Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — Investor Day (September 2008)
56 slides from Teva Pharmaceutical Industries's investor day presentation, Sep 9, 2008
Slide 1: Global Innovative Resources
Global Innovative Resources Moshe Manor, Global Innovative Resources Rivka Riven Kreitman, PhD, Global Innovative R&D September 9, 2008 Jerusalem
Slide 2: Teva's Innovative Strategy
Teva’s Innovative Strategy $3 Billion in risk-adjusted revenues by 2012 Strong growth of Copaxone® and Azilect® Building a portfolio that drives growth past 2012 Leveraging Teva’s expertise, capabilities, synergies Extending our capabilities into additional focused therapeutic areas
Slide 3: Copaxone®
Copaxone®
Slide 4: Multiple Sclerosis Market Dynamics
Multiple Sclerosis Market Dynamics Significant June YTD value growth of 30% globally US: Substantial price increases and slow volume growth Outside US: Higher volume growth than US driven mainly by earlier treatment and patients resuming therapy Copaxone® and Tysabri® increasing their market shares
Slide 5: Global MS Market Represents High Growth Rate
Global MS Market Represents High Growth Rate In-Market Sales ($ Billion) 8.8 Up 26% USA Non USA 7.0 20% 5.9 15% 4.6 Up 28% Volume 5.1 15% Billion USD 21% growth 4.4 24% 3.6 8-14% 3.0 15% 2.6 17% 2.2 25% Up 25% 4.2 Volume 3.4 18% growth 2.5 13% 2.9 16% 2.2 22% 2-4% Source: Published companies financi
Slide 6: Copaxone®, the Number One Global MS Therapy
Copaxone®, the Number One Global MS Therapy Global Market Share (in value) 35% 33% 32% 30% 29% 30% 27% 24% 25% 25% 25% 25% 25% 25% 22% 23% 24% 23% 24% 23% 24% 22% % Market Share 20% 20% 21% 21% 20% 19% 15% 10% 8% 5% 5% 0.7% 0% 2003 2004 2005 2006 2007 H1/2008 Avonex Betaseron Copaxone Rebif Tysabri
Slide 7: Copaxone® Continues to Increase Market Share Both in the US and Outside the US
Copaxone® Continues to Increase Market Share Both in the US and Outside the US US MS Market Share Non-US MS Market Share (in value) (in value) 45% 42% 38% 40% 35% 36% 34% 31% 32% 32% 35% 32% 32% 31% 28% 32% 28% 30% 30% 27% 28% 28% 27% 25% 23% 23% 25% 22% 22% 17% 17% 20% 20% 16% 16% 17% 17% 16% 15% 1
Slide 8: Copaxone®: Highlights of H1 2008 Results
Copaxone®: Highlights of H1 2008 Results Copaxone® In-Market Sales - Development by Geography In-Market Sales ($M) 1800 1,713 +21% 1600 1,414 +20% 1400 619 +24% 1,176 +26% 1200 1,105 +32% Million $ 498 +26% 936 +30% 1000 394 +27% +58% 800 311 +38% 600 1,094 +19% 916 +17% 400 782 +25% 625 +26% +18% 2
Slide 9: Copaxone® – Non-US Markets
Copaxone® – Non-US Markets Canada – Copaxone® is leading the market with share of 31.4% and continues to present high growth rate Germany – Copaxone® ranks #2 with high sales growth, outpacing the market growth and closing the gap with the market leader. Number 1 in naive and switchers patient share
Slide 10: Dynamics in Copaxone® Growth
Dynamics in Copaxone® Growth Treatment-naïve patients IFNß Switchers Pool of COPAXONE® patients Switching to IFNß Switching to Tysabri®
Slide 11: Achieving a Sustained Growth in Copaxone®-treated Patients
Achieving a Sustained Growth in Copaxone®-treated Patients Treatment-naïve patients A trend for early diagnosis and treatment A proven record of increasing market share at the expense of INFs Extension of indication to include CIS patients Most IFNs Patients continue to switch to Copaxone® Results f
Slide 12: Trends Across Clinical Trials: Annualized Relapse Rate
Trends Across Clinical Trials: Annualized Relapse Rate 1.6 1.49 1.5 1.4 Annualized Relapse Rate COPAXONE 1.2 Comparator 1 0.8 0.6 0.34 0.35 0.33 0.4 0.32 0.28 0.29 0.3 0.25 0.2 0 Baseline BEYOND BECOME REGARD FORTE TYSABRI
Slide 13: Future Copaxone® Driven by a Unique Differentiation from Competitors
Future Copaxone® Driven by a Unique Differentiation from Competitors ! " # $ ,&$ ! "# # %& ' " #$ && # +)- # ' % * ./& & # $ ! )&0 / . % ' ( ) **+) 1 ! & !" ,& $ ! " % $ & " &. ##$ $ % ! ' ' 2& . # / # 3& .4 % % % /$
Slide 14: Differential Effect of GA on Neurodegeneration
Differential Effect of GA on Neurodegeneration Brain Atrophy in Early and Mildly Affected RRMS: Results of a five-year imaging study 0 PBVC over 5 years (%) Control IFNß-SC IFNß-IM GA -1 -2 -2.27 -3 -2.62 -3.21 -4 -5 -4.75 Khan O, et al. Presented at: 23rd Congress of the European Committee for Trea
Slide 15: Lasting efficacy and safety confirmed for over 10 years
Lasting efficacy and safety confirmed for over 10 years Only Copaxone® has long-term, continuous-use, prospective studies The majority of patients on long-term Copaxone® therapy remains clinically stable or improved 92% of patients still walking without assistance after 10 years Unsurpassed safety a
Slide 16: Copaxone® – Summary
Copaxone® – Summary Copaxone® will continue to lead the global MS market in this decade Copaxone® reached sales of $1.1 Billion in H1-2008 representing a 32% growth over H1-2007, adding in-market sales of $268 Million in 6 months Copaxone®’s continued growth will be driven by: Increased share in tre
Slide 17: Why a Generic Copaxone® Presents Unique Challenges
Why a Generic Copaxone® Presents Unique Challenges
Slide 18: Copaxone® cannot be fully characterized
Copaxone® It is impossible to fully characterize qualitatively and quantitatively the exact composition of Copaxone® Although Teva is constantly raising the level of scientific understanding through state of the art methods, GA is a complex product that may never be fully characterized In most ways,
Slide 19: Clinical equivalence required for generic glatiramoids
Copaxone® Because GA can not be fully characterized and because blood levels are not indicative of clinical effect, traditional bioequivalence studies are not meaningful A clinical study should be required to determine clinical equivalence New glatiramoids should also be considered new chemical enti
Slide 20: Next Generation MS Projects – Laquinimod for RRMS
Next Generation MS Projects – Laquinimod for RRMS
Slide 21: Laquinimod
Laquinimod A novel synthetic compound licensed from Active Biotech (2004): a quinoline-3-carboxamide derivative Cl O-Na+ O Ph N Et N O CH3 5-chloro-1, 2 – dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3- quinolinecarboxamide sodium salt Indication – Relapsing Remitting MS Route of administration
Slide 22: Laquinimod: Key Characteristics
Laquinimod: Key Characteristics Once daily, oral administration 0.6 mg/day Immunomodulator, NOT AN IMMUNOSUPPRESSOR Favorable long-term safety profile Excellent tolerability Early, sustained & reproducible effects on MRI activity 60% reduction in median number of Gd-T1 Lesions Trend of 33% reduction
Slide 23: Results from the First Phase II Study (AB)
Results from the First Phase II Study (AB) The 0.1mg/d dose did not show any meaningful/significant effect The 0.3mg dose showed a clear biological activity on the evolution of inflammatory lesions in this cohort With an encouraging safety profile, it was decided to perform an additional Phase II st
Slide 24: Teva's Phase IIb Study (LAQ/5062) Study Design
Teva’s Phase IIb STUDY (LAQ/5062 ) Study Design Double-blind, Placebo controlled study Duration – 36 weeks Patient population – RRMS, with 1 enhancing lesions in screening MRI scan Laquinimod 0.6mg – 106 patients Laquinimod 0.3mg – 98 patients Placebo – 102 patients MRI (T1/T2) performed at weeks 12
Slide 25: Laquinimod 0.6 mg Significantly Reduced T1 Gd-Enhancing Lesions
Laquinimod 0.6 mg Significantly Reduced T1 Gd-Enhancing Lesions 51% Reduction (Week 12-36) 60% Reduction (Week 12-36) (Mean*) p < 0.0001 (Median) p=0.01 Enhancing Lesions (week 12-36) 20 16 Mean Number of Cumulative Gd Median Number of Cumulative Gd Enhancing Lesions (week 12-36) 18 14 16 12 14 12 1
Slide 26: Effects of Laquinimod on Additional MRI Measures
Effects of Laquinimod on Additional MRI Measures (0.6 mg dose) % Reduction From Placebo Outcome Measure Mean Median† Cum. Number of Gd-T1 51% (p=0.0001) 60% (p=0.01) Lesions (week 12-36) Cum. Number of Gd-T1 40% (p=0.0048) 55% (p=0.03) Lesions (week 24-36) Cum. Number of New T2 50% (p<0.0001) 55% (p
Slide 27: Laquinimod's Effect on Relapse Rate
Laquinimod’s Effect on Relapse Rate Annualized Relapse Rate & 0.3 mg Laquinimod 0.6 mg Laquinimod Placebo Trend (p=0.09) toward reduction of annualized relapse rate Study was not powered to detect a statistical effect on relapse rate Comi, et al (LAQ/5062 Study Group). Lancet. 2008;371:2085-92.
Slide 28: Laquinimod is Safe and Well Tolerated
Laquinimod is Safe and Well Tolerated Similar drop out rate to placebo No effect on vital signs No effect on ECG No specific pattern of adverse events Elevations to potentially Clinically Significant Levels Liver Enzyme Elevation: LAQ/5062 Study Placebo 0.6mg Reversible (n=102) 0.3mg (n=98) (n=106)
Slide 29: Laquinimod – Summary
Laquinimod – Summary In LAQ/5062 study, an oral, once-daily dose of Laquinimod 0.6mg has shown: A robust, consistent and early effect on MRI activity in RRMS patients A trend in reducing the number of relapses (the study was powered to detect an effect on MRI activity) A trend in slowing the progres
Slide 30: Next Generation MS Projects – ATL/TV-1102 for RRMS
Next Generation MS Projects – ATL/TV-1102 for RRMS
Slide 31: ATL/TV-1102
ATL/TV-1102 TV-1102 was licensed in Feb 08 from ATL, an Australian based company while a Phase IIa in RR-MS patients was ongoing. ATL originally licensed the product from ISIS pharmaceuticals an US based company whose expertise is development of antisense drugs TV-1102 is a 2nd generation novel anti
Slide 32: VLA-4 is a Validated Target for the Treatment in MS
VLA-4 is a Validated Target for the Treatment in MS VLA-4 is a key adhesion molecule which plays important roles in mediating leukocyte trafficking to peripheral organ, such as the brain, by binding to its endothelial cell ligands VCAM-1, JAM-2 and extracellular matrix protein Fibronectin VLA-4 inte
Slide 33: Phase IIa Study Characteristics
Phase IIa Study Characteristics No. of Patients 77 Patients randomized (80 patients were planned) The sample size assumption was 85% power to detect an effect of 66.7% over placebo Countries Germany, Slovakia, Romania, Bulgaria, Czech Republic, Poland No. of centers 20 centers Study PIs Dr Limmroth
Slide 34: TV-1102 Reduced The Cumulative Number of New Active Lesions
TV-1102 Reduced The Cumulative Number of New Active Lesions 1.0 1.0 0.44 0.26 0.0 0.0 p=0.0128 p=0.0026 56% reduction 74% reduction On weeks 4, 8 &12 On weeks 8 &12
Slide 35: ATL/TV-1102 – Summary
ATL/TV-1102 – Summary The efficacy of TV-1102 based on MRI in the Phase II study was remarkable Results were comparable to those observed by Tysabri® in their first Phase II study (Neurology 1999) Potentially attributable adverse events included injection site reactions which were mild to moderate a
Slide 36: Other MS Products in Development
Other MS Products in Development
Slide 37: The Future of MS Therapies
The Future of MS Therapies Naive patients First-line therapies Copaxone® Consistent effect on relapses and MRI Further optimisation of dose and frequency IFNs Effect on long-term disability Potential to further enhance efficacy and ease of use Emerging therapies and strategies Oral treatments Ag-spe
Slide 38: The Future of MS Therapies: Safety Issues
The Future of MS Therapies: Safety Issues Monoclonal antibodies (Alemtuzumab anti CD52; Campath-1H and Natalizumab anti VLA-4) – can be associated with specific side-effects, e.g. PML, Graves’ disease, ITP FTY720 – Macular edema (10 cases in phase III) and 7/250 skin malignancies in phase II Cardiot
Slide 39: Azilect®
Azilect® 39 wits TEVA PHARMACEUTICAL INDUSTRIES LTD.
Slide 40: Parkinson's Market Dynamic
Parkinson’s Market Dynamic Global PD market size 2007 – $3.3 billion Global PD market est. growth in ’08: 2- 4% in patients, 6-8 % value Main growth drivers - earlier treatment and expensive drugs Market split ~50%-50% monotherapy and adjunct therapy Leading PD Products become generic (Requip IR & M
Slide 41: Azilect® In-Market Sales ($ Millions)
Azilect® In-Market Sales ($ Millions) 90 79 80 67 70 60 53 50 40 35 30 20 9 10 0 H2/2005 H1/2006 H2/2006 H1/2007 H2/2007 H1/2008
Slide 42: Azilect® drug of choice for all PD disease stages
Azilect® drug of choice for all PD disease stages 5 1 . - 5 & / - 5 /. - 67&#" / - Azilect® Azilect®
Slide 43: Azilect® Growth Drivers
Azilect® Growth Drivers ADAGIO results will re-position the product from symptomatic treatment in mono and adjunct to disease modifying agent fulfilling PD unmet needs PD early diagnosis & treatment trend will make Azilect® drug of choice for all disease stages Inclusion of ADAGIO results in labelin
Slide 44: ADAGIO
ADAGIO 44 wits TEVA PHARMACEUTICAL INDUSTRIES LTD.
Slide 45: ADAGIO: Attenuation of Disease progression with Azilect® GIven Once-daily
ADAGIO: Attenuation of Disease progression with Azilect® GIven Once-daily Background: Rasagiline is a MAO-B inhibitor containing a propargylamine moiety Approved for symptomatic treatment of Parkinson’s disease Shows neuroprotective effects in vitro and in vivo Objective: To assess rasagiline as a d
Slide 46: Delayed Start Design – Symptomatic vs. disease-modifying effect
Delayed Start Design – Symptomatic vs. disease-modifying effect ebo Plac De la ye d-s Ea rl y Symptomatic tar -st t Delayed-start ar t catches up Symptom Time improvement De ebo Plac la ye d-s tar Symptomatic & Ea t rl y Disease-Modifying -st ar Delayed-start t does not catch up Symptom Time improve
Slide 47: ADAGIO Eligibility
ADAGIO Eligibility Patients Men and women 30–80 years of age Inclusion Criteria Early idiopathic PD judged not to need symptomatic therapy for >9 months Diagnosis of PD 1.5 years before enrollment Hoehn & Yahr stage <3 Exclusion Criteria Patients with atypical or secondary parkinsonism were excluded
Slide 48: ADAGIO Study Design
ADAGIO Study Design 1 mg/day Early PD patients 1 mg/day not using any Placebo anti-PD 2 mg/day medication 2 mg/day Randomization 1:1:1:1 Week -4-4 0 4 12 24 36 42 48 54 60 66 72 36-week (9-month) 36-week (9-month) Double Blind Placebo- Double Blind Active- Controlled Phase Treatment Phase Primary en
Slide 49: ADAGIO Principal Statistical Analyses: 3 Hierarchical Steps
Schematic to Illustrate the ADAGIO Principal Statistical Analyses: 3 Hierarchical Steps Superiority of Slopes in Superiority of Early Start vs Placebo Controlled Delayed Start at Study End (mean Phase (weeks 12 – 36): UPDRS change from baseline to week 72): Mean UPDRS change from baseline Are Curves
Slide 50: ADAGIO Baseline Characteristics
ADAGIO Baseline Characteristics Patients randomized (n) 1176 Male patients (n, %) 718 (61.1%) Age, years (mean, SD) 62.2 (9.6) PD duration, months (mean, SD) 4.5 (4.6) UPDRS total score (mean, SD) 20.4 (8.5) UPDRS motor score (mean, SD) 14.2 (6.4) Modified Hoehn & Yahr (mean, SD) 1.5 (0.5) Olanow et
Slide 51: ADAGIO Results: Primary Analyses (1 mg/day)
ADAGIO Results: Primary Analyses (1 mg/day) Analysis A: Superiority of Slopes in Placebo Controlled Phase, Weeks 12 – 36 Slope(Rasagiline) – Slope(Placebo) = - 0.05 (p=0.0133; 95%CI: -0.08,-0.01) Curves are Diverging Analysis B: Superiority of Mean Change in UPDRS Scores at Week 72) Early-Start(Week
Slide 52: ADAGIO Results: Primary Analyses (2 mg/day)
ADAGIO Results: Primary Analyses (2 mg/day) The 2 mg/day early-start group: showed significant benefits versus placebo in the placebo phase (primary analysis A) did not show superiority versus the delayed-start group at the end of the active phase (primary analysis B) The 2 mg/day dose is not approv
Slide 53: ADAGIO – Summary
ADAGIO – Summary ADAGIO is a prospective delayed-start study in PD that uses novel endpoints to determine effects on disease progression ADAGIO results support a potential “disease modifying” effect for rasagiline 1 mg/day ADAGIO confirms the symptomatic benefit for rasagiline versus placebo in pati
Slide 54: Thank You!
Thank You! 54 EWS TEVA PHARMACEUTICAL INDUSTRIES LTD.
Slide 55: Back-up
55 wits TEVA PHARMACEUTICAL INDUSTRIES LTD.
Slide 56: Innovative Products and Growth Opportunities
Innovative Products and Growth Opportunities - < 1' ( ( 6$ $ 7 6)86 9 1' ( 06 1' ( ( ;$ 1' ( (( = ' 1' ( (( '$ - - . / - . /: ' 1' ( ( ( ( 5 != 01 / 5 # 88 1' ( ( 2 3402/ 5 ! >$ = 0 $ / 5 0 1' ( ( 1' ( (( ) % ) % ' ( $ *++,!*+ + *+ * Study results meet endpoint (announced Dec. 2007); file submitted
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