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`BIOPHARMERS’ MILK FDA FOR GUIDELINES

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Growing vital medicines in animals' milk, a technology some researchers call the future of affordable drugs, just got a boost from the Food and Drug Administration.

The FDA last week quietly signaled it is ready to do business with these "biopharmers," issuing the first guidelines for medicines milked from genetically engineered animals.The fledgling field promises to be "one of the next major technological boosts for biotechnology and the pharmaceutical industries," said Dr. Philip Noguchi, the FDA's biotechnology chief.

The guidelines are "a turning point" that indicate companies should forge ahead with these drugs, said James Geraghty, president of Genzyme Transgenics Corp. He plans to test the first such drug on Americans next year.

"Obviously it can seem funny to people, like we're going backward from stainless steel to a farm," Geraghty said. "People are now realizing this is a more natural and more effective system."

At issue are proteins used to fight disease. They range from the Factor VIII that stops hemophiliacs' uncontrolled bleeding to TPA, which breaks blood clots during heart attacks but is so scarce that it costs $2,000 a dose.

Such medicines are culled from human blood or painstakingly grown in laboratory cell cultures that can produce a mere 100 milligrams (.0035 ounces) of the drugs a day.

But various proteins naturally are present in milk. By altering the genetic makeup of farm animals, companies could grow the proteins doctors need most. Simply milk the animal, extract the protein and purify it.

These animals, usually goats, can produce at least 10 times as much drug as is grown in a cell culture. And it costs 10 times less to engineer enough animals to produce the same amount of drug than to build a $50 million laboratory, Geraghty said.

But companies were reluctant to aggressively pursue these drugs for fear of how strictly the FDA would regulate them.

"The technology is clearly available," said Dr. Richard Bowen of Colorado State University, who created the world's first transgenic calf. "There's been a cloud hanging over that whole issue about regulatory affairs."

That changed last week. The new guidelines are "a signal that, yes, FDA has considered this and thinks that it's a reasonable way to go," Noguchi said.

Under the guidelines, companies seeking FDA approval for a milked medicine must detail how the animal was genetically altered and prove it has no disease or was given no medication that could taint its proteins.