ONO & Gilead Announce Exclusive License Agreement to Develop BTK Inhibitor, ONO-4059, for the Treatment of B-cell Malignancie...
December 19 2014 - 1:00AM
Business Wire
-- Companies will Collaborate Jointly on
Global Development of ONO-4059 --
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.”
About ONO PHARMACEUTICAL
ONO PHARMACEUTICAL, headquartered in Osaka, Japan, is an
R&D-oriented pharmaceutical company committed to creating
innovative medicines in specific areas. It focuses especially on
the diabetes and oncology areas. For more information, please visit
the company’s website at http://www.ono.co.jp/eng/index.html.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
Gilead Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including risks that the parties will be unable to develop and
commercialize ONO-4059, as a potential monotherapy and in
combination with other therapies, for the treatment of B-cell
malignancies or other diseases. These risks, uncertainties and
other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These
and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2014, as
filed with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
ONO PHARMACEUTICALCorporate
Communications:Public_relations@ono.co.jpYukio
Taniy.tani@ono.co.jpKazuhiko Muraokamuraoka@ono.co.jporGilead
SciencesInvestors:Patrick O’Brien,
+1-650-522-1936Media:Nathan Kaiser, +1-650-522-1853
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