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ONO/Gilead Announce Exclusive License Agreement To Develop BTK Inhibitor, ONO-4059, For The Treatment Of B-Cell Malignancies And Other Diseases

ONO/Gilead Announce Exclusive License Agreement to Develop BTK Inhibitor, ONO-4059, for the Treatment of B-cell Malignancies and Other Diseases

OSAKA, Japan & FOSTER CITY, Calif.--(BUSINESS WIRE)-- ONO PHARMACEUTICAL CO., LTD. ("ONO") and Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the companies have entered into an exclusive license agreement for the development and commercialization of ONO-4059, ONO's oral Bruton's tyrosine kinase (BTK) 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 will collaborate jointly on global development of ONO-4059. Gilead will have exclusive rights to develop and commercialize 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 commercialization 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 (CLL) and non-Hodgkin lymphoma (NHL) at several scientific conferences. ONO and Gilead 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.

"We are pleased to partner with Gilead to accelerate worldwide development and commercialization of ONO-4059," said Gyo Sagara, ONO's President, Representative Director and Chief Executive Officer. "Our goal is to bring better therapeutic options as quickly as possible for the patients with B-cell malignancies or other diseases in the world, and we believe we can fulfill the goal by pursuing the development of ONO-4059 with Gilead."

"With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies - PI3K delta, Syk, JAK and BTK," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead's other kinase inhibitors with a goal of achieving more pronounced and more durable response rates. We look forward to working with ONO to move the ONO-4059 development program forward as quickly as possible."

Disclosure: The author is long GILD.