Gilead Sciences has signed on to help expedite development of Ono Pharmaceutical’s Ono-4059 program. The firms will work together to develop and commercialize Ono-4059, an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases.

Gilead will pay Ono an upfront fee plus additional milestone payments as earned. 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 countries, where Ono retains development and commercialization rights.

Ono-4059 has reportedly been shown to play a role in the survival and proliferation of malignant B-cells; Ono has presented preliminary Phase I data showing clinical activity in chronic lymphocytic leukemia and non-Hodgkin lymphoma. Ono-4059 will be development as a monotherapy and in combination with approved and investigational agents, including combinations with kinase inhibitors in Gilead's portfolio.

“With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies—PI3K delta, Syk, JAK, and BTK,” Norbert W. Bischofberger, Ph.D., Gilead's executive vice president, research and development and CSO, said in a statement. “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.”

2014 was a busy year for Ono. Mostly positive news like a July deal with Bristol-Myers Squib. But in June a license deal with, Merck KGaA was terminated and a Phase II candidate returned.

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