SOUTH SAN FRANCISCO, Calif., Dec. 20 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) today announced that it has submitted a comprehensive data report for IND candidate XL139 to Bristol-Myers Squibb (NYSE: BMY). Bristol- Myers Squibb Company now has until the end of January to review the data package and determine if it will select the compound for further development and commercialization as part of its worldwide collaboration agreement with Exelixis to discover, develop and commercialize novel targeted therapies for the treatment of cancer.
XL139 is a small molecule inhibitor of the hedgehog signaling pathway. Hedgehog plays a critical role in regulating cell growth, proliferation and differentiation in normal development. The pathway is deregulated in basal cell carcinoma, medulloblastoma, glioblastoma, multiple myeloma and pancreatic and a variety of other cancers. Inappropriate activation of hedgehog can result from activating mutations, loss of repressors or overexpression of factors that stimulate the pathway. Signaling through hedgehog also has been shown to stimulate production of angiogenic and survival factors, both in tumor cells and in the surrounding stromal tissue. In addition, recent data suggest that hedgehog signaling may play a key role in cancer stem cell (CSC) proliferation and the resistance of CSCs to chemotherapeutics and radiotherapy.
"One of our key R&D goals is to simultaneously develop multiple compounds focused on key pathways and targets that play important roles in cancer," said Michael Morrissey, Ph.D., president of research and development of Exelixis. "Given its role in aberrant cell growth and proliferation, the hedgehog pathway is an exciting target for therapeutic intervention. Our preclinical data suggest that XL139 profoundly inhibits hedgehog signaling and we are excited about the opportunity to work with Bristol-Myers Squibb to advance this very promising compound into clinical development."
Under the terms of the companies' collaboration agreement, which became effective on January 11, 2007, Exelixis deploys its drug discovery platform and is fully responsible for the identification and preclinical development of small molecule drug candidates directed against mutually selected targets. Bristol-Myers Squibb has the right to select up to three IND candidates against three different targets. Following selection by Bristol-Myers Squibb, Bristol-Myers Squibb will lead all global activities, although the parties will co-develop and co-commercialize the programs in the United States. Bristol-Myers Squibb made an upfront payment of $60 million in cash to Exelixis at the time the deal was signed. The terms of the agreement provide for Exelixis to receive $20 million for each of up to three different drug candidates selected by Bristol-Myers Squibb at IND. The parties plan to share equally development costs, commercial profits and co-promotion responsibilities in the United States. Exelixis will also receive royalties on product sales outside of the United States. For each program 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, Exelixis will receive milestones and royalties in lieu of a U.S. profit share.
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 http://www.exelixis.com.
Exelixis Forward Looking Statements
This press release contains forward-looking statements, including, without limitation, all statements related to the future development and potential efficacy of XL139, the discovery, development and commercializing of other small molecule drug candidates and Exelixis' potential receipt of milestone payments and royalties under the collaboration agreement with Bristol-Myers Squibb. Words such as "will," "suggest," "may," "plan" 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, the risk that product candidates that appeared promising in early research do not demonstrate safety or efficacy in clinical trials; the ability of Exelixis to advance preclinical compounds into clinical development; the uncertainty of the FDA approval process; and the therapeutic and commercial value of Exelixis' compounds. 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.
SOURCE Exelixis, Inc.