Exelixis, Inc. (ticker: EXEL, exchange: NASDAQ Global Market (.O))
News Release -
Exelixis and Bristol-Myers Squibb to Co-Develop XL413, a Selective Cdc7 Inhibitor
Exelixis Will Receive $20 Million Milestone Payment and Will Share U.S. Profits 50/50
SOUTH SAN FRANCISCO, Calif., Nov 24, 2008 (BUSINESS WIRE) -- Exelixis, Inc. (Nasdaq:EXEL) today announced that Bristol-Myers Squibb
Company (NYSE:BMY) has exercised its option to develop and commercialize
Exelixis' investigational new drug (IND) candidate XL413, a selective
inhibitor of Cdc7. Under the terms of the collaboration agreement
between the two companies, which became effective in January 2007, the
selection of XL413 by Bristol-Myers Squibb entitles Exelixis to a
milestone payment of $20 million. In addition, Exelixis has exercised
its option under the collaboration agreement to co-develop and
co-commercialize XL413 in the United States. Following the transfer of
the XL413 development program, which is expected to occur promptly,
Bristol-Myers Squibb will lead all global activities. The parties will
co-develop and co-commercialize XL413 in the United States and share
those profits 50/50. Exelixis will be entitled to receive double-digit
royalties on product sales outside of the United States.
XL413 is the second compound selected by Bristol-Myers Squibb in this
collaboration. Previously, in January 2008, Bristol-Myers Squibb
exercised its option to select XL139, an inhibitor of the hedgehog
signaling pathway, for further development and commercialization.
"To our knowledge, no other selective inhibitors of Cdc7 have advanced
to this stage of preclinical development, giving XL413 the potential to
become a first-in-class therapy," said Michael M. Morrissey, PhD,
President of Research and Development at Exelixis. "Our colleagues at
Bristol-Myers Squibb have substantial expertise in developing and
commercializing innovative cancer therapies, and we are excited to have
another opportunity to work with them."
"Providing innovative medicines to patients with cancer is central to
our company's mission," said Francis Cuss, Senior Vice President,
Discovery and Exploratory Clinical Research. "Cdc7 inhibition represents
a novel approach to cancer treatment and we are pleased to add XL413 to
our growing pipeline of cancer compounds, and to further expand our
productive collaborations with Exelixis."
XL413 is a small molecule inhibitor of the serine-threonine kinase Cdc7.
The function of Cdc7 is required for DNA replication to proceed, and its
activity is often upregulated in cancer cells. Studies suggest that Cdc7
plays a role in regulation of cell cycle checkpoint control and protects
tumor cells from apoptotic cell death during replication stress.
Therefore, inhibition of Cdc7 may have utility in the treatment of a
wide variety of cancers, either as a single agent or in combination with
DNA damaging agents.
Background on the Collaboration Agreement
Under the terms of the agreement, Exelixis is fully responsible for the
identification and preclinical development of small molecule drug
candidates directed against mutually selected targets. In addition to an
upfront payment of $60 million in January 2007, the agreement provides
for Exelixis to receive $20 million for each of up to three different
IND-stage drug candidates selected by Bristol-Myers Squibb. For each
candidate selected by Bristol-Myers Squibb, Exelixis has the right to
opt in to the co-development or co-promotion in the United States. If
Exelixis does not opt in to co-promote the selected IND candidates,
Exelixis would be entitled to receive milestones and royalties in lieu
of profits from sales in the United States. Outside of the United
States, Bristol-Myers Squibb will have primary responsibility for
development activities and Exelixis will be entitled to receive
royalties on product sales.
In January 2008, Bristol-Myers Squibb selected XL139, a small molecule
inhibitor of the hedgehog signaling pathway, for further development and
commercialization. In connection with this selection, Exelixis received
a $20 million milestone payment and also exercised its option under the
collaboration agreement to co-develop and co-commercialize XL139 in the
United States. Following the transfer of the XL139 development program
in mid-2008, Bristol-Myers Squibb has been leading all global activities
for that program.
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 3, phase 2, and phase 1 clinical
development. Exelixis has established strategic corporate alliances with
major pharmaceutical and biotechnology companies, including
GlaxoSmithKline, Bristol-Myers Squibb, Genentech, Wyeth Pharmaceuticals,
and Daiichi-Sankyo. For more information, please visit the company's
website at http://www.exelixis.com.
This press release contains forward-looking statements, including,
without limitation, statements related to Exelixis' potential receipt of
royalties under the collaboration with Bristol-Myers Squibb, statements
related to the co-development and co-commercialization of XL413,
Exelixis' related costs and payments under the collaboration with
Bristol-Myers Squibb, expected timing for the transfer of the XL413
development program to Bristol-Myers Squibb, and the potential for XL413
to become a first-in-class therapy. Words such as "will," "expected,"
"potential," 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 XL413 to demonstrate safety and
efficacy in clinical testing, the therapeutic and commercial value of
XL413 and risks related to Exelixis' relationship with Bristol-Myers
Squibb. 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
Exelixis and the Exelixis logo are registered U.S. trademarks.
SOURCE: Exelixis, Inc.
Charles Butler, 650-837-7277
Corporate Communications & Investor Relations
Soleil Harrison, 650-837-7012