A Framingham biotech company yesterday became the first to win federal approval to manufacture a drug by using genetically modified animals, an approach that could eventually be used to produce many drugs using farm animals.
The US Food and Drug Administration yesterday approved GTC Biotherapeutics Inc.'s ATryn, an anticlotting drug made using genetically modified goats that live on a farm in Charlton. GTC engineered the herd to secrete a special therapeutic protein in their milk.
"It's really a milestone event," said Eric Overstrom, chairman of biology and biotechnology at Worcester Polytechnic Institute, who collaborated with GTC on some of its early research using goats. "This adds to the toolbox for the pharmaceutical industry."
Though ATryn is likely to have limited marketing potential because it would serve a relatively small pool of patients, the drug's approval could clear the way to produce many more drugs with genetically modified animals, an approach nicknamed "pharming."
European regulators approved the drug - and the novel production technique - in 2006.
In addition to goats, Overstrom said, drug companies could potentially use other animals, such as cows or rabbits, to produce drugs in their milk, blood, or even urine. Overstrom said animals could be particularly helpful in cultivating enzymes and other large molecules that are more difficult to produce using bacteria or individual cells.
Still, some activists are wary about the use of genetically engineered animals. The Center for Food Safety, a nonprofit group, complained that the animals could pose unforeseen health and environmental risks.
"The creation of GE animals is a very slippery slope," Jaydee Hanson, the center's policy analyst on cloning and genetics, said in a statement. "All it takes is one mating between an escaped specimen and a natural animal to set off a chain of events that could lead to contamination or extinction."
Some investors are also uncertain how much GTC will benefit from its achievement. The company's stock closed at 70 cents yesterday, down 12 cents, far from its peak of more than $44 per share in early 2000.
Thomas Newberry, GTC's vice president of corporate communications, acknowledged the drug's revenue potential is modest. And like many small biotech companies, Newberry said the firm only has a limited amount of cash, which could cause some investors to worry about its future.
But he said GTC's technology could eventually produce billions of dollars in revenue.
"It's still tough times for development-stage companies," Newberry said. "But the upper bounds for the company are virtually limitless."
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