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BROVANA(TM) (Arformoterol Tartrate) Inhalation Solution Data to Be Presented at American College of Chest Physicians Annual Meeting.


BROVANA Recently Approved by U.S. Food & Drug Administration for the Long-Term Maintenance Treatment of COPD COPD chronic obstructive pulmonary disease.

COPD
abbr.
chronic obstructive pulmonary disease


Chronic obstructive pulmonary disease (COPD) 


MARLBOROUGH, Mass. -- Sepracor Inc. (Nasdaq: SEPR) today announced that clinical data for BROVANA([TM] )(arformoterol 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 Solution will be 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), October 21 - 26, 2006 at the Salt Palace Convention Center in Salt Lake City.

The following poster will be presented during the meeting. Please note the presentation date, time and location below. The poster will be available for viewing on Monday, October 23. The investigator will be available to discuss the poster at the time indicated below.
[TABLE OMITTED]


About BROVANA

Approved by the 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.
) on October 6, 2006, BROVANA (arformoterol tartrate) Inhalation Solution 15 mcg 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), including chronic bronchitis and emphysema. BROVANA is for use 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.
 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.

It remains Sepracor's target to complete launch preparations and 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 COPD patients.

About COPD

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 has not been demonstrated to have an impact on the progression of disease or the survival of patients with COPD.

Important Safety Information

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 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.
, 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 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 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 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 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.

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 safety, efficacy and potential benefits of BROVANA, and the expected commercial launch of BROVANA. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor's ability to fund further clinical trials; results of further clinical trials; Sepracor's ability to timely complete preparations for commercial launch of BROVANA and successfully commercialize BROVANA; continued growth of the COPD market; the scope of Sepracor's patents and the patents of others; Sepracor's ability to attract and retain qualified sales personnel and other employees; and certain other factors that are detailed in the company's quarterly report on Form 10-Q for the quarter ended June 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.

Brovana is a trademark of Sepracor Inc.

For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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