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GSK Does Not Option XL784 for Further Development
Date:1/18/2008

SOUTH SAN FRANCISCO, Calif., Jan. 18 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) today 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.

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