Following an FDA advisory committee's recommendationagainst approval of Greenwich Pharmaceuticals Inc.'sTherafectin, the company announced Monday that it will nolonger seek U.S. marketing approval for the drug.
However, the company will "aggressively pursue" approval ofthe drug in Europe, Greenwich chief financial officer JeffRandall told BioWorld. Greenwich has product licenseapplications (PLAs) pending in the United Kingdom, Ireland,France, the Netherlands and Switzerland. Filed within the pastnine months, the applications are based on the same datapackage that FDA's Arthritis Advisory Committee rejected lastThursday (see BioWorld, Jan. 28). The committee voted 5-0with two abstentions that the clinical data did not supportefficacy of Therafectin.
Greenwich (NASDAQ:GRPI) said it will now pursue "strategicpartnerships and other business arrangements" for the tworemaining products the company has in clinical development.GW-80126, in Phase II trials, and GW-92527.HCL, in Phase Itrials, are under development for the treatment of rheumatoidarthritis.
Greenwich of Fort Washington, Pa., also announced that as aresult of its decision to drop efforts to market Therafectin inthe U.S., it is laying off 44 employees -- 65 percent of itsworkforce -- only 24 people will remain with the company.
Greenwich's stock was down 38 cents Monday, closing at $1.06
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