bluebird bio Amends CAR-T Collaboration Agreement

bluebird bio has amended its existing co-promotion/co-development agreement with Bristol Myers Squibb (BMS) to enable the companies to focus their efforts on efficient commercialization of idecabtagene vicleucel (ide-cel; bb2121) in the U.S., the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, currently in review with the FDA.

“Our collaboration with bluebird has resulted in the first CAR T cell therapy submitted for regulatory approval to target the B-cell maturation antigen and for multiple myeloma,” said Krishnan Viswanadhan, senior vice president, global cell therapy franchise lead, Bristol Myers Squibb. “This amended partnership allows Bristol Myers Squibb to leverage our global manufacturing capabilities and consolidate all responsibilities outside the U.S.”

“Under our amended collaboration, we and BMS are redoubling our commitment to ide-cel and optimizing the relationship as we work together to bring this critical treatment to patients in the commercial setting,” said Joanne Smith-Farrell, chief business officer and oncology franchise leader, bluebird bio. “With bluebird exiting the passive participation as supplier outside the U.S., we and BMS are taking steps to ensure an efficient and robust supply chain for this program. This, together with the monetization of our ex-U.S. royalties and milestones will allow bluebird to continue to participate in co-developing and co-commercializing ide-cel within the U.S. and to refocus resources on our internal programs and pipeline.”

The companies will continue to share equally profits and losses in the U.S. Under the terms of the amended agreement, BMS will buy out its obligations to pay bluebird bio future ex-U.S. milestone and royalty payments for ide-cel and bb21217, the companies’ second BCMA-directed CAR T immunotherapy, for a one-time upfront payment of $200 million. bluebird bio is currently in the process of building out and qualifying its wholly-owned manufacturing facility in Durham, North Carolina for the production of lentiviral vector (LVV) to support the U.S. commercial market for ide-cel and for bluebird bio’s pipeline. Over time, BMS will assume responsibility for manufacturing of LVV outside the U.S.