Novartis Respiratory Franchise - ACE Analyseraceanalyser.com/Analyst Meet/100672_20090331.pdf ·...
Transcript of Novartis Respiratory Franchise - ACE Analyseraceanalyser.com/Analyst Meet/100672_20090331.pdf ·...
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Novartis Respiratory FranchiseEmmanuel PuginierGlobal Head of Marketing & Sales, General Medicines – Novartis Pharma
Natixis Securities ConferenceParis, March 2009
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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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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
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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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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
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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
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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
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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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Expanding the franchise aggressively with new launches
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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+
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”
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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
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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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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
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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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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
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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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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
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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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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
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Innovation is an ongoing commitment to patients and results
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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+
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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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
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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
17
Backup
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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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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