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New Data on Perforomist(TM) Inhalation Solution to be Presented at CHEST 2008.

- Data demonstrate patient preference and increased bronchodilation with use of Perforomist(TM) Inhalation Solution -

NAPA, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Dey L.P., a subsidiary of Mylan Inc. , announced today the presentation of clinical data on Perforomist(TM) (formoterol fumarate) Inhalation Solution at the upcoming Annual International Scientific Assembly of the American College of Chest Physicians (CHEST), October 25 - 29 at the Pennsylvania Convention Center in Philadelphia.

The data to be presented will include patient preference, dyspnea, and bronchodilation results for Perforomist(TM) Inhalation Solution, twice daily via nebulization as compared to albuterol/ipratropium taken four times a day via metered-dose inhaler (MDI). Perforomist(TM) Inhalation Solution is approved for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

Study and Presentation Details:

"In this COPD study, nebulized formoterol fumarate provided prolonged bronchodilation and increased patient perception of their disease control compared to albuterol/ipratropium MDI." Sutherland, ER et al.
 Date: Wednesday, October 29
 Room: Convention Center Exhibit Hall
 Time: 1:00 p.m. EDT - 2:15 p.m. EDT
 Session Info: COPD Treatment Posters

 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 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. , 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

CONTACT: Dey, L.P. Media Line, +1-800-755-5560 ext. 8363; or Carrie Sessine, +1-202-585-2107, csessine@powelltate.com, for Dey, L.P.

Web Site: http://www.dey.com/ http://www.mylan.com/
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Date:Oct 24, 2008
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