Clinical Trial Data On The Safety And Efficacy Of Concomitant Formoterol Fumarate/ Tiotropium Treatment For COPD

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Data presented at
CHEST 2007, the annual scientific assembly of the American College of Chest
Physicians (ACCP), demonstrate concomitant use of nebulized formoterol
fumarate and tiotropium provided improved bronchodilation over tiotropium
monotherapy and was well-tolerated in this clinical study. The only
commercially available version of nebulized formoterol fumarate is
Perforomist(TM) Inhalation Solution, which 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 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.



Results presented were from "Safety and Efficacy of Concomitant
Treatment with Nebulized Formoterol and Tiotropium in COPD," a randomized,
placebo-controlled Phase IIIb trial. The trial demonstrated that
concomitant therapy with twice-daily nebulized formoterol fumarate (FFIS)
and once-daily tiotropium provided patients with statistically significant
and clinically relevant improvements in bronchodilation over treatment with
tiotropium alone. In this six-week study, patients receiving concomitant
therapy with nebulized FFIS and tiotropium experienced fewer adverse events
or COPD exacerbations than patients receiving placebo or tiotropium
monotherapy.



According to Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine,
David Geffen School of Medicine at the University of California at Los
Angeles and the lead clinical investigator, "For the patients in this
study, adjunctive use of nebulized formoterol fumarate and tiotropium
showed statistically significant improvements in lung function by improving
bronchodilation over use of tiotropium alone. For physicians,
Perforomist(TM) Inhalation Solution and commonly prescribed long-acting
anticholinergics such as tiotropium offers a new and valuable treatment
option for COPD patients with moderate to severe manifestations of the
disease."



Christy Taylor, Chief Operating Officer at Dey, L.P., commented, "At
DEY, we specialize in developing effective new treatments for serious and
complex respiratory diseases, and it is gratifying that the newest addition
to our franchise, Perforomist(TM) Inhalation Solution, offers physicians
additional prescribing flexibility. For over a decade, Dey, L.P. has been
the U.S. leader in sales of nebulized respiratory medication. We thank Dr.
Tashkin and the other members of the research team for their assessment of
how Perforomist(TM) Inhalation Solution may be used concomitantly with
tiotropium for improved clinical effect for COPD patients."
















For those attending CHEST 2007, the presentation is 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 # 251: Safety and Efficacy of Concomitant Treatment with Nebulized



Formoterol and Tiotropium in COPD



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 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.



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 dey,
accuneb, curosurfusa, cyanokit, duoneb, epipen and perforomist.



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 mylan



This press release includes statements that constitute "forward-looking
statements," including with regard to the concomitant use of nebulized
formoterol fumarate and tiotropium 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 adjunctive use 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.


Dey, L.P.

dey