Pfizer is discontinuing the SUN 1122 Phase III trial evaluating Sutent plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer (CRC). An independent Data Monitoring Committee found that the addition of Sutent to the chemotherapy regimen would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to FOLFIRI alone. No new safety issues were identified.

“We are disappointed with this result, but trial successes and failures are an integral part of cancer drug development and contribute to a growing body of knowledge on improving patient care,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “Pfizer remains committed to developing new agents for colorectal and other GI cancers with ongoing clinical studies evaluating other agents in its pipeline. Investigators will be consulted about the status of sunitinib colorectal studies other than the SUN 1122 trial. Pfizer also continues to study sunitinib in late-stage trials as a potential treatment for various other types of cancer.”

Sutent is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma (RCC).

Astellas Pharma and Maxygen will establish a joint venture focused on the discovery, research and development of multiple protein pharmaceutical programs, including Maxygen’s MAXY-4 program and other early stage programs. As part of the arrangement, Astellas will have an option to acquire all of Maxygen’s ownership interest in the joint venture within three years of the joint venture. The arrangement expands the two companies existing MAXY-4 collaboration in autoimmune diseases and transplant rejection.

Maxygen will contribute all of its programs and technology assets in protein pharmaceuticals, as well as $10 million in cash for the new JV. Maxygen's ownership interest will be approximately 83%. Astellas will also invest $10 million and will have a 17% ownership interest. Should Astellas acquire Maxygen’s ownership interest at specified exercise prices, the increase each quarter will go from $53 million to $123 million during the three-year term of the option. Grant Yonehiro, Maxygen’s chief business officer, is expected to serve as chief executive officer of the venture.

Under a separate collaboration agreement, Astellas will fund all of the costs, as much as $30 million over the three-year option term, for the discovery, research and development of multiple protein therapeutics (other than MAXY-4) by the JV. Astellas will be granted an option to obtain a license to one product developed by the venture under this collaboration, if Astellas does not exercise its buy-out option during the option term. Development costs for the MAXY-4 program will be shared by the JV under the terms of the existing MAXY-4 collaboration agreement.

In the event Astellas does not exercise its buy-out option, all rights to the protein therapeutics developed through the JV will be retained by the JV, and Astellas will provide as much as 18 months of transition funding to it.

Charles River Laboratories has made changes within its Research Models and Services (RMS) and Preclinical Services (PCS) and Sales organizations. Real H. Renaud, corporate executive vice president and president, Global RMS, announced he will retire by the end of 2010. As part of the transition of Mr. Renaud’s responsibilities, Davide Molho, D.V.M. has been promoted to corporate senior vice president, North American and European RMS.

James C. Foster, chairman, president and chief executive officer, said, “Real Renaud has had a stellar career at Charles River, beginning 45 years ago and rising through the ranks to head our global RMS business. Under his leadership, we have become the premier provider of research models and scientific support services to the drug development industry, recognized worldwide for our quality, biosecurity and scientific expertise. Real has developed a world-class management team, including his successor, Davide Molho, which positions us extremely well to maintain our market leadership.”

Dr. Molho joined Charles River Italy in 1999, and was promoted to director of operations for RMS Italy in 2002. In 2005, his role was expanded to include all French RMS operations and in 2007, he became corporate vice president, European RMS.

Through the restructure of the PCS business, the company created a dual-accountability structure with both global functional teams and site-level management, in an effort to increase harmonization and integration of all services across the PCS organization.

Under the new global operations structure, Brian Bathgate, Ph.D., corporate senior vice president, will assume responsibility for Global Laboratory Sciences in addition to his current responsibility for Global Biopharmaceutical Services. Dr. Bathgate will maintain oversight of PCS, Europe. Christopher J. Perkin, D.A.B.T., corporate senior vice president, will oversee site operations in North America and China. He will have responsibility for harmonizing technical operations and site infrastructure. Stephen K. Durham, D.V.M., Ph.D., D.A.C.V.P., corporate vice president, will assume responsibility for global toxicology and pathology. Dr. Durham will set global standards for and ensure effective delivery of these services across all PCS sites. Joseph C. Siglin, Ph.D., D.A.B.T., divisional vice president, will continue to focus on implementation of the company’s Lean Six Sigma program and other global process improvement initiatives.

Charles River is also realigning its sales organization, switching from a sales approach focused on its portfolio of products and services, to one focused on value-based solutions by customer segment. The company is establishing a three-part sales organization for global biopharmaceutical companies, small and mid-size pharmaceutical and biotechnology companies, and the academic and government sector.

Dr. Christophe Berthoux, corporate executive vice president, Global Sales and Marketing, and chief commercial officer, said, “This is the next step in the evolution of our Sales organization from locally to globally focused. Consistent with the PCS restructuring, we believe the realigned sales force will more effectively address our clients’ needs, and be able to access resources throughout the organization to support each client’s specific requirements.”

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