The signing of a gene-therapy licensing agreement with Genetic Therapy Inc. of Gaithersburg represents a major advancement in the National Institutes of Health's attempt to team with the private sector to move scientific discoveries more quickly into the marketplace.
Genetic Therapy recently signed a licensing agreement with the National Institutes of Health (NIH) to market some of the techniques used in the first government-authorized attempt at gene therapy, according to Lee Carter, chief of NIH's technology operations management branch.
Genetic Therapy was the first to craft a "cooperative research and development agreement" with NIH and now becomes the first to gain permission to market jointly developed medical techniques.
Under the agreement, Carter said, Genetic Therapy receives exclusive rights to commercialize three patent applications it developed in conjunction with scientists from NIH.
A potential revolution in medicine got underway at NIH's Bethesda headquarters Sept. 14, when genetically corrected cells were injected into a 4-year-old Cleveland girl suffering from a rare immune system disorder. Researchers have said it will take months before they know if the gene therapy is helping the child.
Another NIH gene-therapy experiment is set to begin soon, in which patients with a deadly type of skin cancer will receive cells that are genetically altered to produce a substance that has dramatically shrunk tumors in animals.
Under the licensing agreement, Genetic Therapy would be allowed to sell products based on basic technologies for gene transfer, genetically modified bacteria and a type of cancer test, Carter said. Any medical uses of the products would still have to receive approval from the Food and Drug Administration before they could be used widely in patients.
Formed in 1987, Genetic Therapy helped produce the crippled mouse virus, called a vector, that NIH researchers are using to insert foreign genes into human cells.
Carter described the venture as "mutually beneficial" to NIH and Genetic Therapy.
He said that he did not know details of the licensing agreement but that government agencies generally receive payments somewhat like royalties from firms that develop commercial products based on public-private research ventures. In addition, the government usually retains the right to make sure such products are not priced too high.