Schering-Plough, Novartis Amend COPD Pact

Schering-Plough and Novartis have amended their global collaboration for the development and commercialization of fixed-dose combination therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Schering-Plough will assume exclusive worldwide rights to develop and commercialize a fixed-dose combination of its inhaled corticosteroid Asmanex (mometasone furoate inhalation powder), and Novartis’ long-acting beta2-adrenergic receptor agonist, Foradil (formoterol fumarate). Novartis will assume exclusive worldwide rights to develop and commercialize a fixed-dose combination of Schering-Plough’s inhaled corticosteroid mometasone furoate with its investigational beta2-agonist QAB149 (indacaterol).

“Schering-Plough has a long history in developing therapies for treating respiratory diseases. This strategic action will allow us to focus our efforts within the asthma and COPD market,” said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. “The investigational fixed-dose combination of ASMANEX and FORADIL, both of which are currently approved and marketed as individual products, is in Phase III development for the treatment of asthma and COPD. Schering-Plough anticipates filing the mometasone furoate/formoterol combination for the treatment of asthma with the FDA in the first half of 2009,” added Dr. Koestler.

This is the latest development in a long-term relationship between the companies, dating back to 2002. The collaboration was expanded in August 2006 to include the joint development and commercialization of a fixed-dose combination of indacaterol and mometasone furoate. The collaboration has completed the mometasone furoate/formoterol combination’s phase II (asthma, COPD) and phase III (asthma) development, while phase III (COPD) continues. Meanwhile, the indacaterol/mometasone combination is in phase II development (asthma, COPD).

Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and COPD medications, in terms of dollar sales, according to statement by SP.

With the new pact, SP will assume the remaining development and commercialization costs of the mometasone furoate/formoterol fixed-combination product, which will utilize a meter-dose inhaler device, while Novartis will assume the remaining development and future commercialization costs of the indacaterol/mometasone furoate combination including the SP Twisthaler multi-dose dry powder inhaler device. There will be a royalty-sharing arrangement based on sales. SP will recognize sales worldwide for mometasone furoate/formoterol upon commercialization. In addition, SP will receive royalties and other compensation for Novartis’ use of the Twisthaler device.