Primary Pulmonary Hypertension News - Menu XOPENEX HFA metered-dose inhaler now available 12/12/2005 - Sepracor Inc. (Nasdaq: SEPR) today announced that XOPENEX HFA(TM) (levalbuterol tartrate) Inhalation Aerosol, a hydrofluoroalkane (HFA) metered-dose inhaler (MDI), is now available by prescription in pharmacies nationwide. XOPENEX HFA is a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. The XOPENEX HFA MDI is a portable, hand-held device consisting of a pressurized canister containing medication and a mouthpiece through which the medicine is inhaled. Reversible obstructive airway disease includes respiratory disorders such as asthma and the reversible component of chronic obstructive pulmonary disease (COPD), affecting approximately 41 million people in the U.S., according to the American Lung Association and Centers for Disease Control and Prevention. "The launch of XOPENEX HFA MDI extends the XOPENEX franchise into the twelfth largest prescription drug category in the U.S.(1)," said William J. O'Shea, President and Chief Operating Officer of Sepracor. "To date, racemic albuterol, which contains both the (R)- and (S)-isomers of albuterol, has been the most widely used short-acting beta-agonist in the world. Now, health care providers can prescribe XOPENEX HFA, a new, single, (R)-isomer alternative to albuterol MDIs." "I am very pleased to now be able to offer patients who require short-acting beta-agonist MDIs a new alternative to albuterol," said William Berger, M.D., Clinical Professor, Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine. "The portability of the XOPENEX HFA MDI will enable health care professionals to provide their patients with a means of getting the XOPENEX therapy they need whenever and wherever asthma symptoms occur." XOPENEX HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. The XOPENEX HFA development program included approximately 1,870 pediatric and adult subjects and 54 studies (preclinical and clinical). In each of the three, large-scale, pivotal Phase III trials that Sepracor conducted, XOPENEX HFA was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma. In the primary airway function measure, FEV(1) (a measure of the amount of air forcefully exhaled in one second), XOPENEX HFA produced statistically and clinically significant improvements relative to placebo. Sepracor continues to conduct both clinical and preclinical studies of XOPENEX. Sepracor's preclinical program includes investigation of (S)-albuterol, a component of racemic albuterol, and the possibility that (S)-albuterol's biological activity may be detrimental in the treatment of bronchospasm. While the overall clinical significance of preclinical findings related to (S)-albuterol is unknown, Sepracor continues to evaluate the biological activity of (S)-albuterol. XOPENEX HFA will be marketed through Sepracor's recently expanded primary care and specialty sales force, which now includes more than 1,400 sales representatives. An additional 175 sales professionals were hired in anticipation of the launch of XOPENEX HFA to complement the existing sales force by providing supplemental coverage to pediatricians, allergists, pulmonologists and hospitals. Sepracor has marketed XOPENEX(R) Inhalation Solution for use with a nebulizer through its primary care and hospital sales force since 1999. XOPENEX Inhalation Solution is approved by the U.S. Food and Drug Administration (FDA) for use in a nebulizer at 0.31 mg and 0.63 mg dosage strengths for treatment of children 6 to 11 years old, and in 0.63 mg and 1.25 mg dosage strengths for patients 12 years of age and older. A nebulizer is a machine that converts liquid medication into a fine mist, which is inhaled through a mask to deeply penetrate into a patient's lungs. Asthma is a chronic lung disorder characterized by reversible airway obstruction and the pathologic finding of airway inflammation. According to the 2002 National Health Interview Survey conducted by the Centers for Disease Control and Prevention, nearly 31 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects nearly 9 million children in the U.S. under the age of 18. Short-acting bronchodilators are the most-prescribed asthma therapy among primary care physicians and pediatricians in the U.S., according to IMS Health information. According to the National Center for Health Statistics, COPD is the fourth leading cause of death in the U.S., and in 2003, an estimated 11 million adults in the U.S. had COPD. COPD is characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. The obstruction is generally progressive and may be accompanied by airway hyper-reactivity so that airway obstruction may be partially reversible in many patients. Bronchodilator medications are useful in improving airflow, symptoms, and reducing the occurrence and/or severity of exacerbations in patients affected by COPD. Approximately 96 percent of the short-acting beta-agonist inhalers sold in 2004 contained chlorofluorocarbon (CFC) propellants, according to IMS Health information. Under provisions in the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement that requires the phase-out of substances that deplete the ozone layer, MDIs containing CFC propellants would qualify for removal from the marketplace. In March 2005, the FDA issued its final rule for the removal of the essential use exemption for albuterol, which currently permits the use of CFC-containing albuterol inhalers despite environmental concerns. Under the rule, all production and sales of albuterol CFC MDIs in the U.S. are required to cease by the end of 2008. XOPENEX HFA uses HFA technology and does not contain a CFC propellant. Important Safety Information XOPENEX HFA and XOPENEX Inhalation Solution are contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol or any other component of XOPENEX HFA or XOPENEX Inhalation Solution. XOPENEX HFA and XOPENEX Inhalation Solution and other beta-agonists can produce paradoxical bronchospasm, which may be life threatening. If additional adrenergic drugs, including other short-acting sympathomimetic bronchodilators or epinephrine, are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Due to the cardiovascular side effects associated with beta-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias and hypertension), diabetes, hyperthyroidism, or convulsive disorders. Also, see the complete prescribing information regarding potential drug interactions with beta-blockers, diuretics, digoxin or MAOI and tricyclic antidepressants. Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. The company's commercialization efforts are carried out by its U.S.-based, primary care and specialty-oriented sales force, which is comprised of more than 1,400 sales professionals. 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 safety, efficacy, potential benefits and commercial success of XOPENEX HFA and XOPENEX Inhalation Solution. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor's ability to supply sufficient quantities of product to the marketplace; Sepracor's ability to fund, and the results of, further clinical trials; the timing and success of submission, acceptance and approval of additional regulatory filings; changes to XOPENEX HFA or XOPENEX Inhalation Solution product labeling; concerns of XOPENEX prescribers or patients; and certain other factors that are detailed in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2005 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) Short-acting beta-agonist MDI market; IMS Health NPA Plus for the twelve months ended September 2005 Xopenex HFA is a trademark and Xopenex is a registered trademark of Sepracor Inc. For a copy of this release or any recent release, visit www.sepracor.com. CONTACT:
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