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Studies Show Once-Daily Alvesco(R) (ciclesonide) Has Minimal Mouth- and
Throat-Related Side Effects in Asthma Patients
Latest Findings of Investigational Inhaled Corticosteroid Presented at 2004
AAAAI Annual Meeting
SAN FRANCISCO, March 20 /PRNewswire-FirstCall/ -- New data show that once-daily
treatment with the investigational therapy Alvesco(R) (ciclesonide) in
mild-to-moderate asthma patients is well-tolerated, with an incidence of
oropharyngeal side effects (thrush, hoarseness and sore throat) similar to
placebo. The data were presented at the 2004 American Academy of Allergy,
Asthma & Immunology (AAAAI) 60th Annual Meeting.
(Logo: http://www.newscom.com/cgi-bin/prnh/20000501/NYM197 )
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.
"Inhaled corticosteroids are first-line therapyfor all severities of persistent
asthma, but patient tolerability and side effects like oral and throat
infections can limit their use," said William E. Berger, MD, MBA, clinical
professor, College of Medicine, Department of Pediatrics, Division of Allergy
and Immunology, University of California, Irvine and lead investigator of the
two studies. "Ciclesonide is a promising new agent that when administered is
activated when it enters the lungs. Our findings suggest that these release and
distribution properties translate into less potential for local side effects."
Trial Design and Results
Investigators conducted two identical phase III, multicenter, double-blind,
randomized, placebo-controlled, parallel-group trials. Mild-to-moderate asthma
patients received either ciclesonide 80 micrograms/day (CIC80), 160
micrograms/day (CIC160), 320 micrograms/day (CIC320) or placebo once daily in
the morning for 12 weeks. Tolerability and oropharyngeal side effects were
monitored. Suspected oral fungal infections were verified by culture.
Results of the two studies showed that more patients on ciclesonide than those
on placebo (85.2% vs. 66.7%) completed 12 weeks of treatment. Incidences of the
following oropharyngeal side effects were similar for ciclesonide and placebo:
* oral candidiasis or thrush (CIC80 1.2%, CIC160 0.0%, CIC320 1.6%,
placebo 0.4%)
* hoarseness (CIC80 0.4%, CIC160 0.0%, CIC320 0.8%, placebo 0.4%)
* pharyngitis or sore throat (CIC80 5.4%, CIC160 4.0%, CIC320 5.1%,
placebo 5.2%)
About Alvesco
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 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 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/.
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 regardingrisks 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.
To receive a copy of this release or any recent release, visit the Aventis
Pharmaceuticals U.S. Web site at http://www.aventis-us.com/.
http://www.newscom.com/cgi-bin/prnh/20000501/NYM197DATASOURCE: Aventis
CONTACT: Corinne Hoff of Aventis Global Media Relations,
+33-3-88-99-19-16, , or Lise Geduldig,
+1-215-416-9211, , or Melissa Feltmann,
+1-908-243-7080, , both of Aventis US Product
Communications
Web site: http://www.aventis.com/