Sanofi-aventis, Exelixis Enter Drug Discovery Pact

Sanofi-aventis and Exelixis, Inc. have entered a global license agreement for XL147 and XL765 and a broad collaboration for the discovery of inhibitors of phosphoinositide-3 kinase (PI3K) for the treatment of cancer. The PI3K pathway in human tumors is related to promoting cell proliferation, survival and resistance to chemotherapy and radiotherapy.

Under the license, Sanofi-aventis will have a worldwide exclusive license to XL147 and XL765, which are currently in Phase I and Phase Ib/II trials, and will be responsible for all subsequent clinical, regulatory, commercial and manufacturing activities. Exelixis will participate in conducting ongoing and future trials and manufacturing activities.

Under the discovery collaboration, the two companies will combine efforts to establish several preclinical PI3K programs and will share responsibility for research and preclinical activities related to isoform-selective inhibitors of PI3K. Sanofi-aventis will be responsible for all subsequent clinical, regulatory, commercial and manufacturing activities of any products arising from the collaboration. Exelixis may be responsible for conducting certain trials.

Exelixis will receive an upfront cash payment of $140 million and will receive $21 million in funding during a three-year research term. Exelixis will be eligible to receive development, regulatory and commercial milestones of more than $1 billion, as well as royalties on sales of any products commercialized under the license or collaboration.

“Sanofi-aventis has a track record of success in commercializing innovative cancer therapies and is deeply committed to advancing the care of cancer patients,” said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. “We believe that their expertise and resources will enable us to move aggressively in advancing the development of XL147 and XL765 and other potential PI3K inhibitors. The data generated to date in the XL147 and XL765 clinical programs suggest that these compounds may have utility in treating diverse cancers. Sanofi-aventis and Exelixis are committed to realizing the full potential of these compounds and other PI3K inhibitors to provide cancer patients with new treatment options.”

The license and collaboration are subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary regulatory approvals.