-- 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. (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
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 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.
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Related links:
http://www.dey.com
http://www.mylan.com
CONTACT:
Dey, L.P. Media Line, +1-800-755-5560, Ext.
8363; or Harriet Ullman of Feinstein Kean Healthcare,
+1-617-761-6776, hullman@fkhealth.com, for Dey, L.P.
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