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Novartis restructures of global collaboration with Schering-Plough for fixed-dose combination respiratory therapies

Novartis assumes exclusive worldwide development and marketing rights for investigational once-daily QMF149 being developed for COPD and asthma

22 May 2009 - Novartis has assumed exclusive worldwide rights to develop and commercialize 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. 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.
 
This transaction is subject to customary regulatory approvals.