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Clinical Trial Data for Perforomist (Formoterol Fumarate),Inhalation Solution Presented at International ATS Conference

, given at 20 mcg/2 mL twice daily, was well tolerated for maintenance treatment over the full 12 weeks of the trial. The side effect profile of Perforomist(TM) Inhalation Solution was similar to that of Foradil(R), the active comparator, and the product was associated with fewer COPD exacerbations than placebo. Significantly, repeated testing for cardiac effects showed nothing to suggest a problem, a highly significant finding for the well-being of this group of patients."

The research presented today was supported by a grant from Dey, L.P., which developed and will market Perforomist(TM) Inhalation Solution.

"DEY is the US leader in nebulized respiratory medication, and bringing the first nebulized formoterol fumarate to market is central to our overall strategy," commented Mel Engle, President and CEO of DEY. "We are highly gratified by the positive safety and efficacy outcomes from the Phase III pivotal study, and thank Drs. Gross and Nelson for their careful oversight of the research and enthusiastic support of these important data. COPD patients and their families will be well served by this new treatment, which for the first time will allow twice-daily treatment with a proven LABA molecule via nebulization, a time-tested and reliable drug delivery option."

About Perforomist(TM) (Formoterol Fumarate) Inhalation Solution

The clinical evaluations of Perforomist(TM) Inhalation Solution included two clinical trials involving a total of 1,045 patients. In the product's pivotal Phase III trial, 351 patients participated in a 12-week, multi-center, safety and efficacy COPD study. In the study, 123 COPD patients were treated with Perforomist(TM) Inhalation Solution 20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil(R)), and 114 COPD patients were treated with placebo. The study's results showed that Perforomist(TM) Inhalation Solution 20 mcg/2 mL taken twice daily was statistically superior to placeb
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