Elotuzumab Antibody Designed to Target Highly Expressed Cell
Surface Protein and Selectively Kill Multiple Myeloma Cells
Bristol-Myers Squibb Company (NYSE:
BMY) and PDL BioPharma, Inc. (NASDAQ:
PDLI) today announced an agreement for the global development and
commercialization of PDL BioPharma’s anti-CS1
antibody, elotuzumab, previously known as HuLuc63, currently in Phase I
development for multiple myeloma.
Elotuzumab provides a novel approach to treating multiple myeloma
because it is an antibody that binds to the CS1 glycoprotein, allowing
the immune system to selectively kill myeloma cells with minimal effects
on other cell types. CS1 is a cell surface glycoprotein that is widely
expressed on multiple myeloma cells but is minimally expressed on normal
cells. Elotuzumab is currently being investigated in Phase I studies as
a monotherapy and in combination with other therapies. There are
currently no approved monoclonal antibodies on the market to treat
multiple myeloma.
Under the terms of the collaboration, Bristol-Myers Squibb would pay PDL
BioPharma an upfront cash payment of $30 million for the development and
marketing rights to elotuzumab and for an option to expand the
collaboration to include PDL241, another anti-CS1 antibody, upon
completion of pre-agreed preclinical studies. PDL BioPharma could
receive additional payments of up to $480 million based on pre-defined
development and regulatory milestones and up to $200 million based on
pre-defined sales-based milestones for elotuzumab in multiple myeloma
and other potential oncology indications.
The companies will share development costs, with Bristol-Myers Squibb
providing 80 percent of the funding and PDL BioPharma providing 20
percent. Bristol-Myers Squibb will lead global development activities,
and PDL BioPharma will complete the ongoing Phase I program and provide
support for Phase II studies. The companies would share profits on sales
of elozutumab in the U.S. PDL BioPharma would receive royalties on net
sales of elotuzumab outside the U.S.
If Bristol-Myers Squibb exercises its option to expand the collaboration
to include PDL241, PDL BioPharma would receive an additional cash
payment of $15 million and could receive additional payments of up to
$230 million based on pre-defined development and regulatory milestones
and up to $200 million based on pre-defined sales-based milestones. The
same division of development costs and profit sharing that apply to
elotuzumab would apply to PDL241.
The closing of the transaction is subject to antitrust clearance under
the Hart-Scott-Rodino Act and other customary regulatory approvals.
“Elotuzumab provides us with the opportunity
to develop and market an innovative therapy that has the potential to
meaningfully address the significant unmet medical need in multiple
myeloma,” said Francis Cuss, MD, senior vice
president, Discovery and Exploratory Clinical Research, Bristol-Myers
Squibb. “Consistent with our company’s
strategy to integrate external innovation and to expand our
capabilities, this collaboration will further strengthen our pipeline of
agents targeting hematologic malignancies, which includes SPRYCEL(R)
and tanespimycin, an Hsp90 inhibitor from our recent acquisition of
Kosan Biosciences.”
“We are delighted to enter this global
alliance with Bristol-Myers Squibb, which we believe will maximize the
potential benefit of elotuzumab to patients, and highlight the value of
our scientific discoveries and antibody technologies to the field,”
said Mark McCamish, MD, PhD, PDL’s senior
vice president and chief medical officer. “In
addition, Bristol-Myers Squibb brings extensive oncology development
experience and resources and we look forward to collaborating with them
to increase the scope of the elotuzumab development program moving
forward.”
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to extend and enhance human life. For more information visit www.bms.com
About PDL BioPharma
PDL BioPharma, Inc. is a biotechnology company focused on the discovery
and development of novel antibodies in oncology and immunologic
diseases. For more information, please visit www.pdl.com.
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 clinical trials will begin on the
timeframe described in this release, that the clinical studies described
in this release will support a regulatory filing or that the product
will receive regulatory approval. There can be no assurance that
if approved, the product described in this release will be commercially
successful. Nor is there any assurance that the transaction described in
this release will receive the necessary regulatory approvals to close.
Forward-looking statements in the 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, 2007, its Quarterly
Reports on Form 10-Q, and 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.
PDL BioPharma Forward-Looking Statements
This press release contains forward-looking statements regarding the
entry into and potential for success of a development and
commercialization collaboration between PDL BioPharma and BMS, including
whether antitrust approval will be obtained to permit the effectiveness
of the agreement; the ability of BMS or PDL BioPharma to achieve any or
all of the milestone payments for products covered by the collaboration;
the scope of the collaboration, including the option exercise and
milestones payments related to the exercise of the PDL241 product option
by BMS; the ability of PDL BioPharma to maintain the
collaboration in effect; the ability of the parties to achieve
regulatory approval; and if approved, the commercial potential of any
products developed pursuant to the collaboration. Other factors that may
cause PDL’s actual results to differ
materially from those expressed or implied in the forward-looking
statements in this press release are discussed in the Current Report on
Form 8-K filed by PDL BioPharma with the Securities and Exchange
Commission (SEC) in connection with this press release and PDL
BioPharma's periodic filings with the SEC, including the “Risk
Factors” sections of its annual and quarterly
reports filed with the SEC. Copies of PDL's filings with the SEC may be
obtained at the “Investors”
section of PDL's website at www.pdl.com.
PDL expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in PDL's expectations with regard
thereto or any change in events, conditions or circumstances on which
any such statements are based for any reason, except as required by law,
even as new information becomes available or other events occur in the
future. All forward-looking statements in this press release are
qualified in their entirety by this cautionary statement.
Bristol-Myers Squibb Company
Media:
Jennifer Fron
Mauer, 609-252-6579
jennifer.mauer@bms.com
Investors:
John
Elicker, 212-546-3775
john.elicker@bms.com
or
PDL
BioPharma
Media:
Kathleen Rinehart, 650-454-2543
kathleen.rinehart@pdl.com
Investors:
Jean
Suzuki, 650-454-2648
jean.suzuki@pdl.com