Chemex Pharmaceuticals Inc. said Wednesday that it completedanalyses of all studies of Amlexanox, and intends to file a new drugapplication in August for the treatment of aphthous ulcers, or cankersores.Chemex, of Fort Lee, N.J., is developing Amlexanox through a jointventure with Block Drug Co. Inc., of Jersey City, N.J., which paid thefirst $3 million in research costs. Research then was split equally.Block recently paid Chemex $1.7 million for an additional 10 percentof the product, and will get 60 percent of marketing revenues toChemex's 40 percent, Len Stigliano, the company's chief financialofficer, told BioWorld.Stigliano wouldn't reveal specific results from two Phase III studiesinvolving 952 patients, but said, "From an efficacy point of view, itshowed statistical significance in terms of acceleration of lesion healingagainst placebo and no treatment. It's also a very safe drug."There is really no drug (on the market) for the treatment of aphthousulcers," he said. "Others don't have the claim for accelerated healing.Most of these treatments are really barriers, or give temporary painrelief."Stigliano said the annual U.S. prescription and over-the-counter marketfor the indication is more than $75 million.Amlexanox is a 5-lipoxygenase inhibitor with anti-inflammatoryproperties, Stigliano said.Chemex (NASDAQ:CHMX) stock was up 19 cents Wednesday,closing at $1 per share. _ Jim Shrine
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