Gilead and Ono enter into a licensing agreement for ONO-4059

Japanese pharma company Ono Pharmaceutical (TYO: 4528) and US biotech major Gilead Sciences (Nasdaq: GILD) have entered into a licensing agreement for ONO-4059, Ono’s oral Bruton’s tyrosine kinase inhibitor for the treatment of B-cell malignancies and other diseases.

Gilead will pay an upfront sum to Ono plus additional developmental, regulatory and commercial milestone payments. The companies will jointly develop ONO-4059, and Gilead will have exclusive rights to develop and commercialize it in all countries outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where Ono retains development and commercialization rights.

It is a selective, once-daily, oral inhibitor of BTK, which has been shown to play a role in the survival and proliferation of malignant B-cells. Ono has presented preliminary Phase I data that showed clinical activity in chronic lymphocytic leukemia and non-Hodgkin. The companies plan to develop ONO-4059 for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with approved and investigational agents, including combinations with kinase inhibitors in Gilead's portfolio.