SOUTH SAN FRANCISCO, Calif., Dec. 22 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL - News) today announced that it signed a license agreement with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News) related to compounds targeting the farnesoid X receptor (FXR), a nuclear hormone receptor implicated in a variety of metabolic and liver disorders. Under the terms of the agreement, Exelixis will receive a $10 million upfront payment and may also receive up to an additional $147.5 million in development and commercialization milestone payments as well as royalties on the sale of products commercialized under the collaboration. Wyeth will be responsible for all further preclinical and clinical development, regulatory, manufacturing and commercialization activities for the compounds.
"This transaction with Wyeth is a further demonstration of the quality of our drug discovery programs. It provides Exelixis with $10 million in near- term capital to help support the ongoing development of our promising pipeline of cancer therapies, and allows us to share in the future value of the FXR program through milestones and royalties," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "Wyeth, with its strong commitment to building a leading presence in metabolic diseases, is an ideal organization to take on the development of the FXR program," continued Scangos.
"This collaboration complements our growing pipeline and overall strategy of discovering and developing new treatments for patients with abnormal lipid metabolism that is associated with the development of cardiovascular and metabolic diseases," said George P. Vlasuk, Ph.D., vice president of cardiovascular and metabolic disease research at Wyeth Pharmaceuticals. "The role of the FXR nuclear receptor in several key biochemical steps involved in maintaining the balance of various lipids through the regulation of bile acid synthesis makes it an attractive drug development target for several high need clinical indications. We look forward to bringing this exciting class of FXR modulators to the clinic in the near future."
About the Exelixis FXR Program
FXR is a member of the nuclear hormone receptor superfamily and functions as a receptor for bile acids. Regulation of FXR with endogenous ligands, such as chenodeoxycholic acid, leads to a series of transcriptional responses that regulate triglyceride, cholesterol and bile acid metabolism. Exelixis has developed a series of potent, selective synthetic FXR ligands that lower triglycerides and improve the cholesterol profile in animal models of dyslipidemia and atherosclerosis. Furthermore, in animal models of liver disorders, these compounds are also highly effective in blocking disease progression. The lead compounds have a very favorable pharmacokinetic and safety profile. These data suggest that synthetic FXR ligands may be more promising therapeutics for the therapy of metabolic syndrome and liver disease. The license agreement with Wyeth covers several small-molecule compounds that have been shown in preclinical studies to modulate the activity of FXR. Exelixis gained rights to FXR through the acquisition of X-Ceptor Therapeutics, Inc. in October 2004.
About Exelixis
Exelixis, Inc. is a biotechnology company dedicated to the discovery and development of novel therapeutics that will potentially enhance the care and lives of patients with cancer and other serious diseases. The company is leveraging its fully integrated gene-to-drug platform to fuel the growth of its proprietary drug pipeline. Exelixis' development pipeline covers cancer and metabolism and is comprised of the following compounds: XL119 (becatecarin), for which a multinational Phase III clinical trial in bile duct tumor is ongoing and which has been exclusively licensed to Helsinn Healthcare S.A. with rights to reacquire commercial rights for North America; XL784, which is being advanced as a treatment for renal disease and will enter Phase II early in 2006; XL999, an anticancer compound, currently in Phase II clinical trials for a variety of solid tumors; XL647, XL880, XL820, XL844 and XL184, anticancer compounds currently in Phase I clinical trials; 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 by Exelixis, to elect to develop a certain number of compounds in Exelixis' product pipeline, which may include XL784 and 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 www.exelixis.com.
This press release contains forward-looking statements, including without limitation all statements related to the discovery, development and commercializing of therapies targeted against FXR under the license agreement as well as related payments; the therapeutic and commercial potential of XL119, XL784, XL647, XL999, XL880, XL820, XL844 and XL184, other compounds in the Exelixis preclinical pipeline and its program in metabolic diseases. Words such as "believes," "anticipates," "plans," "expects," "intends," "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 risk that products candidates that appeared promising in early research do not demonstrate safety or efficacy in clinical trials, the ability of the company to successfully conduct the clinical trials for XL119, XL784, XL647, XL999, XL880, XL820, XL844 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 Exelixis' quarterly report on Form 10-Q for the quarter ended September 30, 2005 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.
NOTE: Exelixis and the Exelixis logo are registered U.S. trademarks. Spectrum Selective Kinase Inhibitor is a trademark of Exelixis, Inc.
Source: Exelixis, Inc.
