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

-- New product recently approved by FDA for long-term maintenance treatment of COPD bronchoconstriction; data demonstrate first nebulized formoterol fumarate provides improved lung function comparable to dry powder formoterol, enhanced patient quality of life, and positive safety profile --

NAPA, CA (May 20, 2007) – Data presented at the International Conference of the American Thoracic Society (ATS) demonstrate that Perforomist™ (formoterol fumarate) Inhalation Solution, delivered by nebulization, is an effective and well-tolerated new treatment option for patients suffering from emphysema or chronic bronchitis, otherwise known as Chronic Obstructive Pulmonary Disease (COPD). “Nebulized Formoterol is an Effective Bronchodilator and Improves the Quality of Life for COPD Patients” presented results of the Phase III pivotal clinical study, a 12-week randomized, double-blind, double-dummy, placebo- and active-controlled trial. The trial found that Perforomist™ Inhalation Solution, a twice-daily, long-acting beta2-agonist (LABA):

• provided rapid bronchodilation that lasted a full 12 hours,
• enabled patients to use less rescue medication,
• maintained improvements in lung function with no evidence of tolerance (tachyphylaxis) over the 12-week period, and
• improved the lung function and quality of life of patients compared to placebo.

No significant difference in efficacy was observed over 12 weeks of treatment between Perforomist™ Inhalation Solution and the active comparator, dry powder Foradil®.

A separate presentation given at ATS detailed the safety results of the same trial. “Safety Profile of Formoterol Fumarate Delivered by Nebulization to COPD Patients” found that Perforomist™ Inhalation Solution was well tolerated, had a safety profile similar to that of Foradil®, and resul
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