|
Investment in Stocks - Forum for sharing info about stocks and options.
|
|
|
|
|
Posted by on May 28, 2009, 12:06 pm
Exelixis and Sanofi-aventis Sign Global License Agreement for XL147 &
XL765 and Launch Broad Collaboration for Discovery of PI3K Inhibitors
1:00a ET May 28, 2009 (Business Wire)
Sanofi-aventis (PARIS:SAN) and (NYSE:SNY) and Exelixis, Inc.
(Nasdaq:EXEL) today announced a global license agreement for XL147 and
XL765 and a broad collaboration for the discovery of inhibitors of
phosphoinositide-3 kinase (PI3K) for the treatment of cancer.
Activation of the PI3K pathway is a frequent event in human tumors,
promoting cell proliferation, survival and resistance to chemotherapy
and radiotherapy. Under the license, sanofi-aventis will have a
worldwide exclusive license to XL147 and XL765, which are currently in
phase 1 and phase 1b/2 clinical trials, and will have sole
responsibility for all subsequent clinical, regulatory, commercial and
manufacturing activities. Exelixis will participate in conducting
ongoing and potential future clinical trials and manufacturing
activities.
Under the discovery collaboration, Exelixis and sanofi-aventis will
combine efforts in establishing several pre-clinical PI3K programs and
jointly share responsibility for research and preclinical activities
related to isoform-selective inhibitors of PI3K. Sanofi-aventis will
have sole responsibility for all subsequent clinical, regulatory,
commercial and manufacturing activities of any products arising from
the collaboration; however, Exelixis may be responsible for conducting
certain clinical trials.
Sanofi-aventis will pay Exelixis aggregate upfront cash payments of
$140 million under the license and collaboration. Exelixis will also
receive guaranteed research funding of $21 million over a three year
research term under the collaboration. For the license and the
collaboration, Exelixis will be eligible to receive development,
regulatory and commercial milestones of over $1 billion in the
aggregate, as well as royalties on sales of any products
commercialized under the license or collaboration.
"Sanofi-aventis has a track record of success in commercializing
innovative cancer therapies and is deeply committed to advancing the
care of cancer patients," said George A. Scangos, Ph.D., president and
chief executive officer of Exelixis. "We believe that their expertise
and resources will enable us to move aggressively in advancing the
development of XL147 and XL765 and other potential PI3K inhibitors.
The data generated to date in the XL147 and XL765 clinical programs
suggest that these compounds may have utility in treating diverse
cancers. Sanofi-aventis and Exelixis are committed to realizing the
full potential of these compounds and other PI3K inhibitors to provide
cancer patients with new treatment options."
The effectiveness of the license and collaboration is subject to
antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements
Act and other customary regulatory approvals.
Oral Presentations
Clinical data from the phase 1 trials of XL147 and XL765 will be
presented at the 2009 American Society of Clinical Oncology Annual
Meeting, which will be held from May 29 to June 2, 2009 in Orlando,
Florida:
-- "Phase 1 dose-escalation study of XL147, a PI3K inhibitor
administered orally to patients with solid tumors" will be presented
on Monday, June 1, 2009, starting at 1:30 p.m. local time (Abstract
#3500)
-- "A Phase 1 dose-escalation study of the safety, pharmacokinetics
(PK) and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor
administered orally to patients (pts) with advanced solid tumors" will
be presented on Monday, June 1, 2009 starting at 2:00 p.m. local time
(Abstract #3502)
XL147 and XL765 target PI3K, which plays an important role in cell
proliferation and survival. XL765 also inhibits the mammalian target
of rapamycin (mTOR), which can be activated via upregulation of PI3K,
or via PI3K-independent mechanisms. mTOR is frequently activated in
human tumors and plays a central role in tumor cell proliferation.
Conference Call and Webcast
Exelixis will hold a live webcast today, Thursday, May 28, 2009, from
8:00 a.m. ET / 5:00 a.m. PT to 9:00 a.m. ET / 6:00 a.m. PT., during
which Exelixis management will discuss the license and collaboration.
The webcast may be accessed in the Event Calendar page under Investors
at http://www.exelixis.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 3, phase 2, and phase 1 clinical
development. Exelixis has established strategic corporate alliances
with major pharmaceutical and biotechnology companies, including
Bristol-Myers Squibb, GlaxoSmithKline, Genentech, Boehringer
Ingelheim, Wyeth Pharmaceuticals, and Daiichi-Sankyo. For more
information, please visit the company's web site at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements by Exelixis,
including, without limitation, statements related to the anticipated
effectiveness of the license and collaboration described in this press
release; the companies' plan for sanofi-aventis to have sole
responsibility for all subsequent clinical, regulatory, commercial and
manufacturing activities with respect to XL147 and XL765 and for
Exelixis to participate in conducting ongoing and potential future
clinical trials and manufacturing activities; the companies' plan to
combine efforts in establishing pre-clinical PI3K programs and jointly
share responsibility for research and preclinical activities under the
collaboration; the companies' plans for sanofi-aventis to have sole
responsibility for all subsequent clinical, regulatory, commercial and
manufacturing activities of any products arising from the
collaboration and for Exelixis to potentially have responsibility for
conducting certain clinical trials; Exelixis' receipt of upfront
payments and guaranteed research funding; Exelixis' potential receipt
of development, regulatory and commercial milestones, as well as
royalties on sales of any products commercialized under the license or
collaboration; and the future development path and commercial and
therapeutic potential of XL147, XL765 and other potential PI3K
inhibitors. Words such as "will," "may," "eligible," "believe,"
"suggest," "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
XL147, XL765 and other potential PI3K inhibitors to demonstrate safety
and efficacy in clinical testing; the therapeutic and commercial value
of XL147, XL765 and other potential PI3K inhibitors; the uncertainty
of the FDA approval process; market competition; and Exelixis'
dependence on its relationship with its collaboration partners. These
and other risk factors are discussed under "Risk Factors" in Exelixis'
Quarterly Report for the quarter ended April 3, 2009 and Exelixis'
other reports filed 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.
SOURCE: Exelixis, Inc.
Exelixis, Inc. Charles Butler, 650-837-7277 (Investor Contact)
Executive Director, Corporate Communications cbutler@exelixis.com or
Exelixis, Inc. Soleil Maxwell Harrison, 650-837-7012 (Media Contact)
Senior Manager, Corporate Communications sharrison@exelixis.com
|
| Similar Threads | Posted | | OpenWave, inked some deals today! | April 5, 2006, 5:39 pm |
| DNDN OR EXEL | October 15, 2006, 3:34 am |
| Stock Alert -------- EXEL | June 17, 2009, 9:28 am |
| Trader Alert -------- EXEL | June 24, 2009, 10:29 am |
| 10/08 Stock Alert -------- EXEL | August 10, 2009, 3:41 pm |
| Partnership Opportunity | May 5, 2005, 2:43 pm |
| Partnership Opportunity | January 12, 2006, 2:54 pm |
| An inconvenient partnership | November 28, 2006, 10:18 am |
| Limited Partnership Question | September 27, 2008, 10:24 pm |
| Finger Lakes NY Partnership | April 15, 2005, 10:10 pm |
|
|
|
Yahoo! 
Google 
Windows Live 
del.icio.us 
digg 
Netscape 
XML Sitemap