Bristol-Myers
Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced
that the U.S. Food and Drug Administration (FDA) has granted elotuzumab,
an investigational humanized monoclonal antibody, Breakthrough Therapy
Designation for use in combination with lenalidomide and dexamethasone
for the treatment of multiple myeloma in patients who have received one
or more prior therapies. The designation is based on findings from a
randomized Phase 2, open-label study that evaluated two dose levels of
elotuzumab in combination with lenalidomide and low-dose dexamethasone
in previously-treated patients, including the 10 mg/kg dose that is
being studied in Phase 3 trials. Data from the Phase 2 trial were most
recently presented at the 18th Annual Congress of the European
Hematology Association (EHA) in 2013 (click here
to view press release).
According to the FDA, Breakthrough Therapy Designation is intended to
expedite the development and review of drugs for serious or
life-threatening conditions. The criteria for Breakthrough Therapy
Designation require preliminary clinical evidence that demonstrates the
drug may have substantial improvement on at least one clinically
significant endpoint over available therapy.
“Despite recent advances in the treatment of relapsed
or refractory multiple myeloma, it remains an area of unmet need,”
said Michael Giordano, senior vice president, Head of Development,
Oncology & Immunosciences, Bristol-Myers Squibb. “This Breakthrough
Therapy Designation underscores the potential of elotuzumab in this
setting and reinforces Bristol-Myers Squibb’s longstanding commitment to
the research and development of novel medicines to treat hematologic
malignancies.”
About Elotuzumab
Elotuzumab is a humanized IgG1 monoclonal antibody targeted against
Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a
glycoprotein expressed on myeloma and Natural Killer cells but not
detectable in normal tissue. The company is investigating whether
through both direct activation and engagement of Natural Killer cells,
elotuzumab may selectively target and kill SLAMF7 expressing myeloma
cells.
Elotuzumab is being studied as a monotherapy in smoldering myeloma and
in combination with other therapies in first-line and relapsed or
refractory multiple myeloma. A clinical development program for the
agent is underway, including Phase 3 trials in first-line multiple
myeloma (ELOQUENT-1) and relapsed or refractory multiple myeloma
(ELOQUENT-2). Elotuzumab is also being investigated in a randomized
Phase 2 study of bortezomib and dexamethasone in relapsed or refractory
multiple myeloma.
Elotuzumab is being co-developed with AbbVie, with Bristol-Myers Squibb
leading the commercialization of the agent.
About Multiple Myeloma
Multiple myeloma is a progressive hematologic cancer that originates in
the bone marrow. It is the second most common blood cancer and remains
incurable, with a 5-year survival rate of 44.9%. In 2014, it is
estimated that approximately 24,050 new cases will be diagnosed in the
U.S. and more than 11,000 Americans will die from the disease. Globally,
an estimated 750,000 people are living with myeloma.
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 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. AbbVie employs
approximately 25,000 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 Statements
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 the compounds
mentioned in this release will move into full product development, that
the clinical trials of these compounds will support regulatory filings,
or that the compounds will receive regulatory approvals 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.
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 our 2012 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.
Copyright Business Wire 2014