Napa, CA (October 24, 2007) – Data from two Phase III clinical trials were presented today in Chicago at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP), supporting the use of Perforomist™ (formoterol fumarate) Inhalation Solution as a safe and effective maintenance treatment for COPD patients. The results of both studies were included as part of the New Drug Application (NDA) filing to the U.S. Food and Drug Administration (FDA) for Perforomist™ Inhalation Solution. Perforomist™ Inhalation Solution 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.
The first of the two safety studies presented, “Long-Term Safety of Nebulized Formoterol in COPD: An Open-Label Active-Control Extension Study,” involved 569 COPD patients and found that twice-daily delivery of nebulized formoterol fumarate was well tolerated over a 12-month treatment period in patients with moderate-to-severe COPD. Over the course of a year, patients in the study received either 20 mcg nebulized formoterol fumarate inhalation solution (FFIS) or 12 mcg formoterol fumarate delivered by dry powder inhaler (FA) DPI.
“The study’s findings indicate that nebulized delivery of formoterol fumarate is a safe long-term treatment option for patients with moderate-to-severe COPD who may prefer or require nebulization,” said James F. Donohue, MD, Chief of Pulmonary Medicine at the University of North Carolina at Chapel Hill and the lead trial investigator. “The incidences of adverse events as well as medication discontinuation due to adverse events were similar between the nebulized FFIS and dry powder FA groups. Physicians should feel confident offering Perforomist™ Inhalation Solution as an additional therapeutic choice for COPD patients with moderate-to-severe disease.”
The study also demonstrated similar electrocardiogram (ECG) results between the groups and no clinically important changes from baseline in laboratory tests, including serum potassium and glucose, vital signs, and physical examinations.
The second NDA safety study, “Cardiovascular Safety of Nebulized Formoterol in COPD Patients: A Double-Blind, Placebo-Controlled Study,” involved 351 COPD patients and described results of extensive cardiac safety monitoring as a part of a pivotal Phase IIII and efficacy trial. Twice-daily treatment with FFIS over a 12-week period was not associated with an increased incidence of cardiovascular events. Patients participating in the study were randomized into three groups to receive 20 mcg FFIS by nebulization, 12 mcg FA DPI, or placebo, each given twice daily. Cardiac safety was assessed with Holter monitoring, 12-lead ECGs, serum potassium levels, cardiac adverse events, vital signs and physical examinations.
“Often, patients with moderate-to-severe COPD have multiple serious co-morbidities, and there has been concern about the cardiovascular safety of beta2-agonists as treatment for respiratory conditions,” noted Harold S. Nelson, MD, Professor of Medicine, National Jewish Medical and Research Center and a clinical investigator. “Our research shows that Perforomist™ Inhalation Solution has a cardiac safety profile that allows its use in COPD patients. It provides another therapy choice for patients who may prefer or require twice-daily dosing by nebulizer.”
Sammy C. Campbell, MD, Professor Emeritus, University of Arizona College of Medicine, was a researcher in the FFIS long-term safety study and also had previously studied cardiovascular safety of formoterol fumarate in its dry powder formulation. “Formoterol fumarate has been shown for decades to be a safe and effective treatment for COPD,” said Dr. Campbell. “My own earlier research on the cardiovascular safety of the molecule is consistent with the research findings in today’s presentation, and together they complement the positive long-term safety data. The weight of these data clearly underscore the clinical value that formoterol fumarate brings to COPD patients. Perforomist™ Inhalation Solution will be a welcome addition to the physician’s arsenal in the battle to manage symptoms of moderate to severe COPD.”
“Dey, L.P. specializes in bringing innovative new medications to market for complex respiratory diseases,” noted Christy Taylor, Chief Operating Officer of Dey, L.P. “For more than a decade we have been the U.S. leader in sales of nebulized respiratory medications, and Perforomist™ Inhalation Solution, launched earlier this month, is the newest addition to this portfolio. We thank Drs. Donohue, Nelson, and Campbell for their contributions to the trials that were presented today. Their research highlights the clinical value of Perforomist™ Inhalation Solution, the first nebulized version of formoterol fumarate, for patients with moderate to very severe COPD.”
For those attending CHEST 2007, the two presentations are 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 # 238: Cardiovascular Safety of Nebulized Formoterol in COPD Patients: A Double-Blind, Placebo-Controlled Study
Poster # 239: Long-term Safety of Nebulized Formoterol in COPD: An Open-Label Active-Controlled Extension Study
Please note that clinical investigators will be available on-site to discuss the research findings.
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 nebulized delivery of formoterol fumarate 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 product 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.