Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Technical Presentation (July 2020)
31 slides from Sanofi Sa's technical presentation, Jul 30, 2020
Slide 1: Nirsevimab: Aiming for RSV prophylaxis for all infants
Nirsevimab Aiming for RSV prophylaxis for all infants July 30, 2020
Slide 2: Forward looking statements
Forward looking statements This document contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlyin
Slide 3: Agenda
Agenda Introduction Thomas Triomphe Global Head of Sanofi Pasteur RSV - A major public Su-Peing Ng Global Head of Medical, Sanofi Pasteur health burden Global Project Head, nirsevimab, Phase 2b data Jon Heinrichs Sanofi Pasteur Conclusion John Shiver Global Head of R&D, Sanofi Pasteur Paul Hudson Ch
Slide 4: Introduction
Introduction Thomas Triomphe Global Head of Sanofi Pasteur
Slide 5: Sanofi – a market leader in both pediatric combos and influenza vaccines
Sanofi – a market leader in both pediatric combos and influenza vaccines Pediatric combos & influenza account Unique blend of experience to drive for ~70% of Sanofi vaccines sales success of RSV immunization Pediatric combos • Pediatric combos provide insights into the Influenza operating model of p
Slide 6: RSV - A major public health burden
RSV - A major public health burden Su-Peing Ng Global Head of Medical, Sanofi Pasteur
Slide 7: Disease burden greatest for all infants facing their first RSV season
Disease burden greatest for all infants facing their first RSV season Annual RSV hospitalization rates for all age groups (U.S., per 100,000) 1,100 270 258 84 40 9 28 0 0-11m 12-23m 24-59m 5-17yo 18-49yo 50-64yo 65-74yo 75+yo 0- 5 years old(1) ≥5 years old(2) m: months; yo: years old 7 (1) Hall et a
Slide 8: Disease burden – all infants are at risk
Disease burden – all infants are at risk Breakdown of U.S. birth cohort, annual RSV hospitalizations and annual hospitalization cost by gestational age Scope: all infants facing their first RSV season 3.9m 49k $679m 4% 1.6% 8% Palivizumab recommended U.S. population: 7% 21% 1.6% of birth cohort 11%
Slide 9: Hospitalizations only the tip of the iceberg
Hospitalizations only the tip of the iceberg RSV cost in the U.S. RSV disease burden Scope: all infants facing their 1st RSV season beyond costs Share of RSV cost • ~215 deaths annually in the Number of visits Total ~ $2bn U.S.(2) Medical care • Burden for healthcare system: increased capacity Hospi
Slide 10: Value proposition - prophylaxis for all infants
Value proposition - prophylaxis for all infants Nirsevimab target profile Palivizumab Recommended Universal, targeting all infants <2% of birth cohort, infants born population regardless of wGA or month of birth < 29 wGA(1) and CHD/CLD >70% relative risk reduction 45-55% relative risk reduction Effi
Slide 11: Phase 2b data
Phase 2b data Jon Heinrichs Global Project Head, nirsevimab, Sanofi Pasteur
Slide 12: Half-life extension allows population approach to protect all infants
Half-life extension allows population approach to protect all infants Technology • Derived from human B-cells • Potent IgG1 neutralizing mAb • Targets a conserved epitope on the F protein • Half-life extension technology Target profile for all infant strategy Nirsevimab • Immediate protection • Once
Slide 13: Phase 2b trial in ~1,500 healthy pre-term infants
Phase 2b trial in ~1,500 healthy pre-term infants Days Study population 1 8 31 91 151 361 • 1,453 pre-term infants 29-35 wGA Day -30 to Day 1 Primary endpoint • Incidence of medically attended LRTI (in and Nirsevimab group: Single IM dose of 50 mg nirsevimab Informed consent outpatient) caused by RT
Slide 14: 70% reduction of medically attended RSV LRTI
70% reduction of medically attended RSV LRTI Incidence, in % (# of cases) 70%(1) Placebo (N=484) Nirsevimab (N=969) 78%(2) 9.5% (46) 4.1% 0.8% 1.0% 1.0% 2.6% 0.0% 0.0% 3.0% 0.4% (20) (8) (5) (5) (0) (0) (15) (4) (25) Medically attended RSV LRTI ICU admissions Patients needing Patients requiring RSV
Slide 15: Consistent efficacy in Ph2b regardless of gestational age
Consistent efficacy in Ph2b regardless of gestational age Medically attended RSV LRTI incidence, in % (# of cases) 74%(1) 70%(2) 10.9% (18) 8.4% (25) Placebo (N=484) 2.8% 2.5% Nirsevimab (N=969) (9) (15) 29-32 wGA 32-35 wGA # of infants 165 326 299 606 Phase 3 MELODY underway to investigate efficacy
Slide 16: Safety results similar to placebo
Safety results similar to placebo Placebo Nirsevimab Parameter, n (%) (N=479) (N=968) Treatment emergent adverse events 416 (86.8) 834 (86.2) Considered related to study drug 10 (2.1) 22 (2.3) ≥Grade 3 severity 60 (12.5) 77 (8.0) Occurred ≤1 day post-dose 12 (2.5) 24 (2.5) Occurred ≤7 days post-dose
Slide 17: Passive immunization - only approach to immediately protect all infants for the entire 1st season
Passive immunization - only approach developed to immediately protect all infants for the entire 1st season mAb immunization (passive): mAbs (passive) • Only known approach to provide Illustrative MI (passive) sufficient Ab titer to all infants in 1st antibody Vaccine (active) RSV season, when the r
Slide 18: Nirsevimab prophylaxis would benefit all infants, regardless of when they are born
Nirsevimab prophylaxis would benefit all infants, regardless of when they are born Modelling the period of potential protection from RSV infection in a temperate country(1) Using mAb immunization with 5m protection Using maternal immunization with 4m protection Oct Nov Dec Jan Feb Mar Apr May Jun Ju
Slide 19: Nirsevimab protection to potentially exceed 5 months
Nirsevimab protection to potentially exceed 5 months Nirsevimab serum concentrations (µg/ml) – Mean ±SD(1) 100.0 10.0 Effective threshold (EC90) 6.8 1.0 Time after nirsevimab 0.1 60 90 120 150 180 210 240 270 300 330 360 390 administration (Days) Assessment of protection duration included in ph3 (in
Slide 20: Overview of passive immunization approaches
Overview of passive immunization approaches Palivizumab Nirsevimab Maternal immunization (marketed) (target profile) (development project) 100% ~40-60%(1) Recommended population <2% Pre- and full-term Full-term only (% of birth cohort) CHD/CLD & ≤29wGA Born in- and out-season Born in-season only Ach
Slide 21: Conclusion
Conclusion John Shiver Global Head of R&D, Sanofi Pasteur
Slide 22: Learning from 60+ years of R&D in RSV to deliver next generation mAb and infant vaccine
Learning from 60+ years of R&D in RSV to deliver next generation mAb and infant vaccine 1950s 1960s 1990s 2000s 2010s 2020s RSV discovery Formalin- RespiGam Subunit Suptavumab Nirsevimab(1) inactivated MedImmune vaccines Regeneron Sanofi, AstraZeneca vaccines MedImmune, Novavax, Sanofi Palivizumab M
Slide 23: Three pivotal studies to enable universal RSV immunization
Three pivotal studies to enable universal RSV immunization wGA Study Target population Study end MELODY Healthy full-term and late pre-term infants Pivotal Ph 3 vs. placebo 2023e ≥ 35 wGA N=3,000 (targeted) PHASE 2b Healthy pre-term infants N=1,453 vs. placebo 29-35 wGA ✔ MEDLEY Palivizumab-eligible
Slide 24: Intranasal live-attenuated vaccine for 2nd & 3rd RSV seasons
Intranasal live-attenuated vaccine for 2nd & 3rd RSV seasons Antibody titers pre & post-immunization(1) RSV PRNT60 (1/Log2) • Leverages decades of rational attenuation of RSV by NIH • Utilizes natural route of RSV infection (intranasal) to generate appropriate immune responses • Demonstrated safety
Slide 25: Summary - aiming for RSV prophylaxis for all infants
Summary - aiming for RSV prophylaxis for all infants Universal, targeting all infants Recommended population • Pre- and full-term • Born in- and out-season 70-80% observed relative risk reduction Efficacy of RSV related complications in pre-term infants Treatment burden One single injection for the
Slide 26: Q&A session
Q&A session Thomas Triomphe Paul Hudson Global Head of Sanofi Pasteur Chief Executive Officer Jon Heinrichs John Reed Global Project Head, nirsevimab, Global Head of R&D Sanofi Pasteur Su-Peing Ng Jean-Baptiste de Chatillon Global Head of Medical, Sanofi Pasteur Chief Financial Officer John Shiver G
Slide 27: Nirsevimab Appendices
Nirsevimab Appendices July 30, 2020
Slide 28: Phase 2b demographics and baseline characteristics
Phase 2b demographics and baseline characteristics Nirsevimab Placebo N=969 N=484 Age (months) 3.29 (2.22) 3.28 (2.31) Weight (kg) on day 1 4.60 (1.92) 4.51 (1.96) Male 501 (51.7%) 260 (53.7%) Race White 693 (71.6%) 355 (73.3%) Black or African American 189 (19.5%) 67 (13.8%) Asian 5 (0.5%) 10 (2.1%
Slide 29: Nirsevimab - one of the largest RSV development programs
Nirsevimab - one of the largest RSV development programs Player Phase ID Size Arms Primary endpoint Maternal immunization GSK Phase 2 NCT04126213 600 3: formulations 1 & 2 + PBO Safety (AEs/SAEs) – Completed Pfizer Phase 3 NCT04424316 6900 1 active group + PBO Medically attended LRTI – Started 8: lo
Slide 30: Nirsevimab: RSV 2020e number of births
Nirsevimab: RSV 2020e number of births (thousands) US 3,900 EU5 3,120 Japan 860 China 16,000 0 1,000 2,000 3,000 4,000 16,000 US Japan EU5(1) China Source: US Census Bureau Population Division; EU Eurostat; National Institute of Population and Social Security Research; World Bank (1) Germany, France
Slide 31: Summary of deal terms with AstraZeneca
Summary of deal terms with AstraZeneca • In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab jointly • Sanofi made an upfront payment of €120m and is obligated to pay up to €495m upon achievement of development and sales-related milestones • The two c