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Arformoterol Study Data Presented at European Respiratory Society Annual Congress.


MARLBOROUGH, Mass. -- Sepracor Inc. (Nasdaq: SEPR) today announced that it presented a poster of pooled data from Phase III trials of 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 at the 16th Annual Congress of the European Respiratory Society (ERS ERS,
n.pr See extended rotated side-bent.
) in Munich, Germany.

Arformoterol tartrate inhalation solution is a long-acting beta-agonist formulation proposed for long-term maintenance treatment of 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. A New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for arformoterol tartrate inhalation solution is currently under U.S. Food and Drug Administration (FDA) review. The Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.  (PDUFA) date for arformoterol is October 12, 2006. A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission.

Arformoterol, a single isomer of formoterol, 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 developed in 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; other long-acting bronchodilators Bronchodilators Definition

Bronchodilators are medicines that help open the bronchial tubes (airways) of the lungs, allowing more air to flow through them.
 currently available in the U.S. are formulated in dry-powder inhalers.

Efficacy of Nebulized Arformoterol, a Long-Acting Beta2-Adrenergic Bronchodilator, in Patients with COPD: Results from Two Pooled Phase III Trials

Results of two identically-designed, double-blind, randomized, placebo-controlled, multicenter studies that included 1,456 adult patients with COPD were presented. The studies evaluated airway function improvement with arformoterol and salmeterol (SEREVENT(R) metered-dose inhaler) compared with placebo over a period of 12 weeks in patients with COPD.

Patients treated with nebulized arformoterol demonstrated clinically meaningful and statistically significant improvement in airway function, as compared to placebo, throughout the dosing interval, over the entire 12-week duration of the trials. The improvement in FEV(1) continued to be observed even at the end (trough) of the dosing interval. The trial data showed that a substantial proportion of arformoterol-treated patients attained a greater or equal to 10% post-dose improvement in FEV(1) after 12 weeks of daily dosing (78.4-86.6% arformoterol; 56.1% salmeterol; and 43.9% placebo). The median time to achieve a 10% response at Week 12 was 3-13 minutes for patients treated with nebulized arformoterol and 142 minutes for patients administered salmeterol.

FEV(1) is the volume exhaled during the first second of a forced expiratory maneuver started after a complete and full inhalation. FEV(1) is a well standardized and frequently used index for assessing airway obstruction in COPD.

"These data suggest that arformoterol provides sustained and rapid bronchodilation bron·cho·di·la·tion or bron·cho·dil·a·ta·tion
n.
An increase in the caliber of a bronchus or bronchial tube.


bronchodilation
 for patients with COPD who need a nebulized long-term maintenance treatment," stated Nicola Hanania, M.D., Associate Professor of Medicine, Baylor College of Medicine Baylor College of Medicine is a private medical school located in Houston, Texas, USA on the grounds of the Texas Medical Center. It has been consistently rated the top medical school in Texas and among the best in the United States. , Houston. "I'm excited that a new nebulized treatment option for patients with COPD is currently under FDA review. For many patients with COPD, nebulization nebulization /neb·u·li·za·tion/ (neb?u-li-za´shun)
1. conversion into an aerosol or spray.

2. treatment by an aerosol.
 can provide a very effective delivery system."

Arformoterol was well tolerated in these studies, with COPD exacerbations (periodic worsening of breathing symptoms) occurring with similar or lower frequency than were observed in the placebo and salmeterol treatment groups.

In addition to the aforementioned poster presentation, three other arformoterol posters were presented. They included: Nebulized Arformoterol in COPD - Safety Results from Two Pooled Phase III Trials; Exposure-Response Relationship for Nebulized Arformoterol in Subjects with COPD; and Population Pharmacokinetics of Nebulized Arformoterol in Subjects with COPD.

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 2003, an estimated 11 million adults in the U.S. had 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. Bronchodilator medications are used to improve airflow and COPD symptoms, and to reduce the occurrence and/or severity of exacerbations in patients affected by COPD.

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 arformoterol, the date by which the FDA is expected to complete its review of the arformoterol NDA and successful development, regulatory approval and expected commercial launch of arformoterol. 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; the timing and outcome of the FDA's review of the arformoterol NDA and other regulatory filings; 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.

Serevent is a registered trademark of Glaxo Group Limited Corporation.

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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Publication:Business Wire
Geographic Code:1USA
Date:Sep 5, 2006
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