Squibb Company (NYSE:BMY) and Ono
Pharmaceutical Co., Ltd. ("Ono") have signed a strategic
collaboration agreement to jointly develop and commercialize multiple
immunotherapies as single agents and combination regimens to help
address the unmet medical needs of patients with cancer in Japan, South
Korea and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono
will jointly develop and commercialize Opdivo (nivolumab) and Yervoy
(ipilimumab) across a broad range of tumor types.
Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan
for the treatment of patients with unresectable melanoma, making it the
first PD-1 immune checkpoint inhibitor to receive regulatory approval
anywhere in the world, and is being developed in multiple tumor types in
more than 35 clinical trials. Yervoy, a CTLA-4 immune checkpoint
inhibitor, is approved in Taiwan for the treatment of patients with
advanced melanoma who have received prior therapy, and is in late-stage
development as a potential treatment option for melanoma, small cell
lung cancer (SCLC) and non-small cell lung cancer (NSCLC) in Japan. The
agreement includes three additional early-stage clinical immuno-oncology
assets from Bristol-Myers Squibb: lirilumab, an antibody that blocks the
KIR receptor on natural killer cells, urelumab, an agonist of the CD137
co-stimulatory receptor, and BMS-986016, a LAG3 immune checkpoint
Bristol-Myers Squibb and Ono will jointly pursue development of
monotherapy and combination regimens, with Opdivo as the
foundational therapy in Japan, South Korea and Taiwan, and leverage
global clinical trials by including patients from the three countries.
"Bristol-Myers Squibb's collaboration with Ono supports our goal to
maximize the full potential of our immuno-oncology portfolio for
patients worldwide," said Lamberto
Andreotti, chief executive officer, Bristol-Myers Squibb. "This
collaboration combines our leadership in immuno-oncology with both
companies' experience and capabilities in Asia, and strengthens our
long-standing relationship with Ono."
"Our collaboration with Bristol-Myers Squibb strengthens our ability to
further enhance the potential of Opdivo, for which Ono recently
received manufacturing and marketing approval in Japan as the first PD-1
inhibitor approved anywhere in the world," said Gyo Sagara, President,
Representative Director and CEO, Ono. "By pursuing the study of
investigational combination regimens of immunotherapies with
Bristol-Myers Squibb, we hope to bring a range of new therapeutic
options to cancer patients."
Under the terms of the agreement, Bristol-Myers Squibb and Ono will
jointly develop and commercialize all collaboration products in Japan,
South Korea and Taiwan. Development costs and commercial profits will be
shared equally when Opdivo is used in
combination with any Bristol-Myers Squibb compound (Yervoy,
lirilumab, urelumab, BMS-986016). For a Bristol-Myers Squibb compound
used as monotherapy, or two Bristol-Myers Squibb compounds used in a
combination regimen, Bristol-Myers Squibb will fund the substantial
majority of development costs and receive the substantial majority of
commercial profits. When Opdivo is used as a single agent, Ono
will fund the substantial majority of development costs and receive the
substantial majority of commercial profits.
Prior to this announcement, Ono held exclusive rights to develop and
commercialize Opdivo in Japan, South Korea and Taiwan while
Bristol-Myers Squibb held such rights in the rest of the world, along
with sole rights to develop and commercialize Yervoy, lirilumab,
urelumab, and BMS-986016 worldwide. The trade name Opdivo has
been proposed in the U.S. and other countries, but remains subject to
health authority approval.
About Opdivo (nivolumab)
Cancer cells may exploit "regulatory" pathways, such as checkpoint
pathways, to hide from the immune system and shield the tumor from
immune attack. Opdivo is an investigational human PD-1 immune
checkpoint inhibitor that binds to the checkpoint receptor PD-1
(programmed death-1) expressed on activated T-cells. The companies are
investigating whether by blocking this pathway, Opdivo would
enable the immune system to resume its ability to recognize, attack and
destroy cancer cells.
Opdivo was approved in Japan on July 4, 2014 for the treatment of
patients with unresectable melanoma and is being studied in multiple
tumor types in more than 35 trials - as monotherapy or in combination
with other therapies - in which more than 7,000 patients have been
enrolled worldwide. Among these are several potentially registrational
trials in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck
cancer, glioblastoma and non-Hodgkin lymphoma. In 2013, the FDA granted
Fast Track designation for Opdivo in NSCLC, melanoma and RCC. In
May 2014, the FDA granted Opdivo Breakthrough Therapy Designation
for the treatment of patients with Hodgkin lymphoma after failure of
autologous stem cell transplant and brentuximab.
About Yervoy (ipilimumab)
Yervoy, which is a recombinant, human monoclonal antibody, blocks
the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a
negative regulator of T-cell activation. Yervoy binds to CTLA-4
and blocks the interaction of CTLA-4 with its ligands, CD80/CD86.
Blockade of CTLA-4 has been shown to augment T-cell activation and
proliferation. The mechanism of action of Yervoy's effect in
patients with melanoma is indirect, possibly through T-cell mediated
anti-tumor immune responses. On March 25, 2011, the FDA approved Yervoy 3
mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is
now approved in more than 40 countries, including Taiwan. There is a
broad, ongoing development program in place for Yervoy spanning
multiple tumor types. This includes Phase 3 trials in prostate and lung
Yervoy (ipilimumab) INDICATION & IMPORTANT SAFETY
Yervoy (ipilimumab) is indicated for the treatment of
unresectable or metastatic melanoma.
Important Safety Information
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
Yervoy can result in severe and fatal immune-mediated
adverse reactions due to T-cell activation and proliferation. These
immune-mediated reactions may involve any organ system; however, the
most common severe immune-mediated adverse reactions are enterocolitis,
hepatitis, dermatitis (including toxic epidermal necrolysis),
neuropathy, and endocrinopathy. The majority of these immune-mediated
reactions initially manifested during treatment; however, a minority
occurred weeks to months after discontinuation of Yervoy.
Assess patients for signs and symptoms of enterocolitis, dermatitis,
neuropathy, and endocrinopathy and evaluate clinical chemistries
including liver function tests (LFTs) and thyroid function tests at
baseline and before each dose.
Permanently discontinue Yervoy and initiate systemic high-dose
corticosteroids for sever immune-mediated reactions.
Recommended Dose Modifications
Withhold dose for any moderate immune-mediated adverse reactions or for
symptomatic endocrinopathy until return to baseline, improvement to mild
severity, or complete resolution, and patient is receiving <7.5 mg
prednisone or equivalent per day.
Permanenly discontinue Yervoy for any of the following:
Other Immune-mediated Adverse Reactions, Including Ocular
Pregnancy & Nursing:
Common Adverse Reactions:
Please see Full Prescribing Information, including Boxed WARNING
regarding immune-mediated adverse reactions, available at www.bms.com.
Immuno-Oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have represented the
mainstay of cancer treatment over the last several decades, but
long-term survival and a positive quality of life have remained elusive
for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is leading
advances in the innovative field of immuno-oncology, which involves
agents whose primary mechanism is to work directly with the body's
immune system to fight cancer. The company is exploring a variety of
compounds and immunotherapeutic approaches for patients with different
types of cancer, including researching the potential of combining
immuno-oncology agents that target different and complementary pathways
in the treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of
immuno-oncology, with the goal of changing survival expectations and the
way patients live with cancer.
About the Bristol-Myers Squibb and Ono Collaboration
Bristol-Myers Squibb, through its wholly owned subsidiary Medarex, Inc.,
and Ono have a long-standing relationship since 2005 to develop and
commercialize PD-1 antibodies, including Opdivo. Bristol-Myers
Squibb obtained rights to develop and commercialize Opdivo in
North America in 2009 as part of the Medarex, Inc. acquisition. Through
a collaboration agreement entered into in September 2011, Ono granted
Bristol-Myers Squibb exclusive rights to develop and commercialize Opdivo
in the rest of the world, except in Japan, South Korea and Taiwan where
Ono retained such rights.
On July 23, 2014, Bristol-Myers Squibb and Ono signed a new
collaboration agreement in which the companies agreed to jointly develop
and commercialize Opdivo, Yervoy and three
early-stage immunotherapies 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, please
or follow us on Twitter at http://twitter.com/bmsnews.
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. It focuses especially on the diabetes and
oncology areas. For more information, please visit the company's website
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 any of the compounds
mentioned in this release will receive regulatory approval in Japan,
South Korea or Taiwan, either as single agents (other than Yervoy in
Taiwan and Opdivo in Japan) or in combination regimens, or, if approved,
that they will become commercially successful products. 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, 2013 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.
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