Perforomist(R) Inhalation Solution Data in Patients With Moderate to Severe COPD...

Perforomist(R) Inhalation Solution Data in Patients With Moderate to Severe
COPD to Be Presented at the International Conference of the American Thoracic
Society

SAN DIEGO, May 19 /PRNewswire/ -- Data from two presentations highlighting the
use of Perforomist(R) (formoterol fumarate) Inhalation Solution in moderate to
severe chronic obstructive pulmonary disease (COPD) patients were featured
today at the International Conference of the American Thoracic Society in San
Diego. In one analysis, use of Perforomist Inhalation Solution, when added to
maintenance tiotropium, resulted in improved pulmonary function, dyspnea
(shortness of breath) and rescue medication use versus treatment with
tiotropium alone. In a second study, patient satisfaction increased in those
treated with Perforomist Inhalation Solution twice daily compared with
ipratropium/albuterol metered-dose inhaler (MDI) four times daily.

Perforomist Inhalation Solution was approved in 2007 by the U.S. Food and Drug
Administration (FDA) for long-term, twice-daily maintenance treatment of
bronchoconstriction in patients with COPD, including chronic bronchitis and
emphysema. It is the only FDA-approved nebulized formoterol fumarate.

"These results are significant because they validate the benefits and
satisfaction when using Perforomist," said Carolyn Myers, Ph.D., President of
Mylan's specialty division, which includes Dey, L.P. "We continue our
dedication to further research surrounding illnesses such as COPD, and are
pleased that patients can benefit from our treatments."

Studies Find Improvements in Pulmonary Function, Dyspnea, and Rescue
Medication Use
A pooled analysis of two similar studies evaluated the efficacy and safety of
adding Perforomist Inhalation Solution to maintenance tiotropium in patients
with moderate to severe COPD versus treatment with tiotropium alone.

This data analysis assessed a combined total of 285 subjects with moderate to
very severe COPD. When combining Perforomist Inhalation Solution with
maintenance tiotropium in such patients, significant improvements in pulmonary
function, dyspnea and rescue medication use were seen over tiotropium
treatment alone, without any additional safety or tolerability issues.

Efficacy was measured by serial spirometry, transitional dyspnea index (TDI),
rescue albuterol use and the St. George's Respiratory Questionnaire (SGRQ).

The primary efficacy endpoint was standardized absolute FEV1 AUC0-3. At Week
6 the primary efficacy endpoint was significantly improved by 192 mL compared
with placebo/tiotropium (1.54 versus 1.37 L, p<0.0001). Following treatment,
the mean TDI score showed a significant and clinically meaningful improvement
in dyspnea in the Perforomist Inhalation Solution/tiotropium group compared
with the placebo/tiotropium group, with mean TDI scores of 1.97 and 0.67,
respectively (p=0.0001).

When Perforomist Inhalation Solution was added to tiotropium there was a
significant decrease in the need for rescue albuterol use throughout the
double-blind period compared with placebo/tiotropium (p<0.0001). SGRQ scores
were similar both between treatments and to baseline, except the symptom
domain score, which fell in the Perforomist Inhalation Solution/tiotropium
group (-5.8) compared with placebo/tiotropium group (-1.0).

Overall, 31 percent of Perforomist Inhalation Solution/tiotropium-treated
subjects experienced adverse events versus 46 percent of the
placebo/tiotropium-treated subjects. COPD exacerbations were the most common
adverse events, and occurred in over twice as many placebo/tiotropium-treated
subjects as Perforomist Inhalation Solution/tiotropium-treated subjects. The
most frequent adverse events following COPD exacerbations were acute
bronchitis and upper respiratory tract infections.

"COPD patients in this analysis saw improvement in several areas when adding
Perforomist Inhalation Solution to their tiotropium treatment," said Davida J.
White Pettaway, M.D., Senior Manager, Medical and Scientific Affairs, Dey,
L.P. "Having replicate data from two well-controlled, double-blind studies
will provide physicians with valuable information as they consider treatment
options for patients with moderate to severe COPD."

Results Suggest Increased Treatment Satisfaction with Twice Daily Perforomist
Inhalation Solution Compared with Ipratropium/Albuterol MDI Four Times Daily
In a separate poster presentation, results were presented from a post-hoc
analysis conducted to assess the effects of age, gender and COPD severity on
patient responses to Perforomist Inhalation Solution and ipratropium/albuterol
MDI.

"Nebulized Formoterol Improved Efficacy and Increased Patient Satisfaction
Compared with Ipratropium/Albuterol MDI," led by E. Rand Sutherland, M.D.,
M.P.H., National Jewish Health, Denver, Colo., was a multicenter, randomized,
open-label, crossover study of 109 patients with moderate to severe COPD.
Perforomist Inhalation Solution was shown to provide superior morning
bronchodilation and increased patient satisfaction versus
ipratropium/albuterol MDI in older, male and more severe patients with COPD.

Efficacy was assessed by spirometry, TDI and a treatment
preference/satisfaction survey. Subgroups with a significant difference in
pre-treatment FEV1 on Day 14 favoring Perforomist Inhalation Solution were
older, (≥65 years), severe to very severe COPD (<50 percent predicted) or
moderate COPD, and males (p<0.05). Other results demonstrated that
severe/very severe subjects preferred Perforomist Inhalation Solution
(p<0.05). Significantly more older, male and severe/very severe subjects were
satisfied with their overall response to Perforomist Inhalation Solution and
more males and severe/very severe subjects perceived increased medication
delivery to the lung and overall control of lung disease following treatment
with Perforomist Inhalation Solution (p<0.05). Improvements in dyspnea were
clinically meaningful, but not significantly different between treatments in
any subgroup.

The complete study results were presented at the 2008 CHEST meeting, and
recently published in Current Medical Research and Opinion in 2009.

The research presented at ATS 2009 was sponsored by Dey, L.P., which developed
and markets Perforomist Inhalation Solution.

About COPD[1]
COPD is a preventable and treatable disease with some significant
extrapulmonary effects that may contribute to the severity in individual
patients. Its pulmonary component is characterized by airflow limitation that
is not fully reversible. The airflow limitation is usually progressive and
associated with an abnormal inflammatory response of the lung to noxious
particles or gases.

COPD is the fourth leading cause of death in America, behind heart disease,
cancer and stroke. 12 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. For patients who smoke, quitting smoking is the single most
important step a patient can take to treat or slow down COPD. 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 convert medication
into a fine liquid mist that the patient inhales through a mouthpiece or
facemask. The patient breathes naturally, inhaling the medicine until the
complete dosage has been delivered. Nebulization is a very gentle, but also
very thorough, method of delivering medicine directly into the lungs.

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 long-acting
beta2-adrenergic agonists (LABAs) such as Perforomist Inhalation Solution.
For example, this COPD treatment may be a valuable clinical option for many
patients whose symptoms are not adequately controlled with their current
therapy. COPD patients should consider asking their doctor whether nebulized
treatment may be right for them.

About Perforomist(R) Inhalation Solution
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(R) (formoterol fumarate) 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 initiated in patients with
acutely deteriorating COPD, which may be a life threatening condition, or to
treat acute symptoms. Acute symptoms should be treated with fast-acting rescue
inhalers. Perforomist Inhalation Solution is not indicated to treat asthma.
The safety and efficacy of Perforomist Inhalation Solution in asthma has not
been established. 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, especially coronary insufficiency, cardiac
arrhythmias and hypertension.

In COPD clinical trials, the most common adverse events reported with
Perforomist Inhalation Solution (>2% and more common than placebo) were
diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and
insomnia.

Please see full Prescribing Information, including Boxed Warning, at
www.perforomist.comor call 800-755-5560 and ask for Customer Service.

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.curosurfusa.com, www.epipen.com
and www.perforomist.com.

About Mylan
Mylan Inc., which provides products to customers in more than 140 countries
and territories, ranks among the leading diversified generics and specialty
pharmaceutical companies in the world. The company maintains one of the
industry's broadest - and highest quality - product portfolios, supported by a
robust product pipeline; owns a controlling interest in the world's third
largest active pharmaceutical ingredient manufacturer; and operates a
specialty business focused on respiratory and allergy therapies. For more
information about Mylan, please visit www.mylan.com.

[1]Definition derived from "Global Initiative for Chronic Obstructive Lung
Disease" Pocket Guide to COPD Diagnosis, Management and Prevention. Updated
2008. Link accessed on April 30, 2009.

SOURCE Dey, L.P.

Dey, L.P. Media Line, +1-1-800-755-5560 ext. 8363; or Julie Piszczor, Powell
Tate, +1-202-585-2106, jpiszczor@powelltate.com, for Dey, L.P.