Results from two clinical trials (ELOQUENT-2
& CA204-009), each combining Empliciti with a different
standard of care regimen included in the submission
Empliciti is poised to be the first-in-class
SLAMF7-directed immunostimulatory antibody
Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie
(NYSE:ABBV) today announced the European Medicines Agency (EMA)
validated for review the Marketing Authorization Application (MAA)
for Empliciti, an investigational Signaling Lymphocyte
Activation Molecule (SLAMF7)-directed immunostimulatory antibody,
for the treatment of multiple myeloma as combination therapy in
adult patients who have received one or more prior therapies. The
application was granted accelerated assessment by the EMA’s
Committee for Medicinal Products for Human Use (CHMP).
Bristol-Myers Squibb and AbbVie are co-developing Empliciti,
with Bristol-Myers Squibb solely responsible for commercial
activities. Bristol-Myers Squibb has proposed the
name Empliciti which, if approved by health authorities, will
serve as the trade name for elotuzumab.
“The MAA validation marks a significant milestone in
Bristol-Myers Squibb’s mission to advance the science and impact
the treatment of hematologic malignancies through our
Immuno-Oncology leadership,” said Michael Giordano, MD, senior vice
president, head of Oncology Development, Bristol-Myers Squibb. “We
believe the CHMP’s acceptance for an accelerated assessment
reflects the need for a new treatment option for multiple myeloma,
a largely incurable disease. We are proud to be one step closer to
bringing Empliciti to patients with relapsed or refractory multiple
myeloma in Europe.”
The MAA is primarily supported by data from two randomized
clinical trials, each combining Empliciti with a different standard
of care regimen for multiple myeloma. ELOQUENT-2, a Phase 3,
randomized, open-label study, evaluated Empliciti in combination
with lenalidomide and dexamethasone versus lenalidomide and
dexamethasone alone. The results of this trial were published in
The New England Journal of Medicine on June 2. Additionally, a
Phase 2, randomized, open-label study (Study CA004-009) evaluated
Empliciti with bortezomib and dexamethasone versus bortezomib and
dexamethasone alone. These Phase 2 results were presented in an
oral session (Abstract #S103) at the 20th Congress of the European
Hematology Association (EHA).
Empliciti previously obtained orphan drug designation in the
European Union (EU). An orphan medicinal product must be intended
for the treatment, prevention or diagnosis of a disease that is
life threatening and chronically debilitating; the prevalence in
the EU must not be more than five in 10,000. The medicine must be
of significant benefit to those affected by the condition. If
maintained, orphan drug designation allows sponsors to access a
number of incentives including protocol assistance and receive
market exclusivity for a ten-year period following approval.
About Empliciti
Empliciti is an investigational immunostimulatory antibody
targeted against SLAMF7, a cell-surface glycoprotein that is highly
and uniformly expressed on myeloma cells and Natural Killer (NK)
cells, but is not detected on normal solid tissues or on
hematopoietic stem cells. The safety and efficacy of Empliciti have
not been evaluated by the FDA or any other health authority.
About Multiple Myeloma
Multiple myeloma is a hematologic, or blood, cancer that
develops in the bone marrow. It occurs when a plasma cell, a type
of cell in the soft center of bone marrow, becomes cancerous and
multiplies uncontrollably. Despite advances in multiple myeloma
treatment over the last decade, only 45% of patients have a
ten-year survival rate. A common characteristic for many patients
is that they experience a cycle of remission and relapse, in which
they stop treatment for a short time, but eventually return to a
treatment shortly after. Following relapse, less than 20% of
patients are alive after five years. It is estimated that annually
more than 114,200 new cases of multiple myeloma are diagnosed
globally and annually more than 79,000 people die from the disease
globally.
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 research in an innovative field of cancer research and
treatment known as 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 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 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 http://www.bms.com/
or follow us on Twitter at http://twitter.com/bmsnews.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company
formed in 2013 following separation from Abbott Laboratories. The
company’s mission is to use its expertise, dedicated people and
unique approach to innovation to develop and market advanced
therapies that address some of the world’s most complex and serious
diseases. Together with its wholly-owned subsidiary, Pharmacyclics,
AbbVie employs more than 28,000 people worldwide and markets
medicines in more than 170 countries. For further information on
the company and its people, portfolio and commitments, please visit
www.abbvie.com. Follow @abbvie on Twitter or view careers on our
Facebook or LinkedIn page.
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 elotuzumab will receive regulatory approval 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, 2014 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.
AbbVie Forward-Looking Statements
Some statements in this news release may be forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995. The words "believe," "expect," "anticipate," "project"
and similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form
10-K/A, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
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Bristol-Myers SquibbMedia:Audrey Abernathy,
609-419-5375cell:
919-605-4521audrey.abernathy@bms.comorInvestors:Ranya
Dajani, 609-252-5330cell: 215-666-1515ranya.dajani@bms.comorBill
Szablewski, 609-252-5894cell:
215-801-0906william.szablewski@bms.com
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