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

een with placebo. Taken together, the data from these two presentations demonstrate that Perforomist(TM) Inhalation Solution will provide a new, safe and effective therapeutic option for long- term maintenance treatment of COPD.

Nicholas J. Gross, MD, PhD, an expert on lung diseases, particularly COPD, was the Principal Investigator for the Phase III pivotal trial. He noted, "The GOLD Guidelines for COPD treatment, issued by the World Health Organization and updated last year, recommend regular treatment with long- acting bronchodilators for patients with moderate to very severe COPD. In my judgment, the results of the rigorous 12-week trial clearly demonstrate that physicians now have a new treatment option that is in accord with these GOLD criteria. Perforomist(TM) Inhalation Solution gives effective, fast bronchodilation that lasts a full 12 hours, allowing patients to nebulize just twice a day -- once in the morning and once in the evening -- for convenient, long-term control of their symptoms. And because the product is nebulized, patient quality of life is improved not only through effective disease control, but also through using a type of drug delivery that many patients prefer."

The new product is the first and only FDA-approved nebulized formoterol fumarate, a well-understood and proven LABA with over 10 million patient-years of exposure. The formoterol fumarate molecule has been used worldwide for more than two decades. Nebulization is a type of drug delivery that converts liquid medication into a mist that patients inhale through a mouthpiece or face mask.

Speaking of the safety findings from the Phase III pivotal trial, Harold S. Nelson, MD, Professor of Medicine, National Jewish Medical and Research Center, said, "One of the challenges of treating patients with moderate to severe COPD is that this population tends to have many serious co-morbidities. What this robust clinical trial established was that nebulized formoterol fumarate
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