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ALTANA Pharma US (AAA) Release: New Data Show Long-Term (52 Week) Use Of Alvesco(R) (Ciclesonide) Had A Low Incidence Of Oropharyngeal Side Effects In Patients With Mild-To-Moderate Asthma


11/7/2005 11:28:25 AM

ANAHEIM, Calif., Nov. 7 /PRNewswire-FirstCall/ -- A new study demonstrated that long-term (52-week) treatment with the investigational therapy Alvesco(R) (ciclesonide) had a low incidence of oropharyngeal side effects (oral candidiasis, dysphonia and pharyngitis) in adult and adolescent patients with mild-to-moderate persistent asthma. The study also found that Alvesco had no effect on the HPA-axis function, a major part of the neuroendocrine system that is believed to be a focus of the body's reactions to external stress. The data were presented today at the 2005 American College of Allergy, Asthma and Immunology annual meeting.

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. While they are generally accepted as first-line treatment for asthma, their potential for adverse systemic events can be assessed by the degree to which they cause HPA-axis suppression.

"Our findings are important because the study demonstrated that long-term therapy with ciclesonide had a favorable safety and local tolerability profile for patients with asthma," said William Berger, M.D., Southern California Research, Mission Viejo, California.

Trial Design and Results

The long-term safety of ciclesonide (CIC) was assessed in a 52-week, multicenter, open-label, extension safety study of two identical, 12-week, placebo-controlled, double-blind, randomized efficacy, safety and dose- response studies of 1,015 patients. From the original 1,015-patient population, a cohort of 229 patients was screened; 226 patients received CIC and 179 completed the extension safety study. Patients initially received CIC320 micrograms in the morning for two weeks, and at the investigators' discretion, this dosage was then individualized to CIC80, CIC160 or CIC320 micrograms, as needed to maintain asthma control. Adverse event reporting, oropharyngeal examinations, and pulmonary function (forced expiratory volume in 1 second [FEV(1)] were evaluated from baseline to study end. HPA-axis function was assessed at baseline and at six and twelve months at selected centers.

Prior to entry into this study, 84 percent of patients had previously received at least 2 weeks treatment (CIC80, 21.2 percent or 48 patients; CIC160, 23.0 percent or 52 patients; CIC320, 21.7 percent or 49 patients; placebo, 18.1 percent or 41 patients). The remaining 15.9 percent of patients (36 patients) were not involved in the initial 12-week studies (prior treatment unknown), but were re-screened for enrollment in the long-term safety study. The mean daily dose of CIC was 231.5 micrograms; 90 patients (39.8 percent) received the highest CIC dose (320 micrograms once daily) throughout the study.

Study results showed that CIC was well-tolerated over the 52-week trial. Two patients (0.9 percent) had positive cultures for oral candidiasis (thrush) and 11 patients (4.9 percent) reported pharyngitis (sore throat); one case of each was considered possibly related to treatment. Overall, 13 patients (5.8 percent) experienced at least 1 adverse event that was considered possibly related to treatment. There were no clinically relevant changes from baseline to study end in HPA-axis function, as measured by serum cortisol levels following low-dose (1 microgram) cosyntropin stimulation and 24-hour urinary free cortisol levels corrected for creatinine. While the study was not powered to detect statistical changes in FEV(1), a numerical improvement in pulmonary function was maintained throughout the study.

About Alvesco

The sanofi-aventis Group and Altana Pharma signed an agreement in 2001 to jointly develop and market Alvesco in the United States. Alvesco is approved in 32 countries and currently marketed in 11 countries. The most frequently reported adverse events seen in Alvesco U.S. 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

The 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 and in New York

About Altana

ALTANA Pharma AG is the pharmaceutical division of ALTANA AG (FWB: ALT), , headquartered in Konstanz, Germany. ALTANA Pharma is an internationally successful, research-driven company producing innovative pharmaceuticals that create a higher quality of life for patients and modern jobs for highly qualified employees. Our product range focuses on therapeutics for the treatment of gastrointestinal and respiratory diseases, which we develop with intense research commitment. In 2004, ALTANA Pharma achieved sales of about euro 2.1 billion, up 7% from 2003. Investment in Research and Development -- approximately 20% of therapeutics sales revenues -- increased steadily and, in 2004, stood at euro 407 million. ALTANA Pharma employs more than 8,700 people in more than 30 countries. Further information is available in the Internet at http://www.altanapharma.com.

Sanofi-Aventis Forward Looking Statements

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," "plans" 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, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2004. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.

ALTANA Pharma Forward-Looking Statements

This press release contains forward-looking statements, i.e., current estimates or expectations of future events or future results. These statements are based on beliefs of ALTANA Pharma's management as well as assumptions made by and information currently available to ALTANA Pharma. Many factors that ALTANA Pharma is unable to predict with accuracy could cause ALTANA Pharma's actual results, performance or achievements to be materially different from those that may be expressed or implied by such forward-looking statements. These factors include ALTANA Pharma's ability to develop and launch new and innovative pharmaceutical products, the granting of marketing approvals by the competent authorities, price regulations for pharmaceuticals and budgeting decisions of local governments and health care providers, the level of ALTANA Pharma's investment in pharmaceuticals related R&D, the sales and marketing methods used by ALTANA Pharma to distribute its pharmaceuticals.

Forward-looking statements speak only as of the date they are made. ALTANA Pharma does not intend, and does not assume any obligation, to update forward-looking statements to reflect facts, circumstances or events that have occurred or changed after such statements have been made.

Sanofi-aventis Contact: Emmy Tsui, +1 908-243-2784, emmy.tsui@sanofi-aventis.com ALTANA Pharma Contact: Dr. Josef Goetz, Phone: +49.7531.84.2284, Fax: +49.7531.84-92284, e-mail: josef.goetz@altanapharma.com

sanofi-aventis Group; ALTANA Pharma AG

CONTACT: Emmy Tsui of Sanofi-aventis Group, +1-908-243-2784,emmy.tsui@sanofi-aventis.com; or Dr. Josef Goetz of ALTANA Pharma AG,+49-7531-84-2284, josef.goetz@altanapharma.com


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