Greenwich Pharmaceuticals Inc. told BioWorld on Tuesday thatit expects to complete in the third quarter the additional worknecessary for filing a new drug application for Therafectin totreat rheumatoid arthritis.
Late Friday the company said that it had been informed by theFDA that it needed to do further analysis of Phase III trial dataand integrate the trial results into the existing Therafectin database before taking further action.
Investors on Tuesday reacted to news of the delay by trimming30 percent off the stock (NASDAQ:GRPI), which dropped $3.38to $7.75.
Therafectin, a synthetic carbohydrate with anti-proliferativeand anti-inflammatory properties, is the Fort Washington, Pa.,company's first product. The drug is designed be taken orallyas a chronic therapy for rheumatoid arthritis.
Greenwich will integrate the Phase III results with results fromtwo Phase II studies conducted in 1988 and 1990, saidcompany spokeswoman Pamela Murphy.
Data from the 1988 study, published in the September 1989Annals of Internal Medicine, indicated efficacy in patients whowere taken off other non-steroidal anti-inflammatory therapyand allowed to flare.
Of the $60 million Greenwich has spent on R&D, all but $5million to $10 million has been for Therafectin, Murphy said.The first IND to test the drug was filed in 1979, but Murphysaid that focused development of Therafectin as a chronicmonotherapy for rheumatoid arthritis didn't begin until 1986.
The company's next product is GW-80126, which is in Phase Itrials. That drug is another synthetic carbohydrate forrheumatoid arthritis.
Greenwich had $2.8 million in cash and cash equivalents as ofMarch 31, enough to see the company through the fourthquarter, said Murphy.
-- Karen Bernstein BioWorld Staff
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