Pharma Focus Asia

Biogen and Innocare Announce License and Collaboration Agreement For Orelabrutinib, an Innovative CNS Penetrant BTK Inhibitor For the Potential Treatment of Multiple Sclerosis

Tuesday, July 13, 2021

Biogen Inc. and InnoCare Pharma Limited announced that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS). Orelabrutinib is a covalent BTKi with high selectivity and the ability to cross the blood-brain barrier, and is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS.

Orelabrutinib inhibits BTK, which is a key enzyme that is part of the signaling cascade of immune cells including B cells and myeloid cells. With the ability to cross the blood brain barrier, orelabrutinib has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system (CNS), and may provide a clinically meaningful benefit on progression in all forms of MS. By addressing the progressive biology of the disease, orelabrutinib may offer people living with MS an additional treatment option and the possibility to slow disease progression.

“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,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. “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.”

“Biogen is a recognized leader in neuroscience and we believe this transaction will help advance the development of orelabrutinib in MS,” said Jasmine Cui, Ph.D., Co-Founder, Chairwoman and Chief Executive Officer at InnoCare. “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.”

Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). InnoCare will receive a $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

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