Novartis Respiratory Franchise Emmanuel Puginier Global Head of Marketing & Sales, General Medicines Novartis Pharma
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1 Novartis Respiratory Franchise Emmanuel Puginier Global Head of Marketing & Sales, General Medicines Novartis Pharma Natixis Securities Conference Paris, March 2009 Disclaimer These materials contain certain forward-looking statements relating to the Group's business, which can be identified by the use of forward-looking terminology such as "outlook", "expected", "will", "potential", "pipeline", or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products, or potential future sales or earnings of the Novartis Group or any of its divisions or business units; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for existing products in any market, or that such products will achieve any particular revenue levels. Nor can there be any guarantee that the Novartis Group, or any of its divisions or business units, will achieve any particular financial results. In particular, management's expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays or government regulation generally; the Group's ability to obtain or maintain patent or other proprietary intellectual property protection, including the uncertainties involved in the US litigation process; competition in general; government, industry, and general public pricing and other political pressures; the impact that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in these materials as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. 2 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 1
2 Respiratory medicines is an industry growth driver and an attractive field for Novartis Respiratory segment one of the largest contributors to global growth Sales growth rates of top 10 therapeutic areas -5% 0% 5% 10% 15% Respiratory segment characteristics Anti-neoplastics Diabetes Asthma / COPD Analgesics Renin-A (ARB/ACE) Anti-psychotics Antibiotics 3% 3% 5% 7% 7% 9% 14% Market segment growing at +7% p.a. driven by Introduction of combination treatments and LCM products Expansion of diagnosis and treatment rates (COPD) Higher entry cost for Gx (due to inhaled delivery) Anidepr., Alzh., ADHD 2% High unmet medical needs persist Antacid/Anti-ulcer Lipid Reg 1% -2% Suboptimal patient outcomes need to be improved Source: IMS Health MIDAS MAT September 2008 (top 10 ATC-2 classes) 3 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Respiratory is a major focus in the Novartis portfolio Business unit/business franchise Exploratory Phase Confirmatory & Registration Total Cardiovascular & metabolism Oncology & hematology Neuroscience & ophthalmology Respiratory Infectious diseases, immunology & dermatology Mature products & other Total Projects are defined according to KMR criteria. (Leading to a separate regulatory filing), Phase I to Registration 4 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 2
3 The Novartis portfolio strategy is to place the unmet needs of the patients at the center of product development COPD Asthma Cystic Fibrosis PAH (Pulmonary Arterial Hypertension) IPF (Idiopathic Pulmonary Fibrosis) 5 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only COPD and asthma treatment dynamics support the rationale for building a strong presence in these areas COPD ASTHMA 2007: 210 million people, 3 million deaths annually 2007: 300 million people, 255,000 deaths annually 2025: 4 th leading cause of death globally 2025: million by 2025 Increased diagnosis rates Globally aging population Lack of treatments that reverse the inflammatory disease progression Continuing use of tobacco Urbanization in EGM markets Increased pollution in EGM markets Changes in housing and diet Increasingly allergic population Global Initiative for Chronic obstructive Lung Disease (GOLD) Global Initiative for Asthma (GINA) Source: WHO estimates 2007; numbers used are worldwide numbers 6 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 3
4 The key to success is to improve relevant patient outcomes; despite well established treatments, unmet needs persist COPD Reduce exacerbation frequency Superior lung function improvement Decrease day-/night-time symptoms Improve overall Quality of Life Decrease in breathless symptoms Reduce rescue medication use ASTHMA Modify course of disease Reduce exacerbations requiring more intensive medical care Improve Quality of Life Improve daytime activity levels Reduce symptoms at night Reduce rescue medication use Source: ATS, Chest, Niagara Phase 1, 2 & 3 Planning Shop, Dec 06 7 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Novartis is also focusing on targeted indications with high unmet need, such as Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension Disease 2008: Estimated prevalence, 270,000 Diagnosis rates ~25%; treatment rates >90% 2018: Estimated prevalence, 329,000. Due to: Increased rates of diagnosis Earlier, more effective therapy and longer survival Key needs Halt & reverse disease progression Improved survival Delayed need for lung transplantation Reduced disability and improved QoL Better ability to perform routine activities without getting breathless Safer, more convenient treatments PAH is incurable; patients suffer considerable disability Present therapy offers only palliative relief Untreated, median time to death <3 y Even with treatment, death in 3-10 y Significant unmet needs for treatments that reverse disease progression and prolong survival in PAH Source: WHO estimates 2007; numbers used are worldwide numbers 8 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 4
5 Novartis is a leader in treating cystic fibrosis (CF) and aims to improve outcomes with improved delivery Cystic Fibrosis Disease 2008: 70,000 patients worldwide & 50% are chronically infected by Pseudomonas aeruginosa (Pa) Key needs Improve administration of existing drugs Treat early to eradicate Pa Maintain patients Pa free 2020: Longer life expectancy for CF patients will see the development of more CF patients infected chronically by Pa (>80% in >18yrs old) Pseudomonas aeruginosa (Pa) accelerates lung function deterioration reducing life expectancy 33% of the chronically infected Pa patient population goes untreated 50% of those treated for Pa are not fully adherent Pseudomonas aeruginosa is the most clinically important respiratory pathogen in patients with cystic fibrosis, affecting up to 80% of patients by the age of 18 years The Cystic Fibrosis Foundation Reduce rates of exacerbation Reduce hospitalization rates and length-of-stay Reduce morbidity/mortality Improve treatment compliance Improve safety for young children Children with cystic fibrosis spend approximately 1 hour each day completing treatment tasks compared with the 6 minutes each day spent by children with asthma Ziaian et al Source: WHO estimates 2007; numbers used are worldwide numbers 9 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Franchise strategy designed to establish today, expand tomorrow and innovate in the future Establish Leverage heritage and build a foundation Maximize and leverage current business (Xolair, Foradil, TOBI ) Launch QAB149 and build foundation for Q portfolio Build share in cystic fibrosis and prepare to extend franchise Extend device platform via integration of Nektar 2 Drive sales growth by broadening portfolio Establish indacaterol as the first once-daily ultra-laba Launch novel QD LAMA (NVA) Launch, position and differentiate the indacaterol FDCs (QVA, QMF) Full complement of COPD modalities including ultra- LABA, LAMA and ICS Extend cystic fibrosis market leadership with TOBI TIP 3 Innovate Advancing care with new breakthroughs Deliver innovative new treatments for IPF, CF and other targeted indications Advance treatment of PAH patients (with Glivec ) Introduce nicotinic vaccine for smoking cessation (Nic002) Next generation devices for FDCs 10 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 5
6 Establishing the foundation for future growth Establish Leverage heritage and build a foundation 2 Drive sales growth by broadening portfolio 3 Innovate Advancing care with new breakthroughs Maximize and leverage current business (Xolair, Foradil, TOBI ) Launch QAB149 and build foundation for Q portfolio Build share in cystic fibrosis and prepare to extend franchise Extend device platform via integration of Nektar 11 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only The success of our innovative respiratory products is the basis for our future expansion Establish 2008: $728m Sales* 2008: $527m Sales* 2008: $295m Sales First biologic (anti-ige) product for asthma; life changing therapy for moderate-to-severe asthma patients Blockbuster potential, in collaboration with Genentech Approved in > 62 countries; Launched in 56 Approved in Japan (Jan 2009) First Xolair liquid approval received in EU (Feb 2009) Long-acting b2-agonist for treating asthma and COPD Fast onset with 12-hr duration of action (twice-daily dosing) WW sales growth continues despite generic competition, and FDA advisory committee recommendation Licensed to Schering Plough in US Provides foothold in important inhaled-products segment Leading inhaled antibiotic for chronic Pseudomonas aeruginosa infection Leading the cystic fibrosis category in market share Sales growth continues despite generic competition Established foundation for future innovation in cystic fibrosis * Xolair includes Genentech sales ($517m), Foradil includes Schering Plough US Sales 12 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 6
7 Xolair keeps the momentum with expanded labeling, dosing options and country access Establish Activity Objective Label Enabling Development Programs Xolair Liquid EU Xolair Liquid US Xolair Liquid* Japan Liquid Line extension Line extension Line extension Xolair Pediatrics Japan Pediatrics age 6-15 US Pediatric age 6-11* EU Pediatric age 6-11 Label expansion Label expansion Label expansion EU Dosing Table Expansion Label expansion (incl. patients with high serum IgE and weight) using data from study A2208 Chronic idiopathic urticaria* New indication EXTRA* Demonstrate efficacy as add on to Advair (ICS+LABA combo) Peds 3-5 yrs old* (FDA) * led by Genentech Assess safety/tolerability of Xolair in asthma patients age Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Impressive profile of QAB149 in COPD addresses patients needs and expected to build the foundation for portfolio Establish QAB149 is the first once-daily ultra longacting beta-2 agonist US and EU files submitted in December 2008 for COPD 2 Phase III shows sustained 24 hr bronchodilation with 150 and 300µg, sustained over 1 year and fast onset Good COPD safety profile, even at higher doses (600 µg) Additional phase III data to be presented at major congresses in 2009 Areas of Unmet Need Targeted Increased time to first exacerbation (and reduction in rate) Superior lung function improvement (FEV 1 ) vs bid LABAs; tiotropium Decrease day-/night-time symptoms Improvement in overall Quality of Life Decrease in breathless symptoms Reduction in rescue med use QAB149 Filed Dec Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 7
8 Released QAB149 Phase III data shows compelling improvement in lung function (FEV 1 ) Establish Study* B2346 B2340 B2334 B2335S B2307 Objective Comparison versus Placebo at 12 weeks 24 Hour Profile versus Placebo at Day 14 Comparison versus Placebo at 12 weeks. 52 week study. Comparison versus Placebo and Spiriva (Open Label) at 12 weeks. 6 month study. Speed of Onset: FEV1 impact 5 mins post dose versus Placebo. Details 396 randomized COPD patients, 2 arms 66 patients crossover design: 3X 14 days 1,600 randomized COPD patients, 4 arms 1,683 randomized COPD patients, 4 arms 89 patients. Single dose crossover study Active Comparator Comparison versus Placebo at 12 weeks. 52 week study. Salmeterol 50mcg bid Formoterol 12mcg bid Tiotropium 18mcg q.d. Salbutamol 200mcg; Seretide 50/500mcg Results vs Placebo +130ml +200ml +170ml (both doses) +180ml (both doses) mls; mls Comments Safety encouraging Note study duration only 2 weeks. Safety encouraging Safety encouraging Confirms rapid onset * selected Indacaterol Phase III studies used for submission 15 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only QAB149 once daily provides consistent 24 hr control and rapid improvements in lung function Establish 24hr profile 1 Study B2334 Week 52 Fast onset 2 Study B2307 Day 1 FEV 1 (L) Indacaterol 300µg qd (n=94) Placebo (n=82) FEV 1 (L) 1.6 Indacaterol 150µg (n=86) Indacaterol 300µg (n=87) Placebo (n=88) Data from 12h spirometry subset; LSM. p<0.001 for indacaterol 300µg dose vs placebo 2.Data from study B2307 d1; LSM. p<0.001 for both indacaterol doses vs placebo at post-baseline time points 16 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Time (min) 8
9 ing the franchise aggressively with new launches Establish Leverage heritage and build a foundation 2 Drive sales growth by broadening portfolio Establish QAB149 as the first once-daily ultra-laba Launch novel QD LAMA (NVA) Launch, position and differentiate the QAB149 FDCs (QVA, QMF) Full complement of COPD modalities including ultra- LABA, LAMA and ICS Extend cystic fibrosis market leadership with TOBI TIP 3 Innovate Advancing care with new breakthroughs 17 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only QAB149 expected to provide a strong platform for growth and franchise expansion into key fixed dose combinations NVA237 + qd LAMA COPD INDACATEROL (QAB149) QD ultra-laba 5 COPD 4 QVA149 qd LABA/ LAMA 6 COPD Mometasone # ICS 1 bid 2 / qd 3 Asthma QMF149* qd LABA/ICS Asthma/COPD # Schering-Plough product * QMF149: Collaboration with Schering-Plough in SP s Twisthaler device + NVA237: Licensed from Sosei R&D and Vectura Group plc 1. ICS: inhaled Corticosteroid, 2. bid: twice a day dosing, 3. qd: once a day dosing, 4. COPD: Chronic Obstructive Pulmonary Disease, 5. LABA: Long Acting β2-agonist, 6. LAMA: Long Acting Muscarinic Antagonist 18 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 9
10 QAB149 could provide foundation for Novartis to offer a wide range of COPD treatment COPD ASTHMA Corticosteroid LABA (long acting β 2 -agonist) Corticosteroid LABA (long acting β 2 -agonist) LAMA (Long acting Muscarinic antagonist) QAB NVA QVA (indacaterol+ NVA) QMF* (indacaterol+ mometasone) QMF* Size of symbol corresponds roughly to peak sales potential *in alliance with Schering-Plough 19 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Each inhaled brand potential to expand the Novartis offering with unique benefits, driving better outcomes and results Potential contribution of each brand to Novartis respiratory portfolio QAB149 NVA237 QVA149 QMF149 Establish cornerstone of franchise as superior bronchodilator Build equity for QAB-based portfolio Drive LABA/LAMA prescription regimen Establish as effective bronchodilator comparable to market leader tiotropium Support the importance of bronchodilation in mono and add-on Drive LABA/LAMA prescription regimen Key revenue driver for the respiratory franchise 1st qd LABA/LAMA FDC Targeting a superior efficacy profile vs. individual compounds for 24 hours Key revenue driver for the respiratory franchise Establish benefits of once-daily ICS/LABA FDC Asthma major source of business; COPD for patients needing an ICS 20 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 10
11 ing first with NVA237, a novel alternative to tiotropium with potential tolerability benefits Product snapshot NVA237 (glycopyrronium bromide) is an inhaled long-acting anticholinergic with selective M3 muscarinic antagonism (LAMA) Ph II trials completed successfully with efficacy similar to tiotropium, but improved tolerability profile (reduced anticholinergic side effects 1 ) Ph II results warrant further development in COPD indication Phase III to start Q2/2009 NVA237 positioned in inhaled COPD portfolio as stand-alone product and stepping stone for QVA149 FEV1 treatment difference (ml) Study A * 131* 127* 90* 75* 12.5 μg 25 μg 50 μg 100 μg Tiotropium Active versus placebo treatment contrast 1 Incidence of dry mouth included in tolerability profile of Ph II program *p<0.05. Data are least squares means ± 95% confidence intervals. 21 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Phase II studies of NVA237 completed and presented at ERS 2008 Study Active product Population Design & Objective Comparator Publication A2205 NVA237 (glycopyrronium bromide) in Concept 1 83 patients Mod.-sev. COPD 4-period incomplete block cross-over 7 day dose ranging Trough FEV 1 at day 7 Open Label Tiotropium 1 ERS 2008 A2206 NVA237 (glycopyrronium bromide) in Concept patients Mod.-sev. COPD Parallel group 28 days Safety and efficacy ECG Placebo ERS Administered via Handihaler 22 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 11
12 Potential expansion of inhaled offerings with QVA149, may be the first QD combination of 2 bronchodilators Fixed dose combination of two bronchodilators for the treatment of COPD QAB149 with NVA237 Competitive profile Anticipated superior bronchodilation compared to mono-therapies due to complementary mechanisms of action: β2-agonist plus muscarinic antagonist Clinical milestones Initial formulation work successfully completed with Concept1 device Phase II studies started in 2007, data to be presented ERS2009 Phase III to start in Q4/ Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Phase II studies for QVA149 conducted with results expected to be presented at ERS 2009 Study Active product Population Design & Objective Comparator Publication A2203 QVA149 (indacaterol & glycopyrronium bromide) in Concept patients Mod.-sev. COPD 14 day CV safety Change in 24h mean heart rate Indacaterol ERS 2009 A2204 QVA149 (Indacaterol & glycopyrronium bromide) in Concept patients Mod.-sev. COPD 4-period crossover 7 days Efficacy Trough FEV 1 at day 7 Indacaterol ERS Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 12
13 QAB149 could expand substantially with the potential introduction of QMF149 for asthma and COPD A once-daily fixed dose combination of indacaterol (ultra-laba) & mometasone (ICS) for COPD and asthma Competitive target product profile Expectation of sustained 24 hour bronchodilation with fast onset and proven QD anti-inflammatory effects A once daily LABA/ICS may provide increased compliance, improved outcomes, and become the new standard of care Initial formulation work successfully completed with Twisthaler multi-dose DPI Clinical program in progress Phase II studies started in 2007, data release anticipated in Q2/2009 FDC, fixed dose combination; LABA, long-acting β2-agonist; ICS, inhaled corticosteroid 25 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only QMF Phase II studies against active comparators Study Active product Population Design & Objective Comparator Data Release A2201 Indacaterol in Twisthaler Asthma, (~360 pts, ~60 per arm) 14-Day dose ranging (Asthma) Formoterol TBC A2202 QMF in Twisthaler Asthma (40 pts, crossover) Single dose study to show 24-hr control Advair TBC B2201 Indacaterol in Twisthaler COPD (~540 pts, ~90 per arm) 14-Day dose ranging (COPD) Formoterol TBC 26 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 13
14 ing the CF franchise beyond TOBI, TIP expected to be first anti-pseudomonal DPI 1 for patients TOBI is the leading brand for CF, indicated for patients with Pseudomonas aeruginosa. 2 TOBI administration: 300 mg / 5 ml, via nebulizer 300 mg lung dose takes 20 minutes (BID) TIP is a novel delivery expected to have the same indication as TOBI and substantial administration benefits T-326 dry powder inhaler BID dosing of 4 capsules, administration time ~3 minutes Easy storage, use and portability TIP is in Phase III of development EU submission planned Dec 2009 Device and formulation from Nektar acquisition 1 Dry Powder Inhaler 2 Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1% <25% or >75% predicted, or patients colonized with B. cepacia 27 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Innovation is an ongoing commitment to patients and results Establish Leverage heritage and build a foundation 2 Drive sales growth by broadening portfolio 3 Innovate Advancing care with new breakthroughs Deliver innovative new treatments for IPF, CF and other targeted indications Advance treatment of PAH patients (with Glivec ) Introduce nicotinic vaccine for smoking cessation (Nic002) Next generation devices for FDCs 28 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 14
15 Innovative use of imatinib (Glivec ) for the reduction of pulmonary vascular resistance in PAH Innovate Progressive disease of the pulmonary blood vessels leading to increased vascular resistance, heart failure and death (untreated, median survival is <3years) Imatinib is a potent inhibitor of PDGF receptor tyrosine kinase and has been shown to reverse pulmonary hypertension in animal models Case reports have claimed clinical benefit for Imatinib in severe PAH Further studies to start in 2009 Preliminary data supports a potential benefit in the treatment of subjects with severe pulmonary hypertension Double-blind placebo-controlled 6 mo study with Imatinib 400mg or Placebo. N= Imatinib 400 mg Placebo p<0.01 Mean Change in pulmonary vascular resistance (PVR) Dyne/s/cm 29 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Innovative approaches to drug delivery can improve outcomes through better efficacy and compliance Innovate The combination of both device and formulation technologies are essential for success of the Respiratory portfolio Novartis focuses on development of delivery platforms which are intuitive to use and train, offer superior performance, and encourage adherence to therapy Acquisition of the Nektar pulmonary business has significantly increased device and formulation options Devices Simple, highly intuitive single dose dry powder inhalers Two multi dose dry powder inhaler devices in development Liquid delivery platform (Nebulizer) Formulation and packaging technologies Particle engineering to increase stability and optimise drug delivery to the lung (lowdensity engineered particles) Leading expertise in spray drying Blister packaging technology Integrated solution to complex demands of inhaled drug delivery 30 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 15
16 Nektar acquisition provides Novartis with new delivery technologies and capabilities (beyond devices) Innovate Unique Inhalation Formulation Drugs are more stable Soluble & insoluble compounds Local & systemic delivery Conventional compounds and biologics Spray Drying Development & Commercial Manufacturing World Class Talent Device Platforms DPI for blister and high volume capsule Nebuliser High volume dry powder inhaler Intellectual Property Extensive portfolio Freedom to operate Primary Packaging Filling fine powders (~1mg 50mg), 31 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Advanced Business Use blister Only & capsule technology In summary, respiratory offers a significant opportunity for improving patient outcomes and growing shareholder value Respiratory segment is large and growing, with unmet needs and treatment dynamics that make the area commercially attractive Novartis has a solid foundation in respiratory with Xolair, Foradil and TOBI, and total current sales of $1.1 bn* QAB149 represents a major opportunity for Novartis, as potentially the first ultra-laba and the platform for QVA and QMF By targeting indications with high unmet needs, there is the potential for substantial benefits for both patients and Novartis * USD 1.5bn with sales of partners 32 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 16
17 Backup Key respiratory projects Exploratory Phase I/II Confirmatory Phase III Registration QAX576 Asthma QAU145 Cystic fibrosis NIC002 Smoking cessation QAX028 COPD 1 Tobramycin dry powder inhaler Cystic fibrosis MFF258 COPD 1 Indacaterol COPD 1 Xolair liquid form. Allergic asthma VAK694 Asthma NVA237 COPD 1 MFF258 Asthma QAV680 Asthma QVA149 COPD 1 QAX935 Allergic asthma QMF149 Asthma ACZ885 COPD 1 QMF149 COPD 1 Glivec PAH 2 1 Chronic obstructive pulmonary disease 2 Pulmonary arterial hypertension NME LCM 34 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 17
18 Xolair Program Road Map Health authority post-approval commitments FDA & EMEA Activity Lead Objective Health authority commitments A2425 EXALT (EMEA) Novartis Demonstrate suitability of Global Evaluation of Treatment Efficacy tool to assess responders at week 16 A2208 / A2210 (EMEA) Novartis Show PK/PD profile / efficacy of high doses for patients outside of current dosing table studies support also EU dosing table expansion EXTRA* Genentech Demonstrate efficacy in inadequate responders to high dose ICS/LABA combo EXCELS (FDA & EMEA) Genentech Safety registry study evaluating clinical effectiveness and long-term safety EXACT (FDA) Genentech Evaluate treatment efficacy in asthma patients with FEV1 >80% EXPECT (FDA) Genentech Evaluate safety during pregnancy Allergy Skin Test (FDA) Genentech Evaluate suitability of skin prick test to identify potential anaphylaxis candidates HAHA registry (FDA) Genentech Collect cases of HAHA 35 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only Xolair Program Road Map Phase IV studies (no IITs) publication strategy Activity A2433 experience A2432 Bronchial Biopsy Dose modulation (EXCELS sub-study) NVS NVS NVS A2437 Allergic NVS Broncho Pulmonary Aspergillosis in Cystic Fibrosis Q4229 Aeroallergen GNE US26 Highlight uncontrolled asthma among children US23 ICATA Inner-city anti-ige therapy for asthma US33 Markers of impairment Driver NVS NVS & Inner City Asthma Consortium (NIH) NVS Objective Phase IV studies Generate real life data with lyo and liquid Understand Xolair impact on airway remodeling Investigate persistency of response after treatment discont. PoC study Efficacy in specific allergic asthma Support peds launch Understand symptoms of pediatric patients living inner cities Assess ACT as tool to monitor response 36 Natixis Securities Conference E. Puginier March 2009 Respiratory Franchise Overview Business Use Only 18
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