Bristol-Myers Squibb Company and Ono Pharmaceutical Co., Ltd. have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens in Japan, South Korea, and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumor types.

Under the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize all collaboration products in Japan, South Korea, and Taiwan. Development costs and commercial profits will be shared equally when Opdivo is used in combination with any Bristol-Myers Squibb compound (Yervoy, lirilumab, urelumab, BMS-986016). For a Bristol-Myers Squibb compound used as monotherapy, or two Bristol-Myers Squibb compounds used in a combination regimen, Bristol-Myers Squibb will fund the substantial majority of development costs and receive the substantial majority of commercial profits. When Opdivo is used as a single agent, Ono will fund the substantial majority of development costs and receive the substantial majority of commercial profits.

Prior to this announcement, Ono held exclusive rights to develop and commercialize Opdivo in Japan, South Korea, and Taiwan while Bristol-Myers Squibb held such rights in the rest of the world, along with sole rights to develop and commercialize Yervoy, lirilumab, urelumab, and BMS-986016 worldwide. The trade name Opdivo has been proposed in the US and other countries, but remains subject to health authority approval.

Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan for the treatment of patients with unresectable melanoma. It is being developed in multiple tumor types in more than 35 clinical trials. Yervoy, a CTLA-4 immune checkpoint inhibitor, is approved in Taiwan for the treatment of patients with advanced melanoma who have received prior therapy, and is in late-stage development as a potential treatment option for melanoma, small-cell lung cancer, and non-small-cell lung cancer in Japan. The agreement includes three additional early-stage clinical immuno-oncology assets from Bristol-Myers Squibb: lirilumab, an antibody that blocks the KIR receptor on natural killer cells, urelumab, an agonist of the CD137 co-stimulatory receptor, and BMS-986016, a LAG3 immune checkpoint inhibitor. Bristol-Myers Squibb and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivoas the foundational therapy in Japan, South Korea,and Taiwan, and leverage global clinical trials by including patients from the three countries.

Source: Bristol-Myers Squibb