By Estel Grace Masangkay
Bristol-Myers Squibb and Ono Pharmaceuticals announced that the companies have entered an agreement to develop and market Opdivo (nivolumab), Yervoy (ipilimumab), and three other drugs in South East Asia. Ono originally held exclusive rights to nivolumab in the three countries while BMS retained rights in the rest of its territories. The new agreement provides BMS access to Opdivo in the three countries. BMS also held global rights to Yervoy and the three other drugs, namely lirilumab, urelumab, and BMS-986016.
Under the agreement, BMS and Ono will develop the drugs as single agents and combination treatments in Japan, South Korea, and Taiwan. The two companies will leverage global clinical trials through recruitment of patients from the three countries. Development costs and profits will be shared equally by the partners when Opdivo is used in combination with any of BMS’ compounds, such as Yervoy. BMS will shoulder a majority of development costs and receive profits when a BMS compound is used as a monotherapy or when two compounds are used in a combo regimen. Ono will be responsible for a majority of costs and receive profits when Opdivo is used a single agent.
Lamberto Andreotti, CEO of BMS, said, “Bristol-Myers Squibb's collaboration with Ono supports our goal to maximize the full potential of our immuno-oncology portfolio for patients worldwide.” BMS has also been in the news lately for its work in NAVF Cardioversion. The company recently announced that it had enrolled its first patient in the EMANATE trial conducted jointly with Pfizer. EMANATE will investigate Eliquis (apixaban) in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion.
Gyo Sagara, CEO of Ono, said, “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.” Last month, Ono was in the news following the conclusion of a partnership that began in 2011. The company announced the termination of its license agreement with Merck for ONO-4641, an investigational drug for the treatment of multiple sclerosis, based upon a changing market and the need for extensive, phase 3 trials.
Nivolumab is an investigational human PD-1 immune checkpoint inhibitor thought to help the immune system recognize and kill cancer cells by blocking the PD-1 receptor pathway on activated T-cells. Yervoy is a recombinant human monoclonal antibody that blocks a negative regulator of T-cell activation to increase T cell activation and proliferation. Lirilumab is an antibody that blocks the KIR receptor in natural killer immune cells while urelumab is an agonist of the CD137 co-stimulatory receptor. BMS-986016 is a LAG3 immune checkpoint inhibitor. All three are in early-stage clinical development.