Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Day (December 2007)
159 slides from Astrazeneca's investor day presentation, Dec 7, 2007
Slide 1: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Looking Statements In order to utilise the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, AstraZeneca is providing the following cautionary statement. These presentations contain forward-looking statements with r
Slide 2: Biologics Day 7 December 2007
Biologics Day 7 December 2007 David Brennan, CEO Biologics Day 7 December 2007
Slide 3: AstraZeneca strategic priorities
AstraZeneca strategic priorities “MAKING THE MOST MEANINGFUL DIFFERENCE TO PATIENT HEALTH THROUGH GREAT MEDICINES” Reshape Change our Strengthen Grow behaviour the the and our the pipeline business business culture OUR VALUES Biologics Day 7 December 2007
Slide 4: Pipeline strengthened
Pipeline strengthened Faster, leaner, better R&D Phase III up from 5 to 10 projects Combined Phase I & II up by 50% Externalisation 13 major licensing deals in ’05-’07 Strategic move into biologics Strengthen the pipeline Biologics Day 7 December 2007
Slide 5: Biologics today and in the future
Biologics today and in the future 100 Best Selling Drugs 2007 USD (consensus estimates) 2012 USD (consensus estimates) Bioengineered vaccines Bioengineered vaccines 2% 5% Biologics Biologics 24% 37% Small molecules Small molecules 74% 58% Source: EvaluatePharma Biologics Day 7 December 2007
Slide 6: AstraZeneca and New MedImmune
AstraZeneca and New MedImmune Fully leverage AZ investment and expertise in key disease areas CAT discovery combined with MEDI development, manufacturing, regulatory and commercial Global network of clinical investigators Commercialisation on a truly global scale Biologics Day 7 December 200
Slide 7: Agenda
Agenda AstraZeneca R&D: Faster, Leaner, Better John Patterson The New MedImmune David Mott MedImmune R&D Overview James Young Antibody and Protein Therapeutics Peter Kiener Vaccine Discovery George Kemble Process Development Gail Wasserman Infectious Disease & Pediatric Vaccines Genevieve Losonsky O
Slide 8: AstraZeneca R&D Faster, Leaner, Better
AstraZeneca R&D Faster, Leaner, Better John Patterson, Executive Director, Development Biologics Day 7 December 2007
Slide 9: Performance: Quality on Time
“Quality on Time” Quality Better Pipeline PERFORMANCE Leaner Faster Organisation Cycle-times Cost Speed Biologics Day 7 December 2007
Slide 10: Better Pipeline
Better Pipeline … since the FY 2006 Results Progressions and additions since FY 2006 results Projects 180 Crestor™/Fenofibric acid, 160 156 Dapagliflozin, ZD4054, Motavizumab, 22 140 10 PN400 & Recentin GBM additions 120 120 106 20 to Phase III 25 100 91 25 5 80 25 6 18 42 MEDI-524, MEDI-561, ME
Slide 11: Better Pipeline
Better Pipeline Phase III Pre- Clinical Phase I Phase II Phase III portfolio LCM PN400 Saxagliptin PN400 CRESTOR™/ ZACTIMA™ Fenofibric Acid Jul – successful FDA interaction RECENTINTM Jul/Aug – development CRESTOR™/ RECENTINTM accelerated by 6 months Fenofibric Acid 7 Sep – passed TG3 Sep – TG3 agre
Slide 12: Faster cycle times
Faster cycle times 2010 <8 years 2007 8.9 years Pre- Phase Phase Phase III 2003 - 05 clinical I II and launch 10.6 years Quality Quality Quality CDs Behaviours Processes Programmes Biologics Day 7 December 2007
Slide 13: Faster cycle times
Faster cycle times Pre-clinical target cycle times 2007 Objective AZD2184 AZD2066 AZD2624 AZD3199 AZD1283 AZD9668 AZD4121 AZD1386 AZD3241 AZD8330 AZD1305 AZD1744 AZD1236 AZD7762 AZD1940 AZD0328 AZD6370 0 10 20 30 Months Biologics Day 7 December 2007
Slide 14: Leaner organisation
Leaner organisation Increasing R&D budget – but improving cost effectiveness Programmes delivering 5% productivity improvements per annum between 2008 and 2011 Approx 1,000 FTEs impacted overall Further Disease Area strategy review conducted Streamlining Clinical data management delivering
Slide 15: AZ R&D/MedImmune
AZ R&D/MedImmune Strategically aligned, operationally independent R&D Board Market Market Biologics Small Molecules Aligned TA strategy Product Product Development Development CDs Biologicals CDs Small Molecules Combined small & large molecule target identification & Discovery collaboration Biologic
Slide 16: R&D Board
R&D Board Governance with a focus on delivery Jan Lundberg Jim Young Discovery MedImmune John Patterson Development Delivering key targets earlier: 10 projects in Phase III in 2007 vs 2010 John Kennerley John Goddard Dev. Projects SPBD Julie Brown Tony Zook Finance Global Marketing & North Ameri
Slide 17: AstraZeneca R&D Faster, Leaner, Better
AstraZeneca R&D Faster, Leaner, Better February 2006 December 2007 • Faster cycle-times • Early evidence of improving • Moving from a cycle time of 10.6 speed and quality years towards target of 8 years • • Leaner organisation Embarking on a change drive • All major R&D functions ‘re-shaping’ • Bett
Slide 18: The New MedImmune
The New MedImmune David M. Mott CEO and President Biologics Day 7 December 2007
Slide 19: The New MedImmune
The New MedImmune Responsible for all global biologics-related activities Combines MedImmune, Cambridge Antibody Technology and AstraZeneca biologics (minus financial synergies) Operationally independent, strategically aligned – Maintain agility and entrepreneurialism – Benefit from expertise
Slide 20: Achievements 1996-2006
Achievements 1996-2006 Revenues: 36% CAGR Headcount: 26% CAGR R&D: 30% CAGR (in millions) (in millions) $1,400 2,500 $500 2,250 $450 $1,200 2,000 $400 $1,000 1,750 $350 1,500 $300 $800 1,250 $250 $600 $200 1,000 $400 750 $150 500 $100 $200 250 $50 $0 0 $0 96 97 98 99 00 01 02 03 04 05 06 96 97 98 99
Slide 21: MedImmune Business Profile
MedImmune Business Profile Fully built-out, vertically integrated biotechnology company – U.S. sales and marketing organization – R&D centers: Md., U.K., Calif. – Cell culture and vaccine manufacturing – Business development, acquisition and venture initiatives Proven entity; end-to-end capabili
Slide 22: Company of Firsts
Company of Firsts Synagis®, first MAb approved for infectious disease ($1.3B WW sales; >1M babies protected) VLP technology for HPV vaccines (>$6B peak sales) Discovered Humira® (>$2B in 2006 WW sales) First advance in flu technology in 60+ yrs (55% better vs. TIV) Biologics Day 7 December 2
Slide 23: MedImmune Operations
MedImmune Operations Philadelphia, PA Bensalem, PA FluMist Blend/Fill/Pack FluMist Warehouse Nijmegen, Netherlands Ethyol Mfg, Clinical Fills Santa Clara, CA Vaccines R&D & Pilot Plant Mountain View, CA Vaccine R&D Hayward, CA MAb R&D site Frederick, MD Cambridge, England MAb Manufacturing Antibody
Slide 24: Major Changes
Major Changes From Dec 2006 to Dec 2007 Capabilities – Discovery research; Ab screening and technology – Global marketing and sales reach People – Approx 300 CAT personnel (~250 R&D) – Two new research sites Expanded pipeline – New targets and new therapeutic areas Accelerated pipeline momen
Slide 25: MedImmune Research Portfolio
MedImmune Research Portfolio Excluding CAT and AZ biologics Target Lead Pre-clinical Phase I Phase II Phase III Validation Development & Profiling Development VM 11 Vaccine 3 Rheum 2 IMK 1 Vaccine 1 anti-IFNaR anti-IL-5R anti-IL-9 motavizumab Rheum 3 Rheum 1 Vaccine 2 Hsp90 oral anti-IFNa Hsp90 iv I
Slide 26: Combined New MedImmune Research Portfolio
Combined “New” MedImmune Research Portfolio Target Lead Pre-clinical Phase I Phase II Phase III Validation Development & Profiling Development VM 11 Vaccine 3 Rheum 2 IMK 1 Vaccine 1 anti-IFNaR anti-IL-5R anti-IL-9 motavizumab Resp 10 VM 9 Rheum 1 Hsp90 oral Hsp90 iv Rheum 3 Vaccine 2 anti-IFNa Resp
Slide 27: MedImmune Staffing
MedImmune Staffing ~3,000 Employees Administrative Sales and 16% Clinical/Regulatory Marketing 15% 20% 47% Clinical / R&D Research & Development 32% Manufacturing/QA/QC 18% Biologics Day 7 December 2007
Slide 28: Biologics Business Characteristics
Biologics Business Characteristics Rapidly growing markets – 13% CAGR 2007-20101 Longer product life cycles – Lower exposure to generic competition; high unmet need Higher probabilities of success – Higher success rates in clinical development2 Higher/more complex COGS Lower/more targeted
Slide 29: Strategic Priorities for Biologics
Strategic Priorities for Biologics 6 INDs (8 CDs) per annum – At least 3 new projects in pivotal trials by 2010; 1 BLA/year steady state Drive value from CAT and Abgenix investments Bring biologics commercial expertise to AstraZeneca Expand external strategic opportunities Fully exploit ta
Slide 30: Recent Progress and Successes
Recent Progress and Successes Approval for refrigerated formulation of FluMist® with label expansion to include children down to 2 – CDC advisory committee recommendations for children under 5 and VFC inclusion Filed IND for 3rd generation RSV MAb FTIM – RSV/PIV-3 and PIV-3 vaccines – Anti-GM-
Slide 31: The New MedImmune
The New MedImmune Delivers biologics ambition faster Positions AstraZeneca as leader in biologics among pharma peers Enhances AstraZeneca pipeline Clear synergies for both parties Above all Provides new strategic, product development opportunities Biologics Day 7 December 2007
Slide 32: MedImmune R&D Overview
MedImmune R&D Overview James Young, Ph.D. President, Research and Development Biologics Day 7 December 2007
Slide 33: Building a World Class Sustainable Biologics Pipeline
Building a World Class Sustainable Biologics Pipeline What is covered under biologics? – Current emerging and novel product classes within MEDI ¾ Naked MAbs ¾ MAbs with altered effector function ¾ MAb conjugates or fusion proteins ¾ Bi functional MAb derivatives (BiTE®, dAb etc) ¾ Polyspecific MAb
Slide 34: Therapeutic Areas of Focus
Therapeutic Areas of Focus Respiratory and Inflammatory Disease Infectious Disease Oncology Cardiovascular Gastrointestinal Neuroscience – CNS & Pain Control Biologics Day 7 December 2007
Slide 35: Therapeutic Area Focus: Respiratory and Inflammatory Diseases
Therapeutic Area Focus Respiratory and Inflammatory Diseases Specialty care products for chronic use in diseases that cause significant morbidity and mortality Significant opportunities exist in asthma, COPD, RA, SLE and OA Target patients will have severe and uncontrolled disease Biologics
Slide 36: Therapeutic Area Focus: Infectious Disease
Therapeutic Area Focus Infectious Disease Focus on antivirals and antibacterials for unmet medical needs and product improvement with novel approaches Vaccines Monoclonal antibodies – Extended half-lives – Optimized Fc functionality – Heteropolymer technology to bypass need for complement – Tu
Slide 37: Therapeutic Area Focus: Oncology
Therapeutic Area Focus Oncology Strong growth expected – New treatments – New biology on previously untreated populations – Earlier diagnosis – Incidence growth Emerging new biological approaches – Enhanced mediated killing – Toxin/drug conjugates – Personalized medicine Biologics Day 7 December
Slide 38: Therapeutic Area Focus: Cardiovascular and Gastrointestinal
Therapeutic Area Focus Cardiovascular and Gastrointestinal Area of significant size and growth – CV and GI disease remains a leading cause of morbidity and mortality on a global basis Expect biologics to become increasing share of treatment market Core disease expertise in AstraZeneca Biologic
Slide 39: Therapeutic Area Focus: Neuroscience
Therapeutic Area Focus Neuroscience – CNS & Pain Control 2nd largest and 2nd fastest growing segment of world-wide pharmaceutical market Size and growth rate sustained by – Aging and demanding population – Negative impact of lifestyle (stress) – Low remission rates of today´s therapies – Huge bu
Slide 40: Building a World Class Sustainable Biologics Pipeline
Building a World Class Sustainable Biologics Pipeline Ability to achieve ~8 CDs per year steady state @~80% success rate, this gives 6 FTIM Per annum – 3-4 CDs from Cancer – 3-4 from Respiratory & Inflammatory Diseases – 0-1 from Infectious Disease – 0-1 from CV/GI/NS Leverage drugs across t
Slide 41: Combined New MedImmune Research Portfolio
Combined “New” MedImmune Research Portfolio Target Lead Pre-clinical Phase I Phase II Phase III Validation Development & Profiling Development VM 11 Vaccine 3 Rheum 2 IMK 1 Vaccine 1 anti-IFNaR anti-IL-5R anti-IL-9 motavizumab Resp 10 VM 9 Rheum 1 Hsp90 oral Hsp90 iv Rheum 3 Vaccine 2 anti-IFNa Resp
Slide 42: Development Goals Through 2010
Development Goals Through 2010 Seven potential pivotal trial go/no-go decisions* 2008 – Hsp90 (Phase II/III - GIST) 2009 – Anti-IFNα (lupus); anti-IL9 (asthma); CAT-8015 (HCL) 2010 – MEDI-538/MT103 (CLL); anti-IL13 (asthma); anti-IL5R (asthma) *Estimate at least three will progress to pivota
Slide 43: Building a World Class Sustainable Biologics Pipeline
Building a World Class Sustainable Biologics Pipeline What do we need to support this – We have considerable internal expertise ¾ Biologics unit collaborates with Therapy Area Teams at all stages – Leverage capabilities across the whole business – MEDI supplants planned growth of CAT, AZ Biologics
Slide 44: Strategic Alignment
Strategic Alignment Biologics Delivery MedImmune AZ Board Board Product Development SET Committee Product R&D Board Development Team Therapy Area Joint Therapy Team Area Strategy Team Research Review Joint Research Area Committee Management Teams Research Team Joint Target Selection Committee Biolog
Slide 45: 1+1+1>3
1+1+1>3 AZ/MEDI/CAT has created – Bigger and broader portfolio with less risk – Larger tool kit – Shared clinical, regulatory and development expertise – Target ID/validation knowledge Biologics Day 7 December 2007
Slide 46: Potential News and Data Flow
Potential News and Data Flow Submit motavizumab BLA by 1Q08 Initiate pivotal trial Hsp90 (Phase II/III - GIST) 1H08 FluMist® EU submission 1H08 Phase II efficacy data IL-9 2008 Anticipate 5 FTIM 2008 7 potential pivotal trial go/no-go decisions ’08 – ’10 Biologics Day 7 December 2007
Slide 47: Biologics R&D Summary
Biologics R&D Summary Leader in antibody and vaccine technology Pipeline contains promising programs across all phases of development and in all target therapeutic areas R&D speed and quality Combine strengths of AZ and MedImmune externalization Biologics Day 7 December 2007
Slide 48: Antibody and Protein Therapeutics
Antibody and Protein Therapeutics Peter Kiener, D.Phil. Senior Vice President, Research Biologics Day 7 December 2007
Slide 49: Building a World Class Biologics Pipeline
Building a World Class Biologics Pipeline What are antibody/protein-based biologics? –Current, emerging and novel technologies within MEDI ¾ Naked MAbs ¾ MAbs with altered effector function ¾ MAbs with altered half-lives ¾ MAb conjugates or fusion proteins ¾ Bifunctional MAb derivatives (BiTE®, dA
Slide 50: Lead Discovery
Lead Discovery Variety of Approaches to Ab Development Hybridoma technology – Murine, rat, and hamster MAbs – Transgenic mice for human MAbs (velocimmune technology) Recombinant human Ab or protein discovery – Phage display (besides Ab display, also protein/peptide display) ¾ Very large naïve an
Slide 51: Antibody Generation
Antibody Generation VelocImmune® Phage Ribosome High mice Display Display Throughput Screening Complementary tools providing HT access to different regions of molecular diversity Biologics Day 7 December 2007
Slide 52: Display Technologies
Display Technologies The Core of Our Lead Generation Phage display Naïve libraries totalling 1x1011 diversity Routinely used for affinity maturation (1x109 diversity) Increasingly used for cell-based selections Ribosome display Large variant libraries (>1x1012) Introduce mutations between
Slide 53: Antibody Structure
Antibody Structure Fab Fc Biologics Day 7 December 2007
Slide 54: Optimization of Leads through Antibody Engineering
Optimization of Leads through Antibody Engineering Affinity maturation (kon and koff manipulation) Humanization (framework shuffling or rational design approach) and germlining Half-life extension (FcRn YTE technology) Effector function engineering (Fc mutation, afucosylation, and hinge engi
Slide 55: Beyond Traditional Ab Technologies
Beyond Traditional Ab Technologies BiTE® (with Micromet) – Bifunctional MAb derivatives; Antibody-drug conjugates (with Seattle Genetics) – Deliver cytotoxic drugs into tumour cells using MAbs Heteropolymer technology (with EluSys) – Target pathogens to RES for clearance Poly-/tri-/bi-specif
Slide 56: Summary
Summary Building world class biologics pipeline Applying display technologies to drug discovery and optimization – HTS drug discovery Adapt MAbs/proteins to have the desired specificity, affinity, “effector” mechanisms – Optimization of drug biological properties Rationally design properties
Slide 57: Vaccine Discovery
Vaccine Discovery George Kemble, Ph.D. Vice President, Vaccine Research and Development Biologics Day 7 December 2007
Slide 58: Vaccine Technologies
Vaccine Technologies Many technologies exist for producing vaccines – Weakened virus: Live, attenuated vaccine (FluMist®) – Vectored vaccine: Live, attenuated vaccine expressing a protein from another virus – Killed virus: Inactivated vaccine (inactivated polio) – Virus mimic: Virus-like particle
Slide 59: Pandemic Vaccines
Pandemic Vaccines Delivering immense numbers of doses in a short time is a key aspect to protecting the population from an oncoming influenza pandemic LAIV has several advantages compared to conventional inactivated vaccines – Over 180 times more doses of LAIV per egg Doses / Total Doses Doses /
Slide 60: Reverse Genetics
Reverse Genetics Reverse genetics: the ability to produce a specific, engineered influenza virus using recombinant DNA technologies – Dramatic refinement in our toolbox for making the vaccine strains on an annual basis – Key to pandemic vaccine production ¾ Specific pathogenic traits of the pandem
Slide 61: Cell Culture Production
Cell Culture Production Flu Vaccine Cell culture production enables modern, controlled manufacturing – Industry standard methods – Significant MedImmune experience Vaccine grown in eggs and in cells has the same genetic composition, therefore, the same properties Clinical trials are expected t
Slide 62: Vaccine Toolbox
Vaccine Toolbox Live attenuated intranasal vaccines – Seasonal flu vaccines – Pandemic influenza vaccines – Reverse genetics – Cell culture production – Vectored vaccines Virus-like particles technology Subunits Biologics Day 7 December 2007
Slide 63: Process Development
Process Development Gail Wasserman Senior Vice President, Development Biologics Day 7 December 2007
Slide 64: Development's Space
Development’s Space Clinical Optimizes the Label SYNAGIS® (PALIVIZUMAB) for Intramuscular Administration DESCRIPTION: Synagis® (palivizumab) is a humanized monoclonal antibody (IgG1 k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respirat
Slide 65: Bridge from Research to Commercialization
Bridge from Research to Commercialization Manufacturing Preclinical supply Clinical supply Product testing Research Support Product Life-time Targets and Support Clinical candidates Analytical and Process Development Assays Process Scale Up Cell line selection Fit to Plant Manufactur
Slide 66: Facilities and Experienced Staff
Facilities and Experienced Staff Gaithersburg, MD Analytical and process Gaithersburg, MD development Clinical manufacturing Cambridge, UK (500 L and 2000 L) Analytical and process development Nijmegen, Netherlands Gaithersburg, MD Clinical fills Process scale up (500 L) Biologics Day 7 December 200
Slide 67: Selection: Get it Right the First Time
Selection Get it Right the First Time Product attributes – Fit the process platform (manufacturability) – Meet formulation goals for intended use (stable, high concentration) Cell line attributes – Meet performance needs (stability, high cell density, high productivity, bioreactor compatible) –
Slide 68: Bioprocess Highlights
Bioprocess Highlights Established high titer production platforms for monoclonal antibodies (NS/0 and CHO) – In-house culture media – Animal protein-free including cell cloning (minimize risk to safety and product/process variability) – Same bioreactor technology from development (5 L) through to
Slide 69: Abegrin Produces g/L at All Scales
Abegrin™ Produces 5 g/L at All Scales 6000 3L Average (n=10) 5000 50L Average (n=2) 06XX01 (500L, LMA) 4000 Titer (mg/L) 3000 2000 1000 0 0 5 10 15 20 25 Time (Days) Biologics Day 7 December 2007
Slide 70: Benefits of High Titers
Benefits of High Titers 1200 1000 Reduced cost of 800 manufacturing product Cost ($/g) 600OTHERS Majority 400 – Patient benefit 200 MEDI – Increased profitability 0 0 1 2 3 4 5 6 Improved plant capacity Titer (g/L) # of Batches – Fewer batches to meet Titer (g/L) to make 100Kg market demand 0.5
Slide 71: Maximize Cell Process Performance and Minimize Facility Changes
Maximize Cell Process Performance and Minimize Facility Changes Enhanced Yield Original 5.0E+06 3000 2500 4.0E+06 Xv (cells/mL) titer (mg/L) 2000 3.0E+06 1500 2.0E+06 1000 1.0E+06 500 0.0E+00 0 0 5 10 15 20 25 0 5 10 15 20 25 time (days) time (days) Biologics Day 7 December 2007
Slide 72: Plants Needed to Mfg Synagis for U.S.
Plants Needed to Mfg Synagis® for U.S. 6 5 Number of Plants 4 3 Today 2 Actual Plant Requirement With Enhanced 1 Yield Process 0 Year 1 Year 2 Year 3 Year 4 Forecast Plant Requirement With Original Production Process Biologics Day 7 December 2007
Slide 73: Purification, Formulation and Drug Delivery
Purification, Formulation and Drug Delivery Established purification process platform for monoclonal antibodies – Delivers high product yield and purity – Scalable and fit to commercial plant – Predictive small scale models Flexible formulation capabilities – Design for route of administration ¾
Slide 74: MEDI Ranks With First in Class
MEDI Ranks With First in Class Among the highest cell growth and product titers in the industry – Leaders: 2 – 5 g/L vs. Majority: 0.5 – 1 g/L Consistent high titers across antibody products and NS/0 & CHO platforms Among the highest purification yields in the industry – Leaders: >70% vs. Majo
Slide 75: Analytical Sciences
Analytical Sciences Advanced product and process characterization tool box facilitates development – Understand relationship between product attributes and safety & efficacy – Understand relationship between process parameters and product attributes – Ability to demonstrate product comparability w
Slide 76: New Pilot Facility Meets Capacity for Clinical Manufacturing
New Pilot Facility Meets Capacity for Clinical Manufacturing Biologics Day 7 December 2007
Slide 77: Clinical Manufacturing Capacity and Capability
Clinical Manufacturing Capacity and Capability Multi-product concurrent operations Multiple scales (500 L and 2,000 L) Mammalian cell culture and microbial fermentation areas Matched to needs of the biologics portfolio; no further capital investment needed Biologics Day 7 December 2007
Slide 78: Industry Leader in Commercial Cell-Culture Mfg
Industry Leader in Commercial Cell-Culture Mfg Commercial production since 1999 World leader in high-yield cell culture process Excellent reputation with FDA – Quality practices; regulatory processes Current capacity at FMC: two 2,500 liter bioreactors – Target expansion: four 15,000 L biore
Slide 79: Key Messages
Key Messages Rich body of knowledge in biologics process and analytical development Mature work force with experience through product commercialization Established NS/0 and CHO high productivity antibody platforms coupled with high yield purification processes Designed predictability into pr
Slide 80: Infectious Disease and Pediatric Vaccines
Infectious Disease and Pediatric Vaccines Genevieve Losonsky, M.D. Vice President, Clinical Development Biologics Day 7 December 2007
Slide 81: Strategic Approach
Strategic Approach ID and Pediatric Vaccines Deliver on RSV disease prevention and treatment – Core strategic area for pipeline development – Multi-prong approach (vaccines, antibodies, small molecules) – Employ novel technologies Apply expertise across therapeutic areas and to other relevant vi
Slide 82: RSV History
RSV History Discovered in 1956 Chanock isolates the virus from children 1957 Epidemiology, transmission, and natural history described over next several decades – 100% of all infants infected before the age of 3 – High risk populations identified with 5 fold higher rates of hospitalization and
Slide 83: Synagis Improvement in RSV Prevention
Synagis® (palivizumab) Improvement in RSV Prevention IgG1 humanized MAb % Relative Reduction in RSV Hospitalization IMpact-RSV Trial 90 Binds to conserved 80 78 RSV F protein Overall Reduction Cardiac Trial 70 10 times the activity 55% p < 0.001 58 60 of RespiGam® 50 Overall Reduction – Blocks
Slide 84: RSV: A Large Unmet Medical Need
RSV: A Large Unmet Medical Need High risk infants: ~15% birth cohort – ~60% do not get immunoprophylaxis Infects 50% infants in first year of life – Deaths: 230K globally*; 17,000 U.S.** – Hospitalizations: 3M globally – ~30% with LRI: 30M globally, 1.6M U.S. Childhood – ~50% of childhood “ast
Slide 85: Strategic Goals: RSV Prevention
Strategic Goals RSV Prevention Increase the clinical benefit of RSV immunoprophylaxis and expand the target population to FT infants born during RSV season – Motavizumab – affinity enhanced MAb – Provide evidence of additional value with prevention of wheezing sequelae in 32-35 week preterm infant
Slide 86: Motavizumab Immunoprophylaxis Indication Clinical Trials
Motavizumab Immunoprophylaxis Indication Clinical Trials Study Population Objective Design Enrollment Status CP101 Healthy Adults Safety, IM, PK, Open-label 30 Completed High-risk Children CP104 Safety, IM, PK Open-label 217 Completed (Premature & CLD) Hospitalized Children Safety, IM, PK, CP106 Pla
Slide 87: Motavizumab: Reduces the Incidence of Serious RSV Disease
Motavizumab: Reduces the Incidence of Serious RSV Disease Relative Reductions in Serious RSV Disease 90 83** 80 CP110: Motavizumab vs Synagis® in 71** 70 % Reduction preterm p<0.01* 60 50** CP117: Motavizumab vs placebo 50 in Native American infants 40 p<0.001 30 26* 20 10 0 I I n n LR LR * Non-infe
Slide 88: Next Steps
Next Steps U.S. BLA for premature and CLD 1Q08 Complete 2nd season of CHD study 3Q08 File in EMEA for all high risk infants 1H09 Continue 4th year enrollment of CP117 – Collecting data on persistent wheezing prevention Biologics Day 7 December 2007
Slide 89: Value Added for High-Risk Infants
Value Added for High-Risk Infants Prevention of Early Childhood Wheezing? Preventing serious RSV IIT Journal of Pediatrics, 2007 may reduce recurrent early childhood wheezing 50% Reduction in Recurrent Wheezing (Simoes/Groothuis 2007) events with palivizumab 30 Placebo controlled trial in 25 unt
Slide 90: RSV Prevention: Third-Generation RSV MAb (YTE)
RSV Prevention Third-Generation RSV MAb (YTE) Potential targets Predicted YTE Concentrations after 3 mg/kg IV – High risk infants 100 – Full term infants <6 months Numax 3 mg/kg IV- Observed born in season YTE Simulated Concentration Mean Serum Conc (mcg/ml) (2M U.S./~60M WW) Challenges – Low CO
Slide 91: Strategic Goals: RSV Live Attenuated Vaccines
Strategic Goals RSV Prevention: Live Attenuated Vaccines Targets: <6 m old, universal vaccination (4M US/120 M WW) Status: 2 constructs in Phase I – MEDI-534 (PIV-3 RSV F) ¾ Acceptable safety profile seen in seropositive children ¾ Phase I dose escalation safety trial in seronegative older child
Slide 92: Strategic Goals: RSV Treatment
Strategic Goals RSV Treatment Develop treatment modalities aimed at patients with early and late RSV disease Targets: pediatrics and adults – Successful modalities in pediatrics will be applied to adults As with prevention, multiple shots on goal is the approach – Motavizumab – Small molecules
Slide 93: RSV Treatment: Motavizumab
RSV Treatment Motavizumab Phase I single iv dose (3, 15, 30 mg/kg) treatment trial in children – Significant reduction in replicating RSV within 24 hours – Dose effect in eradication of viral RNA In-patient: POC Phase II – iv – iv motavizumab treatment indication – Randomized (1:1:1), blinded, p
Slide 94: RSV Treatment: Biota Small Molecule
RSV Treatment Biota Small Molecule Target: pediatric patients with early disease – Application across patient populations Advantages – Oral dosing – Low COG Phase I dose escalation safety trial in healthy adults ongoing ¾ Challenge trial anticipated 2009 Biologics Day 7 December 2007
Slide 95: Addressing the Burden of RSV
Addressing the Burden of RSV Beyond Synagis® Technology MEDI Program Prevention – High risk preterm infant Synagis® (acute/wheezing) Antibodies Motavizumab – High risk term infants YTE – Patients with transplants – All infants in 1st year of life Vaccines RSV Vaccines – Elderly MEDI-534, MEDI-560
Slide 96: Oncology
Oncology Dirk Reitsma, M.D. Vice President, Clinical Development Biologics Day 7 December 2007
Slide 97: AstraZeneca and MedImmune Oncology Portfolio
AstraZeneca and MedImmune Jointly a Large and Competitive Oncology Portfolio Powerful instrument for new drug delivery Access to large and small molecules – Multiple shots on target – Potential to select best compound in class for full development – Potential for combined development strategies
Slide 98: Expanded Development Capabilities and Expertise
Expanded Development Capabilities and Expertise Target identification/validation – Translational science, biomarkers External partnerships Key alliances Multi-regional development strategies Global commercial infrastructure Biologics Day 7 December 2007
Slide 99: MEDI-538/MT103
MEDI-538/MT103 First BiTE® in Clinical Development Unique mode of action (new class of drug) MEDI-538 triggers natural mechanism of T-cell activation CD3 Cytotoxic synapse is formed High potency MT103 CD19 Collaborative program with Micromet – 2 EU trials ongoing – 2 U.S. trials planned ’0
Slide 100: Cancer Statistics 2007
Cancer Statistics 2007 Incidence and Prevalence – NHL 63,190 people will be diagnosed with NHL 18,660 people will die of NHL 381,129 people are alive with a history of NHL (as of 2004) Source: NCI SEER Database Biologics Day 7 December 2007
Slide 101: Frequency of NHL subtypes
Frequency of NHL subtypes DLBC Follicular 1.2% 1.8% MALT 2.5% Peripheral T-cell 2.4% 9.1% DLBC 30.6% CLL/SLL 2.4% Mantle cell Mantle cell 6.0% Primary mediastinal CLL 6.7% ALCL Burkitt's 7.6% 7.6% Follicular 22.1% Nodal marginal zone Lymphoplasmacytic Other WHO classification of tumours, 2001 Biolog
Slide 102: MEDI-538: Lymphoma Cells Eliminated in Bone Marrow
MEDI-538 Lymphoma Cells Eliminated in Bone Marrow Baseline MT103 (Day 17) Patient #1 at dose level 4 (15 µg/m²/24 hrs) Previous treatments included CHOP, Chlorambucil, Fludarabine, Dexa-BEAM, Endoxan and repeated Rituxan Biologics Day 7 December 2007
Slide 103: Objective Responses MEDI-538
Objective Responses MEDI-538 Dose Levels from 15 to 30µg Follicular lymphoma – One complete response – One partial response – One minor response Mantle cell lymphoma – One complete response ongoing for 7 months Chronic lymphocytic leukemia – One partial response – One minor response In total
Slide 104: CAT-8015: The Target CD22
CAT-8015 The Target: CD22, a B-cell Antigen Involved in Adhesion and Signaling V V L H II Ib III -S-S- -Anti-CD22- -Toxin- Pastan 10/04 Therapeutic Indications: – Non-Hodgkin’s lymphoma – Chronic lymphocytic leukemia – Acute lymphoblastic leukemia – Hairy cell leukemia Biologics Day 7 December 2007
Slide 105: CAT-3888 Results in Chemotherapy-resistant HCL
CAT-3888 Results of Initial in Chemotherapy-resistant HCL Hairy Cell Leukemia (n= 31) – 19 complete responses – 6 partial responses 15 non–HCL patients (11 CLL, 4 NHL) treated with CAT-3888 – One partial response (CLL) – CLL and NHL patients did not progress while on CAT-3888 Positive results
Slide 106: CAT-8015 Phase 1/2 Dose Escalation Studies
CAT-8015 Phase 1/2 Dose Escalation Studies Hairy cell leukemia Chronic lymphocytic leukemia CD22+ non-Hodgkin’s lymphoma Pediatric acute lymphoblastic leukemia Biologics Day 7 December 2007
Slide 107: IPI-504 (MEDI-561)
IPI-504 (MEDI-561) Biologics Day 7 December 2007
Slide 108: Heat Shock Protein 90
Heat Shock Protein 90 Emerging Cancer Target Two roles for Hsp90 in cancer General chaperone function essential for protein homeostasis Specific chaperone function stabilizes oncogene products in key cell signaling pathways Cancer cell Hsp90 different from normal cell Hsp90 Preferential target
Slide 109: Pathway Validation by Targeted Cancer Therapies
Pathway Validation by Targeted Cancer Therapies Hsp90 Client Protein Targeted therapy Indication Hematologic Bcr-Abl Imatinib / Dasatinib CML Solid tumor c-Kit Imatinib / Sunitinib GIST HER2 Trastuzumab / Lapatinib Breast (HER2+) EGFR Erlotinib / Cetuximab NSCLC VEGFR / HIF-1a Sorafenib / Sunitinib
Slide 110: GIST Incidence and Prevalence
GIST Incidence and Prevalence US incidence estimates vary from 3,000 - 6,000 new cases per year (10 -20 cases / million) Estimated prevalence of GIST in U.S. ranges from 9,400 patients (high risk or overtly malignant disease only) to 39,000 patients (all patients) EU incidence is estimated at
Slide 111: IPI-504 Rationale for Treatment of GIST
IPI-504 Rationale for Treatment of GIST Kit is the oncogene that drives GIST (>90% driven by activated Kit) < 2 year survival from time of metastasis Gleevec & Sutent inhibit Kit, and are approved treatments for GIST, but all patients eventually progress Kit mutations that render GIST refrac
Slide 112: PET response to IPI-504
PET response to IPI-504 (150 mg/m2) (following failure of imatinib, sunitinib, and AMN-107) Baseline Cycle 1, Day 11 Cycle 1, Day 21 Cycle 3, Day 12 72 hours post After 10 days After treatment rd 3 dose of IPI-504 off treatment re-initiated Dana-Farber Cancer Institute Harvard Medical School Biologi
Slide 113: CT for patient following failure of Imatinib and Sunitinib
CT for patient following failure of Imatinib and Sunitinib – Pt received 400 mg/m2 (Schedule A) of IPI-504 Screening End of Cycle Biologics Day37 December 2007
Slide 114: Diversification in IPI-504 Strategy
Diversification in IPI-504 Strategy Pursue fast path to registration of IPI-504 iv –Capitalize on signal in GIST –Current phase I/II study in NSCLC –Phase II study in melanoma Conduct exploratory Phase II studies in multiple tumor types –“Expand early/Fail early” – Phase IIs include early stop p
Slide 115: Next Milestones
Next Milestones IPI-504 Initiate pivotal trial, 2008 MEDI-538 U.S. phase I, 1Q08 CAT-8015 Go/no-go phase II, 2009 Biologics Day 7 December 2007
Slide 116: Anticipated INDs Next Two Years
Anticipated INDs Next Two Years Insulin-like growth factor (IGF) – AZD4253 Platelet-derived growth factor receptor, alpha (PDGFRα) EphA2 conjugate Anti-CD19 CEA BiTE® Biologics Day 7 December 2007
Slide 117: Enhanced Development Potential for MedImmune
Enhanced Development Potential for MedImmune Responses to three novel biological approaches in ongoing clinical trials – BiTE®, immunotoxin and Hsp90 inhibitor – Phase I trials upcoming with several new targeted MAbs Speed and scope expanded in global clinical trial capabilities – Access to expe
Slide 118: Respiratory & Inflammatory Diseases
Respiratory & Inflammatory Diseases Barbara White, M.D. Vice President, Clinical Development Biologics Day 7 December 2007
Slide 119: Targeting Diseases with Major Burden of Illness
Targeting Diseases with Major Burden of Illness Respiratory Diseases Rheumatology Rheumatoid Arthritis Scleroderma Asthma COPD Lupus Biologics to achieve disease control in moderate to severely active disease Biologics Day 7 December 2007
Slide 120: Targeting Asthma
Targeting Asthma Control disease, reduce exacerbations, In human testing reduce use of oral corticosteroids – Anti-IL-9 (MEDI-528): Phase II (blocks mast cells) – Anti-IL-13 (CAT-354): Phase I (relaxes airway smooth muscle) – Anti-IL-5R (MEDI-563): Phase I (kills eosinophils) Next – OX40L: candi
Slide 121: MEDI-528 (Anti-IL-9) in Asthma
MEDI-528 (Anti-IL-9) in Asthma Phase II IL-9 blockade reduces mast cells in the lung following Go/no-go for large phase II 4Q08 allergen challenge * 3500 3000 Both allergic and Total MCp /Lung 2500 non-allergic asthma 2000 Convenience – SC q 2-4 weeks 1500 1000 500 0 Control IgG Control IgG
Slide 122: MEDI-528 (Anti-IL-9) in Asthma: Studies To Date
MEDI-528 (Anti-IL-9) in Asthma Studies To Date Study Short Title Status FPFV LPLV CP105 SAD IV, HV Complete Aug ’04 Dec ’04 CP109 SAD SC, HV Complete June ’05 April ’06 CP138 SD IV, whole lung Data Nov ’06 Aug ’07 inhaled allergen, LAR analysis CP139 SD IV, segmental Ongoing July ’07 3Q08 allergen c
Slide 123: CAT-354 (Anti-IL-13) in Asthma
CAT-354 (Anti-IL-13) in Asthma Phase I Allergic asthma>non-allergic asthma Phase IIa 4Q07 Relax airway smooth muscle Go/no-go for large Convenience – SC q 2-4 weeks phase IIb/III 2H09 0401: Proof of Biologic Activity of CAT-354 Biologics Day 7 December 2007
Slide 124: CAT-354 (Anti-IL-13) In Asthma: Studies To Date
CAT-354 (Anti-IL-13) In Asthma Studies To Date Study Short Title Status FPFV LPLV 0401 SAD, safety Complete n/a n/a 0602 MD, parallel group, Dosing Aug ’06 Sept ’07 3 dose levels, complete, safety follow-up ongoing 0603 3 dose levels, POC Planned Dec ’07 4Q08 0703 SC vs iv Planned 1Q08 3Q08 bioavail
Slide 125: MEDI-563 (Anti-IL-5R) in Asthma
MEDI-563 (Anti-IL-5R) in Asthma Phase I Eosinophilic asthma Go/no-go for Convenience – SC q4 weeks phase II 4Q08 CP158: Proof of Biologic Activity of MEDI-563 500 400 Eosinophils/mm3 300 200 100 0 1 -14 0 14 Days28 56 0.03 mg/kg IV Biologics Day 7 December 2007
Slide 126: MEDI-563 (Anti-IL-5R) In Asthma: Studies To Date
MEDI-563 (Anti-IL-5R) In Asthma Studies To Date Study Short Title Status FPFV LPLV CP158 SAD, safety Ongoing Jan ’07 2Q08 CP166 SD and MAD Planned Jan ’08 4Q08 depletion of eosinophils in airways Biologics Day 7 December 2007
Slide 127: Targeting COPD
Targeting COPD First targets Reduce exacerbations – PAI-1: candidate Ab ’08 (remove small clots) – IL-1R: candidate Ab ’08 (reduce inflammation) – C5a: lead optimization (reduce inflammation, block smooth muscle constriction) Potential cross-over from asthma or rheumatology – IL-5R: Phase I – GM
Slide 128: Targeting RA
Targeting RA In human testing Control signs and symptoms, induce – GM-CSFR (CAM3001): Phase I (reduce inflammation) clinical responses and remissions, improve patient-reported outcomes, Next halt progressive joint damage – IL-17: FTIM ‘08 TNF failure > biologic naïve patients – IL-6: candidate A
Slide 129: CAM3001 (Anti-GM-CSFR) in RA
CAM3001 (Anti-GM-CSFR) in RA Phase I SC q 2-4 weeks Go/no-go for Potential diagnostic to identify phase II 1Q09 responding patient subset Anti-GM-CSF inhibits joint inflammation and damage in CIA Vehicle Control CSF Receptor antagonist Synovium Synovial Hyperplasia & inflammation Cartilage e
Slide 130: CAM3001 (Anti-GM-CSFR) in RA: Studies To Date
CAM3001 (Anti-GM-CSFR) in RA Studies To Date Study Short Title Status FPFV LPLV 0702 SAD IV, RA Ongoing Oct ’07 1Q09 Biologics Day 7 December 2007
Slide 131: Targeting SLE
Targeting SLE In human testing Control disease activity, reduce flares, – IFNα (MEDI-545): Phase I (stop innate inflammatory reduce immunosuppressive drugs processes) Coming – ICOS: candidate Ab Dec ’07 – CD22: lead optimization – HMGB1: lead optimization – RAGE: lead optimization Potential cr
Slide 132: MEDI-545 (Anti-IFNα) in SLE
MEDI-545 (Anti-IFNα) in SLE Phase I Efficacy Go/no-go for large SC q 2-4 weeks phase II 1H09 Potential diagnostic to identify responding patient subset CP126: Proof of Biologic Activity of MEDI-545 Placebo 0.3 mg/kg 1 mg/kg 3 mg/kg 1-Fraction of neutralization 1.5 10 mg/kg 30 mg/kg 1.0 0.5
Slide 133: MEDI-545 Reduces Type I IFN Gene Signature
MEDI-545 Reduces Type I IFN Gene Signature and Type I IFN–Induced Proteins in Skin Blood, Day 0–28 Skin, Day 0,14 Type I IFN–Induced Proteins in Skin Skin, Day 0–28 Day 0 Day 14 Reduction in protein expression Reduction in gene expression Biologics Day 7 December 2007
Slide 134: MEDI-545 Shows Clinical Activity in Lupus
MEDI-545 Shows Clinical Activity in Lupus SLEDAI = 0 SLEDAI Flares New Systemic Corticosteroids P=0.0947 P=0.0136 P=0.0138 % patients Biologics Day 7 December 2007
Slide 135: Commercial Overview RSV & Vaccines
Commercial Overview RSV & Vaccines Peter Greenleaf Senior Vice President, Marketing & Sales Biologics Day 7 December 2007
Slide 136: Commitment to RSV
Commitment to RSV Biologics Day 7 December 2007
Slide 137: RSV Burden of Disease
RSV Burden of Disease Dangerous, unpredictable, and highly variable virus that attacks almost all infants by age 2 Can have devastating effects in high-risk infants ranging from: – Medically attended out-patient lower respiratory track infections – Acute hospitalizations – Long-term consequences
Slide 138: RSV Burden of Disease
RSV Burden of Disease Leading cause of infant hospitalization – >300,000 hospital admittances each year in U.S. Causes substantial economic burden on the U.S. healthcare system – 1.7 million physician office visits in 2000 – >400,000 emergency room visits – >230,000 hospital outpatient emergency
Slide 139: Synagis (palivizumab)
Synagis® (palivizumab) Technological advancement over polyclonal antibody – Respigam® Standard of care in prevention of serious RSV lower respiratory tract infections in high risk infants Major Launches: U.S. ’98, EU ’00, JP ’02 Liquid formulation intro in U.S. ’05 Marketed by MedImmune in
Slide 140: The Future with Motavizumab
The Future with Motavizumab Near term – Next evolution in RSV prevention ¾ Increased potency; improved efficacy – Improvement in secondary outcomes ¾ Significant protection from RSV disease – More data to support effectiveness of MAbs in RSV prevention Mid to long-term – Provides competitive “hi
Slide 141: MedImmune Reported WW Sales
MedImmune Reported WW Sales RSV Seasonal Basis ($million) $1,400 $1,123 $1,200 $1,056 7% $992 5% 12% $885 $1,000 12% $788 30% $800 $606 26% $482 $600 34% $400 00/01A 01/02A 02/03A 03/04A 04/05A 05/06A 06/07A Reported U.S. sales Reported ex-U.S. sales Biologics Day 7 December 2007
Slide 142: Synagis U.S. Patient Segment Penetration
Synagis® U.S. Patient Segment Penetration Second CLD & Season CHD estimated 90% 32-35 70% Wk GA 85% 22% <32 Wk GA Segment Est. Total Size 06/07 32- 32-35 Wk GA ~248,000 333k <32 Wk GA ~85,000 CHD & CLD 21,000 – 30,000 2nd season ~18,000 >36 Wk GA (TERM) ~3,900,000 Patient portion penetrated Biologic
Slide 143: Evolution of the COID Guidelines
Evolution of the COID Guidelines Group 1998 2003 2006 <32s During their first RSV season … … <6 months of age and two of the <6 months of age and any risk factors following RFs: child care attendance, school-aged siblings, exposure to Same, but tobacco “has not been including: school age siblings; a
Slide 144: Ex-U.S. Strategy
Ex-U.S. Strategy Business continues to see robust growth Work closely with Abbott International to expand global reach Future plans to expand MEDI presence as a global biologics business Biologics Day 7 December 2007
Slide 145: Synagis ROW Patient Segment Penetration
Synagis® ROW Patient Segment Penetration Second CLD & Season CHD estimated 90% 33-35 Wk GA 60%* 6% 70% <33 Wk GA Segment Total “G7” G7” 06/07 33- 33-35 Wk GA ~139,000 216k <33 Wk GA ~77,000 CHD & CLD ~41,000 2nd season ~5,000 Patient portion penetrated Biologics Day 7 December 2007
Slide 146: Key Growth Drivers
Key Growth Drivers RSV Franchise Continue to optimize our base business Further develop our value proposition for Synagis® Increased investment in data generation & display – Prove long-term consequences – Expand risk factors and COID guidelines – Provide for appropriate seasonality – Develop
Slide 147: RSV Franchise Strategy
RSV Franchise Strategy Franchise Growth Expand Expand Advance Advance Optimize Optimize •• Invest Invest in in international international •• Expand Expand high-risk high-risk expansion expansion •• Drive Drive efficiencies efficiencies inin prophylaxis prophylaxis in in infants infants Synagis ®® b
Slide 148: Vaccine Franchise
Vaccine Franchise Biologics Day 7 December 2007
Slide 149: Leadership Will Be Built and Maintained
Leadership Will Be Built and Maintained Continued vaccine development – Human metapneumovirus, Epstein Barr virus, Streptococcus pneumoniae and respiratory syncytial virus/parainfluenza virus (RSV/PIV-3) targets NIH pandemic CRADA – Preparing library of prototype pandemic LAIV strains (H2, H4-H1
Slide 150: FluMist: First Nasal Mist Flu Vaccine in the U.S.
FluMist® Platform for Commercial Entry Into Vaccines First Nasal Mist Flu Vaccine in the U.S. Biologics Day 7 December 2007
Slide 151: FluMist
FluMist® First advance in flu vaccines in 60+ years – Highly effective, needle free seasonal flu vaccine – For healthy people 2-49 years of age Proven efficacy against matched and mismatched strains Multiple studies versus “the shot” have demonstrated superior efficacy – CP111: 52.5% and 54.2%
Slide 152: FluMist
FluMist® Improved product profile for the 2007/2008 season – Expanded indication down to 2 years of age – New refrigerated formulation – 50% volume reduction Favorable reimbursement coverage October 2007: ACIP recommends FluMist® for use in children down to 2 years of age, including VFC Biolog
Slide 153: Vaccine-Preventable Disease/Deaths U.S.
Vaccine-Preventable Disease/Deaths U.S. Influenza is Leading Vaccine-Preventable Disease for Mortality Annual Cases Annual Deaths Diseases (Year) (Year) Influenza 31,000,000 36,000/year (’90 - ’99) Pneumococcal disease, invasive 40,000 (’02) 5,500 (’02) (bacteremia & meningitis) HPV (cervical cancer
Slide 154: Influenza Infection Rates
Influenza Infection Rates Children have the highest infection rates and are most likely to spread the disease to others 45 41 40 38 Infection rate (%) 35 31 30 24 25 20 15 11 12 9 9 10 7 5 0 0-4 5-9 10-14 15-19 20-29 30-39 40-49 50-59 60+ Age (years) Biologics Day 7 December 2007
Slide 155: Influenza Market Projections
Influenza Market Projections Market growth for 18 and under segment will outpace overall market CAGR 160 Total 5.1% 136 138 140 134 Military 0.7% 131 126 HCW 6.0% 121 120 112 Number of Doses 107 65+ 3.5% 100 100 93 84 50-64 3.4% 80 19-49 2.9% 60 All peds 10.8% 41 42 43 43 39 13-18 12.1% 40 36 30 27
Slide 156: FluMist Coverage
FluMist® Coverage Can be used for the majority of children aged ≥2 Years Children aged 2 – 17 years Approx 80% of children aged 2-17 years - more 80% than 50M children - do not have exclusionary respiratory conditions and may therefore be Children with no candidates for FluMist if no other preexisti
Slide 157: Expansion of Commercial Vaccine Business
Expansion of Commercial Vaccine Business Global commercialization of FluMist® Continued improvement of FluMist label/profile – Currently excluded populations/additional B strain Continued business progression and pipeline developments Biologics Day 7 December 2007
Slide 158: Vaccines Summary
Vaccines Summary Large worldwide influenza market Newly differentiated superior product profile Significant growth in pediatric segment Strong launch plan and selling resources Pandemic possibility leverages product and company strengths Opportunity to expand focus on adults and ex-U.S.
Slide 159: An Exciting Future!
An Exciting Future! We have the ability to make a meaningful difference in patient health – Foster a broad spectrum of high-quality science ¾ Biologics ¾ Vaccines – Continued innovation – Commercial execution excellence – Expanding our global reach Biologics Day 7 December 2007