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Clinical Trial Data for Perforomist(TM) Inhalation Solution to be Presented at ATS on May 20, 2008
Date:5/16/2008

- Data demonstrates safety and efficacy of first FDA-approved nebulized

formoterol fumarate in patients with moderate to severe COPD -

NAPA, Calif., May 16 /PRNewswire/ -- Dey, L.P. announced today that three clinical data presentations will be given at the International Conference of the American Thoracic Society (ATS) on May 20, 2008 at the Metro Toronto Convention Center. One of the presentations details the effects on dyspnea and other COPD symptoms of using Perforomist(TM) Inhalation Solution, nebulized formoterol fumarate, adjunctively with tiotropium to treat COPD patients. The other two presentations compare the clinical effect of two types of drug delivery - nebulization versus DPI - when treating COPD patients with formoterol fumarate.

Perforomist(TM) (formoterol fumarate) Inhalation 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.

For those attending ATS, the three presentations are available as follows:

-- "Addition of Nebulized Formoterol Fumarate to Tiotropium Treatment

Relieves Dyspnea and Symptoms in COPD Patients," Poster Board #F4

-- "Dose-Ranging Study in COPD Patients Comparing Pharmacodynamics of

Formoterol Fumarate Delivered by Nebulization and DPI," Poster Board

#F13

-- "A Pharmacokinetic Study in COPD Patients Comparing Formoterol Fumarate

Delivered by Nebulization and DPI," Poster Board #F14

Poster Viewing: Tuesday May 20th, 10:45 AM - 12:15 PM EDT

Room: Area F (Halls A-B, North Building, Level 300), Metro Toronto

Convention Centre

Session Info: Thematic Poster Session, [C42] COPD Pharmacotherapy I:

Effects of Bronchodilators

Please note that the principal investigators will be available to discuss the research results.

About Perforomist(TM) Inhalation Solution

Indication

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 used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. 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. Perforomist(TM) Inhalation Solution is not a substitute for inhaled or oral corticosteroids. The safety and efficacy of Perforomist(TM) Inhalation Solution in asthma has not been established.

In COPD clinical trials, the most common adverse events reported with Perforomist(TM) Inhalation Solution 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 COPD(1)

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 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. 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 new 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 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.

Perforomist(TM) is a trademark of Dey, L.P.

Media contacts: Dey, L.P. Media Line

1-800-755-5560 ext. 8363

or

Amy Techtmann

Feinstein Kean Healthcare

617-761-6784

amy.techtmann@fkhealth.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/hw/health_guideatoz/stn166150.asp?navbar=hw32561.

(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


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SOURCE Dey, L.P.
Copyright©2008 PR Newswire.
All rights reserved

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