LONDON, June 20 (Reuters) - British biotech firm Oxford GlycoSciences (LSE: OGS.L - news) Plc said on Tuesday its OGT 918 treatment for Gaucher disease had been awarded fast-track status by the U.S. Food and Drug Administration, boosting its shares nine percent.
The FDA grants fast-track status to new drugs intended to treat serious or life threatening conditions for which few treatments are available.
Gaucher is a rare hereditary disease stemming from an enzyme defect, causing a range of debilitating symptoms including bone pain, organ damage and sometimes premature death.
The only treatment at present is intravenous administration of replacement enzyme -- one of the world's most costly drug interventions at an average annual cost of $175,000. This market is dominated by Genzyme General's product Cerezyme.
"This is good news for Oxford GlycoSciences but it's not unexpected. OGT 918 is almost certain to have a role to play in the treatment of Gaucher disease," said Ghenghis Lloyd-Harris, biotech analyst at CSFB.
OGT 918, given as an oral capsule three times a day, is undergoing further clinical trials following initial encouraging results published in April.
If approved by regulators, it will be the first drug from the Oxford-based company to reach the market, probably in 2002. CSFB estimates peak OGT 918 sales for the treatment of Gaucher at $100 million.
A further $50 million could be generated from sales of OGT 918 to treat Fabry disease, according to Lloyd-Harris. He believes the drug will also win fast-track designation for this second indication, with launch likely in 2003, since there is currently no approved treatment for Fabry. |
