Data Show Once-Daily Alvesco(R) (ciclesonide) Has No Effect on HPA-Axis Function in Asthma Patients

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: [phone]
   

   Melissa Feltmann
   Aventis US Product Communications
   Tel: [phone]
   

DATASOURCE: Aventis



CONTACT:  Lise Geduldig, [phone], , or

Melissa Feltmann, [phone], , both of

Aventis US Product Communications



Web site:  http://www.aventis-us.com/ 

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