Two Clinical Trials for Nebulized Formoterol Fumarate on Long-Term and Cardiovascular Safety in Treating COPD

-- Data from two clinical safety trials included in NDA filing for

Perforomist(TM) Inhalation Solution provided at CHEST 2007 presentations --

    NAPA, Calif., Oct. 24 /PRNewswire/ -- 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(TM) (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(TM) Inhalation
 Solution. Perforomist(TM) 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 beta(2)-agonist (LABA)
 that has been previously available in the U.S. in a dry powder formulation
 and has twenty years of worldwide experience. Perforomist(TM) 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(TM)
 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
 beta(2)-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(TM) 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(TM) 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(TM)
 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(TM) 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(TM)
 Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. ( MYL).
     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 beta(2)-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
     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(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
 who are not adequately controlled with short-acting bronchodilators.
     About Dey, L.P.
     Dey, L.P., a subsidiary of Mylan Inc. ( 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 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 http://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.
     Media contacts:  Dey, L.P. Media Line
                      1-800-755-5560 ext. 8363
                              or
                      Harriet Ullman
                      Feinstein Kean Healthcare
                      617-761-6776
                      hullman@fkhealth.com
 
 

SOURCE Dey, L.P.