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21
May
2009

Novartis announces restructuring of global collaboration with Schering-Plough to develop fixed-dose combination respiratory therapies

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 today to the companies' collaboration to develop fixed-dose combination respiratory therapies.


(1888PressRelease) May 21, 2009 - 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 centered around indacaterol to relieve suffering from COPD and asthma, two of the most prevalent respiratory ailments," said Trevor Mundel, MD, 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.
This transaction is subject to customary regulatory approvals.

About Novartis
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world.

For more information, please visit http://www.novartis.com.

Novartis Media Relations
Central media line : +41 61 324 2200

Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff ( @ ) novartis dot com

Peter Shelby
Novartis Pharma Communications
+41 61 324 4470 (direct)
+41 79 597 6353 (mobile)
peter.shelby ( @ ) novartis dot com

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