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
PRINCETON, N.J.--(BUSINESS WIRE)--
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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Source: Bristol-Myers Squibb