Exelixis, Inc. (ticker: EXEL, exchange: NASDAQ Global Market (.O))
News Release -
9-May-2005
Exelixis Achieves $35 Million in Milestones From GSKSOUTH SAN FRANCISCO, Calif., May 9, 2005 /PRNewswire-FirstCall via COMTEX/ -- Exelixis,
Inc. (Nasdaq: EXEL) today announced that it has achieved two milestones
totaling $35 million under its collaboration agreement with GlaxoSmithKline
(GSK). The first of these milestones, totaling $30 million, was achieved as a
result of the submission of the investigational new drug (INDs) applications
for XL880 in December 2004, and XL820 and XL844 in April 2005. All three of
these compounds have shown excellent preclinical efficacy in a variety of
tumor models. The Phase I trial for XL880 is underway and the Phase I trials
for the other two compounds will commence upon FDA approval. The filing of
these INDs brings the number of compounds to six that Exelixis has internally
generated and brought into clinical development in the past two years. The
$30 million milestone was part of the amendment to the collaboration signed in
January 2005. It recognizes the fact that Exelixis has advanced internally
derived compounds into clinical development faster than originally
anticipated, and is intended to help support the consequent acceleration of
clinical expenses.
The second milestone payment, totaling $5 million, was achieved as a
result of progress that Exelixis has made in earlier stage programs, and is a
reflection of the continued productivity of Exelixis' drug discovery and
development.
"I am gratified by the progress that Exelixis has made in our
collaboration with GSK," said Michael Morrissey, Ph.D., senior vice president
of discovery. "Our collaboration with GSK has been extremely productive and
very positive for both companies. We are grateful for the support and advice
that we have received from GSK, and for the confidence they have shown in us
by agreeing to advance substantial milestone payments. I believe that we have
advanced a number of potentially exciting compounds into clinical development
and we are all anticipating the data that will emerge from these trials."
About Exelixis
Exelixis, Inc. is a leading genomics-based drug discovery company
dedicated to the discovery and development of novel therapeutics for the
treatment of cancer and metabolic diseases. The company is leveraging its
fully integrated gene-to-drug platform to fuel the growth of its proprietary
drug pipeline. Exelixis' development pipeline is comprised of the following
compounds: XL119 (becatecarin), for which a multinational Phase III clinical
trial has been initiated in patients with bile duct tumors; XL784, initially
an anticancer compound, which completed a Phase I clinical trial and is being
developed as a treatment for renal disease; XL647, XL999 and XL880, anticancer
compounds currently in Phase I clinical trials; XL820 and XL844, anticancer
compounds for which investigational new drug (IND) applications have been
filed; XL184, a potential IND candidate for the treatment of cancer; and
multiple compounds in preclinical development for diseases including cancer
and various metabolic and cardiovascular disorders. Exelixis has established
broad corporate alliances with major pharmaceutical and biotechnology
companies including GlaxoSmithKline (GSK) and Bristol-Myers Squibb Company.
Pursuant to a product development and commercialization agreement between
Exelixis and GSK, GSK has the option, after completion of Phase IIa clinical
trials, to elect to develop a certain number of compounds in Exelixis' product
pipeline, which may include the cancer compounds identified in this press
release (other than XL119), thus potentially triggering milestone payments and
royalties from GSK and co-promotion rights by Exelixis. For more information,
please visit the company's web site at http://www.exelixis.com .
This press release contains forward-looking statements, including without
limitation all statements related to reductions in future payments owed to GSK
as part of the collaboration, the therapeutic and commercial potential of
XL119, XL784, XL647, XL880, XL999, XL820, XL844 and XL184, other compounds in
the Exelixis preclinical pipeline and its program in metabolic diseases. Words
such as "believes," "anticipates," "plans," "expects," "intend," "will,"
"slated," "goal" 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,
the ability of the company to successfully conduct the clinical trials for
XL119, XL647, XL999, XL880, XL 844 and XL184; the ability of the company to
advance additional preclinical compounds into clinical development; the
uncertainty of the FDA approval process; and the therapeutic and commercial
value of the company's compounds. These and other risk factors are discussed
under "Risk Factors" and elsewhere in our annual report on Form 10-K for the
year ended December 31, 2004 and other filings with the Securities and
Exchange Commission. Exelixis 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 the company's
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
Exelixis and the Exelixis logo are registered U.S. trademarks.
SOURCE Exelixis, Inc.
Charles Butler, Associate Director, Corporate Communications of Exelixis, Inc.,
+1-650-837-7277, cbutler@exelixis.com
http://www.prnewswire.com
|