Clinical trial data for Perforomist Inhalation solution

May 22 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 resulted in fewer COPD exacerbations than was seen with placebo. Taken together, the data from these two presentations demonstrate that Perforomist, 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, 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, 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, Inhalation Solution was similar to that of Foradil, 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 was supported by a grant from Dey, L.P., which developed and will market Perforomist, 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."