Sepracor Announces Submission of Arformoterol NDA to FDA for Chronic Obstructive Pulmonary Disease

Business Wire, Dec 13, 2005

MARLBOROUGH, Mass. -- Sepracor Inc. (Nasdaq: SEPR) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for arformoterol tartrate inhalation solution, 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.

Under the Prescription Drug User Fee Act, the FDA has 60 days after submission to review an NDA in order to determine if the application may be filed. The filing of an application means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.

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 FEV(1), which is a test of lung function, versus those patients administered placebo.

"If approved, arformoterol inhalation solution may provide a meaningful medical benefit as it is the first long-acting bronchodilator to be developed in an inhalation solution that can be used in a nebulizer," said Mark H.N. Corrigan, M.D., Executive Vice President of Research and Development at Sepracor. "Many patients who are affected by COPD, which encompasses chronic bronchitis and emphysema, may prefer the inhalation solution delivery method since it can be easier to administer than other drug delivery systems."

"A significant number of patients with COPD already use nebulizers for their respiratory medications," said William J. O'Shea, President and Chief Operating Officer at Sepracor. "Many of these patients prefer nebulization over MDI therapy and may find arformoterol tartrate inhalation solution to be a useful complement to their current treatment regimen."

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 useful in improving airflow, symptoms, and reducing 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, which is comprised of more than 1,400 sales professionals. 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 and the successful development 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 success of acceptance and approval 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.