Novartis Respiratory Franchise - ACE Analyseraceanalyser.com/Analyst Meet/100672_20090331.pdf ·...

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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 2 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only 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.

Transcript of Novartis Respiratory Franchise - ACE Analyseraceanalyser.com/Analyst Meet/100672_20090331.pdf ·...

Page 1: Novartis Respiratory Franchise - ACE Analyseraceanalyser.com/Analyst Meet/100672_20090331.pdf · Present therapy offers only palliative relief Untreated, median time to death

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Novartis Respiratory FranchiseEmmanuel PuginierGlobal Head of Marketing & Sales, General Medicines – Novartis Pharma

Natixis Securities ConferenceParis, March 2009

2 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

DisclaimerThese 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.

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3 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Respiratory medicines is an industry growth driver and an attractive field for Novartis

Source: IMS Health MIDAS MAT September 2008 (top 10 ATC-2 classes)

Sales growth rates of top 10 therapeutic areas

9%

7%

7%

5%

3%

3%

2%

1%

14%

-2%

-5% 0% 5% 10% 15%

Anti-neoplastics

Diabetes

Asthma / COPD

Analgesics

Renin-A (ARB/ACE)

Anti-psychotics

Antibiotics

Anidepr., Alzh., ADHD

Antacid/Anti-ulcer

Lipid Reg

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)

High unmet medical needs persist

Suboptimal patient outcomes need to be improved

Respiratory segment one of the largest contributors to global growthRespiratory segment characteristics

4 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Respiratory is a major focus in the Novartis portfolio

1 Projects are defined according to KMR criteria. (Leading to a separate regulatory filing), Phase I to Registration

Business unit/business franchisePhase

Exploratory Confirmatory& Registration Total

Oncology & hematology

Respiratory

Mature products & other

Cardiovascular & metabolism

Neuroscience & ophthalmology

Infectious diseases, immunology & dermatology

524111

21147

431

23221

16106

362115

Total1 41 111 152

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Asthma

COPD

Cystic Fibrosis

IPF (Idiopathic Pulmonary Fibrosis)

PAH (Pulmonary Arterial Hypertension)

The Novartis portfolio strategy is to place the unmet needs of the patients at the center of product development

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COPD and asthma treatment dynamics support the rationale for building a strong presence in these areas

Increased diagnosis ratesGlobally aging population Lack of treatments that reverse the inflammatory disease progressionContinuing use of tobacco

2007: 210 million people, 3 million deaths annually

2025: 4th leading cause of death globally

Global Initiative for Chronic obstructive Lung Disease (GOLD)

2007: 300 million people, 255,000 deaths annually

2025: 400-450 million by 2025

Source: WHO estimates 2007; numbers used are worldwide numbers

Urbanization in EGM marketsIncreased pollution in EGM marketsChanges in housing and dietIncreasingly allergic population

Global Initiative for Asthma (GINA)

ASTHMAASTHMACOPDCOPD

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ASTHMA ASTHMA COPDCOPDModify 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

The key to success is to improve relevant patient outcomes; despite well established treatments, unmet needs persist

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

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Novartis is also focusing on targeted indications with high unmet need, such as Pulmonary Arterial Hypertension (PAH)

2008: Estimated prevalence, 270,000Diagnosis rates ~25%; treatment rates >90%

2018: Estimated prevalence, 329,000. Due to:− Increased rates of diagnosis−Earlier, more effective therapy and longer survival

PAH is incurable; patients suffer considerable disabilityPresent therapy offers only palliative reliefUntreated, median time to death <3 yEven with treatment, death in 3-10 ySignificant unmet needs for treatments that reverse disease progression and prolong survival in PAH

Pulmonary Arterial Hypertension

Halt & reverse disease progressionImproved survivalDelayed need for lung transplantationReduced disability and improved QoLBetter ability to perform routine activities without getting breathlessSafer, more convenient treatments

Disease Key needs

Source: WHO estimates 2007; numbers used are worldwide numbers

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Novartis is a leader in treating cystic fibrosis (CF) and aims to improve outcomes with improved delivery

Pseudomonas aeruginosa (Pa) accelerates lung function deterioration reducing life expectancy33% of the chronically infected Pa patient population goes untreated50% of those treated for Pa are not fully adherent

2008: 70,000 patients worldwide & 50% are chronically infected by Pseudomonas aeruginosa (Pa)

2020: Longer life expectancy for CF patients will see the development of more CF patients infected chronically by Pa (>80% in >18yrs old)

Source: WHO estimates 2007; numbers used are worldwide numbers

Cystic Fibrosis

“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

Disease Key needs

Improve administration of existing drugs

Treat early to eradicate Pa

Maintain patients Pa free

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. 2006

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Franchise strategy designed to establish today, expand tomorrow and innovate in the future

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32

Leverage heritage and build a foundation

Drive sales growth by broadening portfolio

Advancing care with new breakthroughsEstablish

ExpandInnovate

2009-2010 2011-2014 2014+

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

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”

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

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Establishing the foundation for future growth

1

32

Leverage heritage and build a foundation

Drive sales growth by broadening portfolio

Advancing care with new breakthroughsEstablish

ExpandInnovate

2009-2010 2011-2014 2014+

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

12 | 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

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

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

2008: $527m Sales*2008: $728m Sales* 2008: $295m Sales

* Xolair includes Genentech sales ($517m), Foradil includes Schering Plough US Sales

Establish

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Xolair® keeps the momentum with expanded labeling, dosing options and country access

Line extensionJapan Liquid

Label expansionJapan Pediatrics age 6-15

Demonstrate efficacy as add on to Advair (ICS+LABA combo)

EXTRA*

Assess safety/tolerability of Xolair in asthma patients age 3-5

Peds 3-5 yrs old* (FDA)

Label Enabling Development Programs

New indicationChronic idiopathic urticaria*

20132008 2009 2010

Label expansion (incl. patients with high serum IgE and weight) – using data from study A2208

EU Dosing Table Expansion

Label expansionEU Pediatric age 6-11

Label expansionUS Pediatric age 6-11*

Line extensionUS Xolair Liquid*

Line extensionEU Xolair Liquid

201420122011ObjectiveActivity

* led by Genentech

Xolair®

Liquid

Xolair®

Pediatrics

Establish

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Impressive profile of QAB149 in COPD addresses patients’needs and expected to build the foundation for portfolio

QAB149 is the first once-daily ultra long-acting beta-2 agonist

US and EU files submitted in December 2008 for COPD2

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

Increased time to first exacerbation (and reduction in rate)

Superior lung function improvement (FEV1) vs bid LABAs; tiotropium

Decrease day-/night-time symptoms

Improvement in overall Quality of Life

Decrease in ‘breathless’ symptoms

Reduction in rescue med use

Areas of Unmet Need TargetedAreas of Unmet Need Targeted

Establish

QAB149Filed Dec 2008

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150 – +100mls; 300 – +120mls

+180ml (both doses)

+170ml (both doses)

+200ml

+130ml

Results vs Placebo

Note study duration only 2 weeks.

Salmeterol 50mcg bid

66 patients crossover design: 3X 14 days

24 Hour Profile versus Placebo at Day 14

B2340

Safety encouraging

Formoterol 12mcg bid

1,600 randomized COPD patients, 4 arms

Comparison versus Placebo at 12 weeks. 52 week study.

B2334

Safety encouraging

Tiotropium 18mcg q.d.

1,683 randomized COPD patients, 4 arms

Comparison versus Placebo and Spiriva (Open Label) at 12 weeks. 6 month study.

B2335S

Confirms rapid onset

Salbutamol 200mcg; Seretide 50/500mcg

89 patients. Single dose crossover study

Speed of Onset: FEV1 impact 5 mins post dose versus Placebo.

B2307

Safety encouraging

Comparison versus Placebo at 12 weeks. 52 week study.

396 randomized COPD patients, 2 arms

Comparison versus Placebo at 12 weeksB2346

CommentsActive ComparatorDetailsObjectiveStudy*

Released QAB149 Phase III data shows compelling improvement in lung function (FEV1)

* selected Indacaterol Phase III studies used for submission

Establish

16 | 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

1.Data from 12h spirometry subset; LSM. p<0.001 for indacaterol 300µg dose vs placebo2.Data from study B2307 d1; LSM. p<0.001 for both indacaterol doses vs placebo at post-baseline time points

24hr profile1Study B2334 Week 52

FEV1 (L)

1.3

1.4

1.4

1.5

1.5

1.6

1.6

0 15 30 45 60

Time (min)

FEV1 (L)

Fast onset2Study B2307 Day 1

Indacaterol 150µg (n=86)Indacaterol 300µg (n=87)Placebo (n=88)

Indacaterol 300µg qd (n=94)Placebo (n=82)

Establish

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17 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Expanding the franchise aggressively with new launches

1

32

Leverage heritage and build a foundation

Drive sales growth by broadening portfolio

Advancing care with new breakthroughsEstablish

ExpandInnovate

2009-2010 2011-2014 2014+

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”

18 | 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

QMF149*qd LABA/ICSAsthma/COPD

QVA149qd LABA/LAMA6

COPD

INDACATEROL(QAB149)QD ultra-LABA5

COPD4

Mometasone#

ICS1 bid2/ qd3

Asthma

NVA237+

qd LAMACOPD

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

# Schering-Plough product* QMF149: Collaboration with Schering-Plough in SP’s “Twisthaler” device

+ NVA237: Licensed from Sosei R&D and Vectura Group plc

Expand

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QMF*

QVA(indacaterol+

NVA)

QMF*(indacaterol+ mometasone)

QAB149 could provide foundation for Novartis to offer a wide range of COPD treatment

LAMA (Long actingMuscarinicantagonist)

Size of symbol corresponds roughly to peak sales potential

LABA (long actingβ2-agonist)

CO

PD

AS

THM

A Corticosteroid

Corticosteroid

LABA (long actingβ2-agonist)

NVA

Expand

QAB

*in alliance with Schering-Plough

20 | 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

QAB149

NVA237

QVA149

QMF149

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

Establish benefits of once-daily ICS/LABA FDC

Asthma major source of business; COPD for patients needing an ICS

Key revenue driver for the respiratory franchise

1st qd LABA/LAMA FDC

Targeting a superior efficacy profile vs. individual compounds for 24 hours

Establish cornerstone of franchise as superior bronchodilator

Build equity for QAB-based portfolio

Drive LABA/LAMA prescription regimen

Expand

Potential contribution of each brand to Novartis respiratory portfolio

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21 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Expanding first with NVA237, a novel alternative to tiotropium with potential tolerability benefits

75*

90*

131*142*

127*

0

20

40

60

80

100

120

140

160

180

200

12.5 μg 25 μg 50 μg 100 μg Tiotropium

FEV1

trea

tmen

t diff

eren

ce (m

L)

Active versus placebo treatment contrast

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 effects1)

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

1 Incidence of “dry mouth” included in tolerability profile of Ph II program *p<0.05. Data are least squares means ± 95% confidence intervals.

Study A2205

Expand

22 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

ERS 2008Placebo28 daysSafety and efficacyECG

281 patientsMod.-sev. COPDParallel group

NVA237(glycopyrronium bromide)in Concept 1A2206

ERS 2008

Publication

Open Label Tiotropium1

Comparator

7 day dose rangingTrough FEV1 at day 7

Design & ObjectivePopulationActive productStudy

NVA237(glycopyrronium bromide)in Concept 1

83 patientsMod.-sev. COPD4-period incomplete block cross-over

A2205

Phase II studies of NVA237 completed and presented at ERS 2008

1 Administered via Handihaler ®

Expand

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23 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

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 Q4/2009

Expand

24 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

ERS 2009Indacaterol7 daysEfficacyTrough FEV1at day 7

154 patientsMod.-sev. COPD4-period cross-over

QVA149(Indacaterol & glycopyrronium bromide)in Concept 1

A2204

ERS 2009

Publication

Indacaterol

Comparator

14 dayCV safetyChange in 24h mean heart rate

Design & ObjectivePopulationActive productStudy

QVA149(indacaterol & glycopyrronium bromide)in Concept 1

257 patientsMod.-sev. COPDA2203

Phase II studies for QVA149 conducted with results expected to be presented at ERS 2009 Expand

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25 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

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 asthmaCompetitive 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 DPIClinical 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

Expand

26 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

TBCAdvair

Single dose study to show 24-hr control

Asthma (40 pts, crossover) QMF in TwisthalerA2202

TBCFormoterol14-Day dose ranging (COPD)

COPD (~540 pts, ~90 per arm)

Indacaterol in TwisthalerB2201

TBC

Data Release

Formoterol

Comparator

14-Day dose ranging (Asthma)

Design & ObjectivePopulationActive productStudy

Indacaterol in Twisthaler

Asthma, (~360 pts, ~60 per arm)A2201

QMF Phase II studies against active comparators Expand

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27 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Expanding the CF franchise … beyond TOBI®, “TIP” expected to be first anti-pseudomonal DPI1 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 Inhaler2 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

Expand

28 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Innovation is an ongoing commitment to patients and results

1

32

Leverage heritage and build a foundation

Drive sales growth by broadening portfolio

Advancing care with new breakthroughsEstablish

ExpandInnovate

2009-2010 2011-2014 2014+

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

Page 15: Novartis Respiratory Franchise - ACE Analyseraceanalyser.com/Analyst Meet/100672_20090331.pdf · Present therapy offers only palliative relief Untreated, median time to death

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29 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Innovative use of imatinib (Glivec®) for the reduction of pulmonary vascular resistance in PAH

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

Mean Change in pulmonary vascular resistance (PVR)

Dyne/s/cm

-350

-300

-250

-200

-150

-100

-50

0

Imatinib400 mg Placebo

Double-blind placebo-controlled 6 mo study with Imatinib 400mg or Placebo. N=59

p<0.01Preliminary data supports a

potential benefit in the treatmentof subjects with

severe pulmonary hypertension

Innovate

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Innovative approaches to drug delivery can improve outcomes through better efficacy and compliance

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

Simple, highly intuitive single dose dry powder inhalers

Two multi dose dry powder inhaler devices in development

Liquid delivery platform (Nebulizer)

Devices

Particle engineering to increase stability and optimise drug delivery to the lung (low-density engineered particles)

Leading expertise in spray drying

Blister packaging technology

Formulation and packaging technologies

Integrated solution to complex demands of inhaled drug delivery

Innovate

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Nektar acquisition provides Novartis with new delivery technologies and capabilities (beyond devices)

Unique Inhalation Formulation• Drugs are more stable• Soluble & insoluble compounds• Local & systemic delivery• Conventional compounds and biologics

Device Platforms• DPI for blister and high volume capsule• Nebuliser• High volume dry powder inhaler

Primary Packaging• Filling fine powders (~1mg – 50mg),• Advanced blister & capsule technology

World Class Talent

Intellectual Property• Extensive portfolio• Freedom to operate

Spray Drying• Development &

Commercial Manufacturing

Innovate

32 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

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

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Backup

34 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Key respiratory projects

QAX576Asthma

QAU145Cystic fibrosis

ACZ885COPD1

NVA237 COPD1

IndacaterolCOPD1

QAX028COPD1

VAK694Asthma

NIC002Smoking cessation

MFF258Asthma

Xolair®liquid form.

Allergic asthma

1 Chronic obstructive pulmonary disease2 Pulmonary arterial hypertension

NME LCM

QAV680Asthma

QMF149Asthma

QVA149COPD1

QMF149COPD1

MFF258COPD1

Tobramycin dry powder inhaler

Cystic fibrosis

Glivec®

PAH2

QAX935Allergic asthma

ExploratoryConfirmatory

Phase IIIRegistration

Phase I/II

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35 | Natixis Securities Conference | E. Puginier | March 2009 | Respiratory Franchise Overview | Business Use Only

Xolair – Program Road MapHealth authority post-approval commitments FDA & EMEA

Health authority commitments

Demonstrate efficacy in inadequate responders to high dose ICS/LABA combo

GenentechEXTRA*

Activity Lead Objective

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 outsideof current dosing table – studies support also EU dosing table expansion

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

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Xolair – Program Road MapPhase IV studies (no IITs) – publication strategy

Investigate persistency of response after treatment discont.

NVSDose modulation (EXCELS sub-study)

PoC studyNVS

Understand Xolair impact on airway remodeling

NVS

Generate real life data with lyo and liquid

NVS

Phase IV studies A2433 eXperience

A2432 Bronchial Biopsy

A2437 Allergic Broncho Pulmonary Aspergillosis in Cystic Fibrosis

Assess ACT as tool to monitor response

NVSUS33 Markers of impairment

Understand symptoms of pediatric patients living inner cities

NVS & Inner City Asthma Consortium (NIH)

US23 ICATA Inner-city anti-IgE therapy for asthma

Support peds launchNVSUS26 Highlight uncontrolled asthma among children

GNE

Driver

Efficacy in specific allergic asthma

Q4229 Aeroallergen

20132008 2009 2010 201420122011ObjectiveActivity