GTC Biotherapeutics entered into a collaboration with AgResearch to develop transgenic founder animals for the production of two follow-on biologic (FOB) mAbs. GTC points out that securing production capabilities outside of the U.S. will enable earlier sales of the products in territories such as Europe.
The relevant patents will expire in Europe before the associated patents in the U.S. Additionally, the U.S. does not yet have a path to approve FOBs.
AgResearch will work with GTC to establish the production lines with a majority of the funding provided by a grant awarded by the New Zealand government. AgResearch will receive a royalty on future sales of the products.
“We are pleased to build on our relationships in New Zealand to leverage their scientific expertise and strong record of animal husbandry,” states Geoffrey F. Cox, Ph.D., GTC’s chairman and CEO. “We see AgResearch as a natural research partner in our goal to develop biosimilar monoclonal antibodies, and we look forward to working with them to develop production herds for these programs.”
AgResearch currently has applications before New Zealand’s Environmental Risk Management Authority in which it seeks approval to expand and extend its research on transgenic animals.
In 2008, GTC began research programs to develop biosimilar versions of marketed mAbs that will begin to come off patent in the U.S. from 2014. The products targeted reportedly had combined sales in 2008 of greater than $17 billion.