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ALTANA Pharma: Once-Daily Alvesco Provides Comparable Relief of Asthma Symptoms to Twice-Daily Budesonide and Fluticasone

Posted on: Monday, 21 March 2005, 06:00 CST

ALTANA Pharma, the pharmaceutical group of ALTANA AG (NYSE:AAA; FWB:ALT), presented data during the American Academy of Allergy, Asthma and Immunology's (AAAAI) 61st annual meeting, demonstrating that once-daily Alvesco(R) (ciclesonide), a new inhaled corticosteroid for the treatment of asthma, is comparable to already marketed twice-daily inhaled corticosteroids, budesonide and fluticasone propionate.

"Often, patients will miss a dose of their asthma medication, which could increase the likelihood of serious asthma complications," noted principal investigator Professor H. Magnussen, Medical Director of the Centre of Pneumology and Thoracic Surgery in Grosshansdorf, Germany. "These findings are significant because they show that patients can control their symptoms with a once-daily inhalation like Alvesco, which may enhance compliance."

Once-Daily Ciclesonide vs. Twice-Daily Fluticasone

In a 12-week study comparing Alvesco(R) with fluticasone propionate, 697 patients 12-75 years of age, with persistent asthma, received either one inhalation of Alvesco(R) 80 mcg or Alvesco(R) 160 mcg in the evening, or inhalations of fluticasone propionate 88 mcg in both the morning and evening (fluticasone propionate total daily dose 176 mcg). Both once-daily Alvesco(R) treatments were as effective as fluticasone 88 mcg twice-daily in improving FEV(1) which was the primary measure for assessing efficacy. In addition, both treatments resulted in comparable improvements in asthma symptoms and use of rescue medication. The treatment was well tolerated while the incidence of adverse events was comparable in all treatment groups. Most common adverse events were nasopharyngitis and asthma deterioration.

Once-Daily Ciclesonide vs. Twice-Daily Budesonide

In the second study, 404 adult patients with persistent asthma, who were receiving 400-500 mcg/day of the inhaled corticosteroid beclomethasone dipropionate or equivalent doses from other products were switched to budesonide 200 mcg twice-daily for 2 - 2.5 weeks (budesonide total daily dose 400 mcg). Following the baseline treatment, patients were randomized to receive either budesonide (200 ug twice-daily) or once-daily inhalation of Alvesco(R) (160 mcg either in the morning or evening) for 12 weeks. All treatments maintained their lung function at the end of the baseline period with no significant change from baseline in FEV1 for any of the treatment groups, which was the primary measure for assessing efficacy. In all patients, asthma symptom scores and the use of rescue medication decreased or remained comparable to the baseline values during the 12-week treatment period. Patients had asthma symptom- and rescue medication-free days on 91% of the days with Alvesco(R) 160 mcg once-daily, and 93% of the days with budesonide 200 mcg twice-daily.

The treatment was well tolerated. The incidence of adverse events was comparable in all treatment groups with asthma deterioration and upper respiratory tract infection as the most reported ones.

"An important observation in this study," noted Stefan Hellbardt, PhD, Clinical Research Pulmonology, ALTANA Pharma, "was that once-daily Alvesco could be taken in either the morning or evening. The added dosing flexibility provides patients with the opportunity to structure their medication regimen in a way that will help them remember to take their treatment daily."

Further Information About Alvesco

Alvesco(R) is currently approved in more than 20 countries and to-date has been launched in the UK and Germany. UK served as the Reference Member State for the Mutual Recognition Procedure of Alvesco(R) in other European countries and 20 European countries have mutually agreed to the summary of product characteristics (SmPC) for Alvesco(R). ALTANA Pharma plans further Alvesco(R) launches worldwide later this year. A New Drug Application (NDA) for Alvesco(R) has been filed with the U.S. FDA.

Alvesco(R) is an inhaled corticosteroid with novel release and distribution properties resulting in lung-targeted anti-inflammatory effects. Inhaled corticosteroids (ICS) are 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 Alvesco(R), a newly launched orally inhaled corticosteroid, the platform also includes ciclesonide nasal spray (phase III) and ciclesonide as a fixed combination product with formoterol (phase II). ALTANA partners with Sanofi-Aventis in the United States and with Teijin in Japan on the future marketing and distribution of ciclesonide.

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. 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 ALTANA's plans to launch Alvesco(R) in further countries in 2005. These statements are based on beliefs of ALTANA's management as well as assumptions made by and information currently available to ALTANA. Many factors that ALTANA is unable to predict with accuracy could cause ALTANA'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'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's investment in pharmaceuticals related R&D, the sales and marketing methods used by ALTANA to distribute its pharmaceuticals.

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.

Source: Business Wire

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