Lonza and Agennix AG announced an agreement for the production of Agennix’s first-in-class oral dendritic cell mediated immunotherapy (DCMI), talactoferrin, currently in Phase 3 testing for the treatment of non-small cell lung cancer (NSCLC). Under the agreement, Lonza will produce commercial material at its microbial manufacturing facility in Kouřim, Czech Republic. This agreement initiates the process needed to be able to ultimately 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, COO 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 3 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.”
Date: April 11, 2012
Filed Under: Drug Discovery