclusive global rights to orelabrutinib. (Credit: bertholdbrodersen from Pixabay.)

Biogen has reached a license and collaboration agreement with InnoCare Pharma for the latter’s potential multiple sclerosis (MS) treatment orelabrutinib.

Under the terms of the agreement, Biogen will obtain exclusive global rights to orelabrutinib in the field of MS and certain autoimmune diseases outside of China, including Hong Kong, Macau and Taiwan.

InnoCare would retain exclusive rights in the field of oncology and certain autoimmune diseases in China, including Hong Kong, Macau and Taiwan.

Biogen will make an upfront payment of $125m to InnoCare, which is eligible to receive up to $812.5m in potential development and commercial milestone payments.

InnoCare is also eligible to receive tiered royalties on potential future net sales of any product commercialised from the collaboration.

Biogen research and development head Alfred Sandrock said: “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 BTKi programs.

“For over 30 years, Biogen has led in MS research and today has a leading portfolio of MS products. We are focused on developing next-generation approaches that we hope will improve outcomes for those living with progressive and relapsing forms of MS.”

Orelabrutinib an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) intended for the treatment of cancer and in the development for the potential treatment of autoimmune diseases.

The drug’s capability to cross the blood-brain barrier is believed to inhibit B cell and myeloid cell effector functions in the CNS and provide clinical benefit in all forms of MS.

InnoCare is currently evaluating the drug in a global, placebo-controlled Phase 2 clinical trial in relapsing-remitting MS (RRMS) patients.

Orelabrutinib received China’s National Medical Products Administration (NMPA) approval for two indications in the field of oncology.

It was indicated for relapsed/refractory chronic lymphocytic leukaemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and relapsed/refractory mantle cell lymphoma (R/R MCL).

InnoCare co-founder, chairwoman and CEO Jasmine Cui said: “Biogen is a recognized leader in neuroscience and we believe this transaction will help advance the development of orelabrutinib in MS.

“We are excited about the potential of orelabrutinib for the treatment of patients with all forms of MS given the potential efficacy and safety profile, plus a promising level of blood-brain barrier penetration.

“BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS.”