Agreements

Date: 2017-12-21

Type of information: Licensing agreement

Compound: LCAR-B38M

Company: Janssen Biotech, a J&J company (USA - NJ) Legend Biotech USA and Legend Biotech, subsidiaries of Genscript Biotech Corporation (China)

Therapeutic area: Cancer - Oncology

Type agreement: licensing - development - production - commercialisation

Action mechanism:

cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. LCAR-B38M is a type of bi-epitope Chimeric Antigen Receptor T cell (CAR-T) immunotherapy developed by Legend Biotech. Autologous T cells isolated from patients can be genetically engineered to express bi-epitope chimeric antigen receptors on their surface, so that allows the autologous T cells to specifically recognize and bind the two epitopes on BCMA molecule that is a biomarker of multiple myeloma (MM). Therefore the autologous genetically engineered T cells are able to specifically identify and kill the MM cancer cells.
LCAR-B38M is currently accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the United States for multiple myeloma. LCAR-B38M is the first CAR-T therapy accepted for review by the CFDA.

Disease: multiple myeloma

Details:

• On December 21 2017, Janssen Biotech announced that it has entered into a worldwide collaboration and license agreement with Legend Biotech USA and Legend Biotech Ireland, subsidiaries of Genscript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen (BCMA).
Under terms of the agreement, Legend will grant Janssen a worldwide license to jointly develop and commercialize LCAR-B38M in multiple myeloma with the Legend team of experts. Janssen will record worldwide net trade sales, except for sales made in Greater China . The companies have entered into a 50/50 percent cost-sharing/profit-split arrangement, except in Greater China , where Janssen and Legend have a 30/70 percent cost-sharing/profit-split arrangement.

Financial terms:

Janssen will make an upfront payment of $350 million that will be recorded in the fourth quarter and additional payments based upon the achievement of certain development, regulatory and sales milestones.

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