Healthcare Industry News: arformoterol
News Release - February 13, 2006
Sepracor's Arformoterol NDA Filed by FDADrug Candidate for Chronic Obstructive Pulmonary Disease Moves Into Formal Review
MARLBOROUGH, Mass.--(HSMN NewsFeed)--Feb. 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.
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. 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 and potential benefits of arformoterol, the date by which the FDA is expected to complete its review of the arformoterol NDA and the 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, and the 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 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.
For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
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