Preliminary Phase III Data Is Positive for Novartis’ COPD Drug

QAB149 provided rapid, long-lasting benefits to patients.

Initial results from Phase III trials of Novartis’ bronchodilator candidate suggest the drug significantly improves lung function in patients with chronic obstructive pulmonary disease (COPD) compared with formoterol and tiotropium. The compound is currently under regulatory review in the EU and U.S.

These findings board well not only for approval of QAB149 but also for development of the compound in combination with other therapies. Just 48 hours ago Novartis amended its deal with Schering-Plough to obtain exclusive, worldwide development and marketing rights to such a combination therapy, which is already in Phase II. CMF149 is a fixed-dose combination of QAB149 and Schering-Plough’s inhaled corticosteroid, mometasone furoate.

Initial evaluations of QAB149 found that significant improvements in patients’ lung function were evident within five minutes of first dosing with the long-acting beta2 agonist and lasted for 24 hours. Improvements were seen from the first day of treatment, up to one year. The findings were presented at the American Thoracic Society 2009 International Conference, in San Diego.