FDAnews
www.fdanews.com/articles/90456-exelixis-genentech-to-develop-cancer-drug

EXELIXIS, GENENTECH TO DEVELOP CANCER DRUG

January 3, 2007

U.S.-based biotechnology firm Exelixis announced it has entered into an agreement with Genentech for the worldwide co-development of XL518, a small-molecule inhibitor of MEK, for treating cancer. Exelixis submitted an investigational new drug application for XL518 to the FDA last month.

MEK, also known as mitogen activated protein kinase, is a key component of the RAS/RAF/MEK/ERK pathway, which is frequently activated in human tumors. Inappropriate activation of this pathway can promote cell growth in the absence of exogenous growth factors.

Under the terms of the agreement, Exelixis will receive upfront and milestone payments totaling $40 million upon signing of the agreement, and the company is responsible for developing XL518 through the end of Phase I. If Genentech exercises its option to further develop XL518, Exelixis will receive an additional payment and Genentech will be responsible for further development. Exelixis has the option to co-promote the drug in the U.S., and Exelixis will receive royalties on any sales of the product outside the U.S.

"This collaboration also combines our world class drug discovery and development platform with Genentech's proven track record in commercializing novel compounds that positively impact the lives of patients with cancer," George Scangos, president and CEO of Exelixis, said.