GTC Biotherapeutics Inc has signed a definitive agreement to form a joint venture with Fresenius AG to expand the commercial development opportunities of GTC's recombinant human serum albumin (rhSA) program. The joint venture will manage development of rhSA for both the blood expander market and for the use of rhSA in the excipient market. GTC has a strategic interest in developing rhSA in the excipient market with the potential for commercial sales within the next few years. GTC will have a majority interest in the joint venture.
GTC and Fresenius are making available all relevant commercial licenses, manufacturing rights, and intellectual property to enable the joint venture to operate worldwide in both the excipient and blood expander markets.
"This joint venture provides an opportunity for GTC to expand the commercial opportunities of rhSA to include the excipient market and develop a production platform that can also support development of the blood expander market," stated Paul K. Horan, GTC's Senior Vice President of Corporate Development and General Manager of the rhSA joint venture.
Human serum albumin produced from blood plasma has been used as an excipient to maintain structural stability and activity in many biological drug formulations for long periods of time under a wide range of storage conditions. GTC estimates the total production volume to meet the needs of the excipient market is in the range of one to two metric tons per year. The rhSA product has the potential to address the issue of heterogeneous supply associated with the multiple human plasma sources used for many drugs in their current clinical and commercial product formulations.
The joint venture structure allows the development of the excipient market by GTC and has the potential to attract additional marketing or strategic partners that may also assist with the financing of the joint venture. This structure also enables Fresenius to maintain its investment in the rhSA program as part of an integrated development plan that can also provide entry to the blood expander market. Ownership interests will be adjusted based on future levels of financial participation from existing and new partners.
GTC has developed and continues to add to the number of cattle that express rhSA in their milk. Bench scale purification of clinical grade quality has been achieved and the purification process is being scaled up for clinical production quantities.