Schering-Plough to file for approval of asthma therapy during first half of 2009.

Amendments to Novartis and Schering-Plough’s combination respiratory therapies collaboration has given Novartis exclusive worldwide development and marketing rights to CMF149, a fixed-dose combination of its own long-acting beta2-adrenergic agonist candidate, QAB149 (indacaterol), and Schering-Plough’s inhaled corticosteroid, mometasone furoate.

Schering-Plough gets exclusive worldwide rights to a fixed-dose combination of mometasone furoate and formoterol (Foradil®), another Novartis long-acting beta2-adrenergic agonist.

The companies will each be responsible for the development and commercialization costs of their respective combination therapies. There will also be a royalty sharing arrangement based on sales, and Schering-Plough will receive royalties and other compensation for Novartis’ use of its Twisthaler delivery system for CMF149.

Both formoterol and mometasone furoate are already approved products, and the combination therapy is in Phase III development for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Schering-Plough said it expects to file for U.S. approval of the mometasone furoate/formoterol combination, for the treatment of asthma, during the first half of 2009. CMF149 is currently in Phase II development for the treatment of asthma and COPD.

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