Data Show Once-Daily Alvesco(R) (ciclesonide) Has No Effect on HPA-Axis Function in Asthma Patients Findings Presented Suggest Minimal Potential for Adverse Effects Commonly Seen With Inhaled Corticosteroids ORLANDO, Fla., May 23 /PRNewswire-FirstCall/ -- New data show that once-daily treatment with the investigational therapy Alvesco(R) (ciclesonide) in mild-to-moderate asthma patients has no effect on adrenal function, as demonstrated by measurements of the hypothalamic-pituitary-adrenal (HPA)-axis. The data were presented at the 100th International Conference of the American Thoracic Society (ATS). The HPA-axis is a major part of the neuroendocrine system, involving the interactions of the hypothalamus, the pituitary gland and the adrenal glands. The HPA-axis is believed to be a focus of the body's reactions to stress and is recognized as a surrogate marker for common adverse effects associated with the body's reaction to extra cortisol production as seen with steroid treatment. Inhaled corticosteroids are considered to be the foundation of asthma treatment. However, their use may be associated with HPA-axis suppression. "Inhaled corticosteroids, while powerful, at times can predispose patients to potentially harmful side effects, such as slowed bone growth, osteoporosis, fluid retention, or other systemic side effects," said Edward M. Kerwin, MD, medical director, Clinical Research Institute of Southern Oregon and lead investigator of the study. "In this study, ciclesonide has shown no identifiable effects on the HPA-axis integrity. This indicates that the drug may have no detectable effects on the adrenal glands." Trial Design and Results Effects of ciclesonide (CIC) on the HPA-axis were investigated in two identical Phase III, multicenter, double-blind, randomized, placebo-controlled, parallel-group trials. Mild-to-moderate persistent asthma patients (n=1,015) ages twelve and older received CIC 80 mcg (CIC80), CIC 160 mcg (CIC160), CIC 320 mcg (CIC320) or placebo (PBO) once-daily in the morning for 12 weeks. HPA-axis function was assessed at baseline and at week 12 by determining peak serum cortisol levels stimulated by one mcg cosyntropin (n=179). Additionally, 24-hour urinary cortisol levels corrected for creatinine (n=176) were assessed. Results of the two studies showed that no significant differences from baseline to week 12 in cosyntropin-stimulated peak serum cortisol levels or 24-hour urinary cortisol levels corrected for creatinine were observed for ciclesonide versus placebo. No statistically significant differences in the mean change from baseline in cosyntropin-stimulated peak cortisol (mcg/dL) after 12 weeks of treatment were observed for PBO, +0.49; CIC80, +0.22; CIC160, +1.51; and CIC320, +0.38 (P= NS for CIC80, CIC160, and CIC320 vs PBO). No statistically significant differences in the mean change from baseline in 24-hour urinary cortisol levels corrected for creatinine (mcg/mg) after 12 weeks of treatment were observed for PBO, +0.0009; CIC80, -0.0013; CIC160, +0.0033; and CIC320, +0.0001 (P= NS for CIC80, CIC160, and CIC320 vs PBO). About Alvesco Alvesco is an inhaled corticosteroid with novel release and distribution properties. In December 2003, Aventis submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of Alvesco for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children four years of age and older. Aventis and Altana 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 inflammatory 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 Aventis Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of euro 16.79 billion (US $18.99), invested euro 2.86 billion (US $3.24) in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information, please visit: http://www.aventis-us.com/. For Aventis Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Reference"- on file with the "Autorite des marches financiers" in France. Lise Geduldig Aventis US Product Communications Tel: +1 908-243-6580 Melissa Feltmann Aventis US Product Communications Tel: +1 908-243-7080 DATASOURCE: Aventis CONTACT: Lise Geduldig, +1-908-243-6580, , or Melissa Feltmann, +1-908-243-7080, , both of Aventis US Product Communications Web site: http://www.aventis-us.com/

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