Greenwich Pharmaceuticals Inc. said Tuesday that it receivednotification from the FDA that an additional review of Therafectinconcluded there was not enough evidence to show the drug waseffective in treating rheumatoid arthritis.The FDA has offered the Fort Washington, Pa., company a meetingwith the agency and those who reviewed the data. Greenwich expectsthe meeting to occur before the end of the month, resulting in eitherapproval of the drug or the publishing of a notice of opportunity for ahearing with the FDA."Based upon this notification, we anticipate we'll get a notice ofopportunity for a hearing," Ed Thompson, chairman, president andCEO of Greenwich, told BioWorld.The company's board of directors will decide shortly whether to attendthe meeting, and then whether Greenwich will file for a hearing,Thompson said."I think this drug has met and/or exceeded the law and the usualstandards applied to drugs for the same indication," Thompson said."The agency has reversed its position on prior (Therafectin) studies thatit put in written minutes."Deficiencies Identified By FDAGreenwich filed a new drug application for the drug in January 1993.In September the FDA sent Greenwich a "not approvable" letter forTherafectin, which identified deficiencies that needed to be resolvedbefore the synthetic carbohydrate derivative could be approved. InJanuary the FDA's Arthritis Advisory Committee, in a vote of 5 to 0(with two abstentions), recommended against approval of Therafectinfor rheumatoid arthritis. That decision hinged on the drug's apparentlack of efficacy.Michael Walsh, an analyst with Robertson, Stephens & Co. of SanFrancisco, said, "From what I've seen, the drug seems safe and non-efficacious. They've tried and tried to get somebody at the FDA to careabout this drug, and the FDA continues to reject it. I think the FDA hasgone out of its way to be nice to [Greenwich]."It's unfortunate," Walsh said. "This looks like one of those caseswhere the drug doesn't work and the FDA won't allow it on themarket."Product license applications for Therafectin are pending in Ireland andSwitzerland. Agencies in the U.K., France and the Netherlands, citingPLA deficiencies, have notified Greenwich that more data is needed.Thompson would not disclose the nature of the deficiencies.On May 2 Greenwich released Phase II results of its second rheumatoidarthritis drug, GW-80126, that showed it was no more effective thanplacebo. A company spokesman said that day that a Phase I trial of athird drug being developed for the same indication, GW-92527.HCL,probably would be put on hold until a partner with funding was found.Jeff Randall, Greenwich's chief financial officer, said then thatGreenwich (NASDAQ:GRPI) had $11.8 million cash on hand at theend of December and was burning about $4 million per quarter. Thecompany's stock was down 25 cents Tuesday, closing at 69 cents pershare."We are pursuing partnerships and joint ventures and multiple businessstructures to enhance shareholder value," Thompson said. "We shouldentertain the best structures we can get for shareholders."
-- Jim Shrine
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