Investors trashed Greenwich Pharmaceuticals Inc.'s stock onTuesday, reacting to the news that FDA had sent the company a"not approvable" letter on its drug Therafectin. The stock(NASDAQ:GRPI) fell by 52 percent as more than 4.7 millionshares traded hands. It closed at $2.88 a share.
Greenwich announced late Monday that it had received the "notapprovable" letter, which "identified deficiencies that must beresolved if an approval is to be issued for Therafectin," thecompany's synthetic carbohydrate drug for treatingrheumatoid arthritis. Greenwich, of Fort Washington, Pa., filedthe new drug application (NDA) on Therafectin with FDA inmid-January.
The Agency apparently offered the company a meeting withthe Arthritis Advisory Committee to assess the points at issue.FDA stated in its letter, "If you disagree with our findings andbelieve that there is substantial evidence in your applicationshowing Therafectin effective in treating rheumatoid arthritis,we would be willing to take the issue, without prejudice, to ourArthritis Advisory Committee within such a six-month periodand provide you with the opportunity to lay before them suchdata as you believe supports your claim."
Greenwich intends to do just that. "We think it's clearly a goodroute to pursue to get the differences resolved," PamelaMurphy, Greenwich's vice president, told BioWorld. "Thequestion is scientific."
And company president and chief executive officer EdwinThompson added, "Greenwich maintains that there issubstantial evidence of efficacy demonstrated in two adequateand well-controlled studies (RA9 and RA11)."
Greenwich has previously met with FDA in closed sessions --once in May 1990 and again in September 1992 -- to discussissues surrounding Therafectin's efficacy. The next meeting willbe open, Murphy said.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.