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.

Metrics has consolidated its quality-related operations and has promoted Thomas R. Wilson to vice president of quality operations. Mr. Wilson joined the company in 2000. Previously he managed the company’s quality control division, which was a separate function from quality assurance. The two functions have joined together as quality operations.

“By consolidating all quality operations and elevating their autonomy and authority to a vice president position, we at Metrics are sending a clear signal that quality control and assurance make up the foundation of everything we do here,” said Phil Hodges, president. “We grew quickly last year, so we are committed to ensuring that Metrics’ exacting quality operations stay focused and coordinated to deliver the excellence that our clients expect from us.”

Last year, the company doubled its facility size with an $18 million expansion. The expanded facility has the capacity to produce one billion tablets per year and includes four new analytical labs, stability storage, a segregated cytotoxic and potent compound development facility, and a microbiology lab.

Peg Connelly has been promoted to vice president of clinical operations, Kforce Clinical Research, Inc. She is responsible for strategic leadership and operational excellence for pharmaceutical client alliances.

Ms. Connelly has led the company's Pfizer alliance for site management since joining Kforce in July 2007. Under her leadership, the company was awarded the Pfizer 2008 Strategic Supplier Award. She has more than 17 years of industry experience in regional site management operations, study and data management, operational excellence skills and in-depth work across numerous therapeutic areas.

Prior to joining Kforce she worked for Pfizer in multiple positions, receiving Pfizer's Manager of the Year award in 2004.

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