SEPRACOR'S NDA FOR INHALED COPD DRUG APPROVED

Sepracor has announced that the FDA approved its new drug application (NDA) for Brovana (arformoterol tartrate) Inhalation Solution 15 micrograms as a long-term, twice-daily, maintenance treatment for broncho-constriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Brovana is for use by nebulization only. The drug is the first long-acting beta2-agonist to be approved as an inhalation solution for use with a nebulizer.

Sepracor completed 16 clinical studies of Brovana, involving more than 2,000 patients. Among the clinical studies conducted were two 12-week studies, each with more than 700 patients, as well as an 800-patient, 12-month safety study. In Phase III studies, patients treated with Brovana demonstrated a statistically greater improvement in FEV1, a measure of lung function, than placebo. Brovana 15 micrograms twice daily significantly improved broncho-dilation compared with placebo over the 12 hours after dosing. This improvement was maintained over the 12-week study period.

"The approval of Brovana adds another important treatment option to Sepracor's respiratory franchise," said W. James O'Shea, president and CEO of Sepracor. "Upon launch, Sepracor's sales force will promote Brovana in hospitals and to primary care physicians and pulmonologists who treat COPD patients. It remains our target to complete launch preparations and introduce Brovana during the second quarter of 2007."