Bristol-Myers Squibb Company (NYSE:BMY), Pharmacyclics, Inc.
(NASDAQ:PCYC), and Janssen Research & Development, LLC
announced today they have entered into a clinical trial
collaboration agreement to evaluate the safety, tolerability and
preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1
immune checkpoint inhibitor OPDIVO® (nivolumab) in combination with
IMBRUVICA® (ibrutinib), an oral Bruton's tyrosine kinase (BTK)
inhibitor co-developed and co-marketed by Pharmacyclics and
Janssen. The Phase 1/2 study will focus on evaluating the safety
and anti-tumor activity of combining OPDIVO and IMBRUVICA as a
potential treatment option for patients with non-Hodgkin lymphoma
(NHL), including diffuse large B-cell lymphoma (DLBCL), follicular
lymphoma (FL) and chronic lymphocytic leukemia (CLL). Bristol-Myers
Squibb has proposed the name OPDIVO (pronounced
op-dee-voh), which if approved by health authorities, will serve as
the trademark for the investigational drug, nivolumab.
OPDIVO is part of a new class of cancer treatments known as
immunotherapies, which are designed to harness the body’s own
immune system in fighting cancer by targeting distinct regulatory
components of the immune system. Each agent has individually shown
activity against hematologic malignancies in clinical trials;
pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the
potential for additive treatment effects in patients with
hematologic malignancies.
“Our collaboration to study OPDIVO in combination with IMBRUVICA
is an innovative approach to accelerating Bristol-Myers Squibb’s
progress in the study of immuno-oncology and hematologic
malignancies, gaining further insight into promising areas of drug
development and research,” stated Michael Giordano, senior vice
president, Head of Development, Oncology, Bristol-Myers Squibb. “We
look forward to working with Pharmacyclics and Janssen to evaluate
the potential of these two therapies as options for patients with
lymphomas.”
“We are excited about the opportunity to understand and evaluate
the potential activity of IMBRUVICA and OPDIVO together, and the
benefits this combination may offer patients,” said Peter F.
Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “We look
forward to working with Bristol-Myers Squibb and Pharmacyclics on
this study as we continue to grow the body of knowledge about
IMBRUVICA in different settings and patient populations.”
“This collaboration underscores our interest in exploring the
use of IMBRUVICA in combination with other therapies to address a
variety of histologies in which we believe IMBRUVICA can make a
meaningful clinical difference,” said Bob Duggan, Chairman and CEO,
Pharmacyclics. “We value our strategic collaboration with Janssen
and look forward to extending our relationship to Bristol-Myers
Squibb for this project as our companies collectively seek to
advance treatment options for patients.”
The study will be conducted by Janssen. Additional details of
the collaboration were not disclosed.
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, fully-human
PD-1 (programmed death-1) immune checkpoint inhibitor that binds to
the checkpoint receptor PD-1 expressed on activated T-cells.
Bristol-Myers Squibb has a broad, global development program to
study OPDIVO in multiple tumor types consisting of 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 non-small
cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC),
head and neck cancer, glioblastoma and NHL.
In 2013, the FDA granted Fast Track designation for OPDIVO in
NSCLC, melanoma and RCC. In April 2014, the company initiated a
rolling submission with the FDA for OPDIVO in third-line
pre-treated squamous cell NSCLC and expects to complete the
submission by year-end. The FDA granted its first Breakthrough
Therapy Designation for OPDIVO in May 2014 for the treatment of
patients with Hodgkin lymphoma after failure of autologous stem
cell transplant and brentuximab. On July 4, Ono Pharmaceutical
Co. announced that OPDIVO received manufacturing and marketing
approval in Japan for the treatment of patients with unresectable
melanoma, making OPDIVO the first PD-1 immune checkpoint inhibitor
to receive regulatory approval anywhere in the world. On September
26, Bristol-Myers Squibb announced that the FDA accepted for
priority review the Biologics License Application for previously
treated advanced melanoma, and the Prescription Drug User Fee Act
goal date for a decision is March 30, 2015. The FDA also granted
OPDIVO Breakthrough Therapy status for this indication. In the
European Union, the European Medicines Agency (EMA) has validated
for review the Marketing Authorization Application (MAA) for OPDIVO
in advanced melanoma. The application has also been granted
accelerated assessment by the EMA’s Committee for Medicinal
Products for Human Use. The EMA also validated for review the MAA
for nivolumab in NSCLC.
About IMBRUVICA®
IMBRUVICA® (ibrutinib) is a first-in-class, oral, once-daily
therapy that inhibits a protein called Bruton's tyrosine kinase
(BTK). BTK is a key signaling molecule in the B-cell receptor
signaling complex that plays an important role in the survival and
spread of malignant B cells. IMBRUVICA blocks signals that tell
malignant B cells to multiply and spread uncontrollably.
IMBRUVICA is approved for the treatment of patients with CLL who
have received at least one prior therapy, and for the treatment of
CLL patients with del 17p, a genetic mutation that occurs when part
of chromosome 17 has been lost.
IMBRUVICA is also approved for the treatment of patients with
mantle cell lymphoma (MCL) who have received at least one prior
therapy. Accelerated approval was granted for the MCL indication
based on overall response rate (ORR). Improvements in survival or
disease-related symptoms have not been established. Continued
approval for the MCL indication may be contingent upon verification
of clinical benefit in confirmatory trials.
IMBRUVICA is being studied alone and in combination with other
treatments in several blood cancers including CLL, MCL,
Waldenstr�m's macroglobulinemia (WM), DLBCL, FL and multiple
myeloma (MM). Approximately 3,500 patients have received IMBRUVICA
in clinical trials conducted in 35 countries by more than 800
investigators around the world. As of June 30, 2014, 12 Phase 3
trials have been initiated with IMBRUVICA and approximately 50
trials are registered on www.clinicaltrials.gov. The overall
clinical development program in CLL currently includes seven Phase
3 trials and covers all lines of therapy and various combinations
of treatments.
IMBRUVICA was one the first medicines to receive U.S. FDA
approval via the new Breakthrough Therapy Designation pathway, and
is the only product to have received three Breakthrough Therapy
Designations. IMBRUVICA is jointly developed and commercialized by
Janssen Biotech, Inc. and Pharmacyclics.
IMBRUVICA INDICATIONS
IMBRUVICA is indicated to treat people with:
- Mantle cell lymphoma (MCL) who have
received at least one prior therapy
- Accelerated approval was granted for
this indication based on overall response rate. Improvements in
survival or disease-related symptoms have not been established.
Continued approval for this indication may be contingent upon
verification of clinical benefit in confirmatory trials.
- Chronic lymphocytic leukemia (CLL) who
have received at least one prior therapy
- Chronic lymphocytic leukemia (CLL) with
17p deletion
IMBRUVICA - IMPORTANT SAFETY INFORMATION
Warnings and Precautions include hemorrhage, infection,
cyptopenias, atrial fibrillation, second primary malignancies, and
embryo-fetal toxicity.
The most common adverse reactions include thrombocytopenia,
diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain,
peripheral edema, upper respiratory tract infection, nausea,
bruising, dyspnea, constipation, rash, abdominal pain, pyrexia,
vomiting, and decreased appetite.
For additional important safety information, please see Full
Prescribing Information at www.imbruvica.com/isi/.
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 visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
About Pharmacyclics
Pharmacyclics, Inc. (NASDAQ: PCYC) is a biopharmaceutical
company focused on developing and commercializing innovative
small-molecule drugs for the treatment of cancer and
immune-mediated diseases. The Company's mission and goal is to
build a viable biopharmaceutical company that designs, develops and
commercializes novel therapies intended to improve quality of life,
increase duration of life and resolve serious unmet medical
healthcare needs; and to identify and control promising product
candidates based on scientific development and administrational
expertise, develop its products in a rapid, cost-efficient manner
and pursue commercialization and/or development partners when and
where appropriate.
Pharmacyclics markets IMBRUVICA® (ibrutinib) and has
three product candidates in clinical development and several
preclinical molecules in lead optimization. The Company is
committed to high standards of ethics, scientific rigor, and
operational efficiency as it moves each of these programs to viable
commercialization. Pharmacyclics is headquartered
in Sunnyvale, CA. Please
visit http://www.pharmacyclics.com.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we are dedicated to addressing and solving some of
the most important unmet medical needs of our time in oncology,
immunology, neuroscience, infectious diseases and vaccines, and
cardiovascular and metabolic diseases. Driven by our commitment to
patients, we develop innovative products, services and healthcare
solutions to help people throughout the world. Janssen Research
& Development is part of the Janssen Pharmaceutical Companies
of Johnson & Johnson (NYSE: JNJ). Please visit
www.janssenrnd.com for more information.
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 nivolumab will receive regulatory approval in the U.S. either
as a single agent or in a combination regimen, or, if approved,
that it will become a commercially successful product.
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.
Pharmacyclics Safe Harbor Statement
This announcement may contain forward-looking statements made in
reliance upon the safe harbor provisions of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, including statements,
among others, relating to our future capital requirements,
including our expected liquidity position and timing of the receipt
of certain milestone payments, and the sufficiency of our current
assets to meet these requirements, our future results of
operations, our expectations for and timing of ongoing or future
clinical trials and regulatory approvals for any of our product
candidates, and our plans, objectives, expectations and intentions.
Because these statements apply to future events, they are subject
to risks and uncertainties. When used in this announcement, the
words "anticipate", "believe", "estimate", "expect", "expectation",
"goal", "should", "would", "project", "plan", "predict", "intend",
"target" and similar expressions are intended to identify such
forward-looking statements. These forward-looking statements are
based on information currently available to us and are subject to a
number of risks, uncertainties and other factors that could cause
our actual results, performance, expected liquidity or achievements
to differ materially from those projected in, or implied by, these
forward-looking statements. Factors that may cause such a
difference include, without limitation, our need for substantial
additional financing and the availability and terms of any such
financing, the safety and/or efficacy results of clinical trials of
our product candidates, our failure to obtain regulatory approvals
or comply with ongoing governmental regulation, our ability to
commercialize, manufacture and achieve market acceptance of any of
our product candidates, for which we rely heavily on collaboration
with third parties, and our ability to protect and enforce our
intellectual property rights and to operate without infringing upon
the proprietary rights of third parties. Although we believe that
the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, performance or
achievements and no assurance can be given that the actual results
will be consistent with these forward-looking statements. For more
information about the risks and uncertainties that may affect our
results, please see the Risk Factors section of our filings with
the Securities and Exchange Commission, including our Form
10-K for the year ended December 31, 2013 and quarterly
reports on Form 10-Q. We do not intend to update any of the
forward-looking statements after the date of this announcement to
conform these statements to actual results, to changes in
management's expectations or otherwise, except as may be required
by law.
Johnson & Johnson Note on Forward-Looking
Statements
This press release contains \"forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development. The reader is cautioned not to rely
on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of Janssen Research & Development,
LLC and/or Johnson & Johnson. Risks and uncertainties include,
but are not limited to: challenges inherent in new product
development, including obtaining regulatory approvals; competition,
including technological advances, new products and patents attained
by competitors; challenges to patents; changes to regulations and
domestic and foreign health care reforms; and general industry
conditions, including trends toward health care cost containment. A
further list and description of these risks, uncertainties and
other factors can be found in Johnson & Johnson's Annual Report
on Form 10-K for the fiscal year ended December 29, 2013, including
in Exhibit 99 thereto, and the company's subsequent filings with
the Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov, www.jnj.com or on
request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies or Johnson & Johnson undertakes to
update any forward-looking statement as a result of new information
or future events or developments.
IMBRUVICA is a registered trademark of Pharmacyclics, Inc.
Bristol-Myers SquibbMedia:Ken Dominski,
609-252-5251ken.dominski@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.comorPharmacyclicsMedia:Samina
Bari, 408-215-3169orInvestors:Ramses Erdtmann,
408-215-3325orIMBRUVICA Medical Information:Pharmacyclics
Medical Information:
877-877-3536orJanssenMedia:Kellie McLaughlin,
908-927-7477Mobile: 609-468-8356orInvestors:Stan Panasewicz,
732-524-2524orLouise Mehrotra, 732-524-6491
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2024 to May 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From May 2023 to May 2024