ALTANA Pharma Receives First Approval to Market Alvesco-R- -Ciclesonide-.Business Editors/Health/Medical Writers BAD HOMBURG, Germany--(BUSINESS WIRE)--Feb. 27, 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 the Australian Health Agency (TGA) has granted marketing approval for Alvesco(R) (Ciclesonide) a novel inhaled corticosteroid for the treatment of asthma in adults and adolescents 12 years of age and older. This is worldwide the first approval for Alvesco(R). "Alvesco(R) is an innovative inhaled corticosteroid with unique properties that offer an important treatment option for patients with asthma. The approval of Alvesco(R) is a major milestone for ALTANA Pharma and we eagerly anticipate making the product available to patients in other important markets as well," said Dr. Hans-Joachim Lohrisch, Member of the Management Board of ALTANA AG and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of ALTANA Pharma. In the U.K., the reference member state for the EU regulatory procedure, we expect the final approval in the near future before mid of the year. 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. ALTANA Pharma and Aventis signed an agreement in 2001 to jointly develop and market Alvesco(R) in the United States. Finally, Teijin has submitted an application for approval for Alvesco(R) in January 2004 in Japan. The cooperation agreement with Teijin was signed in 1998 for marketing Alvesco(R) in Japan. Alvesco(R) is a new generation inhaled corticosteroid with novel pharmacokinetics properties. Inhaled corticosteroids are considered to be the cornerstone of asthma treatment, and they work by reducing inflammation - the underlying disease process - in the lungs and airways. 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 expected granting of the marketing approval for Alvesco(R) in the U.K. 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 currently unknown and unforeseeable side effects of ALTANA's product. 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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