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 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 today 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.”

About Perforomist™ (Formoterol Fumarate) Inhalation Solution
The clinical evaluations of Perforomist™ 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™ Inhalation Solution 20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil®), and 114 COPD patients were treated with placebo.  The study’s results showed that Perforomist™ Inhalation Solution 20 mcg/2 mL taken twice daily was statistically superior to placebo for the primary endpoint, FEV1 AUC 0-12.  The safety and efficacy of Perforomist™ Inhalation Solution observed in this study were comparable to those of Foradil®.  Additionally, patients treated with Perforomist™ Inhalation Solution used less rescue albuterol throughout the 12-week treatment period compared to patients treated with placebo. 

Perforomist™ Inhalation Solution was approved by the FDA on May 11 for long-term, twice-daily maintenance of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

About COPD
COPD refers to a number of chronic lung disorders in which the airways to the lungs become narrowed and breathing becomes increasingly difficult. The most common forms of COPD are chronic bronchitis and emphysema, and many patients suffer from a combination of the two diseases.

According to the National Heart, Lung and Blood Institute of the National Institutes of Health, COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. Twelve million Americans have been diagnosed with COPD and at least another 12 million have symptoms but are not diagnosed. COPD is not well understood or recognized – most Americans have not heard of it, not even those who may be living with the condition. The most common cause of COPD is cigarette smoking, which is responsible for an estimated 80 to 90 percent of COPD cases.  Estimates of the total incidence of COPD in America range from 24 to 30 million.

About Nebulization
Perforomist™ Inhalation Solution is a long-acting bronchodilator that is taken by nebulizer.  Of the three types of devices used to deliver bronchodilators – nebulizers, metered-dose inhalers, and dry powder inhalers – nebulizers may offer the easiest method because they require no special technique or coordination, as the medication is converted into a fine mist that the patient inhales through a mouthpiece or face-mask while breathing naturally.  Because nebulization is an easy, effective, and thorough method of delivering medicine directly into the lungs, many COPD patients prefer it, particularly as they become increasingly frail due to their disease progression.

Perforomist™ Inhalation Solution changes the paradigm regarding nebulization.  Now, nebulization may become a more valuable and widely used treatment option for the millions of COPD patients at earlier treatment stages who would benefit from twice-daily maintenance dosing of a nebulized LABA such as Perforomist™ Inhalation Solution.  For example, the clinical benefit of this new COPD treatment may be a valuable clinical option for patients who are not adequately controlled with short-acting bronchodilators.

For those attending ATS, the two presentations are available as follows:

• “Nebulized Formoterol is an Effective Bronchodilator and Improves the Quality of Life for COPD Patients,” Poster Board #A10, Publ. pg. A128.

• “Safety Profile of Formoterol Fumarate Delivered by Nebulization to COPD Patients,” Poster Board #A11, Publ. pg. A128

Poster Viewing: 10:45 AM - 12:15 PM
Room: Area A (Hall D, Lower Level), Moscone Center
Session Info: Thematic Poster Session, [A47] COPD Treatment I: Bronchodilators, Inhaled Corticosteroids and PDE4 Inhibitors. 

Please note that the principal investigators will be available to discuss the research results.

Indication
Perforomist™ Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information
Perforomist™ Inhalation Solution belongs to a class of medications known as long-acting beta2-adrenergic agonists (LABAs). LABAs may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a LABA), the active ingredient in Perforomist™ Inhalation Solution.
Perforomist™ Inhalation Solution should not be used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist™ Inhalation Solution should not be used with other medications containing LABAs.  Do not use more than one nebule twice daily. Perforomist™ Inhalation Solution should be used with caution in patients with cardiovascular disorders. Perforomist™ Inhalation Solution is not a substitute for inhaled or oral corticosteroids.  The safety and efficacy of Perforomist™ Inhalation Solution in asthma has not been established.

In COPD clinical trials, the most common adverse events reported with Perforomist™ Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

About Dey, L.P.
Dey, L.P. is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, respiratory-related allergies, and emergency care medicine.  As the US leader in nebulized respiratory medication, DEY puts patients first through its development of innovative and affordable therapies. 

Posted: May 2007

Comments