Mylan Inc. Subsidiary, Dey, L.P., Announces that Perforomist (Formoterol Fumarate) Inhalation Solution is Now Available for Maintenance Treatment of COPD- Emphysema and chronic bronchitis patients to benefit from rapid, long-lasting symptom control with twice-daily dosing of first nebulized formoterol fumarate -
NAPA, Calif., October 08, 2007 /PRNewswire-FirstCall/ -- Dey, L.P., a subsidiary of Mylan Inc. , 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
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 www.perforomist.com or call 800-755-5560 and ask for Customer Service.
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.
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 www.dey.com, www.accuneb.com, www.curosurfusa.com, www.cyanokit.com, www.duoneb.com, www.epipen.com and www.perforomist.com.
Perforomist is a trademark of Dey, L.P.
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 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 firstname.lastname@example.org
CONTACT: Dey, L.P. Media Line, +1-800-755-5560 ext. 8363; or HarrietUllman of Feinstein Kean Healthcare for Dey, L.P., +1-617-761-6776, email@example.com
Web site: http://www.mylan.com/http://www.dey.com/
Ticker Symbol: (NYSE:MYL)
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Posted: October 2007