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Plant-grown Fabry's drug gets FDA orphan status

(Friday, Jan. 24, 2003 -- CropChoice news) -- Deena Beasley, Reuters via Agnet: LOS ANGELES - Large Scale Biology Corp. on Thursday was cited as saying its tobacco leaf-produced treatment for a rare genetic disorder, Fabry's disease, has been granted "orphan drug" status by U.S. regulators.

The story explains that orphan status, aimed at encouraging research into rare illnesses, grants seven years of market exclusivity to a product and allows a firm to apply for research funding, tax credits, and other benefits. It does not mean that the drug is approved for sale.

Company President John Fowler was cited as saying LSBC plans to ask the U.S. Food and Drug Administration to approve early-stage clinical trials of its Fabry treatment, which is manufactured in Owensboro, Kentucky, and that if trials are successful, the drug could be commercialized in two to four years.

Large Scale Biology, based in Vacaville, California, believes that by growing biotech drugs in plants, in this case a species of tobacco, it can make therapeutic enzymes available to patients at a much lower cost than traditional biotech firms.