FDA Approves Dey, L.P.'s Perforomist (Formoterol Fumarate) Inhalation Solution for Maintenance Treatment of COPD

NAPA, Calif., May 11, 2007 /PRNewswire/ -- Dey, L.P. announced today that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

Formoterol is a rapid and long-lasting beta(2) agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has twenty years of worldwide use. Perforomist Inhalation Solution is the first and only FDA-approved nebulized formoterol fumarate. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

"The first nebulized formoterol fumarate, Perforomist Inhalation Solution offers a new treatment option to COPD patients," said Nicholas J. Gross, MD, PhD, Principal Investigator of the Phase III pivotal clinical trial and an expert on lung diseases, particularly COPD. "By nebulizing with Perforomist Inhalation Solution twice a day - once in the morning and once in the evening - many COPD patients can achieve better control of their disease symptoms. The convenience of such simple dosing combined with a drug delivery option favored by many patients may provide improved symptom control and a better quality of life for the millions of Americans who live with COPD."

Mel Engle, President and CEO at DEY, noted, "As the US leader in nebulized respiratory products, we are thrilled to bring Perforomist Inhalation Solution, a new patented treatment option for COPD patients, to the market. Nebulization is a time tested and reliable drug delivery option. DEY has a long history of developing and marketing innovative respiratory therapeutics. The approval of Perforomist Inhalation Solution fits perfectly with our overall strategy for respiratory medications."

Gene L. Colice, MD, Department Director, Pulmonary, Critical Care and Respiratory Service, Washington Hospital Service, commented, "In my clinical experience, formoterol has been shown over many years to be an extremely effective clinical option for many COPD patients. It is a proven, well- understood compound whose fast onset of action combined with sustained symptomatic relief is highly stabilizing for many patients, offering them a safe and effective maintenance therapy. DEY's nebulized formoterol will be a valuable addition to the clinician's arsenal."

FDA's approval of Perforomist Inhalation Solution is a significant milestone for the product as well as for DEY's continuing commitment to nebulized respiratory products and patients. The company expects to announce the commercial launch of Perforomist Inhalation Solution in the near future.

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(R)), 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, FEV(1) AUC(0-12). The safety and efficacy of Perforomist Inhalation Solution observed in this study were comparable to those of Foradil(R). Additionally, patients treated with Perforomist Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.

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.

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 beta(2)-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 U.S. 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.
Foradil is a registered trademark of Novartis AG.

hullman@fkhealth.com

CONTACT: Dey, L.P. Media Line, +1-800-755-5560 ext. 8363; or HarrietUllman of Feinstein Kean Healthcare, +1-617-761-6776, hullman@fkhealth.com

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Posted: May 2007

Perforomist (formoterol fumarate) FDA Approval History

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