September 8, 2008
ALVESCO(R) (Ciclesonide) Inhalation Aerosol Now Available in U.S. For Treatment of Asthma
Sepracor Inc. (Nasdaq: SEPR) today announced that ALVESCO HFA Inhalation Aerosol MDI (metered-dose inhaler) is now available by prescription in the U.S. ALVESCO HFA is a new inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. This asthma treatment is available in 80 mcg/actuation and 160 mcg/actuation dosage strengths.
"We believe that ALVESCO HFA is an excellent fit with our portfolio of respiratory products, and we are extremely pleased to be able to now make this product available in the U.S.," said Adrian Adams, President and Chief Executive Officer of Sepracor. "Our respiratory sales specialists, as well as our recently deployed, Sepracor-managed contract sales force, have begun to introduce the product to allergists and pulmonologists, and we anticipate expanding our reach to primary care physicians and other specialists in the coming months. Our commercial organization has significant experience in promoting respiratory products, and we believe that this experience, combined with our established relationships with allergists, pulmonologists, pediatricians and primary care physicians, provides a strong platform from which to launch this product."
ALVESCO HFA contains the active ingredient ciclesonide, a unique corticosteroid prodrug that is activated into des-ciclesonide after oral inhalation, and which has potent anti-inflammatory activity. The small particle size of the ALVESCO HFA solution formulation permits the medication to effectively penetrate small airways. In addition, the product has extremely low systemic exposure due to low gastrointestinal absorption and first pass metabolism, a factor that may explain its favorable side effect profile.
In large, well-controlled clinical trials, when compared to patients administered placebo, patients with persistent asthma taking ALVESCO HFA demonstrated:
-- Improved lung function;
-- Reduced total asthma symptom scores compared to baseline;
-- Reduced daily rescue albuterol use from baseline; and
-- Reduced nighttime awakenings from baseline.
In addition, patients with severe asthma who were corticosteroid-dependent demonstrated reduced use of oral corticosteroids compared to baseline when administered ALVESCO HFA.
"We know that, for many asthma patients, their condition is controlled best using inhaled corticosteroid therapy, and now there is an important new addition to the arsenal of asthma treatments," said William E. Berger, M.D., MBA, Clinical Professor, Department of Pediatrics, Division of Allergy and Immunology at the University of California, Irvine. "ALVESCO HFA is formulated as a prodrug and has some clear benefits, including small particle size, which enables the medication to reach small airways and allows for a thorough distribution of the drug. Also, its low systemic exposure could indicate the potential for a favorable side effect profile. I believe that ALVESCO HFA is a good option for those asthma patients who have never been treated with an inhaled corticosteroid as well as those who are not being adequately served by their current inhaled corticosteroid or combination therapy."
Asthma is a chronic lung disorder characterized by reversible airway obstruction and a pathologic finding of airway inflammation. According to the National Heart Lung and Blood Institute, when taken every day, maintenance inhalers like ALVESCO HFA can help prevent the coughing, wheezing and shortness of breath associated with asthma. According to the Centers for Disease Control and Prevention's National Center for Health Statistics, in 2006 an estimated 34.1 million people had been diagnosed with asthma during their lifetime.
Inhaled corticosteroids are well accepted as first-line asthma therapy. They inhibit the activity of pro-inflammatory cells and promote the endogenous production of anti-inflammatory substances. With regular use of these corticosteroids, the inflammation in the airways that underlies asthma diminishes.
About ALVESCO HFA
ALVESCO (ciclesonide) HFA Inhalation Aerosol is an inhaled corticosteroid that reduces inflammatory processes and is indicated for use in adolescent and adult asthma patients 12 years of age and older. ALVESCO HFA has been approved in 48 countries including the U.S. and introduced in 33, with more launches expected in 2008 and 2009. The active ingredient in ALVESCO HFA is ciclesonide. ALVESCO HFA has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response.
ALVESCO HFA should be used regularly as prescribed. The effectiveness of the medication depends on its regular use. It may take 4 weeks or longer before a patient feels the full benefits of ALVESCO HFA. Patients should not increase their prescribed dosage; if symptoms do not improve or asthma symptoms worsen, patients should contact their doctor.
ALVESCO HFA is not a bronchodilator and is not intended to provide rapid relief of breathing difficulties during an asthma attack. Patients should not use ALVESCO HFA if they are experiencing sudden symptoms of shortness of breath. Patients should use an inhaled short-acting bronchodilator, or rescue medication, such as levalbuterol, to relieve sudden symptoms of shortness of breath. Patients using doses of corticosteroid drugs that weaken the immune system are more susceptible to infection and should avoid exposure to chickenpox and/or measles. ALVESCO HFA can worsen existing conditions such as tuberculosis (TB), herpes of the eye, and other infections.
Orally inhaled corticosteroids, including ALVESCO HFA, may cause slowed growth in children and adolescents. These patients should have their growth monitored regularly.
Yeast infections in the mouth and throat (thrush) have occurred in some patients treated with ALVESCO HFA. Eye problems have been reported following the use of inhaled corticosteroids including ALVESCO HFA. Patients should speak to their doctor if they have a history of eye problems or experience a change in vision.
For more information about ALVESCO HFA, please visit www.alvesco.us, or click here.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving large and growing markets and unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA(R) brand eszopiclone, XOPENEX(R) brand levalbuterol HCl Inhalation Solution, XOPENEX HFA(R) brand levalbuterol tartrate Inhalation Aerosol, BROVANA(R) brand arformoterol tartrate Inhalation Solution and OMNARIS(TM) brand ciclesonide Nasal Spray. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the launch of ALVESCO HFA, the safety, efficacy, potential benefits, possible uses and commercial success of ALVESCO HFA and the anticipated expansion of Sepracor's introduction of ALVESCO HFA to primary care physicians and other specialists in the coming months. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the clinical benefits, efficacy and safety of products containing ciclesonide; unexpected delays in commercial introduction and the commercial success of ALVESCO HFA; changes in the use and/or label of ALVESCO HFA; the ability of Nycomed GmbH, Sepracor's collaboration partner for ciclesonide, to supply or obtain from third parties Sepracor's requirements for ALVESCO HFA or its components in accordance with Sepracor's exclusive distribution and development agreement with Nycomed; the success of Sepracor's alliance with Nycomed; the scope of Nycomed's and/or Sepracor's patents and the patents of others; the ability of Sepracor and Nycomed to attract and retain qualified personnel; Sepracor's ability to successfully integrate and manage its new contract sales force and certain other factors that may affect future operating results that are detailed in Sepracor's quarterly report on Form 10-Q for the quarter ended June 30, 2008 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
1. IMS Health, 12-month moving average total for inhaled corticosteroids as of July 2008.
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. OMNARIS is a trademark and ALVESCO is a registered trademark of Nycomed GmbH. For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.