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Alvesco (Ciclesonide) Additionally Approved for Adolescents in Europe for All Severities of Persistent Asthma
BAD HOMBURG and KONSTANZ, GERMANY -- February 17, 2006 -- Altana AG has announced today that the indication of AlvescoŽ (ciclesonide), a novel inhaled corticosteroid (ICS), 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 of Altana Pharma. "This extended approval will strengthen the Alvesco opportunity."
Alvesco 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) for Alvesco has been filed with the U.S. FDA.
Further information about Alvesco
Alvesco 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, the recently launched inhaled corticosteroid, the ciclesonide platform also includes a nasal spray (phase 3) and a fixed combination product with long-acting beta-agonist formoterol (phase 2). 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, 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 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.
SOURCE: Altana AG
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