Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and Pharmacodynamic...

Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and
Pharmacodynamic Profile to Dry Powder Formulation
- Data from two clinical trials presented at International ATS Conference -

NAPA, Calif., May 20 /PRNewswire/ -- Data presented today at the
International Conference of the American Thoracic Society (ATS) demonstrate
that Perforomist(TM) Inhalation Solution (formoterol fumarate inhalation
solution; FFIS) has a pharmacodynamic and pharmacokinetic profile that is
comparable to the dry powder inhaler (DPI) formulation of formoterol fumarate,
Foradil(R) Aerolizer(R) 12mcg (FA).
Perforomist(TM) (formoterol fumarate) Inhalation Solution, the only FDA-
approved nebulized formoterol fumarate, 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.
The first of the two studies presented, "Dose-Ranging Study in COPD
Patients Comparing Pharmacodynamics of Formoterol Fumarate Delivered by
Nebulization and DPI," showed that 20mcg of FFIS (Perforomist(TM) Inhalation
Solution) delivered by nebulization provides bronchodilation comparable to DPI
delivery.
The second study; "A Pharmacokinetic Study in COPD Patients Comparing
Formoterol Fumarate Delivered by Nebulization and DPI," showed comparability
in linear kinetics and excreted drug levels between formoterol fumarate
administered by nebulization and DPI. Transient and dose-related effects on
serum potassium, serum glucose and vital signs were observed and found to be
comparable between the two formulations.
Dr. Nicholas J. Gross, MD, PhD, Hines VA Hospital, Stricht Loyola School
of Medicine and lead clinical investigator in the first study, commented, "The
results of both of these studies provide additional evidence of the clinical
benefit of Perforomist(TM) Inhalation Solution as a valuable treatment option
for patients with COPD. Nebulization is an alternative way to deliver
medication to the lungs and since many patients may have difficulty
coordinating the use of other devices as their disease progresses, nebulized
Perforomist(TM) offers an effective, long-term treatment option."
The first study was a single-dose, double-blind, double-dummy crossover
dose-ranging study conducted in 47 patients to establish the dose of
Perforomist(TM) Inhalation Solution comparable to that of the marketed DPI,
Foradil(R) Aerolizer(R). Mean FEV(1) AUC(0-12) (standardized area under the
curve for FEV(1) over twelve hours) following FFIS treatment ranged from 1.3
to 3.0 L/hr in a dose-related manner, with identical values (2.3 L/hr) for
Perforomist(TM) Inhalation Solution 20mcg and Foradil(R) Aerolizer(R). All
other spirometry measures were comparable between FFIS and FA.
The second study involving thirteen COPD patients was a randomized,
single-dose, open-label, crossover study comparing FFIS 10, 20, and 24mcg with
Foradil(R) Aerolizer(R), which confirmed pharmacokinetic comparability between
Perforomist(TM) Inhalation Solution 20mcg by nebulization and Foradil(R)
Aerolizer(R) 12mcg (Foradil) by DPI.
"This research continues to support and highlight the clinical value of
Perforomist(TM) Inhalation Solution," said Carolyn Myers, Ph.D., President of
Dey, L.P. "We thank all of these eminent researchers for their contributions
to the trials that were presented today and we remain dedicated to developing
nebulized treatment options for those suffering from serious respiratory
illnesses such as COPD."
For those attending ATS 2008, the presentations are available as follows:

Poster viewing: Session ID C42 COPD Pharmacotherapy I: Effects of
Bronchodilators
Tuesday, May 20, 2008, 10:45 a.m. - 12:30 p.m. EDT
Metro Toronto Convention Center; Area F: Halls A-B North Building, Level
300

-- Poster #F13: Dose-Ranging Study in COPD Patients Comparing
Pharmacodynamics of Formoterol Fumarate Delivered by Nebulization and
DPI

-- Poster #F14: A Pharmacokinetic Study in COPD Patients Comparing
Formoterol Fumarate Delivered by Nebulization and DPI

The research presented at ATS 2008 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. (NYSE: 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
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 www.dey.com, www.accuneb.com, www.curosurfusa.com,
www.cyanokit.com, www.duoneb.com, www.epipen.com and www.perforomist.com.
Perforomist(TM) is a trademark of Dey, L.P.
Foradil(R) Aerolizer(R) is a registered trademark of Novartis Pharma AG

(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

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

SOURCE Dey L.P.

Dey, L.P. Media Line, +1-800-755-5560, ext. 8363; or Amy Techtmann of
Feinstein Kean Healthcare, +1-617-761-6784, amy.techtmann@fkhealth.com