DSM Pharmaceutical Products and Agennix AG have announced that they have signed a new contract under which DSM will manufacture the oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin for Agennix at commercial levels in anticipation of positive Phase III clinical data and product approval.
DSM is currently manufacturing talactoferrin for use in ongoing clinical trials, including the FORTIS-M trial in non-small cell lung cancer (NSCLC), and will continue to supply talactoferrin for clinical trials as well as to support a potential commercial launch.
Villaume Kal, Vice President of DSM BioSolutions, a business unit of DSM Pharmaceutical Products serving the biopharmaceutical market, stated, "This agreement recognizes intensive collaboration between DSM and Agennix. DSM's process design for application in large scale manufacturing largely contributed to this success, and we are delighted to continue our support of Agennix."
Rajesh Malik, M.D., Chief Medical Officer and Management Board member of Agennix, said: “We are pleased to continue our productive relationship with DSM. Their long-term experience with talactoferrin will be invaluable as we work with them in preparation for a potential product approval and subsequent commercialization of talactoferrin. It is important for Agennix to put in place now the key elements of the talactoferrin supply chain, and expanding our contract with DSM is an important part of this process.”
The contract includes the manufacture of commercial supply of talactoferrin, process development to continue to optimize the manufacturing process, and the opportunity to significantly expand production capacity as needed.