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Nebulized Perforomist(TM) Inhalation Solution Provided Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI
Date:10/29/2008

Clinical trial data for Perforomist(TM) Solution presented at International CHEST Conference

PHILADELPHIA, Oct. 29 /PRNewswire-USNewswire/ -- Data from a Phase IIIb clinical trial demonstrate that Perforomist(TM) (formoterol fumarate) Inhalation Solution nebulized treatment provided prolonged bronchodilation and increased patient satisfaction compared to albuterol/ipratropium by metered-dose inhaler (MDI). These data were presented today in Philadelphia at CHEST 2008, the annual scientific assembly of the American College of Chest Physicians (ACCP).

Perforomist(TM) Solution was approved in 2007 by the FDA for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is the only FDA-approved nebulized formoterol fumarate.

Results from "In COPD, Nebulized Formoterol Fumarate Provides Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI" were presented in a poster session today.

"COPD patients in this study preferred twice-daily treatment with Perforomist(TM) Inhalation Solution nebulized formoterol fumarate over the albuterol/ipratropium combination MDI," said E. Rand Sutherland, M.D., M.P.H., National Jewish Health and lead clinical investigator. "These data provide physicians valuable information as they consider treatment options for COPD patients with moderate to severe forms of the disease."

This multicenter, randomized, open-label, two-period crossover study was conducted in 109 patients with moderate-to-severe COPD to evaluate the safety and efficacy of twice-daily Perforomist(TM) Inhalation Solution, nebulized FFIS, compared to albuterol/ipratropium MDI four times daily, as well as patient satisfaction and treatment preference. Efficacy was assessed by spirometry at the start and end of each two-week period, the transition dyspnea index, and a treatment satisfaction/preference survey.

In this trial, baseline dyspnea index results at Day 1 were similar between treatments for all subjects and for age, gender and severity subgroups. Transition dyspnea index results at Day 14 indicated that two weeks of treatment with either Perforomist(TM) Inhalation Solution or albuterol/ipratropium MDI provided improvements in dyspnea > 1.5 for all subjects and subgroups. Additionally, treatment with Perforomist(TM) Inhalation Solution resulted in a distribution of responses to medication showing greater satisfaction for Perforomist(TM) Inhalation Solution than albuterol/ipratropium (p<0.013) and an increased perception that medication went into the lungs (p<0.028). Overall, subjects perceived more control of their COPD while using Perforomist(TM) Inhalation Solution (p>0.007).(5)

"We are extremely pleased to announce these study results, and more importantly, the benefits that patients are experiencing with the use of Perforomist," said Carolyn Myers, Ph.D., president of Mylan's specialty division, which includes Dey, L.P. "Dey is committed to developing effective treatments for serious illnesses such as COPD, and we are happy to see that patients and health care providers are benefiting from our products".

The research presented at CHEST 2008 was supported through grants provided by Dey, L.P., which developed and markets Perforomist(TM) Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).

About COPD(1)

COPD refers to a number of chronic lung disorders in which the airways in 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 have not been 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. For patients who smoke, quitting smoking is the single most important step a patient can take to treat or slow down COPD. Estimates of the total incidence of COPD in America range from 24 to 30 million.

About Nebulization

Of the three types of devices used to deliver bronchodilators - nebulizers, metered-dose inhalers, and dry powder inhalers - nebulizers 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.(2) Nebulization is an easy and effective method of delivering medicine directly into the lungs for patients, particularly as their symptoms worsen.(3)

With Perforomist(TM) Inhalation Solution, nebulization may become a more widely used treatment option for many COPD patients at earlier treatment stages who could benefit from twice-daily maintenance dosing of a nebulized LABA such as Perforomist(TM) Inhalation Solution. For example, this COPD treatment may be a valuable clinical option for many patients whose symptoms are not adequately controlled with their current therapy.(4) COPD patients should consider asking their doctor whether nebulized treatment may be right for them.

About Perforomist(TM) Inhalation Solution

Perforomist(TM) 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(TM) 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(TM) Inhalation Solution.

Perforomist(TM) Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life threatening condition, or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist(TM) Inhalation Solution is not indicated to treat asthma. The safety and efficacy of Perforomist(TM) Inhalation Solution in asthma has not been established. Perforomist(TM) Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist(TM) Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.

In COPD clinical trials, the most common adverse events reported with Perforomist(TM) Inhalation Solution (>2% and more common than placebo) were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

Please see full Prescribing Information, including Boxed Warning, at http://www.perforomist.com or call 800-755-5560 and ask for Customer Service.

About Dey, L.P.

Dey, L.P., a subsidiary of Mylan Inc. (NYSE: MYL), 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 sales of nebulized respiratory medication, Dey, L.P. puts patients first through its development of innovative and affordable therapies. The Web sites for Dey, L.P. include http://www.dey.com, http://www.accuneb.com, http://www.curosurfusa.com, http://www.cyanokit.com, http://www.duoneb.com, http://www.epipen.com and http://www.perforomist.com.

About Mylan

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information about Mylan, please visit http://www.mylan.com

1. National Heart Lung and Blood Institute. COPD: Are you at Risk? Fact

Sheet. Available at

http://www.nhlbi.nih.gov/health/public/lung/copd/campaign-materials/index

.htm.

2. WebMD. "A-Z Health Guide from WebMD." Accessed on May 9, 2006

from http://www.webmd.com/a-to-z-guides/common-topics/default.htm

3. Ibid.

4. Gross, N. et. al. Efficacy and safety of formoterol fumarate delivered by

nebulization to COPD patients. Respiratory Medicine, 2008, 102, 189-197.

5. Data to be presented at CHEST 2008. E. Rand Sutherland et. al. In

Chronic Obstructive Pulmonary Disease, Nebulized Formoterol Fumarate

Provides Prolonged Bronchodilation and Increased Patient Satisfaction

Compared to Ipratropium/Albuterol MDI. Sponsored by Dey, L.P.


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SOURCE Dey, L.P.
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