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ALTANA Pharma AG (AAA) Release: New Research Validates A Lower Dose Of Ciclesonide Is As Effective As Fluticasone Propionate In Asthma Maintenance Therapy


9/5/2006 2:30:22 PM

MUNICH, Germany, Sept. 4 /PRNewswire-FirstCall/ -- New efficacy data was presented for the first time at the 16th Annual European Respiratory Society (ERS) Congress confirming that a lower dose, or "stepping-down" to ciclesonide (Alvesco®), a once-daily, novel, inhaled corticosteroid (ICS) therapy for the treatment of asthma, is an equally effective maintenance treatment as twice-daily fluticasone propionate, another available asthma therapy. The goal, according to the Global Initiative for Asthma (GINA) asthma treatment guidelines, is to decrease treatment to the least medication necessary to maintain control.(1) "This study demonstrates that ciclesonide is as effective in maintaining asthma symptom control as another widely used therapy, and at a lower dose," said Professor Martin Adler, Belmont Health Centre, Harrow, UK. "In addition, because ciclesonide has once-daily dosing convenience, we may increase patient compliance and have a significant impact on quality of life."

Data from a clinical trial* included the following: - Succeeding a 2-week baseline period with ICS pre-treated patients, a 12-week randomized study was conducted. Findings demonstrate that CIC 160 micrograms once-daily is as effective as FP 250 micrograms twice-daily in maintaining symptom control in patients with stable asthma. - The median percentage of days without asthma symptoms was high and comparable between groups (98% CIC and FP). Similar results were observed for the median percentages of days without rescue medication use (p=0.59) and days without nocturnal awakenings (p=0.66). The median percentage of days where patients neither experienced asthma symptoms nor needed rescue medications was high and similar (97% CIC; 98% FP).

* Ciclesonide (CIC) 160 micrograms once-daily compared with fluticasone propionate (FP) 250 micrograms twice-daily in maintenance therapy of patients with stable asthma

Further Information About Ciclesonide

Ciclesonide is currently approved in 38 countries for the treatment of persistent asthma in adults, and is available in 20 countries, including Germany, UK, Australia, Brazil and South Africa. Additional market launches are planned for 2006. A New Drug Application (NDA) for ciclesonide has been filed with the U.S. FDA.

Ciclesonide is an inhaled corticosteroid with novel release and distribution properties resulting in lung-targeted anti-inflammatory effects. Inhaled corticosteroids (ICS), considered to be the foundation of asthma treatment, work by reducing inflammation -- the underlying disease process -- in the lungs and airways.

Ciclesonide: A Broader Product Platform

In addition to ciclesonide, a newly launched orally inhaled corticosteroid, the platform also includes ciclesonide nasal spray OMNAIR(TM) (phase III) and ciclesonide as a fixed combination product with formoterol (phase II). ALTANA Pharma partners with Sanofi-Aventis in the United States and with Teijin in Japan on various ciclesonide-based products.

About 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, coughing and a tightening of the airways, which causes shortness of breath and can be life-threatening. According to the Global Initiative for Asthma (GINA), more than 300 million people worldwide suffer from asthma; the prevalence varies from 0 to 30 percent in different populations. The prevalence of asthma is increasing by approximately 50 percent every decade and worldwide deaths from asthma total more than 180,000 annually.

About ALTANA Pharma

ALTANA Pharma AG is the pharmaceutical division of ALTANA AG (NYSE: AAA, FSE: ALT), headquartered in Konstanz, Germany. ALTANA Pharma is an internationally successful, research-based company providing innovative pharmaceuticals that create a higher quality of life for patients, modern jobs for highly qualified employees and a good return for shareholders.

The product range of ALTANA Pharma focuses on therapeutics for the treatment of gastrointestinal and respiratory diseases, which the company develops with intense research commitment.

In 2005, ALTANA Pharma achieved sales of about euro 2.4 billion, up 12% from 2004. Investment in Research and Development -- approximately one-fifth of therapeutics sales revenues -- increased steadily and, in 2005, stood at euro 418 million. ALTANA Pharma employs about 9,000 people in over 30 countries.

Further information is available on the Internet at www.altanapharma.com (1) GINA "Pocket Guide for Asthma Management and Prevention," 2005. Available at: http://www.ginasthma.org/Guidelineitem.asp??l1=2&l2=1&intId=37. Accessed on August 18, 2006.

Source: ALTANA Pharma AG



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