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PHARMETRIX "SECOND GENERATION" 21 MG NICOTINE PATCH IS IN PHASE II TRIALS

Executive Summary

Pharmetrix' "second generation" nicotine patch is currently in Phase II trials, Chairman and CEO Alexander Cross told the Mabon Securities Drug Delivery Conference Feb. 19 in New York City. The transdermal patch will offer an "initial burst" of nicotine on application, addressing smokers' need for a "morning fix," Cross said. The blood level "drops sharply for the nighttime, thereby avoiding sleep disturbance." Cross called the 21 mg patch "cosmetically elegant" at 20 cm. Cross told the Mabon audience that Pharmetrix views a "second generation" nicotine patch as an opportunity to cash in on consumer "frustration" with the four first generation patches. Published data on the currently marketed patches -- Ciba Geigy's Habitrol, Marion Merrell Dow/Alza's Nicoderm, and Lederle/Elan's ProStep -- show that only about 20% of patch users successfully have quit after one year, Cross maintained. That leaves "80% presumably with some level of frustration and hopefully a willingness to try again." Privately-held Pharmetrix, based in Menlo Park, Calif., was formed in 1987 as a joint venture between the Italian pharmaceutical and chemical firm Recordati and a U.S. R&D company, Membrane Technology and Research. Recordati, which owns 78.7% of Pharmetrix and has been funding its operations since inception, assigned its two transdermal nicotine patents to the company. Under an October agreement, Pharmetrix licensed those patents to Elan in exchange for a "multimillion dollar" cash payment, royalties from "any" nicotine patch marketed by Elan in the U.S. (including ProStep), and shared recoveries from any nicotine patch related litigation, Cross said. Elan has filed suit against Marion Merrell Dow/Alza, Ciba- Geigy, and Cygnus, whose Nicotrol 16 patch has an NDA pending in the U.S. ("The Pink Sheet" Dec. 9, T&G-1). A proposed joint venture of Elan and Recordati has an option to the Pharmetrix patch and will be responsible for future development. Pharmetrix was issued an allowance for a third transdermal nicotine patent the week of Feb. 10-14, Cross said. A second transdermal patch, for estradiol, is in Phase I trials, Cross said, and Pharmetrix has a combination estrogen/progestogen patch in development. The company is also developing a "novel nitrate patch" for angina which will deliver the nitrate at variable rates to avoid tolerance problems, Cross said. That patch is in "preclinical IND-enabling trials." Recordati has rights to both the estradiol and nitrate patches.

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