Date: 2014-07-23
Type of information: Development agreement
Compound: Opdivo® (nivolumab), Yervoy® (ipilimumab), lirilumab, urelumab and BMS-986016 as single agents and combination regimens
Company: BMS (USA - NY) Ono Pharmaceutical (Japan)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism: monoclonal antibody/immune checkpoint inhibitor. Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. Yervoy® (ipilimumab) is a recombinant, human monoclonal antibody. It blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of Yervoy’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses. Lirilumab is an antibody that blocks the KIR receptor on natural killer cells. Urelumab is an agonist of the CD137 co-stimulatory receptor. BMS-986016 is a LAG3 immune checkpoint inhibitor.
Disease: various tumor types
Details: * On July 23, 2014, BMS and Ono Pharmaceutical have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer 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. Opdivo® is approved in Japan for the treatment of patients with unresectable melanoma, making it the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world, and is being developed in multiple tumor types in more than 35 clinical trials.Yervoy® 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 (SCLC) and non-small cell lung cancer (NSCLC) in Japan. The agreement includes three additional early-stage clinical immuno-oncology assets from BMS: lirilumab (IPH2102 - developed with Innate Pharma), 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. BMS and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo® as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries. 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 commercializeYervoy, lirilumab, urelumab, and BMS-986016 worldwide.
Financial terms: Under the terms of the agreement, BMS 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 BMS compound (Yervoy, lirilumab, urelumab, BMS-986016). For a BMS compound used as monotherapy,or two BMS compounds used in a combination regimen, BMS 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.
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