04.12.12
Lonza and Agennix AG have entered an agreement for the production of Agennix's oral Dendritic Cell Mediated Immunotherapy (DCMI), talactoferrin, currently in Phase III testing for the treatment of non-small cell lung cancer (NSCLC). Lonza will produce commercial material at its microbial manufacturing facility in Kourim, Czech Republic. This agreement initiates the process needed to seek approval for Lonza as a second manufacturer of talactoferrin after the initial commercial launch.
"We are committed to supporting emerging therapeutics through clinical trial milestones," said Dr. Stephan Kutzer, chief operating officer of Lonza Custom Manufacturing. "Our partnership with Agennix is an example of this commitment and demonstrates Lonza's ability to offer access to our development and manufacturing expertise at an early stage of production."
Rajesh Malik, M.D., chief medical officer and management board member of Agennix, said, "We are pleased to enter this agreement with Lonza, which has extensive experience manufacturing biologics on a commercial scale. In anticipation of positive Phase III data and a potential product approval, it is important that we have more than one manufacturer in place to ensure we can meet anticipated commercial demand and that we have security of supply."
"We are committed to supporting emerging therapeutics through clinical trial milestones," said Dr. Stephan Kutzer, chief operating officer of Lonza Custom Manufacturing. "Our partnership with Agennix is an example of this commitment and demonstrates Lonza's ability to offer access to our development and manufacturing expertise at an early stage of production."
Rajesh Malik, M.D., chief medical officer and management board member of Agennix, said, "We are pleased to enter this agreement with Lonza, which has extensive experience manufacturing biologics on a commercial scale. In anticipation of positive Phase III data and a potential product approval, it is important that we have more than one manufacturer in place to ensure we can meet anticipated commercial demand and that we have security of supply."