SEPRACOR PRESENTS RESULTS FROM BROVANA TRIAL

Sepracor has presented data from a Phase III pivotal trial of Brovana (arformoterol tartrate) Inhalation Solution at the annual meeting of the American College of Chest Physicians.

The data included results of a double-blind, randomized, placebo-controlled, multicenter Phase III study that included 739 adult patients with chronic obstructive pulmonary disease (COPD). The study evaluated airway function improvement with Brovana and Serevent (salmeterol) metered-dose inhaler compared with placebo over a period of 12 weeks in patients with COPD.

Patients treated with Brovana demonstrated clinically meaningful and statistically significant improvement in morning trough FEV1 throughout the 12-week study period versus patients given placebo. Morning trough FEV1 refers to the measure of forced expiratory volume in one second, obtained just prior to the morning dose. On the first day of treatment, patients treated with Brovana 15 micrograms demonstrated mean percent improvement in morning trough FEV1 change from baseline of 21.8 percent versus 6.3 percent for those given placebo. At week 12, Brovana patients showed a mean percent improvement in morning trough FEV1 change from baseline of 14 percent versus 4.7 percent for those given placebo.

Approved by the FDA earlier this month, Brovana is a long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. The drug is for use by nebulization only. Brovana is the first long-acting bronchodilator to be approved as an inhalation solution for use with a nebulizer. Sepracor plans to launch Brovana during the second quarter of 2007.