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Brovana

Generic name: arformoterol tartrate
Treatment for: COPD

Sepracor's Arformoterol NDA Filed by FDA; Drug Candidate for Chronic Obstructive Pulmonary Disease Moves Into Formal Review

MARLBOROUGH, Mass., February 13, 2006 - Sepracor Inc. (Nasdaq: SEPR) today announced that it was notified by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for arformoterol tartrate inhalation solution has been filed and is under formal review by the FDA. Arformoterol tartrate is a long-acting beta-agonist formulation for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Arformoterol, a single isomer of formoterol, is the first long-acting bronchodilator to be developed in an inhalation solution for use with a nebulizer, which is a machine that converts liquid medication into a fine mist that is inhaled through a mask; other long-acting bronchodilators currently available are formulated in dry-powder inhalers or metered-dose inhalers.

The Prescription Drug User Fee Act (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.

Sepracor completed more than 100 preclinical and 16 clinical studies of arformoterol involving more than 2,000 patients. Among the clinical studies conducted were two 12-week pivotal studies, each with more than 700 patients, as well as a large-scale, 12-month safety study. In Phase III studies, patients treated with arformoterol demonstrated a statistically significant improvement in FEV1, which is a test of lung function, versus those patients administered placebo.

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. 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 (NHLBI). 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.

Source: Sepracor Inc.

Posted: February 2006

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