Concomitant Use of Nebulized Formoterol Fumarate and Tiotropium Provides Significant...

Concomitant Use of Nebulized Formoterol Fumarate and Tiotropium Provides
Significant Improvement in Dyspnea, COPD Symptoms and Rescue Medication Use
over Tiotropium Alone
-- Clinical trial data for Perforomist(TM) (Formoterol Fumarate) Inhalation
Solution 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 concomitant therapy with Perforomist(TM) Inhalation Solution (formoterol
fumarate inhalation solution; FFIS), delivered by nebulization, and Spiriva(R)
(tiotropium; TIO) is significantly more effective than treatment with
tiotropium alone.
Perforomist(TM) 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.
Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen
School of Medicine at the University of California at Los Angeles and lead
clinical investigator, presented the results from "Addition of Nebulized
Formoterol Fumarate to Tiotropium Treatment Relieves Dyspnea and Symptoms in
COPD Patients" in a poster session today.
"In this study there was a significant improvement in patients treated
concomitantly with Perforomist(TM) nebulized formoterol fumarate and
tiotropium over tiotropium alone," said Dr. Tashkin. "These data provide
physicians with a new and valuable treatment option for COPD patients with
moderate to severe manifestations of the disease."
This randomized, placebo-controlled double-blind trial was conducted in
130 patients with moderate to severe COPD to evaluate the efficacy and safety
of Perforomist(TM), nebulized FFIS, when added to Spiriva maintenance
treatment. Patient-centered outcomes were measured by the
baseline/transitional dyspnea index, daily recording of COPD symptoms, rescue
albuterol use and St. George's Respiratory Questionnaire (SGRQ).
In this trial there was a statistical significance between the mean
transitional dyspnea index scores in the Perforomist(TM)/TIO and TIO/placebo
groups (2.30 and 0.16, respectively; p=0.0002). Shortness of breath, chest
tightness, nighttime awakenings, and total symptom scores all improved
significantly with the Perforomist(TM)/TIO treatment compared with TIO/placebo
(p<0.05). Cough scores did not differ between groups. Albuterol use declined
in the Perforomist(TM)/TIO group from 2.4 to1.3 puffs/day and increased in the
TIO/placebo group from 2.8 to 3.4 puffs/day over six weeks; another
statistically significant difference (p< 0.0001). SGRQ total scores did not
change markedly from baseline or differ between groups except for the symptom
domain score, which was superior in the Perforomist(TM)/TIO group compared to
TIO/placebo (-6.3, p<0.04).
"DEY is very pleased with the results of this study and the benefit that
patients are seeing with Perforomist(TM) Inhalation Solution," said Carolyn
Myers, Ph.D., President of Dey, L.P. "We wish to thank Dr. Tashkin and the
other members of the research team for their careful investigation into the
clinical benefits of concomitant therapy of Perforomist and tiotropium. At
DEY, we are committed to developing effective new treatments for serious and
complex diseases, and with Perforomist are proud to provide physicians and
patients a twice-daily COPD maintenance medication that offers the flexibility
of dosing via nebulization."
For those attending ATS 2008, the presentation is 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 # F4: Addition of Nebulized Formoterol Fumarate to Tiotropium
Treatment Relieves Dyspnea and Symptoms in COPD Patients

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 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
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.
Spiriva(R) is a registered trademark of Boehringer Ingelheim
Pharmaceuticals, Inc.
(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 for Dey, L.P., +1-617-761-6784, amy.techtmann@fkhealth.com