BioWorld International Correspondent
Altana AG and Aventis SA jointly filed a new drug application with the FDA for Alvesco, a corticosteroid for the treatment of persistent asthma.
"Altana has had a partnership with Aventis on this compound since 2001 that covers co-development and marketing," Steffen Mueller, Altana spokesman, told BioWorld International. "Aventis is responsible for submission in the United States, and the companies will be doing joint sales in the U.S. Altana is responsible for submission in both the European Union and the rest of the world. Altana holds the marketing rights outside the United States."
Altana submitted the drug for approval in the UK in the summer of 2002.
Alvesco is an inhaled corticosteroid that the companies said has novel release and distribution properties. Most asthma treatments are based on corticosteroids, which reduce inflammation in patients' lungs and airways.
Aventis, of Lyon, France, will steer the compound through the NDA process. Mueller declined to speculate on how long approval might take.
Along with the FDA submission, Aventis has begun a year-long Phase IIIb trial to examine more closely the safety and tolerability of high doses of Alvesco in adult patients with moderate to severe asthma. The American Academy of Allergy, Asthma and Immunology estimates that more than 17 million Americans currently have asthma.
The trial will study the occurrence of lens opacity ocular events, sometimes seen in patients treated with high doses of inhaled corticosteroids, including a small number of patients in one previous Phase III Alvesco trial. The study was not a required for submitting the application to the FDA.
"This submission opens up a new field for Altana," Mueller said. "This is our first large project in respiratory diseases." The Bad Homburg, Germany-based company has another respiratory product well advanced in its pipeline. "Daxas, the company's brand name for roflumilast, is a treatment for asthma and chronic obstructive pulmonary disease. It's well into clinical trials, and we have an agreement for co-development with Pfizer [Inc., of New York]. We want to submit it for approval in Europe in February 2004. Afterward, Pfizer will do the same for the United States."
In September 2003, Altana completed a Phase III trial for roflumilast in 1,400 patients suffering from chronic obstructive pulmonary disease.