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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. | |
