Napa, CA (October 24, 2007) – Data presented today at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP), demonstrate concomitant use of nebulized formoterol fumarate and tiotropium provided improved bronchodilation over tiotropium monotherapy and was well-tolerated in this clinical study. The only commercially available version of nebulized formoterol fumarate is Perforomist™ Inhalation Solution, which is indicated for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).
Formoterol fumarate is a rapid and long-acting beta2-agonist (LABA) that has been previously available in the U.S. in a dry powder formulation and has twenty years of worldwide experience. Perforomist™ Inhalation Solution is the first and only FDA-approved nebulized form of this molecule. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.
Results presented were from “Safety and Efficacy of Concomitant Treatment with Nebulized Formoterol and Tiotropium in COPD,” a randomized, placebo-controlled Phase IIIb trial. The trial demonstrated that concomitant therapy with twice-daily nebulized formoterol fumarate (FFIS) and once-daily tiotropium provided patients with statistically significant and clinically relevant improvements in bronchodilation over treatment with tiotropium alone. In this six-week study, patients receiving concomitant therapy with nebulized FFIS and tiotropium experienced fewer adverse events or COPD exacerbations than patients receiving placebo or tiotropium monotherapy.
According to Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles and the lead clinical investigator, “For the patients in this study, adjunctive use of nebulized formoterol fumarate and tiotropium showed statistically significant improvements in lung function by improving bronchodilation over use of tiotropium alone. For physicians, Perforomist™ Inhalation Solution and commonly prescribed long-acting anticholinergics such as tiotropium offers a new and valuable treatment option for COPD patients with moderate to severe manifestations of the disease.”
Christy Taylor, Chief Operating Officer at Dey, L.P., commented, “At DEY, we specialize in developing effective new treatments for serious and complex respiratory diseases, and it is gratifying that the newest addition to our franchise, Perforomist™ Inhalation Solution, offers physicians additional prescribing flexibility. For over a decade, Dey, L.P. has been the U.S. leader in sales of nebulized respiratory medication. We thank Dr. Tashkin and the other members of the research team for their assessment of how Perforomist™ Inhalation Solution may be used concomitantly with tiotropium for improved clinical effect for COPD patients.”
For those attending CHEST 2007, the presentation is available as follows:
Poster viewing: Session ID 902 - COPD Treatment II
Wednesday, October 24, 2007, 12:30 – 2:00 PM
Convention Center, Exhibit Hall, McCormick Place, Lakeside Center, Chicago.
Poster # 251: Safety and Efficacy of Concomitant Treatment with Nebulized Formoterol and Tiotropium in COPD
The research presented at CHEST 2007 was supported through grants provided by Dey, L.P., which developed and markets Perforomist™ Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).
About Perforomist™ Inhalation Solution 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 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™ 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.
Please see full Prescribing Information, including Boxed Warning, at www.perforomist.com or call 800-755-5560 and ask for Customer Service.
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
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. Because nebulization is an easy, effective, and thorough method of delivering medicine directly into the lungs, many COPD patients ask for it, particularly as their symptoms worsen.
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 LABA such as Perforomist™ Inhalation Solution. For example, this new COPD treatment may be a valuable clinical option for many patients who are not adequately controlled with short-acting bronchodilators.
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.accuneb.com, www.curosurfusa.com, www.cyanokit.com, www.duoneb.com, www.epipen.com and www.perforomist.com.
Perforomist is a trademark of Dey, L.P.
About Mylan
Mylan Inc. is one of the world’s leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry’s broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey L.P., Mylan’s fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.
For more information about Mylan, please visit www.mylan.com
This press release includes statements that constitute "forward-looking statements," including with regard to the concomitant use of nebulized formoterol fumarate and tiotropium and its effects. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the risk that the adjunctive use may not ultimately prove to be as successful as anticipated; the impact of the competitive COPD environment; and the other risks detailed in the Company's Form 10-Q for the quarter ended June 30, 2007 and its other periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.