Lonza lined up as backup manufacturer for Agennix’s talactoferrin
pharmafile | April 16, 2012 | News story | Manufacturing and Production |Â Â Agennix, DSM Pharmaceutical, LonaÂ
Agennix has taken a ‘belt-and-braces’ approach to manufacturing its lead pipeline product, signing a new deal with Lonza a month after firming up a long-term supply agreement with DSM Pharmaceutical Products.
The new deal with Lonza covers the production of Agennix’s first-in-class oral dendritic cell mediated immunotherapy (DCMI), talactoferrin, which is currently in Phase III testing as a treatment for non-small cell lung cancer (NSCLC).
The orally-administered product is a recombinant form of the human protein lactoferrin, which Agennix says plays an important role in the functioning of the immune system.
Lonza said in a statement that the agreement covers the production of talactoferrin at its microbial manufacturing facility in Kourim, in the 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,” said the two companies in a joint statement.
Agennix started a Phase III trial (FORTIS-M) of talactoferrin in March 2011 as a third-line therapy for NSCLC following two or more prior treatment regimens, while a second Phase III trial is looking at a combination of talactoferrin with chemotherapy (carboplatin plus paclitaxel) as a first-line treatment for NSCLC patients.
A Phase II/III trial of the drug in severe sepsis was discontinued in February after it found that the mortality rate in the talactoferrin group was greater than in the placebo group.
“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,” said Agennix’ chief medical officer Rajesh Malik.
Agennix’ agreement with DSM was signed in March and extended an ongoing relationship between the companies in which DSM was producing clinical supplies of talactoferrin. Datamonitor has predicted that talactoferrin could achieve peak sales of around $75 million five years from launch.
Phil Taylor
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