The Food and Drug Administration has granted orphan drugdesignation to Glycomed Inc.'s GM6001, a compound intendedto retard or reverse corneal ulcers, the company announcedThursday.
GM6001, called Galardin, will be Glycomed's firstinvestigational new drug. The Alameda, Calif., company(NASDAQ:GLYC) expects to file its IND in mid-1992.
The stock closed Thursday at $17, down 50 cents.
Persistent corneal ulcers from infections, abrasions andautoimmune diseases such as rheumatoid arthritis affect up to167,000 patients annually, and there are no FDA-approvedagents for treating non-healing corneal ulcers, said BrianAtwood, Glycomed's senior vice president of operations.
Glycomed's "aggressive estimate" of the market potential fortreatment of persistent corneal ulcers is $100 million annually,Atwood told BioWorld.
Galardin is matrix metalloproteinase inhibitor, which promoteshealing by blocking the degradation of a lattice ofcarbohydrate-containing molecules that forms next to an ulcer.Galardin inhibits proteoglycanase, an enzyme that degradesproteoglycan-containing complex carbohydrates in the lattice,and collagenases, which break down collagen.
The treatment will be in eye-drop form.
-- Kris Herbst BioWorld Washington Bureau
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