Bristol-Myers Squibb and Ono Pharmaceutical signed an agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for cancer patients in Japan, South Korea, and Taiwan. The companies will focus on Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumor types.
Development costs and commercial profits will be shared equally when Opdivo is used in combination with any Bristol-Myers Squibb compound (Yervoy, lirilumab, urelumab, and BMS-986016). For a Bristol-Myers Squibb compound used as monotherapy or if two of its compounds are used in a combination regimen, the company 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.
Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan for the treatment of patients with unresectable melanoma. 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.
“Our collaboration with Bristol-Myers Squibb strengthens our ability to further enhance the potential of Opdivo, for which Ono recently received manufacturing and marketing approval in Japan as the first PD-1 inhibitor approved anywhere in the world,” said Gyo Sagara, CEO, president, and representative director of Ono. “By pursuing the study of investigational combination regimens of immunotherapies with Bristol-Myers Squibb, we hope to bring a range of new therapeutic options to cancer patients.”
Prior to this agreement, 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.