Schering and Novartis tweak respiratory drug collaboration

In a joint statement today, Schering-Plough and Novartis announced changes to the collaboration agreements regarding both companies' respiratory portfolios.

Schering Plough will assume exclusive worldwide rights to develop and commercialize a fixed-dose combination of its Asmanex, an inhaled corticosteroid, and Novartis's Foradil, a beta2-adrenergic receptor agonist. As a tradeoff, Novartis will assume exclusive worldwide rights to develop and commercialize a fixed-dose combination of its investigational beta2-agonist QAB149 (indacaterol), and Schering-Plough's Asmanex. Previously, both combination therapies were to be developed and marketed as joint ventures.

The Asmanex/Foradil combination is currently in phase III trials for a chronic obstructive pulmonary disease (COPD) indication, having already completed phase III for asthma. The QAB149/Asmanex combination is in phase II trials for asthma and COPD.

The Novartis combo will utilize Schering's Twisthaler, a multi-dose dry powder inhaler device, for which Schering will receive royalties based on sales, according to the statement.

“Schering-Plough has a long history in developing therapies for treating respiratory diseases,” said Thomas Koestler, EVP and president, Schering-Plough Research Institute, in the statement, adding that the company hopes to submit an NDA for the Asmanex/Foradil combo, for asthma, by the end of June.

Asmanex was FDA approved for the treatment of asthma in 2005. Foradil is indicated for asthma and COPD, and received FDA approval in 2001.

In 2002, Schering-Plough and Novartis agreed to give Schering exclusive US distribution and marketing rights to Foradil. In 2003, the companies announced an agreement for joint worldwide development and marketing for the Asmanex/Foradil combo. In 2006, the companies announced a similar joint agreement for QAB149/Asmanex.

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