GSK plc · LSE:GSK
GSK — Raymond James Conference 2008
40 slides from GSK's conference presentation, Mar 31, 2008
Slide 1: GSK Biologicals: Delivering a Unique Vaccines Pipeline
GSK BIOLOGICALS: DELIVERING A UNIQUE VACCINES PIPELINE Thomas Breuer, MD, MSc Senior Vice President Global Clinical R&D Vaccines & Chief Medical Officer GSK Biologicals Monday 31 March 2008
Slide 2: Today's Agenda
Today’s Agenda GSK GSK within within the Vaccines Q&A the Vaccines Pipeline Vaccines Market Market
Slide 3: Vaccines Business Characteristics
Vaccines Business Characteristics Few Global Players – Complex Manufacturing – Large Scale Investment Long Product Life Cycles High Probability of R&D Success New Technology/ Novel Products Better Pricing Heightened Awareness New Markets
Slide 4: GSK Vaccines Business in 2007
GSK Vaccines Business in 2007 £2 billion sales (+21%) 1.1 billion vaccine doses delivered Over 30 marketed vaccines available worldwide Over 20 vaccines in clinical development Over 9,000 employees worldwide Over 1,600 scientists
Slide 5: GSK Vaccines: Broad Geographic Opportunity
GSK Vaccines: Broad Geographic Opportunity Total Vaccines Market* GSK 2006 sales GSK 2007 sales £7.6bn (+24%) £1.7bn £2bn US US US EU 53% 27% EU 31% EU 41% 42% EU EU 30% Int’l Int'l Int'l Int'l 27% 27% 20% 31% 28% *GSK estimates from consolidated 2006 Annual Reports
Slide 6: US Vaccines Sales
US Vaccines Sales Total 2006 £465m +40% Total 2007 £628m +44% Engerix-B (-1%) Engerix-B +6% Infanrix / Infanrix / Pediarix Pediarix Havrix +23% Havrix +20% +51% +79% Twinrix +13% Twinrix Influenza +24% Boostrix >100% Boostrix >100% +5% Influenza franchise >100% Note: % growth is CER
Slide 7: US Vaccines
US Vaccines Current Porfolio Pipeline expanded age Hib-MenCY H5N1 Pandemic Improved Flu
Slide 8: Advancing quickly into new segments
Advancing quickly into new segments Inactivated/ Live Virus Bacterial Flu Cancer Hepatitis MMR Varicella Hib Hep A/B HPV Rotavirus Hib Polio Seasonal MCV DTaP Influenza TdaP/Td PCV-7 MCV Seasonal Influenza DTaP-Combo MMR PHiD-CV Polio MMR (Combo) Seasonal HPV Hib-MenCY DTaP-Polio Varicella Influenza
Slide 9: Today's Agenda
Today’s Agenda GSK GSK within within Vaccines the Q&A the vaccine vaccine Pipeline market market
Slide 10: A Rich Pipeline
A Rich Pipeline Phase I Phase II Phase III Submitted/Approved HIV Mosquirix™ Simplirix™ Cervarix® (BLA) (Herpes Simplex Virus) S. pneumo adult (Malaria) * (Cervical cancer) Flu Pre-pandemic Cytomegalovirus TB New generation flu (Dresden - MAA) * Epstein-Barr virus * MAGE-A3 ASCI Flu Pandemic (Non Sm
Slide 11: A Rich Pipeline: Rotarix and Meningitis
A Rich Pipeline ROTARIX Prevention of gastroenteritis in infants Protection versus 5 most common rotavirus types Convenient 2-dose schedule Licensed in over 100 countries (EU & International) £91 million sales 2007 FDA PDUFA date: 3 April 2008 MENINGITIS Huge market potential Hib-MenCY and ACWY conj
Slide 12: A Rich Pipeline: Mosquirix and ASCI
A Rich Pipeline MOSQUIRIX Mosquirix (RTS,S) is the world’s most advanced malaria vaccine Phase II studies demonstrated protection in infants Moving to phase III late 2008 Antigen-Specific Cancer Immunotherapeutics (ASCI) MAGE-A3 in Non-Small Cell Lung Cancer (NSCLC) Positive phase II data 27 % reduc
Slide 13: A Rich Pipeline
A Rich Pipeline Phase I Phase II Phase III Submitted/Approved HIV Mosquirix™ Simplirix™ Cervarix® (BLA) (Herpes Simplex Virus) S. pneumo adult (Malaria) * (Cervical cancer) Flu Pre-pandemic Cytomegalovirus TB New generation flu (Dresden - MAA) * Epstein-Barr virus * MAGE-A3 ASCI Flu Pandemic (Non Sm
Slide 14: Morbidity of S. pneumoniae
Morbidity of S. pneumoniae ive as Meningitis Inv Bacteremia Pneumonia ive as Otitis media nv n-i No
Slide 15: Burden of Acute Otitis Media (AOM)
Burden of Acute Otitis Media (AOM) High impact of AOM on health care utilization and costs AOM causes millions of child visits to physicians each year AOM is most frequent indication for antibiotic use in children Globally, ~80% of bacterial AOM due to two bacteria1,2 Ear drum 40% - S. pneumoniae 40
Slide 16: Incremental Serotype Coverage of Synflorix vs. Prevnar
Incremental Serotype Coverage of Synflorix™ (PHiD-CV) vs. Prevnar® (PCV-7) + 11% + 3% + 27% + 19% + 21% + 8% Globally, Globally, PHiD-CV PHiD-CV covers covers 80% 80% of of circulating circulating invasive invasive pneumococcal pneumococcal disease disease US: CDC 2003; Europe: Hausdorff unpub.; Afr
Slide 17: PHiD-CV: Designed For Dual Pathogen Protection
PHiD-CV – Designed For Dual Pathogen Protection Broader coverage against S. pneumoniae disease Serotypes Serotypes -- 4, 4, 6B, 6B, 9V, 9V, 14, 14, 18C, 18C, 19F, 19F, 23F, 23F, 1, 1, 5, 5, 7F** 7F** + Added protection against non-typeable H. influenzae (NTHi) resulting from new carrier protein* * H
Slide 18: PHiD-CV: An Innovative Vaccine
PHiD-CV: An Innovative Vaccine 10 valent (global coverage) with a greater impact on severe disease Meets the WHO-endorsed AMC minimum target profile Significant protection against AOM caused by non-typeable H. influenzae AMC = Advance Market Commitment
Slide 19: A Rich Pipeline
A Rich Pipeline Phase I Phase II Phase III Submitted/Approved HIV Mosquirix™ Simplirix™ Cervarix® (BLA) (Herpes Simplex Virus) S. pneumo adult (Malaria) * (Cervical cancer) Flu Pre-pandemic Cytomegalovirus TB New generation flu (Dresden - MAA) * Epstein-Barr virus * MAGE-A3 ASCI Flu Pandemic (Non Sm
Slide 20: Influenza Virus: The Disease
Influenza Virus: The Disease Seasonal Influenza - “Each year, half a million people die from seasonal infection” Seasonal Flu vaccine (trivalent vaccine) Pandemic Influenza - “Spanish Influenza killed more than 20 million people worldwide” Pandemic Flu vaccine (monovalent vaccine)
Slide 21: Increased GSK Presence In The Flu Vaccine Market
Increased GSK Presence In The Flu Vaccine Market 100+ million dose capacity Manufacturing capacity expansion Dresden (Germany) and Ste Foy (Canada) 2010 Acquisitions Marietta (US) & IDB (Can) 2007/08 2005
Slide 22: Robust Seasonal Flu Sales
Robust Seasonal Flu Sales 200 £181 mn £168 mn 150 Millions (£) £105 mn 100 50 0 2005 2006 2007 New generation flu vaccine in development
Slide 23: Pandemic Scenario: Reactive Approach
Pandemic Scenario: Reactive Approach Declaration Peak intensity Pandemic pandemic World-Wide H5N1 Pandemic Availability of Pandemic Initiation of vaccine Reference strain Production (20-60 days) (90 days) Most people are likely to be exposed to pandemic flu before they can be vaccinated Pandemic pea
Slide 24: Clinical Trial Data Support Feasibility Of Pre-Pandemic Concept
Clinical Trial Data Directly Support The Feasibility Of The Pre-Pandemic Concept World-wide H5N1 Pandemic Phase 3/4 Phase 5 Phase 6 : PANDEMIC Time Only planning for 1st 2nd manufacturing Protection during pandemic dose dose 3-4 weeks Manufacturing of 1st 2nd prepandemic Protection vaccine dose dose
Slide 25: Persistence Of Cross-Reactive Neutralizing Antibodies
Persistence Of Cross-Reactive Neutralizing Antibodies - Seropositivity (%) Day 0 20 subjects per group Day 21 Day 42 Day 180 A/Indonesia/5/05 A/turkey/Turkey/1/05 A/Anhui/1/05 Clade 2.1 Clade 2.2 Clade 2.3 100 Seropositivity (%) 80 60 40 20 0 3.8µg 3.8µg + AS 3.8µg 3.8µg + AS 3.8µg 3.8µg + AS Neutra
Slide 26: Flu Franchise: Summary
Flu Franchise: Summary Robust seasonal flu vaccine sales First pre-pandemic vaccine to receive CHMP positive opinion February 2008 Significant sales of pandemic/pre-pandemic vaccines Advanced supply agreements for pandemic vaccine UK Denmark Iceland 16 Governments of the German Laender Purchase of p
Slide 27: A Rich Pipeline
A Rich Pipeline Phase I Phase II Phase III Submitted/Approved Mosquirix™ Simplirix™ Cervarix® (BLA) HIV (Malaria) (Herpes Simplex Virus) * (Cervical cancer) S. pneumo adult Flu Pre-pandemic Cytomegalovirus TB New generation flu (Dresden - MAA) * Epstein-Barr virus * MAGE-A3 ASCI Flu Pandemic (Non Sm
Slide 28: Cervarix
Cervarix® Now approved in 59 countries including EU Launched in more than 30 countries Filed in US Complete Response Letter received December 2007 Strong differentiating label in International markets Including cross-protection and broad age-range indication Reimbursement in several EU countries Com
Slide 29: Cervarix Development Strategy
Cervarix® Development Strategy No compromise on cervical cancer protection Inclusion of oncogenic HPV types only Avoid risk of interference Highly purified antigens by addition of other types assembled in VLPs Adjuvant enhances immune responses High and sustained antibody levels = MPL + Al(OH)3
Slide 30: Longest Duration Of Protection For Any Cervical Cancer Vaccine
Longest Duration Of Protection For Any Cervical Cancer Vaccine HPV 16/18 related CervarixTM Control Vaccine Efficacy CIN2+ n n % 95% CI Initial efficacy study 27 months1 0 3 100 NA 4.5 yrs2 0 5 100 -7.7 - 100 Combined analysis initial efficacy study and 5.5 yrs3 0 7 100 32.7 - 100 extended follow-up
Slide 31: Up To 6.4 Years: Sustained Protection Against CIN and HPV Infections
Up To 6.4 Years: Sustained Protection Against CIN, HPV-16/18 Persistent & Incident Infections Combined analysis initial efficacy study and extended follow-up CervarixTM Control Vaccine Efficacy HPV-16/18 Endpoints n n % 95% CI CIN2+ 0 9 100 51.3 - 100 12 Month Persistence 0 20 100 81.8 - 100 6 Month
Slide 32: Long term efficacy
Long term efficacy Phase II studies Cervarix® & Gardasil® 0 12 24 36 48 60 72 84 Months Villa, Villa, N=550 225 Olsson 2007 Efficacy against CIN2+ HPV-001, N= 1113 HPV-007, N=776 on going Efficacy against CIN2+ Up to 9.5 years follow-up
Slide 33: Cervarix Potential for Broad Protection
Cervarix® Potential for Broad Protection 16 +18 > 70% 6.7 ~ 80% +45 +31 2.9 HPV genotype +33 2.6 +52 2.3 +58 2.2 +35 1.4 +59 1.3 +56 1.2 +51 1.0 +39 0.7 +68 0.6 +73 0.5 +82 0.3 +Other 5.6 0 20 40 60 80 100 Global cervical cancer coverage by HPV high risk (cumulative) Adapted from Munoz N et al. Int
Slide 34: Only Cervical Cancer Vaccine With Cross-Protection Against HPV-45
Only Cervical Cancer Vaccine With Cross-Protection Against HPV-45 Interim analysis of HPV-008 data in High Risk HPV naïve cohort Efficacy against persistent infection (6 month definition) HPV-types N VE 95% CI HPV-45 (A7) 8734 83 43, 97 HPV-31 (A9) 8734 42 -17, 72 HPV-45/31 8734 60 28, 79 HPV-45/31/
Slide 35: High And Sustained Antibody Levels For Cervarix Against 16 & 18
High And Sustained Antibody Levels Demonstrated For Cervarix® Against Both 16 & 18 Gardasil® Cervarix® HPV 16 HPV 16 HPV 18 HPV 18 Adapted from S. E. Olsson et al., 2007, Vaccine 25, 4931. Adapted from Dessy IPC Bejing Nov 2007
Slide 36: Head-to-Head Trial: Cervarix vs Gardasil
Head-to-Head Trial : Cervarix® vs Gardasil® Initiated in January 2007 Approximately 1,000 women aged 18 to 45 years old across US Primary endpoint immune responses against HPV 16 and 18 measured by neutralization assay in women aged 18 to 26 years old Secondary endpoint immune responses against HPV
Slide 37: Cervarix: Summary
Cervarix®: Summary Longest duration of protection against the four most common and aggressive HPV types Cervarix induces consistently high antibody levels for more than 6 years against both HPV 16 & 18 Head-to-head data available late 2008
Slide 38: GSK Biologicals
GSK Biologicals Global vaccines market is poised for explosive growth GSK is a world leader in vaccines and continues to develop vaccines to meet public health needs in developed and developing countries GSK has one of the strongest vaccine pipelines in the industry Over 20 vaccines in clinical deve
Slide 39: Today's Agenda
Today’s Agenda GSK GSK within within the Vaccines Q&A the Vaccines Pipeline Vaccines Market Market
Slide 40: GlaxoSmithKline
GlaxoSmithKline