New Data Demonstrate Alvesco® (ciclesonide) Significantly Reduces Oral Corticosteroid Use in Patients with Severe, Persistent Asthma
San Diego, CA
May 23, 2005
Latest Findings Presented at the 101st International Conference of the American Thoracic Society

New data show that treatment with the investigational therapy Alvesco® (ciclesonide), an inhaled corticosteroid, significantly reduced oral corticosteroid use in adults with severe, persistent asthma while maintaining asthma control.  The data were presented today at the 101st International Conference of the American Thoracic Society. 

“These findings are important because oral corticosteroids such as prednisone are known to cause systemic adverse events which can be reduced by replacing them with inhaled corticosteroids,” said Sally E. Wenzel, MD, Professor at the National Jewish Medical and Research Center, Denver, Colorado. “Our study found a significant reduction in the need for oral corticosteroid use by patients with severe, persistent asthma who were treated with ciclesonide.” 

Alvesco is an inhaled corticosteroid with novel release and distribution properties.  Inhaled corticosteroids, considered to be the foundation of asthma treatment, work by reducing inflammation – the underlying disease process – in the lungs and airways. 
 
Trial Design and Results 
The reduction of oral corticosteroid (OCS) use with the replacement of ciclesonide (CIC) was evaluated in a Phase III, 12-week, multinational, multicenter, double-blind, randomized, parallel-group, placebo (PBO)-controlled trial. A total of 141 adult patients with severe, persistent asthma, previously taking oral corticosteroids, were randomized to CIC320 or CIC640 μg BID (CIC640; CIC1280) or PBO. The minimal effective OCS dose was established for each patient during the baseline period (mean, 12.4 mg; range, 5–30 mg). The primary objective was the percent reduction in OCS dose from baseline to week 12. Secondary variables included the number of patients who eliminated OCS therapy and change in OCS dose.

The results showed that approximately 30 percent of patients treated with ciclesonide were able to eliminate their OCS use entirely: CIC640, 14 patients (29.8 percent) [P=0.0386]; CIC1280, 15 patients (31.3 percent) [P=0.0233]); PBO, 5 patients (11.1 percent). All 

ciclesonide doses resulted in a significant percent change from baseline in OCS dose compared with placebo: CIC640, -47.39 [10.10] P=0.0003; CIC1280, -62.54 [9.80] P=0.0001.  Similarly, OCS dose (mg/day) was significantly changed from baseline in ciclesonide-treated patients (CIC640, -5.97 [1.43] P=0.0008; CIC1280, -8.00 [1.38] P=0.0001). 
 
About Alvesco
The sanofi-aventis Group and Altana Pharma signed an agreement in 2001 to jointly develop and market Alvesco in the United States.  The most frequently reported adverse events seen in Alvesco US clinical trials were nasopharyngitis, headache and upper respiratory tract infection.

About Asthma
Asthma is a chronic disease of the lungs and airways. It is characterized by wheezing, coughing and a tightening of the airways, which causes shortness of breath and can be life-threatening. According to the Centers for Disease Control and Prevention (CDC), more than 20 million Americans report having asthma.  

About sanofi-aventis
Sanofi-aventis Group is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

The sanofi-aventis Group conducts its business in the United States through its subsidiaries Sanofi-Synthélabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.

Forward Looking Statements
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applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

U.S. Contact: Melissa Feltmann, +1 908-243-7080, melissa.feltmann@sanofi-aventis.com