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Dey, L.P. Highlights Perforomist(R) Inhalation Solution Data to Be Presented at the International Conference of the American Thoracic Society

May 14, 2009

NAPA, Calif., May 14 /PRNewswire/ — Dey, L.P., a subsidiary of Mylan Inc. (NYSE: MYL), announced today that data from two presentations highlighting the use of Perforomist(R) (formoterol fumarate) Inhalation Solution will be featured in poster format at the International Conference of the American Thoracic Society on May 19, 2009 in San Diego.

In one analysis, use of Perforomist Inhalation Solution, when added to maintenance tiotropium, resulted in improved pulmonary function, dyspnea (shortness of breath) and rescue medication use versus treatment with tiotropium alone. In a second study, patient satisfaction increased in those treated with Perforomist Inhalation Solution twice daily compared with ipratropium/albuterol metered-dose inhaler (MDI) four times daily.

Presentation Details

In COPD, Adding Nebulized Formoterol to Tiotropium Treatment Provides Added Benefits in Pulmonary Function, Dyspnea, and Rescue Medication Use: A Pooled Analysis; poster board # J51

Date: Tuesday, May 19, 2009

Poster viewing: 10:30 a.m. to 12:45 p.m. PT

Location: Area J (Sails Pavilion, Upper Level), San Diego Convention Center

Nebulized Formoterol Improved Efficacy and Increased Patient Satisfaction Compared with Ipratropium/Albuterol MDI; poster board # J50

Date: Tuesday, May 19, 2009

Poster viewing: 10:30 a.m. to 12:45 p.m. PT

Location: Area J (Sails Pavilion, Upper Level), San Diego Convention Center

About COPD (1)

COPD is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.

COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. 12 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 convert medication into a fine liquid mist that the patient inhales through a mouthpiece or facemask. The patient breathes naturally, inhaling the medicine until the complete dosage has been delivered. Nebulization is a very gentle, but also very thorough, method of delivering medicine directly into the lungs.

With Perforomist 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 long-acting beta2-adrenergic agonists (LABAs) such as Perforomist 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. COPD patients should consider asking their doctor whether nebulized treatment may be right for them.

About Perforomist(R) Inhalation Solution

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(R) (formoterol fumarate) 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 U.S. 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 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 Inhalation Solution is not indicated to treat asthma. The safety and efficacy of Perforomist Inhalation Solution in asthma has not been established. 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, especially coronary insufficiency, cardiac arrhythmias and hypertension.

In COPD clinical trials, the most common adverse events reported with Perforomist 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 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 www.dey.com, www.curosurfusa.com, www.epipen.com and www.perforomist.com.

About Mylan

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics 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 third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information about Mylan, please visit www.mylan.com.

(1) Definition derived from “Global Initiative for Chronic Obstructive Lung Disease” Pocket Guide to COPD Diagnosis, Management and Prevention. Updated 2008. Link accessed on April 30, 2009.

SOURCE Dey, L.P.


Source: newswire