Exelixis confirmed that it has agreed to the request from GSK to initiate its review of XL880 before the compound reaches proof-of-concept. Exelixis expects to deliver the appropriate diligence information to GSK in mid-September, at which point GSK will begin its review to determine whether or not to select XL880 for further development and commercialization.
Both GSK and Exelixis have agreed to expedite the review of XL880 in order to build on its position as a leading MET inhibitor, which the companies believe to be the most advanced in clinical development. Under the terms of the product development and commercialization agreement between the parties, GSK’s review period would have otherwise commenced once proof-of-concept data became available.
In addition, the companies have initiated preliminary transition activities in the event that GSK decides to select XL880 for further clinical development and commercialization.
“We are extremely pleased that GSK has asked us to expedite its review process for XL880. This request reflects the high level of excitement around both the compound and the therapeutic potential of MET inhibition,” said George Scangos, president and CEO of Exelixis. “Our recently reported data from the XL880 phase I trial at the 2007 ASCO Annual Meeting underscore our belief that XL880 is the most advanced MET inhibitor in clinical development, and we and GSK are committed to building upon this leadership position.”