GTC Biotherapeutics, Inc. has entered into a collaboration agreement with AgResearch Limited of New Zealand to develop transgenic founder animals to produce two follow-on biologic, also referred to as biosimilar, monoclonal antibodies.
The establishment of a production capability outside of the United States is an important step in GTC's long term biosimilar strategy. This approach will enable earlier sales of the products in territories such as Europe where the relevant patents expire before the associated patents in the United States.
Working in collaboration with GTC scientists, AgResearch will establish appropriate transgenic founder 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," stated Geoffrey F. Cox, PhD, 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 programmes."
AgResearch has significant experience and expertise in pioneering transgenic techniques and has successfully developed transgenic animals in a number of other programs. New Zealand is an ideal location for the production of transgenic animals due to its strong animal health record, and due to its significant commercial expertise in animal husbandry and the dairy industry. 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.
GTC has successfully produced transgenically-derived monoclonal antibodies that possess similar activity to the innovator products, based on data generated with in vitro and in vivo assays as well as animal disease models. In 2008, GTC initiated the first of several research programmes to develop biosimilar versions of marketed monoclonal antibodies that will begin to come off patent in the US from 2014 onwards. The products targeted had combined sales in 2008 of greater than $17 billion. GTC is seeking development partners to help commercialize its portfolio of biosimilar monoclonal antibodies.
Follow-on biologics, referred to as biosimilars in Europe, are therapeutic products that have the same or similar amino acid structure and are produced utilizing an expression system separate from that originally approved by the appropriate regulatory agencies. Transgenic production technology is able to generate large volumes of products such as monoclonal antibodies at lower costs, contributing to the benefit of establishing lower market prices while retaining a significant profit margin. A regulatory pathway for approving biosimilars is established in the European Union. Similar enabling legislation is under consideration in the United States.
AgResearch Limited, based in New Zealand, is a government owned research institute specializing in research for the pastoral agriculture industry. AgResearch aims to apply the depth of experience and expertise it has in every aspect of biotechnology and in pastoral farming to continue to build substantial competitive advantage throughout the value chain.
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. ATryn, GTC's recombinant human antithrombin, has been approved for use in the United States and Europe.