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Ono, Gilead to Collaborate on BTK Inhibitor Development
19 December 2014 - - Japan-based Ono Pharmaceutical Co Ltd. and US-based Gilead Sciences, Inc. (NASDAQ: GILD) have entered into an exclusive license agreement for the development and commercialisation of ONO-4059, the companies said on Friday.

Ono's oral Bruton's tyrosine kinase inhibitor for the treatment of B-cell malignancies and other diseases.

Under the terms of the agreement, Gilead will pay Ono an upfront payment plus additional payments based upon achievement of certain development, regulatory and commercial milestones.

The companies said they will collaborate jointly on global development of ONO-4059.

Gilead will have exclusive rights to develop and commercialise ONO-4059 in all countries of the world outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where Ono retains development and commercialisation rights.

ONO-4059 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 1 data showing clinical activity in chronic lymphocytic leukemia and non-Hodgkin lymphoma at several scientific conferences.

The Japanese company and Gilead said they 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.
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