Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells.

The agreement means that Mycenax will sell its LusiNEX (tocilizumab) biosimilar project, including cell banks, chemistry, manufacturing and controls (CMC) technology, intellectual properties and clinical trial results to Richter for a total of US$16.5 million.

Mycenax has already received a payment of US$2 million from Richter for exclusive negotiation rights and will receive an additional US$3 million as the signing fee. The company will receive additional payments as it completes the stages of asset transfer.

Mycenax intends to use the money from this agreement for operation and facility expansion to further strengthen the company’s capacities as a contract development and manufacturing organization (CDMO). The decision to focus on the CDMO business was taken in 2019 and the company says that it intends to become one of the best CDMOs in Asia.

Mycenax started developing LusiNEX in 2013 and announced positive phase I results for the candidate tocilizumab biosimilar in 2019 [1], which the company says ‘demonstrated its bioequivalence’ to the originator biological Roche’s Actemra.

Richter is expected to start a phase III trial for LusiNEX and receive marketing approval for the biosimilar in the near future.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Mycenax’s tocilizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 8]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Mycenax-s-tocilizumab-biosimilar

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