• Phase III results show improvements in asthma symptom control for marketed doses of ALVESCO HFA (hydrofluoroalkane)
• ALVESCO HFA treatment shown to be safe and well-tolerated
• Ciclesonide in an HFA MDI (metered-dose inhaler) nasal aerosol, in development for treatment of allergic rhinitis, was well-tolerated in clinical study

Sepracor (Nasdaq: SEPR) today announced the presentation of Phase III study data for ALVESCO^® (ciclesonide) HFA Inhalation Aerosol and Phase I data for a ciclesonide HFA MDI nasal aerosol formulation for the treatment of allergic rhinitis. These results were presented at the Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Seattle.

Ciclesonide HFA MDI Nasal Aerosol Trial

The results of a 14-day, randomized, double-blind, placebo-controlled, 3-period crossover, single-center study in healthy volunteers (n=17) and patients with perennial allergic rhinitis (n=18) were orally presented. This study evaluated the pharmacokinetics, pharmacodynamics, safety and tolerability of two dosages (150 mcg and 300 mcg) of an HFA MDI formulation of the intranasal corticosteroid. In this study, systemic exposure to des-ciclesonide, which is the activated form of ciclesonide, was found to be low and similar in both healthy volunteers and patients with perennial allergic rhinitis, with no evidence of systemic accumulation over the study period. In this study, no significant effect on HPA-axis (hypothalamic-pituitary-adrenal axis; a significant part of the neuroendocrine system, which regulates several body functions) function was observed following treatment with ciclesonide HFA nasal aerosol as measured by comparable serum cortisol levels in both the ciclesonide HFA nasal aerosol and placebo groups. Both dosages of ciclesonide HFA nasal aerosol were well tolerated.

Sepracor recently initiated Phase III development for ciclesonide in an HFA nasal aerosol for the treatment of allergic rhinitis. OMNARIS is currently available in the U.S. in a hypotonic aqueous suspension nasal spray for the treatment of allergic rhinitis.

ALVESCO HFA Phase III Trial in Patients Not Previously Treated With an Inhaled Corticosteroid

The results of a 691-patient, double-blind, placebo-controlled, parallel-group, multicenter study of patients 12 years of age and older were summarized in three posters at the conference. In this study, patients received either:

• ALVESCO 80 mcg twice daily (BID) for 16 weeks;
• ALVESCO 160 mcg once daily (QD) in the morning for 16 weeks;
• ALVESCO 80 mcg BID for four weeks followed by ALVESCO 160 mcg QD in the morning for 12 weeks; or
• Placebo for 16 weeks.

The study was comprised of patients who demonstrated FEV₁^(a) of ≥60 to ≤85 percent of predicted lung function and who were determined to have uncontrolled asthma based on symptom scores, rescue inhaler use and peak expiratory flow measurements. The study demonstrated that patients who were treated with ALVESCO 80 mcg BID or ALVESCO 160 mcg QD experienced improved pulmonary function versus those patients administered placebo. In this study, ALVESCO HFA was well tolerated.

Each of the ALVESCO treatment groups (ciclesonide 80 mcg BID p<0.0001; ciclesonide 160 mcg QD p=0.0021; ciclesonide 80 mcg BID + 160 mcg QD p=0.0016) demonstrated significantly improved FEV₁ from baseline to the average of Weeks 12 and 16, compared to the placebo group (300 mL for ciclesonide 80 mcg BID; 180 mL for ciclesonide 160 mcg QD; 190 mL for ciclesonide 80 mcg BID + 160 mcg QD; and 70 mL for placebo at Week 16). Each of the ALVESCO treatment groups (ciclesonide 80 mcg BID p<0.0001; ciclesonide 160 mcg QD p=0.0006; ciclesonide 80 mcg BID + 160 mcg QD p<0.0001) also demonstrated significantly improved morning peak expiratory flow from baseline to Week 16 versus the placebo group.

All ALVESCO treatment groups (ciclesonide 80 mcg BID p<0.0001; ciclesonide 160 mcg QD p=0.0116; ciclesonide 80 mcg BID + 160 mcg QD p=0.0002) significantly reduced rescue racemic albuterol use from baseline to Week 16 versus the placebo group. The ALVESCO 80 mcg BID group (p=0.0002) and the ALVESCO 80 mcg BID + 160 mcg QD group (p=0.0325) demonstrated significant improvement in total daily asthma symptom scores versus placebo, but the reduction for the ALVESCO 160 mcg QD treatment group was not significantly different from placebo.