-- Companies will Collaborate Jointly on Global Development of
ONO-4059 --
OSAKA, Japan & FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2014--
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.
Source: Gilead Sciences, Inc.
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
