Sepracor Announces Fourth Quarter and Full Year 2006 Results.2006 Product Revenues Increased by 51% Over 2005 MARLBOROUGH, Mass. -- Sepracor Inc. (Nasdaq: SEPR SEPR Senior Enlisted Performance Report ) today announced its consolidated financial results for the fourth quarter and full year 2006. For the three months ended December 31, 2006, Sepracor's consolidated revenues were approximately $357.2 million, of which revenues from Sepracor's pharmaceutical product sales were approximately $348.8 million (XOPENEX([R]) brand levalbuterol HCl Inhalation Solution revenues were $179.9 million, XOPENEX HFA HFA Harvard Film Archive (Harvard University) HFA Harry Fox Agency, Inc. HFA Housing Finance Agency (District of Columbia government) HFA Hyogo Framework for Action HFA High-Functioning Autism ([R]) brand levalbuterol tartrate tartrate /tar·trate/ (tahr´trat) a salt of tartaric acid. tar·trate n. A salt or ester of tartaric acid. tartrate a salt of tartaric acid. Inhalation Aerosol MDI (1) (Multiple Document Interface) A Windows function that allows an application to display and lets the user work with more than one document at the same time. revenues were $20.9 million and LUNESTA([R]) brand eszopiclone revenues were $148.0 million). Net income for the fourth quarter of 2006 was approximately $99.1 million, or $0.85 per diluted share. Reported results for the fourth quarter of 2006 included charges of $13.8 million, or $0.12 per diluted share, for stock-based compensation due to Sepracor's adoption in January 2006 of Statement of Financial Accounting Standards, or SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System No. 123R. These consolidated results compare with consolidated revenues of $311.1 million, of which revenues from Sepracor's pharmaceutical product sales were approximately $302.9 million (XOPENEX Inhalation Solution revenues were $146.0 million, XOPENEX HFA revenues were $12.0 million and LUNESTA revenues were $144.9 million), and a net income of $36.9 million, or $0.31 per diluted share, for the three months ended December 31, 2005. For the year ended December 31, 2006, Sepracor's consolidated revenues were approximately $1,196.5 million, of which revenues from Sepracor's pharmaceutical product sales were approximately $1,162.8 million (XOPENEX Inhalation Solution revenues were $555.0 million, XOPENEX HFA revenues were $41.0 million and LUNESTA revenues were $566.8 million). Net income for the year ended December 31, 2006 was approximately $184.6 million, or $1.60 per diluted share. Reported results for the full year 2006 included charges of $45.2 million, or $0.39 per diluted share, for stock-based compensation due to Sepracor's adoption of SFAS No. 123R. These consolidated results compare with consolidated revenues of $820.9 million, of which Sepracor's pharmaceutical product sales were approximately $769.7 million (XOPENEX Inhalation Solution revenues were $428.5 million, XOPENEX HFA revenues were $12.0 million and LUNESTA revenues were $329.2 million) and a net income of $3.9 million, or $0.03 per diluted share, for the year ended December 31, 2005. As of December 31, 2006, Sepracor had approximately $1,166 million in cash and short- and long-term investments. Sepracor expects to spend approximately $451 million, including $11 million in interest, to repay all of its outstanding 5% convertible subordinated debentures when they come due on February 15, 2007. 2006 Highlights "The year 2006 was a year of significant achievement for Sepracor and its stakeholders. It marks our first full year of operating profits and the first year that revenues exceeded one billion dollars," said Timothy J. Barberich, Chairman and Chief Executive Officer of Sepracor." Other highlights in 2006, discussed in more detail below, include: * Published and/or Presented at Scientific Meetings: LUNESTA Co-Morbidity Data, XOPENEX Inhalation Solution Data, XOPENEX HFA Data and BROVANA Phase III Data * BROVANA([TM]) (arformoterol tartrate) Inhalation Solution First-Cycle U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Approval * Advanced Serotonin and Norepinephrine Reuptake Inhibitor Norepinephrine reuptake inhibitors (NRIs), also known as noradrenaline reuptake inhibitors (NARIs), are compounds that elevate the extracellular level of the neurotransmitter norepinephrine in the central nervous system by inhibiting its reuptake from the for Treatment of Depression * Advanced Triple Reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. Inhibitor for Treatment of Depression Commercialized Products LUNESTA([R]) brand eszopiclone -- LUNESTA is indicated for the treatment of sleep onset and/or sleep maintenance insomnia and is available by prescription in 1 mg, 2 mg and 3 mg dosage strengths. Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night. An estimated 36 percent of adult Americans reported suffering from either chronic or occasional insomnia in the last year.1 Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed. * LUNESTA Geographic Expansion Update In December 2006, Sepracor submitted the equivalent of an Investigational New Drug Application (IND) for LUNESTA for the treatment of insomnia, to regulatory authorities in Japan and has begun a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in Japan. In Europe, Sepracor is preparing to submit a Marketing Authorization Application (the equivalent of a New Drug Application) for LUNESTA for the treatment of insomnia to the European Union regulatory agency during the second half of 2007. Recent LUNESTA Publications and Clinical Data Presentations * Insomnia-Perimenopause Study Publication In December 2006, Sepracor announced the publication of results from its Phase IIIB/IV, 410-patient, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled study evaluating the safety and efficacy of LUNESTA for the treatment of insomnia in perimenopausal perimenopausal adjective Referring to a period of a ♀'s life–age 45 to 55-ish–in which menstrual periods become irregular; perimenopause is immediately before, during and after menopause. See Menopause. and menopausal women suffering from insomnia. The results of this study were published in the December 2006 issue of the Journal of Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. . In this study, perimenopausal or early menopausal women experiencing insomnia according to DSM-IV DSM-IV Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). This reference book, published by the American Psychiatric Association, is the diagnostic standard for most mental health professionals in the United States. ([R]2) criteria were randomized to LUNESTA 3 mg or matching placebo nightly for four weeks. This four-week, double-blind treatment period was followed by a one-week discontinuation phase during which all patients received single-blind placebo. Patients treated with LUNESTA demonstrated statistically significant improvement (p<0.01) compared with placebo in patient-reported measures of sleep latency (onset of sleep), wake time after sleep onset (WASO WASO West Australian Symphony Orchestra WASO Wake-time After Sleep Onset WASO Washington Support Office (US National Park Service) WASO WWMCCS ADP Security Officer ; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep) and total sleep time for each week of the study. Secondary measures of sleep quality, depth of sleep, daytime alertness, ability to function, ability to concentrate and physical well-being were also statistically significantly (p<0.05) improved over the double-blind period for patients administered LUNESTA versus those administered placebo. Additionally, insomnia severity index-assessed sleep quality, feeling refreshed/rested, daytime fatigue, attention/concentration, and relationship enjoyment parameters were statistically significantly (p<0.05) improved with LUNESTA compared with placebo. There was no evidence of rebound insomnia or other withdrawal phenomena during the discontinuation phase in the patients who had received 28 days of nightly dosing with LUNESTA 3 mg. Measures of other menopausal symptoms including mood, quality of life, and impairment in daily activities were also assessed in this study using the Greene Climacteric climacteric: see menopause. Scale (GCS GCS Glasgow Coma Scale GCS Guilford County Schools (North Carolina) GCS Ground Control Station GCS Grand Central Station GCS Ground Control System GCS Ground Combat Systems GCS Group Communication Systems ), Montgomery Asberg Depression Rating Scale, the Menopause Quality of Life questionnaire (MENQoL), the Sheehan Disability Scale (SDS 1. (company) SDS - Scientific Data Systems. 2. (tool) SDS - Schema Definition Set. ), as well as the physician global assessment of menopausal symptoms. As compared with placebo, patients administered LUNESTA for 4 weeks demonstrated a statistically significantly (p<0.05) greater reduction from baseline at the end of the 4-week period in nighttime awakenings due to hot flashes and a significant improvement in mood as measured by the Montgomery Asberg Depression Rating Scale. Statistically significantly (p<0.05) greater changes from baseline were noted with LUNESTA on the GCS (total score, psychological and vasomotor vasomotor /vaso·mo·tor/ (-mo´tor) 1. affecting the caliber of blood vessels. 2. a vasomotor agent or nerve. va·so·mo·tor adj. domains), MENQoL (vasomotor and physical domains), and the SDS (family/home domain). A physician global assessment, which evaluated the overall improvement in menopausal symptoms at the end of the four-week period, demonstrated that more patients (p<0.001) administered LUNESTA were "very much improved" or "much improved" in menopausal symptoms versus those patients administered placebo. No significant difference was observed between treatment groups in number or severity of daytime hot flashes at each week or over the four-week treatment period. LUNESTA was well tolerated in the study. * Insomnia in Patients with Co-Existing Generalized Anxiety Disorder Generalized Anxiety Disorder Definition Generalized anxiety disorder is a condition characterized by "free floating" anxiety or apprehension not linked to a specific cause or situation. Study Results Presented In December 2006, results from a Phase IV, 595-patient study were presented at the annual meeting of the American College of Neuropsychopharmacology. This placebo-controlled, double-blind, ten-week study evaluated the efficacy and safety of LUNESTAin patients with insomnia and co-existing Generalized Anxiety Disorder (GAD Gad, in the Bible, son of Jacob and Zilpah and eponymous founder of one of the 12 tribes of Israel. Its allotment was half of Gilead; this was the land best suited to the pastoral life, which Gad, like Reuben, continued after the years in Egypt. ). Patients with insomnia and GAD were randomized to receive nightly LEXAPRO([R])brand escitalopram oxalate 10 mg, which is approved for the treatment of GAD, and either LUNESTA 3 mg (n=294) or placebo (n=301) for the first eight weeks, followed by a two-week period in which patients discontinued study drug but continued receiving escitalopram and placebo. As compared with patients in the placebo-escitalopram treatment group, patients in the LUNESTA-escitalopram treatment group showed statistically significant (p<0.05) improvements from baseline in sleep onset, total sleep time (TST TST 1 Toxic shock toxin 2 Treadmill stress test, see there ), wake time after sleep onset (WASO) and number of awakenings, during each double-blind assessment week and when averaged over the 8-week, double-blind treatment period. The LUNESTA-escitalopram group demonstrated reductions from baseline in HAM-A (Hamilton Anxiety Rating Scale, a standard scale used to assess anxiety in clinical trials and consisting of a list of symptoms commonly associated with anxiety) and HAM-D HAM-D Hamilton Depression Scale 17 (Hamilton Depression Rating Scale The Hamilton Depression Rating Scale (HAM-D) is a 21-question multiple choice questionnaire which doctors may use to rate the severity of a patient's depression. It was originally published in 1960 by Max Hamilton, and is presently one of the most commonly used scales for rating , a standard scale used to assess depression in clinical trials and consists of a list of symptoms commonly associated with depression) scores that were statistically significantly greater (p<0.05) than those seen in the placebo-escitalopram group during each assessment week of the 8-week, double-blind treatment period. LUNESTA was well tolerated over the treatment period. * LUNESTA Elderly Study Publication The results of a large, randomized, double-blind, placebo-controlled, two-week study of LUNESTA for the treatment of insomnia in elderly patients were published in the September 2006 edition of the journal, Current Medical Research and Opinion. The study was conducted in 49 centers across the United States and included elderly patients (64-86 years of age; n=264) who met DSM-IV criteria for primary insomnia and screening polysomnographic (PSG PSG, n polysomnograph; polygraph performed during sleep. Physiological variables such as pulse, blood pressure, and respiration are monitored and charted. ; a type of study conducted in a sleep laboratory) criteria. Patients were randomized to two weeks of nightly treatment with either LUNESTA 2 mg or placebo. Efficacy and safety were assessed at overnight sleep laboratory visits using PSG measures and Interactive Voice Response System (IVRS IVRS Interactive Voice Response System IVRS Iowa Vocational Rehabilitation Services IVRS Ironside Volunteer Rescue Squad (Maryland) ) morning and evening questionnaires, and through patient-reported IVRS morning and evening questionnaires at home. The study showed that elderly patients with chronic primary insomnia who were administered LUNESTA 2 mg experienced statistically significant (p<0.05) improvements in measures of sleep maintenance (ability to sleep through the night), sleep induction (time to fall asleep) and sleep duration (total sleep time), as assessed by both PSG objective measurements and patient-reported subjective measures, versus those patients administered placebo. In this study, LUNESTA was generally well tolerated with the most frequently reported adverse events being pain, dry mouth, dizziness, somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess. som·no·lence n. 1. A state of drowsiness; sleepiness. 2. and unpleasant taste. Important Safety Information - LUNESTA LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of depression, GAD or menopause. LUNESTA works quickly and should only be taken immediately before bedtime. Patients should have at least eight hours to devote to sleep before becoming active. Patients should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. Patients should use extreme care when engaging in these activities the morning after taking LUNESTA. Patients should not use alcohol while taking any sleep medicine. Most sleep medicines carry some risk of dependency. Patients should not use sleep medicines for extended periods without first talking to their doctor. Patients should see their doctor if they experience unusual changes in thinking or behavior, or if sleep problems do not improve in 7 to 10 days as this may be due to another medical condition. Side effects may include unpleasant taste, headache, drowsiness and dizziness. XOPENEX([R]) brand levalbuterol HCl Inhalation Solution -- XOPENEX Inhalation Solution is a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma. bron·cho·spasm n. in patients 6 years of age and older with reversible obstructive airway disease, such as asthma. Asthma is a chronic lung disorder characterized by reversible airway obstruction and a pathologic finding of airway inflammation. According to the 2002 National Health Interview Survey conducted by the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. , 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 Bronchodilators Definition Bronchodilators are medicines that help open the bronchial tubes (airways) of the lungs, allowing more air to flow through them. are the most-prescribed asthma therapy among primary care physicians and pediatricians in the U.S., according to IMS Health information. Recent XOPENEX Inhalation Solution Clinical Data Presentation * XOPENEX Inhalation Solution Clinical Outcomes and Cost-Effectiveness Study Results Presented In October 2006, results of a randomized, prospective, open-label, multi-center study assessing clinical outcomes and cost-effectiveness of the use of XOPENEX Inhalation Solution in hospitalized patients were presented at CHEST 2006, the annual meeting of the American College of Chest Physicians The American College of Chest Physicians (ACCP) is a medical organization consisting of physicians and non-physician specialists in the field of chest medicine, which includes pulmonology, thoracic surgery, and critical care medicine. (ACCP ACCP American College of Chest Physicians ACCP American College of Clinical Pharmacy ACCP Army Correspondence Course Program ACCP Atlantic Climate Change Program ACCP Association of Caribbean Commissioners of Police ACCP Assembly of Caribbean Community Parliamentarians ). In this study, patients were administered either XOPENEX Inhalation Solution (n=241) or racemic racemic /ra·ce·mic/ (ra-se´mik) optically inactive, being composed of equal amounts of dextrorotatory and levorotatory isomers. ra·ce·mic adj. Abbr. albuterol albuterol /al·bu·ter·ol/ (al-bu´ter-ol) a ß agonist used as the base or sulfate salt as a bronchodilator. al·bu·ter·ol n. (n=238) by nebulization nebulization /neb·u·li·za·tion/ (neb?u-li-za´shun) 1. conversion into an aerosol or spray. 2. treatment by an aerosol. . Patients administered XOPENEX Inhalation Solution received fewer total nebulizations during their hospital stay versus patients administered albuterol (median 10 for XOPENEX, 12 for albuterol; p=0.03). No significant differences were observed between the two groups in measures of FEV FEV forced expiratory volume. FEV abbr. forced expiratory volume FEV forced expiratory volume. 1 (forced expiratory volume in one second forced expiratory volume in one second (fōrsdˑ ek·spīˑ·r ), duration of hospital stay, relapse rate, total hospital costs or respiratory costs. The results of this study confirmed that less frequent administration of XOPENEX Inhalation Solution maintained comparable efficacy compared with albuterol without increasing the cost of therapy and may be cost effective when compared to the use of albuterol. XOPENEX Inhalation Solution was generally well tolerated in this study. XOPENEX HFA([R]) brand levalbuterol tartrate Inhalation Aerosol MDI -- XOPENEX HFA is a hydrofluoroalkane (HFA) metered-dose inhaler (MDI), which is a portable, hand-held device consisting of a pressurized pres·sur·ize tr.v. pres·sur·ized, pres·sur·iz·ing, pres·sur·iz·es 1. To maintain normal air pressure in (an enclosure, as an aircraft or submarine). 2. canister containing medication and a mouthpiece through which the medication is inhaled. Indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease, XOPENEX HFA complements the XOPENEX Inhalation Solution product line and provides patients with a portable means of administering XOPENEX. Recent XOPENEX HFA Clinical Data Presentations * XOPENEX HFA Long-Term Safety and Tolerability Study Results Presented In October 2006, results of a randomized, open-label, active-controlled, multi-center, parallel-group safety study were presented at CHEST 2006. The study evaluated patients 12 years of age and older with stable asthma who were treated four times daily with either XOPENEX HFA (n=496) or PROVENTIL([R]) HFA (albuterol; n=250) over 12 months. In the study, the overall incidence of adverse events in the XOPENEX HFA (72%) and PROVENTIL HFA (76.8%) groups was similar. The rate of adverse events with the potential to be related to the specific pharmacologic action of these drugs, including tachycardia, palpitation palpitation (păl'pĭtā`shən), abnormal heartbeat that is often associated with a sensation of fluttering or thumping. The normal heartbeat is not noticeable to the individual. , chest pain, arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of , hypertension, dyspepsia dyspepsia: see indigestion. , nausea, leg cramps, dizziness, insomnia, nervousness, anxiety and tremor, was 13.3% in patients administered XOPENEX HFA, and 18.4% in patients administered PROVENTIL HFA. Asthma-related adverse events were similar between treatment groups: 18.3% for the XOPENEX HFA treatment group and 19.6% for the PROVENTIL HFA treatment group. Lung function with chronic dosing was also assessed in this study. The mean percent change in FEV1 one hour after the first dose was 18.1% for patients treated with XOPENEX HFA and 16.3% for patients treated with PROVENTIL HFA. At Week 52, the mean percent change in FEV1 was 12.7% for patients treated with XOPENEX HFA and 11.6% for patients treated with PROVENTIL HFA. XOPENEX HFA was generally well tolerated in this study. * XOPENEX HFA Exercise-Induced Bronchospasm Study Results Presented Also presented at CHEST were the results of a double-blind, randomized, placebo-controlled crossover study of 15 adult mild-to-moderate asthmatic patients with exercise-induced bronchospasm (EIB See NIST binary. ) who were administered either XOPENEX HFA or placebo pre-exercise to evaluate the ability to prevent EIB. The study evaluated the maximum decrease in FEV1 post-exercise. In the study, patients treated with XOPENEX HFA demonstrated a statistically significantly smaller (p<0.001) decrease in post-exercise FEV1 compared with patients treated with placebo (5.82% decrease for patients treated with XOPENEX HFA and 21.8% decrease for patients administered placebo; p=0.0002). A statistically significantly higher percentage of patients administered XOPENEX HFA were protected from EIB compared with patients treated with placebo (93.3% for patients treated with XOPENEX HFA compared with 53.3% patients administered placebo; (p=0.0143). XOPENEX HFA was generally well tolerated in this study. XOPENEX HFA is not indicated for prevention of EIB and this study was not specifically designed to support such an indication. * XOPENEX HFA Safety and Tolerability Study Results Presented In November 2006, clinical data for XOPENEX HFA were presented at the American College of Allergy, Asthma and Immunology annual meeting. This study compared safety and tolerability of cumulative doses of XOPENEX HFA MDI with those from a racemic albuterol HFA MDI in a group of asthmatic subjects. Asthmatic patients who met randomization randomization (ranˈ·d to disperse or empty by flooding with water or other solvent. medullary solute washout a syndrome in which the relative hyperosmolarity of the renal medulla is reduced due to an excessive loss of sodium and chloride from period, they were crossed-over and received a total of 16 puffs of the other treatment. Measures of heart rate, blood pressure, serum potassium and glucose concentrations were obtained pre-dose, after each dose, and up to eight hours after the final dose. Changes in mean heart rate following one and two cumulative puffs did not differ significantly between the XOPENEX HFA and racemic albuterol HFA groups. However, changes in mean heart rate after 4, 8, and 16 cumulative puffs were significantly higher for racemic albuterol compared to XOPENEX HFA. Median (R)-albuterol concentrations appeared to increase proportionally with dose for both treatments. Median plasma concentrations of (R)-albuterol following each dose of XOPENEX HFA were approximately 10% to 28% lower than those observed following the corresponding doses of racemic albuterol HFA, and this difference in (R)-albuterol levels became more pronounced with increased doses. When subjects received racemic albuterol HFA, median (S)-albuterol concentrations were consistently two-to-five-times higher than (R)-albuterol concentrations. Improvement in FEV1 was comparable between treatment groups, as were changes in serum potassium, glucose concentrations and blood pressure. Important Safety Information - XOPENEX XOPENEX HFA Inhalation Aerosol and XOPENEX Inhalation Solution are contraindicated in patients with a history of hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to levalbuterol, racemic albuterol or any other component of XOPENEX HFA Inhalation Aerosol or XOPENEX Inhalation Solution. XOPENEX HFA Inhalation Aerosol 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 sympathomimetic /sym·pa·tho·mi·met·ic/ (-mi-met´ik) 1. mimicking the effects of impulses conveyed by adrenergic postganglionic fibers of the sympathetic nervous system. 2. an agent that produces such an effect. 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 hyperthyroidism: see thyroid gland. , or convulsive con·vul·sive adj. 1. Characterized by or having the nature of convulsions. 2. Having or producing convulsions. convulsive pertaining to, characterized by, or of the nature of a convulsion. disorders. Also, see the complete prescribing information regarding potential drug interactions with beta-blockers, diuretics Diuretics Definition Diuretics are medicines that help reduce the amount of water in the body. Purpose Diuretics are used to treat the buildup of excess fluid in the body that occurs with some medical conditions such as congestive heart , digoxin digoxin: see digitalis. or MAOI MAOI monoamine oxidase inhibitor. MAOI abbr. monoamine oxidase inhibitor Monoamine oxidase inhibitor (MAOI) An older class of antidepressants. and tricyclic antidepressants. BROVANA[TM] brand arformoterol tartrate Inhalation Solution -- Approved by the FDA on October 6, 2006, BROVANA is a long-term, twice-daily (morning and evening), maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. (COPD COPD chronic obstructive pulmonary disease. COPD abbr. chronic obstructive pulmonary disease Chronic obstructive pulmonary disease (COPD) ), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only. BROVANA is the first long-acting bronchodilator bronchodilator /bron·cho·di·la·tor/ (-di´la-ter) 1. expanding the lumina of the air passages of the lungs. 2. an agent which causes dilatation of the bronchi. to be approved as an inhalation solution for use with a nebulizer nebulizer /neb·u·liz·er/ (neb´u-li?zer) atomizer; a device for throwing a spray. neb·u·liz·er n. , which is a machine that converts liquid medication into a fine mist that is inhaled through a mouthpiece or mask. According to the National Center for Health Statistics National Center for Health Statistics (NCHS) is part of the Centers for Disease Control and Prevention (CDC), which is part of the United States Department of Health and Human Services. NCHS is the United States' principal health statistics agency. , COPD is the fourth leading cause of death in the U.S., and in 2004, approximately 12 million adults in the U.S. were reported to have COPD. Approximately 24 million adults have evidence of impaired lung function, which may indicate that COPD is under-diagnosed, according to the National Heart, Lung, and Blood Institute National Heart, Lung, and Blood Institute, n.pr established in 1948, this division of the National Institutes of Health is responsible for research and education on cardiovascular, pulmonary, systemic diseases, and sleep disorders. (NHLBI NHLBI, n.pr See National Heart, Lung, and Blood Institute. ). COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function. According to the NHLBI, COPD includes chronic bronchitis, chronic obstructive bronchitis and emphysema, or combinations of these conditions. * BROVANA Launch Update Sepracor plans to complete launch preparations and commercially introduce BROVANA during the second quarter of 2007. Upon launch, Sepracor's sales force will promote BROVANA in hospitals and to primary care physicians and pulmonologists who treat patients with COPD. Recent BROVANA Clinical Data Presentation * BROVANA Phase III Study Results Presented In October 2006, results of a double-blind, randomized, placebo-controlled, multi-center Phase III study that included 739 adult patients with COPD were presented at CHEST 2006. The study evaluated airway function improvement with BROVANA and salmeterol (SEREVENT([R])) MDI compared with placebo over a period of 12 weeks in patients with COPD. Patients treated with BROVANA demonstrated clinically meaningful and statistically significant improvement in morning trough FEV1 throughout the 12-week study period versus patients administered placebo. At Week 0, representing the first day of treatment, patients treated with BROVANA 15 mcg demonstrated mean percent improvement in morning trough FEV1 change from baseline of 21.8% versus 6.3% for those administered placebo (p<0.001). At Week 12, patients treated with BROVANA 15 mcg showed a mean percent improvement in morning trough FEV1 change from baseline of 14% versus 4.7% for those administered placebo (p=0.003). In the study, the percentage of patients in the BROVANA 15 mcg treatment group who achieved improvement in FEV1 that was greater than or equal to 10% from predose was 88.3% versus 55.1% for patients administered placebo, at Week 0. The median time to achieve this response was 3.3 minutes in the BROVANA 15 mcg group and 213.7 minutes for those administered placebo. At Week 12, 84.3% of patients administered BROVANA 15 mcg demonstrated a 10% or greater increase in FEV1 while 40.7% of patients in the placebo group achieved a 10% or greater improvement in FEV1. At Week 12, the median time to achieve this response was 10.0 minutes for the BROVANA 15 mcg group and not applicable for the placebo treatment group, given that less than 50% of subjects responded. BROVANA was well tolerated in this study. BROVANA has not been demonstrated to have an impact on the progression of disease or the survival of patients with COPD. Important Safety Information - BROVANA Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (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 arformoterol (a long-acting beta2-adrenergic agonist), the active ingredient in BROVANA. Data are not available to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists. BROVANA is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only. BROVANA is not indicated for the treatment of acute episodes of bronchospasm, i.e. rescue therapy. BROVANA should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists. BROVANA should not be used with other medications containing long-acting beta2-agonists. As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted. BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of BROVANA at the recommended dose, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. changes, such as flattening of the T wave, prolongation of the QTC interval and ST segment depression. The clinical significance of these findings is unknown. BROVANA, as with other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension; in patients with convulsive disorders or thyrotoxicosis thyrotoxicosis /thy·ro·tox·i·co·sis/ (thi?ro-tok?si-ko´sis) a morbid condition due to overactivity of the thyroid gland; see Graves' disease. thy·ro·tox·i·co·sis n. ; and in patients who are unusually responsive to sympathomimetic amines. In clinical studies, the numbers and percent of patients who reported adverse events were comparable in the BROVANA 15 mcg twice daily and placebo groups. The most frequent adverse events reported in patients taking BROVANA that were greater than the frequency reported in patients taking placebo were pain (8%), chest pain (7%), back pain (6%), diarrhea (6%) and sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. (5%). BROVANA, as with other long-acting beta2-adrenergic agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors Monoamine Oxidase Inhibitors Definition Monoamine oxidase inhibitors (MAO inhibitors) are medicines that relieve certain types of mental depression. , tricyclic antidepressants, or drugs known to prolong the QTC interval because these agents may potentiate po·ten·ti·ate v. 1. To make potent or powerful. 2. To enhance or increase the effect of a drug. 3. To promote or strengthen a biochemical or physiological action or effect. the action of adrenergic agonists on the cardiovascular system. Phase I and Preclinical Development The following is a summary of some of Sepracor's products under development. SEP-225289 Update -- SEP-225289 is a serotonin, norepinephrine norepinephrine (nôr'ĕpīnĕf`rən), a neurotransmitter in the catecholamine family that mediates chemical communication in the sympathetic nervous system, a branch of the autonomic nervous system. and dopamine reuptake inhibitor Dopamine Reuptake Inhibitors (DARI), Dopamine Uptake Inhibitors, Dopamine Transporter Inhibitors are compounds that inhibit the reuptake of extracellular dopamine back into the presynaptic cell by blocking the cell membrane-spanning dopamine transporter. (SNDRI SNDRI Scottish Nutrition and Diet Resources Initiative ), for the treatment of major depressive disorder Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder and is currently in Phase I. Sepracor plans to advance SEP-225289 into a Phase II proof-of-concept study during 2007. Based on preclinical data, SEP-225289 appears to be a highly potent reuptake inhibitor with a mechanism that has a balanced action across the three neurotransmitters. According to the National Institutes of Health, major depression is one of the most common chronic conditions as approximately 18 million Americans have a depressive disorder in any given year. Major depression is described as when five or more symptoms of depression are present for at least two weeks. These symptoms include feeling sad, hopeless, worthless or pessimistic. In addition, people with major depression often have behavior changes, such as new eating and sleeping patterns. Evidence suggests that between 29 percent and 46 percent of depressed patients fail to fully respond to antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. treatment with marketed drugs.3 According to IMS Health information, the U.S. market for prescription antidepressants Antidepressants Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics was approximately $10.1 billion in 2005. SEP-227162 Update -- SEP-227162 is a serotonin and norepinephrine reuptake inhibitor (SNRI SNRI Serotonin and Norepinephrine Reuptake Inhibitor SNRI Sierra Nevada Research Institute (University of California - Merced) SNRI Stark Neurosciences Research Institute (Indiana University) ) for the treatment of depression and is currently in Phase I. Sepracor plans to advance SEP-227162 into a Phase II proof-of-concept study during 2007. Partnered Programs Sepracor continues to earn royalties on sales of out-licensed antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. products. These include: * ALLEGRA([R]) brand fexofenadine HCl - Marketed by sanofi-aventis, Sepracor earns royalties in countries outside the U.S. where Sepracor holds patents relating to fexofenadine, including Japan, Europe, Canada and Australia; * CLARINEX([R]) brand desloratadine HCl - Marketed by Schering-Plough Corporation, Sepracor earns royalties on sales of all formulations of CLARINEX in the U.S. and other countries where Sepracor holds patents relating to desloratadine; and * XYZAL([R])/XUSAL([TM]) brand levocetirizine - Marketed by UCB UCB - University of California at Berkeley , Sepracor earns royalties on sales of levocetirizine in European countries in which the product is sold and will be entitled to receive royalties on product sales of levocetirizine in the U.S. if and when it is approved. About Sepracor 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 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 Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . Sepracor's corporate headquarters are located in Marlborough, Massachusetts. Forward-Looking Statement This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the expected commercial launch of BROVANA brand arformoterol tartrate Inhalation Solution and the successful development and commercialization of the company's other pharmaceuticals under development; the safety, efficacy, potential benefits, possible uses and commercial success of LUNESTA brand eszopiclone, XOPENEX brand levalbuterol HCl Inhalation Solution, XOPENEX HFA brand levalbuterol tartrate and BROVANA, and all of the company's pharmaceutical candidates; and expectations with respect to collaborative agreements, the FDA approval process, and Sepracor's future growth and profitability. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected delays in commercial introduction of BROVANA and other Sepracor products; Sepracor's ability to fund and the results of further clinical trials with respect to products under development; the timing and success of submission, acceptance, and approval of regulatory filings; the scope of Sepracor's patents and the patents of others and the success of challenges by others of Sepracor's patents; the clinical benefits of the company's products; the commercial success of Sepracor's products; changes in the use and/or label of LUNESTA or Sepracor's other products; the outcome of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and regulatory decisions relating to Sepracor's patents, products and product candidates; the outcome of two class action lawsuits pending against Sepracor; the effects and outcome of the SEC's inquiry into Sepracor's stock option granting practices; the ability of the company to attract and retain qualified personnel; the performance of Sepracor's licensees and other collaboration partners and its ability to enter into new licenses and collaborations; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2006 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) Ancoli-Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353 (2 )Diagnostic and Statistical Manual of Mental Disorders Diagnostic and Statistical Manual of Mental Disorders /Di·ag·nos·tic and Sta·tis·ti·cal Man·u·al of Men·tal Dis·or·ders/ (DSM) a categorical system of classification of mental disorders, published by the American Psychiatric Association, that delineates objective - Fourth Edition (3 )Data Monitor, October 2004 Brovana is a trademark and Lunesta, Xopenex and Xopenex HFA are registered trademarks of Sepracor Inc. Lexapro is a registered trademark of American Home Products Corporation. Clarinex and Proventil are registered trademarks of Schering Corporation. Allegra is a registered trademark of Merrell Pharmaceuticals. Xusal is a trademark and Xyzal is a registered trademark of UCB, Societe Anonyme. Serevent is a registered trademark of Glaxo Group Limited. DSM-IV is a registered trademark of the American Psychiatric Association The American Psychiatric Association (APA) is the main professional organization of psychiatrists and trainee psychiatrists in the United States, and the most influential world-wide. Its some 148,000 members are mainly American but some are international. . In conjunction with this fourth quarter and full-year 2006 results press release, Sepracor will host a conference call and live audio webcast beginning at 8:30 a.m. ET on January 31, 2007. To participate via telephone, dial 973-582-2749, referring to access code 8292745. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at www.sepracor.com and access the For Investors section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A PDF (Portable Document Format) The de facto standard for document publishing from Adobe. On the Web, there are countless brochures, data sheets, white papers and technical manuals in the PDF format. of the slides will be available in the For Investors section of the web site as well as in the left-hand navigation menu of the webcast viewer just prior to the start of the call. A replay of the call will be accessible by telephone after 11:00 a.m. ET and will be available for approximately one week. To replay the call, dial 973-341-3080, access code 8292745. A replay of the webcast will be archived on the Sepracor web site in the For Investors section. Condensed, consolidated statements of operations and consolidated balance sheets follow. [TABLE OMITTED] [TABLE OMITTED] For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion