Alvesco Additionally Approved for Adolescents in Europe; Approval for All Severities of Persistent Asthma; Strengthening of Product Profile.BAD HOMBURG & KONSTANZ, Germany -- 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) (GER:ALT) has announced today that the indication of Alvesco(R) (ciclesonide), a novel inhaled corticosteroid (ICS (1) (Internet Connection Sharing) A Windows feature that enables two or more computers to share one Internet connection. First introduced in Windows 98 Second Edition, sharing is accomplished with network address translation (NAT), which is the common method. ), has been extended to treat mild to severe persistent asthma in adolescent patients ages 12 and older. Following this European Mutual Recognition Variation Procedure national marketing authorizations will succeed. "We're delighted that we can now make Alvesco available as an innovative therapy option even to adolescent asthma patients," said Dr. Hans-Joachim Lohrisch, President 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. "This extended approval will strengthen the Alvesco opportunity." Alvesco(R) is currently approved in 35 countries worldwide for the treatment of persistent asthma, and is available in 15 countries, among others Germany, UK, the Netherlands, Australia, and Brazil. Additional market launches are planned for the first half of 2006. A New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Alvesco(R) has been filed with the U.S. 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. . Further information about Alvesco(R) Alvesco(R) 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 Alvesco(R), the recently launched inhaled corticosteroid, the ciclesonide platform also includes a nasal spray (phase III) and a fixed combination product with long-acting beta-agonist formoterol (phase II). ALTANA Pharma 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 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 and in children under 18, 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. 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 expectation that the extended approval will strengthen the Alvesco(R) opportunities and ALTANA's plans to launch Alvesco(R) in further countries in 2006. 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. This press release is also available on the Internet at www.altana.com. |
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