CI-1 Foradil ® (formoterol fumarate inhalation powder) FDA Advisory Committee Meeting July 13, 2005 FDA Advisory Committee Meeting July 13,

CI-2 Regulatory History Eric A. Floyd, MS, MBA, PhD Vice President – Global Head RDI Drug Regulatory Affairs Novartis Eric A. Floyd, MS, MBA, PhD Vice President – Global Head RDI Drug Regulatory Affairs Novartis 4

CI-3 Current Situation  Safety concerns with LABAs have been expressed in public venues  The FDA would like to review the safety profile of LABAs  The safety data of Foradil ® will be reviewed – Based on clinical trial data and post-approval experience, formoterol continues to exhibit a favorable risk/benefit profile  Safety concerns with LABAs have been expressed in public venues  The FDA would like to review the safety profile of LABAs  The safety data of Foradil ® will be reviewed – Based on clinical trial data and post-approval experience, formoterol continues to exhibit a favorable risk/benefit profile 4 LABA = Long-acting β 2 -agonist.

CI-4 Timeline First approval FranceSpain 1995 ItalyGermany 2001 US million person-yr of exposure  Approved in 83 countries

CI-5 Foradil ® Aerolizer ® in the US  The Foradil Aerolizer (formoterol fumarate inhalation powder) uses dry powder capsules for oral inhalation  12 µg bid was approved in the US for the following indications: – Maintenance treatment for asthma in individuals ≥ 5 yr of age – Acute prevention of exercise-induced bronchospasm in individuals ≥ 5 yr of age, when administered on an occasional, as-needed basis – COPD, including chronic bronchitis and emphysema  The Foradil Aerolizer (formoterol fumarate inhalation powder) uses dry powder capsules for oral inhalation  12 µg bid was approved in the US for the following indications: – Maintenance treatment for asthma in individuals ≥ 5 yr of age – Acute prevention of exercise-induced bronchospasm in individuals ≥ 5 yr of age, when administered on an occasional, as-needed basis – COPD, including chronic bronchitis and emphysema MDI = Metered dose inhaler. 4

CI-6 Foradil ® Outside the US  Foradil 12 to 24 µg bid is a widely prescribed bronchodilator outside the US – For inhalation use in adults and children 5 yr of age and older – Prophylaxis and treatment of bronchoconstriction in patients with asthma – Prophylaxis of bronchospasm induced by inhaled allergens, cold air, or exercise – Prophylaxis and treatment of bronchoconstriction in patients with reversible or irreversible COPD, including chronic bronchitis and emphysema  In some countries, it is also approved as a MDI and a multidose dry powder inhaler 10 µg (Certihaler ® )  Foradil 12 to 24 µg bid is a widely prescribed bronchodilator outside the US – For inhalation use in adults and children 5 yr of age and older – Prophylaxis and treatment of bronchoconstriction in patients with asthma – Prophylaxis of bronchospasm induced by inhaled allergens, cold air, or exercise – Prophylaxis and treatment of bronchoconstriction in patients with reversible or irreversible COPD, including chronic bronchitis and emphysema  In some countries, it is also approved as a MDI and a multidose dry powder inhaler 10 µg (Certihaler ® ) MDI = Metered dose inhaler.

CI-7 Agenda for Presentation IntroductionEric A. Floyd, MS, MBA, PhD Vice President – Global Head RDI Drug Regulatory Affairs Novartis Safety of Foradil ® Gregory P. Geba, MD, MPH Vice President – US Head RDI Clinical Development and Medical Affairs Novartis Clinical ImplicationsJames F. Donohue, MD Professor of Medicine Chief of Pulmonary Division University of North Carolina, Chapel Hill, NC 4

CI-8 Additional Expert Gary Koch, PhD Professor of Biostatistics School of Public Health University of North Carolina - Chapel Hill Gary Koch, PhD Professor of Biostatistics School of Public Health University of North Carolina - Chapel Hill 4 Novartis produces and is the license holder for Foradil ® Aerolizer ® while Schering Corporation markets the compound in the US.