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Sanofi-Aventis (US Headquarters) (SNY) Release: New Data Demonstrate Alvesco(R) (ciclesonide) Has A Low Incidence Of Mouth- And Throat-Related Side Effects In Pediatric Asthma Patients


10/19/2005 5:13:06 PM

SAN ANTONIO, Texas, March 22 /PRNewswire/ -- New data presented today at the American Academy of Allergy Asthma and Immunology 61st Annual Meeting show that once-daily treatment with the investigational therapy Alvesco(R) (ciclesonide) is associated with a low incidence of local oropharyngeal side effects (thrush, hoarseness and sore throat), and is well-tolerated in pediatric patients with mild-to-severe asthma.

"Inhaled corticosteroids are often associated with local mouth- and throat-related side effects that can negatively impact initiation of treatment and patient compliance, especially among children," states Erwin W. Gelfand, MD, Chairman of the Department of Pediatrics, National Jewish Medical and Research Center, Denver, and lead investigator of the study. "The low incidence of these side effects in our study demonstrates that Alvesco was well-tolerated in pediatric patients."

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

Ciclesonide tolerability and oropharyngeal adverse events were evaluated in two identical multicenter, multinational, double-blind, placebo-controlled, parallel-group clinical trials. A total of 1,031 pediatric patients with mild-to-severe persistent asthma were randomized to receive ciclesonide (CIC) 40 MCG (CIC40), 80 MCG (CIC80), 160 MCG (CIC160), or placebo once-daily for 12 weeks. At each study visit (weeks 1, 2, 4, 8 and 12), patients underwent oropharyngeal examination to test for oral candidiasis (thrush), and suspected oral fungal infections were verified by culture.

Within the safety population (n=1,025), only three cases (0.4%) of oral candidiasis were reported; all incidences occurred in the CIC groups (CIC80, n=1; CIC160, n=2). The incidence of pharyngitis (sore throat) was similar across all CIC groups, and only one case of hoarseness (0.1%) was reported in the CIC treatment group.

About Alvesco

The sanofi-aventis Group 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 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 is the world's 3rd largest pharmaceutical company, ranking number 1 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 disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York .

The sanofi-aventis Group conducts business in the U.S. through its subsidiaries Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by Sanofi-aventis and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the year ended December 31, 2003. Other than as required by 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 Poster Session #5200, 847

sanofi-aventis

CONTACT: Melissa Feltmann of sanofi-aventis, +1-908-243-7080,melissa.feltmann@sanofi-aventis.com


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