Public Release: 

Clinical trial data for Perforomist Inhalation Solution to be presented at ATS on May 20, 2007

Data from Phase III pivotal trial demonstrate safety and efficacy of first FDA-approved nebulized formoterol fumarate for patients with moderate to severe COPD

Feinstein Kean Healthcare

Napa, CA (May 16, 2007) - Dey, L.P. announced that two clinical data presentations will be given at the International Conference of the American Thoracic Society (ATS) on Sunday, May 20, at the Moscone Center in San Francisco. The presentations will detail Phase III clinical data demonstrating the safety and efficacy of Perforomist™ (formoterol fumarate) Inhalation Solution, approved on May 11 by the FDA for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

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.

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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.

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. The Web sites for DEY include www.dey.com, www.accuneb.com, www.curosurfusa.com, www.cyanokit.com, www.duoneb.com, www.epipen.com and www.perforomist.com. Dey, L.P. is an affiliate of Merck KGaA, Darmstadt, Germany.

Perforomist is a trademark of Dey, L.P.

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