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Executive Summary

INTEGRATED GENETICS MILKING TUFTS TRANSGENIC LIVESTOCK R&D with the initial focus on production of TPA and protein C under an agreement announced Oct. 11. The terms of the three-year R&d agreement with Tufts University School of Veterinary Medicine provide that Integrated Genetics is providing over $ 1 mil. in funding. The three-year program to pursue development of livestock for pharmaceutical production "follows the successful completion of a joint study by Tufts and Integrated Genetics, designed to assess the feasibility of utilizing livestock for the production of pharmaceuticals in milk," the release explains. The feasibility of animals producing human proteins first received public attention in November 1987, with the publication of a joint Integrated Genetics/NIH study of transgenic mice induced to produce TPA in their milk ("The Pink Sheet," Nov. 2, 1987, p. 21). To produce transgenic animals capable of excreting pharmaceutical proteins in their milk, Integrated Genetics explained that genetic material is microinjected into a fertilized single cell embryo to be implanted in the recipient mother for gestation. The gene fragments include both the gene for the desired therapeutic protein as well as regulatory sequences that control the cells through which the protein will be expressed. When the transgenic animals are bred, their offspring will also produce the pharmaceutical protein in their milk. Future generations will likewise carry this production capability. "Since several livestock species produce large volumes of milk at low cost, transgenic protein production is likely to have substantial cost advantages over other methods," the release states. The project's initial focus is to use goats for protein production, with the possibility of introducing cows and other livestock in the future. The Tufts veterinary school is currently discussing R&D projects using transgenic animal technology with several other biotech and pharmaceutical firms. The school is also working with Transgenic Sciences on transgenic poultry. The patentability of transgenic animals has been the subject of congressional hearings. After Harvard University received the first patent for a transgenic animal in April, for genetically altered mice, legislation was introduced requiring a two-year moratorium on the issuance of additional transgenic animal patents. That bill (HR 3119) was defeated in the House Judiciary/Courts Subcommittee in July. A replacement bill (HR 4970) sponsored by Rep. Kastenmeier (D-Wis.), which would exempt single-family farms from transgenic animal patents, has passed the House.

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