- Emphysema and chronic bronchitis patients to benefit from rapid,
long-lasting symptom control with twice-daily dosing of first nebulized
formoterol fumarate -
NAPA, Calif., Oct. 8 /PRNewswire-FirstCall/ -- Dey, L.P., a subsidiary
of Mylan Inc. (NYSE: MYL), today announced the launch of Perforomist(TM)
(formoterol fumarate) Inhalation Solution, which will be available
nationwide through retail pharmacies, hospitals, long-term care facilities,
and home healthcare companies. 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).
The formoterol molecule is a rapid and long-acting beta2-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.
"In treating patients with moderate to advanced COPD, I have found
LABAs to be very effective, and in particular I think formoterol provides
excellent long-term symptom control," said Donald P. Tashkin, MD, FACP,
FCCP, Professor of Medicine, David Geffen School of Medicine at the
University of California at Los Angeles. "Since patients have difficulty
adhering to complicated medication regimens, it's very helpful that
Perforomist(TM) Inhalation Solution offers a twice-daily nebulized version
of formoterol. I consider nebulization to be an especially effective way to
deliver medication into the lungs, and this new product should provide a
valuable treatment for COPD patients."
Perforomist(TM) Inhalation Solution is nebulized once in the morning
and once in the evening, providing many COPD patients with round-the-clock
symptom management. GOLD treatment guidelines recommend that physicians use
a LABA (such as Perforomist(TM) Inhalation Solution) as an option for
patients with moderate to very severe COPD.
Christy Taylor, Chief Operating Officer at Dey, L.P., noted, "We are
delighted to make Perforomist(TM) Inhalation Solution available to the
millions of Americans who live with COPD. We are confident that
Perforomist(TM) Inhalation Solution is a rapid and efficacious maintenance
medication that can improve symptoms for many patients and fit suitably
into their daily routines. For more than a decade we have been the US
leader in sales of nebulized respiratory products, and Perforomist(TM)
Inhalation Solution is a valuable and innovative addition to this
portfolio."
Robert J. Coury, Vice Chairman and CEO of Mylan Inc., stated, "We are
extremely pleased with the management team at Dey for their ability to
execute on their initiatives by the launch of Perforomist(TM) Inhalation
Solution approximately six months in advance of what was originally
anticipated and forecasted. Additionally, we are thrilled about this
differentiated next generation product, which we believe will substantially
replace the sales resulting from the loss of exclusivity of DuoNeb(R)
Inhalation Solution.
Gene L. Colice, MD, Department Director, Pulmonary, Critical Care and
Respiratory Service, Washington Hospital Service, remarked, "Formoterol is
a wonderful molecule. It's a very effective bronchodilator and works
quickly, but probably its biggest benefit is that it works for 12 hours.
Having formoterol in a nebulized form is an important option, since in my
experience with hospitalized patients, the nebulizer is our preferred
approach. Perforomist(TM) Inhalation Solution will be a major addition to
our treatment options."
Under an agreement with Critical Therapeutics, Perforomist(TM)
Inhalation Solution will be jointly marketed by the combined sales teams of
Dey, L.P. and Critical Therapeutics. Dey, L.P. also has a partnership with
PARI Respiratory Equipment, whose breath enhanced nebulizer system, the
PARI LC PLUS and PRONEB Ultra compressor, was used exclusively in DEY's
clinical trials.
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. 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 its effectiveness
and commercial success. 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.mylan.com
http://www.dey.com
CONTACT:
Dey, L.P. Media Line, +1-800-755-5560 ext.
8363; or Harriet Ullman of Feinstein Kean Healthcare for Dey,
L.P., +1-617-761-6776, hullman@fkhealth.com
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