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ALTANA AG: New Clinical Data on Alvesco, Ciclesonide, and its Intranasal Formulation.


Business Editors/Health/Medical Writers

BAD HOMBURG, Germany--(BUSINESS WIRE)--March 22, 2004

ALTANA AG (NYSE NYSE

See: New York Stock Exchange
:AAA AAA: see American Automobile Association.


(Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied.
) (FWB (Fixed Wireless Broadband) See fixed wireless. :ALT) announced today that new clinical data on its inhaled asthma drug Alvesco(R) (ciclesonide), and on its intranasal formulation of ciclesonide were presented at the 2004 American Academy of Allergy, Asthma and Immunology (AAAAI AAAAI American Academy of Allergy Asthma and Immunology ) 60th Annual Meeting in San Francisco. Safety studies with Alvesco(R) showed that lower-leg growth in children was not affected. The data presented for the intranasal formulation of ciclesonide showed a dose response in patients with allergic rhinitis.

In safety studies with Alvesco(R) (inhaled ciclesonide) in pre-pubertal children with mild asthma, 40, 80 and 160 micron g/day of Alvesco(R) did not affect short-term lower-leg growth (growth velocity of the right lower leg was about 0.4 mm/week in each treatment group) or HPA-axis function (mean values of urinary free cortisol cortisol (kôr`tĭsôl') or hydrocortisone, steroid hormone that in humans is the major circulating hormone of the cortex, or outer layer, of the adrenal gland. : placebo - 7.85+/-4.88; 40 micron g/d ciclesonide - 8.48+/-5.51; 80 micron g/d ciclesonide - 7.03+/-3.79; 160 micron g/d ciclesonide - 8.98+/-5.68; nmol/mmol creatinine). In children with asthma, treatment with daily doses of 40-160 micron g Alvesco(R) was associated with a minimal potential for systemic side effects and a local adverse event profile similar to placebo.

Intranasal formulation for allergic rhinitis

The intranasal formulation of ciclesonide is in Phase II/III of clinical development for the treatment of allergic rhinitis. The data presented from a phase II study showed that ciclesonide 100 micron g/day and 200 micron g/day resulted in a significantly greater change from baseline compared with placebo reflected in total nasal symptom score (TNSS TNSS total nasal symptom score ). TNSS changed from baseline: placebo - 4.19, 25 micron g/d ciclesonide - 4.81, 50 micron g/d - 4.79, 100 micron g/d -5.33, 200 micron g/d - 5.83. Intranasal ciclesonide was generally well tolerated, with a relatively low incidence of adverse events. The most common adverse events were headache and pharyngitis.

The product will primarily be developed in the U.S. where the allergic rhinitis market is valued at $6 billion, with intranasalsteroids valued at approximately $2 billion. The intranasal formulation of ciclesonide is one of the next exciting ciclesonide programs to follow Alvesco(R) in the development of this unique molecule.

Alvesco(R)

Alvesco(R) is an inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids are considered to be the foundation of asthma treatment, and they work by reducing inflammation - the underlying disease process - in the lungs and airways. In clinical trials, Alvesco(R) was shown to improve lung function, asthma symptoms, and reduce the need for medications necessary to treat acute asthma attacks. The most frequently reported adverse events seen in Alvesco(R) clinical trials were nasopharyngitis, headache and upper respiratory tract infection upper respiratory tract infection URI Infectious disease A nonspecific term used to describe acute infections involving the nose, paranasal sinuses, pharynx, and larynx, the prototypic URI is the common cold; flu/influenza is a systemic illness involving the URT .

Alvesco(R) was approved in Australia in February and has been submitted for approval in the United Kingdom, Canada and other countries. Additionally, ALTANA's U.S. partner Aventis applied to the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 for approval of the asthma drug Alvesco(R) at the end of 2003. Teijin, our partner in Japan, has submitted an application for approval for Alvesco(R) in January 2004.

Asthma

Asthma is a chronic lung disease caused by airway inflammation and results in airway constriction in response to certain stimuli. It is characterized by a variety of symptoms including wheezing Wheezing Definition

Wheezing is a high-pitched whistling sound associated with labored breathing.
Description

Wheezing occurs when a child or adult tries to breathe deeply through air passages that are narrowed or filled with mucus as a
, coughing and a tightening of the airways, which causes shortness of breath Shortness of Breath Definition

Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity.
 and can be life-threatening. According to the Global Initiative for Asthma This article is a stub. You can help Wikipedia by [ expanding it].
<includeonly></includeonly>

The Global Initiative for Asthma (GINA) is a medical guidelines organisation which works with public health officials and health care professionals globally to
 (GINA GINA - Generic Interactive Application. An application framework based on Common Lisp and OSF/Motif, designed to simplify the construction of graphical interactive applications. ) more than 300 million people worldwide suffer from asthma. The prevalence of asthma is increasing by approximately 50 percent every decade and worldwide deaths from asthma total more than 180,000 annually.

This press release contains forward-looking statements, i.e., current estimates or expectations of future events or future results. The forward-looking statements appearing in this press release include information on the presentation of study results. These statements are based on beliefs of ALTANA's management and information currently available to ALTANA. Many factors that ALTANA is unable to predict with accuracy could cause ALTANA's actual performance to be materially different from the one that may be expressed or implied by such forward-looking statements.

Forward-looking statements speak only as of the date they are made. ALTANA 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.

This press release is also available on the Internet at www.altana.com
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Mar 22, 2004
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