Greenwich Pharmaceuticals Inc. (NASDAQ/NMS:GRPI) has signed anexclusive licensing and distribution agreement for its drug Therafectinwith Irotec Laboratories Ltd. of Cork, Ireland. The agreement coverssales in Ireland and the Netherlands. However, implementation will bestalled until regulatory issues related to the drug have been resolved.In January 1994, the FDA's Arthritis Advisory Committee (AAC)recommended against approval of Therafectin as a treatment forrheumatoid arthritis, contending that its efficacy had not been proved.This week, Greenwich reported that its Product License Applications(PLAs) in various European countries were being held up because ofquestions raised by regulatory authorities in those countries.Agencies in the United Kingdom and France have sent Greenwichwritten notification of deficiences in its PLAs, and given the companythe opportunity to respond. The Netherlands has given similar verbalnotification. PLAs in Ireland and Switzerland continue to be reviewedby regulatory authorities.Jeff Randall, the company's vice president for finance, said some of theissues raised by the Europeans were similar to those raised by the FDA,and others related to the way the data were presented."If any of the questions were so severe as to have constituted arejection of the drug we would have discussed that. We believe it canbe dealt with, but it's a question of how much time is involved,"Randall said.Randall said Greenwich has submitted a letter to the FDA andrequested that the agency make a final determination so that thecompany can exercise its option of requesting a hearing if the drug isnot going to be approved. Randall said the company was notified earlythis month that the AAC's recommendation was being reviewed by"some very senior people" and that the company would be notified byMay 9 of the decision. "If they reject it, we would then have theopportunity to request a hearing," Randall said.Phase II trials of Therafectin are presently being undertaken in Japanand Russia. The company also has a licensing agreement with KisseiPharmaceuticals Ltd. of Japan giving Kissei distribution rights inJapan, Russia, and parts of Southeast Asia. n

-- Philippa Maister

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