Lonza and Agennix Sign Development and Manufacturing Deal for Production of Talactoferrin
News Apr 19, 2012
Lonza and Agennix AG have announced an agreement for the production of Agennix’s first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI), talactoferrin, currently in Phase III 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.
Dr. Kutzer continued, “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.”
A form of the hallucinogenic party drug ketamine has cleared one of the final hurdles toward clinical use as an antidepressant. During a meeting at the US Food and Drug Administration (FDA) in Silver Spring, Maryland, an independent advisory panel voted 14-2 in favor of recommending a compound known as esketamine for use in treating depression.READ MORE