Novartis has assumed exclusive worldwide rights to develop and commercialise QMF149, a fixed-combination of its investigational QAB149 (indacaterol) with Schering-Plough Corporation's inhaled corticosteroid mometasone, in changes announced to the companies' collaboration to develop fixed-dose combination respiratory therapies.

In development for chronic obstructive pulmonary disease (COPD) and asthma, QMF149 combines the anti-inflammatory properties of mometasone with the bronchodilation of QAB149, a long-acting beta2-adrenergic agonist.

"Novartis is seeking to build a portfolio of innovative respiratory treatments centred around indacaterol to relieve suffering from COPD and asthma, two of the most prevalent respiratory ailments," said Trevor Mundel, global head of Development at Novartis Pharma AG. "This strengthens our strategic capabilities to develop key respiratory health solutions to people with respiratory diseases."

The changes are the latest development in a successful long-term relationship between Novartis and Schering-Plough that dates back to 2002. Since August 2006, when the collaboration was expanded to jointly develop and commercialize a fixed-dose combination of QAB149 (indacaterol) and mometasone, this collaboration has completed the formoterol/mometasone combination's phase-II (asthma, COPD) and phase-III (asthma) development, while phase-II development of QAB149 (indacaterol)/mometasone (asthma, COPD) continues.

Under the new agreement with Schering-Plough, Novartis assumes exclusive worldwide rights to develop and commercialize QMF149. Schering-Plough assumes exclusive rights to develop and commercialize a fixed-combination of mometasone plus the Novartis product Foradil (formoterol), another long-acting beta2-adrenergic agonist.

Novartis will assume the remaining development and commercialization costs for the QAB149 (indacaterol)/mometasone combination, including use of the Twisthaler device, while the remaining development and future commercialization costs of the formoterol/mometasone combination, including use of a pMDI device, will be borne by Schering-Plough. There will be a royalty sharing arrangement based on sales. Novartis will also recognize sales worldwide for QMF149 upon commercialization.

QAB149 (indacaterol) is currently under regulatory review. In December 2008, Novartis submitted regulatory dossiers for approval of indacaterol in the United States and the European Union. Mometasone and formoterol are currently marketed under the trade names Asmanex and Foradil, respectively.