Morphotek and Lonza have executed a manufacturing services agreement to support the development and manufacturing of a subset of antibodies in Morphotek's therapeutic antibody pipeline. The agreement will reserve capacity for commercial manufacturing of Morphotek's lead compound farletuzumab (also known as MORAb-003), which recently entered Phase III clinical trials for ovarian cancer under a Special Protocol Assessment (SPA) agreement with the FDA. The collaboration between both parties already encompasses several other monoclonal antibodies currently in clinical or preclinical development.

"Lonza is an ideal partner and collaborator on this project," said Philip Sass, Ph.D., executive vice president and chief operating officer of Morphotek. "They have a great deal of experience and expertise with large scale expression and purification of commercial antibody products. They have demonstrated their ability to develop high-quality material and documentation with several of our programs and serve as an extension of our development team at Morphotek. Based on our working experience, we are confident that Lonza will meet our production, quality goals and timelines for our antibody programs."

"Lonza is excited to participate in supporting the commercial manufacturing of Morphotek's lead compound, farletuzumab," said Stephan Kutzer, head of Lonza Biopharmaceuticals. "Lonza looks forward to continuing and expanding the Morphotek relationship for both development and manufacturing services using Lonza's proprietary GS Gene Expression System toward their pipeline of promising compounds."

Through the use of its proprietary Morphodoma technology, Morphotek develops optimized antibodies, including antibodies optimized for affinity and/or titer, for therapeutic applications and high-titer manufacturing cell lines. The antibodies within the company's pipeline are targeted against antigens licensed from its collaborative partners.

Genentech and Biogen Idec have submitted two supplemental Biologics License Applications (sBLAs) to the FDA for Rituxan plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.

CLL is the most common type of adult leukemia, accounting for one-third of all leukemias in the U.S. It is a slow-growing disease that occurs when too many abnormal white blood cells develop in the blood and bone marrow. The abnormal cells outnumber the normal white blood cells, making it difficult for the body to fight infection.

The applications are based on positive results from two of the largest global Phase III clinical trials conducted in patients with CLL. The randomized, comparative studies, known as CLL8 and REACH, showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing (progression-free survival or PFS) compared to those receiving chemotherapy alone. In CLL8, previously untreated patients who received Rituxan plus chemotherapy had a 69% improvement in PFS (41% risk reduction, hazard ratio=0.59; p<0.0001; 95% confidence interval: 0.44,0.72) compared to those who received chemotherapy alone. In REACH, patients whose cancer relapsed after previous treatment had a 54% improvement in PFS after receiving Rituxan plus chemotherapy compared to patients receiving chemotherapy alone (35% risk reduction, hazard ratio=0.65; p=0.0002; 95% confidence interval: 0.51, 0.82). These findings were based on assessments made by the study investigators.

“There is no cure for CLL, and the primary goal of treatment is to keep the cancer from getting worse,” said Cecil Pickett, Ph.D., Biogen Idec’s president of R&D. “These data showed that Rituxan was able to extend the period of time before cancer progression by about 10 months for people with newly diagnosed or recurrent disease.”

“Results from these two large studies, which involved nearly 1,500 patients, give us confidence in Rituxan’s efficacy and safety in CLL,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “We believe the data support the potential role of Rituxan as both an initial and second-line treatment for CLL, and look forward to working with the FDA during the review period.”

XenoBiotic Laboratories (XBL), a contract lab focused on bioanalytical and ADME, will open XBL-China this summer.

XBL-China's new 36,000-sq.-ft. laboratory in Nanjing has a 12,000-sq.-ft. vivarium and analytical instrumentation. With additional offices in Shanghai, XBL-China will provide bioanalytical and metabolism services to the standards standards comparable to XBL's New Jersey facility. Jinn Wu, president and chief executive officer of XBL, "The initial goal for XBL-China is to offer GLP-level bioanalytical as well as discovery PK services to support drug development programs being conducted in Asian countries. Additional services such as synthetic chemistry, formulation services, Phase I clinical trial conduct, and SFDA registration are planned for the future. This is a significant expansion for XBL and will allow us to provide services to global pharmaceutical companies." An open house ceremony is planned for October 2009.

XBL has also boosted its U.S.-based services with the addition of a large molecule bioassay/cell-based assay group, Debra LIMS, QWBA and in-house NMR services.

"With the addition of a state-of-the-art laboratory and expertise to conduct Quantitative Whole Body Autoradiography (QWBA) studies, in-house NMR (500 MHz) and the industry standard Debra LIMS software, we now offer a complete and comprehensive package of services for ADME studies," saidDennis Heller, XBL's vice president of Pharmaceutical Development. "In addition, we recognized the expanding need for quantitative bioanalytical services for biologics (biotherapeutics and biomarkers) and, as a result, invested in a new biologics group that will provide ELISA-based services for quantitative PK bioanalysis for biotherapeutics, immunogenicity screening and biomarker assays. Our biologics group is also developing key cell-based assays to screen the biological activity of macromolecules."

Fredric N. Eshelman, vice chairman and chief executive officer of PPD, Inc., has been named to the newly created position of executive chairman of the board of directors. Ernest Mario, Ph.D., who has served as the non-executive chairman of the board of PPD since 1993, has been appointed lead independent director. PPD also announced that Brigadier General David L. Grange (ret.), a member of PPD’s board of directors since 2003, has been named PPD’s new chief executive officer. General Grange will report to Mr. Eshelman in his new capacity as executive chairman. These appointments will be effective July 1, 2009.

In his new position, Mr. Eshelman will continue to be responsible for providing strategic direction to the company and overseeing the implementation of the company’s strategic and business plans, including the company’s compound partnering business. Working closely with General Grange, he will also focus on key initiatives, strategic outsourcing plans and core aspects of the company’s operations.

General Grange most recently had a decade of service at the McCormick Foundation, first as executive vice president and chief operating officer, and as president and chief executive officer since 2005. The foundation is a nonprofit organization that conducts grant-making programs and other operations, and has $1.2 billion in assets. Prior to joining the foundation in 1999, he had a 30-year career in the U.S. Army, with his final position as commanding general of the First Infantry Division, known as the Big Red One. During his military career, Brig Gen. Grange served as a Ranger, Green Beret, Aviator, Infantryman and a member of Delta Force. While stationed at the Pentagon, he served as the deputy director and director of Army Current Operations and Readiness and Mobilization, and was responsible for coordinating military support within the U.S. in response to natural disasters and for domestic preparedness against acts of terrorism.

“General Grange brings a great combination of global geographical experience and knowledge, demonstrated leadership from his business and military careers, financial management experience and first-hand knowledge of PPD as a member of our board since 2003,” said Mr. Eshelman. “I look forward to working closely with General Grange and his executive management team to chart our course and execute our business plans to drive long-term shareholder value.”

Mr. Eshelman added, “On behalf of the board of directors, I extend our sincere appreciation to Dr. Mario for his outstanding service as our non-executive chairman for the past 16 years. He and I have worked closely together over this period to grow PPD, and I look forward to his continued leadership and counsel as our lead independent director.”

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