Exelixis, Inc. (Nasdaq: EXEL) announced that GlaxoSmithKline (GSK)
has decided not to exercise its option to license XL784 for further
development and commercialization. Exelixis previously announced that XL784
failed to meet its primary endpoint in a phase 2 trial in patients with
diabetic nephropathy. Although the data in one subgroup were encouraging,
Exelixis believes that the exciting data being generated by other compounds
to which GSK has an option under its collaboration agreement with Exelixis
made it unlikely that GSK would use one of its one or two remaining options
to choose XL784. As a result of GSK's decision, Exelixis has the right to
develop and commercialize XL784 either independently or in collaboration
with third parties, subject to payment to GSK of a 3% royalty on sales of
any products incorporating the compound.
XL784 is a potent inhibitor of the ADAM-10 and MMP-2 metalloprotease
enzymes, targets of significant interest because of their important role in
renal fibrosis and impairment. Although the phase 2 trial in patients with
diabetic nephropathy did not meet its primary endpoint, there were
encouraging data from the trial. The compound was well tolerated, and the
subgroup of patients who were being treated with maximal doses of ACE
inhibitors or ARBs did appear to show a substantial benefit from XL784,
although this difference did not reach statistical significance. Exelixis
itself does not intend to invest further in the development of this drug,
but will seek a partner with which to take the compound forward.
XL784 is part of Exelixis' clinical development financing arrangement
with Symphony Evolution, Inc.
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 2 and phase 1 clinical development for cancer and renal
disease. Exelixis has established strategic corporate alliances with major
pharmaceutical and biotechnology companies, including GlaxoSmithKline,
Bristol-Myers Squibb Company, Genentech, Wyeth Pharmaceuticals and
Daiichi-Sankyo. For more information, please visit the company's web site
at exelixis.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to the future development and
potential efficacy of Exelixis' compounds, including the other compounds on
which GSK has an option, and the likelihood that GSK will exercise its
option to license additional compounds for further development and
commercialization. Words such as "believes," "intend," "will" and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon Exelixis' current 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 Exelixis' compounds to demonstrate safety and efficacy
in clinical testing and Exelixis' dependence on and relationship with GSK.
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 30, 2007 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.
Exelixis, Inc.
exelixis