- Bristol-Myers Squibb to develop and commercialize ONO-4578, Ono’s Phase 1 selective Prostaglandin E 2 (PGE 2 ) receptor 4 (EP 4 ) antagonist
- Strengthens Bristol-Myers Squibb’s oncology development program with potential to expand and enhance the benefit of immunotherapy in a broad range of tumor indications
- Expands companies’ Immuno-Oncology alliance established in 2014
Bristol-Myers
Squibb Company (NYSE:BMY) and Ono
Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative
Director, Gyo Sagara; “Ono”) announced an agreement that grants
Bristol-Myers Squibb an exclusive license for the development and
commercialization of ONO-4578, Ono’s selective Prostaglandin E2
(PGE2) receptor 4 (EP4) antagonist. The companies
will also collaborate on discovery efforts to identify additional
compounds from Ono’s PGE2 receptor antagonist programs.
“To improve long-term outcomes for more patients with cancer, we believe
more Immuno-Oncology based combinations may be required, and we are
pleased to continue our long-standing collaboration with Ono with this
focus in mind,” said Fouad Namouni, M.D., head of Development, Oncology,
Bristol-Myers Squibb. “Ono’s Prostaglandin E2 receptor
antagonist programs offer the potential to develop targeted therapies
that counteract the effects of an immunosuppressive tumor
microenvironment. Researching Prostaglandin E2 receptor
antagonists in combination with our oncology portfolio has the potential
to result in an enhanced response in a broad range of tumors.”
“We are very pleased to collaborate with Bristol-Myers Squibb on
ONO-4578, an innovative Immuno-Oncology therapy candidate derived from
our long-standing Prostaglandin projects, and to further work with
Bristol-Myers Squibb on other Prostaglandin E2 receptor
antagonist programs,” said Hiroshi Awata, Vice President Executive
Officer and Executive Director, Clinical Development, Ono Pharmaceutical
Co., Ltd. “We are committed to further pursuing the worldwide
development of ONO-4578 with Bristol-Myers Squibb with the goal of
improving outcomes of patients suffering from cancer around the world as
promptly as possible.”
Under the terms of the agreement, Bristol-Myers Squibb will make an
upfront payment of $40 million to Ono. Bristol-Myers Squibb will be
solely responsible for the development, manufacturing and
commercialization of ONO-4578 as well as other PGE2 receptor
antagonist products in all countries of the world except Japan, South
Korea, Taiwan, China and Association of Southeast Asian Nations (ASEAN)
countries. Ono is eligible to receive subsequent clinical, regulatory
and sales-based milestone payments, as well as royalties in these
countries where Bristol-Myers Squibb has exclusive license. In Japan,
South Korea and Taiwan, Bristol-Myers Squibb and Ono will partner on the
development and commercialization under the companies’ existing
collaboration agreement, while in China and ASEAN countries, Ono will
retain exclusive rights.
About Prostaglandin E
2
and Immuno-Oncology
Prostaglandin E2 (PGE2), a major immunosuppressive
factor in the tumor microenvironment, is believed to suppress tumor
immunity and promote tumor progression. Preclinical data suggests that
modulation of PGE2 through any PGE2 receptor
antagonists may complement Immuno-Oncology therapies, including
anti-PD-1 and anti-CTLA-4, and potentially increase both the rate and
durability of response in tumors that are refractory to immunotherapy.
Certain patients and tumor types have higher expression of PGE2-related
molecules and/or immune characteristics that are more likely to respond
to PGE2 receptor blockade, presenting an opportunity for
patient stratification to improve outcomes.
About ONO-4578
ONO-4578 is a selective, oral antagonist of EP4, which is a
Prostaglandin E2 receptor. In results from experiments using
mouse models, ONO-4578 showed an anti-tumor effect by improving
immunosuppressive tumor microenvironment. Ono has already commenced
Phase I clinical study of ONO-4578 in Japan.
About the Bristol-Myers Squibb and Ono
Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co.,
Ltd., Bristol-Myers Squibb expanded its territorial rights to develop
and commercialize Opdivo globally except in Japan, South Korea
and Taiwan, where Ono had retained all rights to the compound at the
time. On July 23, 2014, Ono and Bristol-Myers Squibb further expanded
the companies’ strategic collaboration agreement to jointly develop and
commercialize multiple immunotherapies – as single agents and
combination regimens – for patients with cancer in Japan, South Korea
and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information about
Bristol-Myers Squibb, visit us at BMS.com
or follow us on LinkedIn, Twitter, YouTube and Facebook.
About Ono Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co., Ltd., headquartered in Osaka, Japan, is an
R&D-oriented pharmaceutical company committed to creating innovative
medicines in specific areas, especially in oncology and diabetes areas.
For more information, please visit the company’s website at http://www.ono.co.jp/eng/index.html.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding the research, development, and commercialization of
pharmaceutical products. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed.
Among other risks, there can be no guarantee that ONO-4578 or any other
compounds from the PGE
2
receptor programs will
be successfully developed or approved for any of the indications
described in this release. Forward-looking statements in this press
release should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those identified in
the cautionary factors discussion in Bristol-Myers Squibb's Annual
Report on Form 10-K for the year ended December 31, 2016, in our
Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Bristol-Myers Squibb: Media: Ken Dominski, 609-252-5251 ken.dominski@bms.com or Investor: Tim Power, 609-252-7509 timothy.power@bms.com orBill Szablewski, 609-252-5894 william.szablewski@bms.com or Ono Pharmaceutical: Corporate Communications public_relations@ono.co.jp