- Presentations on long-term safety and cardiovascular safety of nebulized
formoterol fumarate and safety/ efficacy of concomitant use with tiotropium
for treatment of COPD -
NAPA, Calif., Oct. 16 /PRNewswire/ -- Dey, L.P., a subsidiary of Mylan
Inc. (NYSE: MYL), announces three clinical data presentations will be given
at CHEST 2007, the annual scientific assembly of the American College of
Chest Physicians (ACCP) on Wednesday, October 24, 2007 at the McCormick
Place Convention Center in Chicago. Data will be presented from two safety
studies that 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. The third presents results from a Phase IIIb study of
the concomitant use of Perforomist(TM) Inhalation Solution with tiotropium
for the treatment of COPD.
Perforomist(TM) Inhalation Solution is the first and only FDA-approved
nebulized form of formoterol fumarate and is indicated for long-term,
twice- daily maintenance treatment of bronchoconstriction for emphysema and
chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease
(COPD). Nebulizers convert liquid medication into a mist that patients
inhale through a mouthpiece or face mask.
For those attending CHEST, the three presentations are available as
follows:
-- "Long-Term Safety of Nebulized Formoterol in COPD: An Open-Label
Active-Control Extension Study" Poster # 239
-- "Cardiovascular Safety of Nebulized Formoterol in COPD Patients: A
Double-Blind, Placebo-Controlled Study" Poster # 238
-- "Safety and Efficacy of Concomitant Treatment with Nebulized Formoterol
and Tiotropium in COPD," Poster # 251
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.
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.
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
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. (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 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 Perforomist and research results.
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.
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Related links:
http://www.dey.com
http://www.perforomist.com http://www.mylan.com
CONTACT:
Harriet Ullman of Feinstein Kean Healthcare,
+1-617-761-6776, hullman@fkhealth.com, for Dey, L.P.
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