New Data Show Long-Term (52 Week) Use of Alvesco(R) (ciclesonide) Had a Low Incidence of Oropharyngeal Side Effects in Patients
07 Novembro 2005 - 11:02AM
PR Newswire (US)
Latest Findings Presented at the 2005 American College of Allergy,
Asthma and Immunology Annual Meeting Also Demonstrated Alvesco Had
No Effect on HPA-Axis Function 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 (EURONEXT: SAN) and in
New York (NYSE:SNY) About Altana ALTANA Pharma AG is the
pharmaceutical division of ALTANA AG (FWB: ALT), (NYSE:AAA),
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
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ALTANA Pharma's ability to develop and launch new and innovative
pharmaceutical products, the granting of marketing approvals by the
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the level of ALTANA Pharma's investment in pharmaceuticals related
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Sanofi-aventis Contact: Emmy Tsui, +1 908-243-2784, ALTANA Pharma
Contact: Dr. Josef Goetz, Phone: +49.7531.84.2284, Fax:
+49.7531.84-92284, e-mail: DATASOURCE: sanofi-aventis Group; ALTANA
Pharma AG CONTACT: Emmy Tsui of Sanofi-aventis Group,
+1-908-243-2784, ; or Dr. Josef Goetz of ALTANA Pharma AG,
+49-7531-84-2284, Web site: http://www.sanofi-aventis.com/
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