-Submission initiates 90-day review period-
SOUTH SAN FRANCISCO, Calif., Sept. 14 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) today announced that the company has submitted a comprehensive data report relating to XL880 to GlaxoSmithKline (GSK). As announced in August 2007, GSK requested to initiate its review of XL880 before the compound reaches proof-of-concept as defined under the product development and commercialization agreement between the two companies. GSK now has 90 days to review the data package and determine if it will select the compound for further clinical development and commercialization.
"Both GSK and Exelixis have been very encouraged by the results seen to date in the comprehensive clinical program for XL880," said George A. Scangos, Ph.D, president and chief executive officer of Exelixis, Inc. "We have seen very encouraging signs of anti-tumor activity, and XL880 remains the only MET inhibitor for which there is human pharmacodynamic data demonstrating that the compound does inhibit MET in human tumors. The increasing recognition that MET is likely to play a role in the proliferation of many types of solid tumors, including lung, breast, and colon tumors, coupled with the demonstrated ability of XL880 to inhibit MET in humans, has generated considerable enthusiasm. We are pleased that GSK asked to review the data early in order to clarify ownership of the compound and expand XL880's position as what we believe is the most advanced MET inhibitor in clinical development."
Pursuant to the product development and commercialization agreement between Exelixis and GlaxoSmithKline, GlaxoSmithKline has the option, after completion of clinical proof-of-concept by Exelixis, to elect to develop up to three compounds in Exelixis' product pipeline from among XL784, XL880, XL184, XL820, XL999, XL844, XL228, XL281 and XL418.
XL880 has attractive pharmaceutical properties, with high solubility and oral bioavailability. In preclinical studies, XL880 inhibited its targets with nanomolar potency, and retained potent activity against mutationally activated forms of MET found in hereditary papillary renal cell carcinomas. The compound also demonstrated dose-dependent tumor growth inhibition in models of breast cancer, colorectal cancer, non-small cell lung cancer, and glioblastoma, and has been shown to cause substantial tumor regression in all models tested. Significantly, a single dose of XL880 completely inhibited tumor growth for 21 days in a glioblastoma model. Encouraging phase 1 data were presented at ASCO in June, and are available on our web site.
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 GSK, Bristol-Myers Squibb, Genentech, Wyeth Pharmaceuticals and Daiichi-Sankyo. For more information, please visit the company's web site at http://www.exelixis.com.
|SOURCE Exelixis, Inc.|
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