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Under a new agreement with ProGenetics LLC (Blacksburg, VA), GTC Biotherapeutics (GTC, Framingham, MA) will expand its portfolio to include protein therapeutics produced in the milk of transgenic pigs.
Under a new agreement with ProGenetics LLC (Blacksburg, VA), GTC Biotherapeutics (GTC, Framingham, MA) will expand its portfolio to include protein therapeutics produced in the milk of transgenic pigs. GTC currently produces and markets ATryn, a recombinant form of human antithrombin, produced in the milk of transgenic goats.
The agreement grants GTC an exclusive license to develop and commercialize ProGenetics’ recombinant human factor IX, recombinant human factor VIII, and recombinant human fibrinogen for North America, Europe, and Japan. ProGenetics will be responsible for the production of the proteins in the milk of their transgenic pigs. GTC will be responsible for manufacturing, clinical development, regulatory affairs, and commercialization activities in its territories.
In exchange, ProGenetics will receive a non-exclusive license to GTC’s patent in the US for the transgenic expression of therapeutic proteins in milk to enable the commercial development of these products outside of North America, Europe, and Japan.
GTC was the first company to receive approval anywhere in the world for a transgenically produced protein for human therapeutic use when it received European Commission approval for ATryn in August 2006. The company plans to submit a biologics license application in the US in the first half of 2008.