GTC’s Blood Drug From DNA-Altered Goats Called Safe

GTC Biotherapeutics Inc.’s anti- clotting medicine made from the milk of genetically altered goats was termed safe and effective by a U.S. advisory panel, the company said.

GTC’s ATryn was backed by an advisory panel of the Food and Drug Administration to treat people with a rare inherited deficiency in the protein that prevents blood clots, the Framingham, Massachusetts-based company said today in a statement on Business Wire.

An estimated one in 1,000 to one in 5,000 people can’t produce enough of the protein antithrombin, which helps prevent dangerous blood clots. GTC manufactures ATryn from about 200 goats whose genome was created by injecting a goat embryo with the human antithrombin gene. Offspring produce the protein in their milk, which is purified, and infused as a drug.

The advisory panel, meeting in Rockville, Maryland, said ATryn is safe for those patients with the protein disorder to prevent clotting during surgery or childbirth. The FDA usually follows the recommendations of its panels, though it isn’t required to do so.

“Bringing ATryn to market would give us the opportunity to make a meaningful difference in the lives of people suffering from this rare disorder,” said Jeffrey S. Aronin, chief executive officer of closely held Ovation Pharmaceuticals Inc. of Deerfield, Illinois, which markets the drug with GTC.

ATryn could reach a peak market of $40 million to $50 million, GTC has said.