Programs include XL184, a Phase III inhibitor of MET, VEGFR2 and RET, and XL281, a Phase I Inhibitor of RAF Kinase
PRINCETON, N.J. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 12, 2008--Bristol-Myers Squibb Company (NYSE: BMY) and Exelixis, Inc. (Nasdaq:
EXEL) today announced a global collaboration covering two novel
molecules for cancer with their associated development programs:
Exelixis' XL184, a small molecule inhibitor of MET, VEGFR2 and RET,
which is currently in Phase III development for medullary thyroid
cancer; and Exelixis' XL281, a small molecule inhibitor of RAF kinase,
which is currently in Phase I development for the treatment of patients
with advanced solid tumor malignancies.
Under the terms of the collaboration, Bristol-Myers Squibb agreed
to pay Exelixis an upfront cash payment of $195 million for the
development and commercialization rights to both programs and to make
additional license payments of $45 million in 2009.
The companies have agreed to co-develop XL184. Exelixis will have the
option to co-promote XL184 in the United States. The companies will
share worldwide development costs and commercial profits on XL184 in the
United States. Exelixis will be eligible to receive sales performance
milestones of up to $150 million and double-digit royalties on sales
outside the United States. The clinical development of XL184 will be
directed by a joint committee. It is anticipated that Exelixis will
conduct a significant portion of clinical development activities through
2010. Exelixis may opt out of the co-development of XL184, in which case
Exelixis would instead be eligible to receive development and regulatory
milestones of up to $295 million, double-digit royalties on XL184
product sales worldwide, and sales performance milestones.
Bristol-Myers Squibb will receive an exclusive worldwide license to
develop and commercialize XL281 and will be responsible for funding all
future development. Exelixis is eligible for development and regulatory
milestones of up to $315 million, sales performance milestones of up to
$150 million and double-digit royalties on worldwide sales of XL281.
"For nearly a decade, the foundation for our close collaborations with
Exelixis has been a commitment to discover and develop new medicines to
help patients prevail over serious disease," said Elliott Sigal, M.D.,
Ph.D., executive vice president, chief scientific officer, and
president, Research and Development of Bristol-Myers Squibb. "XL184 and
XL281 represent significant new opportunities to inhibit the progression
of many different tumor types. This agreement represents the next pearl
in our on-going String of Pearls initiative, designed to accelerate our
company's strategy to transform into a BioPharma leader by blending
external scientific innovation with our own internal research and
development expertise. Together with Exelixis, we intend to fully
explore how these compounds can potentially extend the treatment options
of patients with cancer."
"There have been many attempts to blend the best of big pharma with the
best of biotech, and over the years Exelixis and Bristol-Myers Squibb
have learned how to do just that. This new collaboration maximizes the
capabilities and strengths of each partner and sets the stage for the
aggressive development of XL184 and XL281. The collaboration provides
the development programs with appropriate resources and positions both
compounds to be developed to their full potential in indications with
significant commercial potential," said George Scangos, president and
chief executive officer of Exelixis. "Exelixis and Bristol-Myers Squibb
are working toward a shared vision of maximizing the potential of these
compounds to benefit patients who suffer from numerous types of cancer."
XL184 provides a novel approach to the treatment of a variety of solid
tumors where signaling through MET, VEGFR2 or RET plays an important
role in dysregulated tumor growth and progression. XL184 has recently
begun a Phase III clinical trial in medullary thyroid cancer, a disease
in which RET mutations are found in a large proportion of patients. In
addition, clinical trials to exploit the MET and VEGFR2 targeting of
XL184 are ongoing in patients with non-small cell lung cancer and
glioblastoma. Preclinically, XL184 also exhibits inhibitory activity for
MET and VEGFR2 in a variety of breast, colon and brain tumor models.
XL281 is a novel small molecule designed to selectively inhibit RAF
kinase, which lies immediately downstream of RAS and is a key component
of the RAS/RAF/MEK/ERK kinase signaling pathway. The RAS/RAF/MEK/ERK
pathway plays a key role in the transmission of growth-promoting signals
downstream of receptor tyrosine kinases. Dysregulation of this pathway
plays a pivotal role in the progression of many human tumors, and
inhibition of the pathway may be useful in the treatment of cancer.
Phase I trials with this molecule are underway in order to select a dose
and schedule for Phase II disease-directed trials.
The effectiveness of the agreement is subject to antitrust clearance
under the Hart-Scott-Rodino Antitrust Improvements Act and other
customary regulatory approvals.
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 Exelixis
Exelixis, Inc. is a development-stage biotechnology company dedicated to
the discovery and development of novel small molecule therapeutics for
the treatment of cancer and other serious diseases. The company is
leveraging its fully integrated drug discovery platform to fuel the
growth of its development pipeline, which is primarily focused on
cancer. Currently, Exelixis' broad product pipeline includes
investigational compounds in Phase III, Phase II and Phase I clinical
development. Exelixis has established strategic corporate alliances with
major pharmaceutical and biotechnology companies, including
Bristol-Myers Squibb, GlaxoSmithKline, Genentech, Wyeth Pharmaceuticals
and Daiichi-Sankyo. For more information, please visit the company's
website at http://www.exelixis.com.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements by Exelixis,
including, without limitation, statements related to the anticipated
effectiveness of the agreement described in this press release and
Exelixis' receipt of an upfront cash payment from Bristol-Myers Squibb;
potential license and milestone payments by Bristol-Myers Squibb to
Exelixis; the companies' plan to share development costs and commercial
profits and losses for XL184 in the United States; Exelixis' potential
receipt of royalties for XL184 products sales; Exelixis' right to opt
out of the co-development and co-promotion of XL184 in the United States
and the related impact on potential royalties and milestones; Exelixis'
potential receipt of development, regulatory and sales milestones and
royalties on worldwide sales of XL281; and the future funding,
development path and commercial and therapeutic potential of XL184 and
XL281 and associated compounds. Words such as "will," "plan,"
"eligible," "may," "shall," "intend," "potential," "positions" and
similar expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Exelixis' current
plans, assumptions, beliefs and expectations. Forward-looking
statements involve risks and uncertainties. Exelixis' actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
related to the potential failure of XL184 and XL281 to demonstrate
safety and efficacy in clinical testing; the therapeutic and commercial
value of XL184 and XL281; the uncertainty of the FDA approval process;
market competition; and Exelixis' dependence on its relationship with
Bristol-Myers Squibb and ability to maintain its co-development rights
under the collaboration. These and other risk factors are
discussed under "Risk Factors" and elsewhere in Exelixis' quarterly
report on Form 10-Q for the quarter ended September 26, 2008 and
Exelixis' other filings with the Securities and Exchange Commission. Exelixis
expressly disclaims any duty, obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Exelixis' expectations with
regard thereto or any change in events, conditions or circumstances on
which any such statements are based.
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 described in this release will
support a regulatory filing or that the products described in this
release will receive regulatory approval. There can be no
assurance that if approved, the products will be commercially
successful. 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.
CONTACT: Bristol-Myers Squibb Company
Media
Jennifer Fron Mauer, 609-252-6579
jennifer.mauer@bms.com
or
Investors
John Elicker, 609-252-4611
john.elicker@bms.com
Exelixis
Media
Soleil Harrison, 650-837-7012
sharriso@exelixis.com
or
Investors
Charles Butler, 650-837-7277
cbutler@exelixis.com
Source: Bristol-Myers Squibb Company and
Exelixis, Inc.
