Shionogi & Co., Ltd. · TSE:4507
Shionogi & — Corporate Update (November 2022)
32 slides from Shionogi &'s corporate update, Nov 24, 2022
Slide 1: Briefing Session on COVID-19
Briefing Session on COVID-19 November 24, 2022 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda • Opening Isao Teshirogi, Ph.D., Chief Executive Officer • Filled for domestic approval of COVID-19 vaccine S-268019 Takeki Uehara, Ph.D., and Post-Marketing Safety Surveillance of Xocova® Tablets 125mg Senior Vice President, Drug Development and Regulatory Science Division • Xocova® Tablets
Slide 3: Filing for domestic approval of COVID-19 vaccine S-268019 and Xocova surveillance
Filled for domestic approval of COVID-19 vaccine S-268019 and Post-Marketing Safety Surveillance of Xocova® Tablets 125mg Takeki Uehara, Ph.D. Senior Vice President, Drug Development and Regulatory Science Division 3
Slide 4: Filed for approval of COVID-19 vaccine S-268019 in Japan
Filled for approval of COVID-19 vaccine S-268019 in Japan 4
Slide 5: S-268019: Progress summary
S-268019: Progress summary FY2021 FY2022 FY2023 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Phase 1/2*1 Interim Report (12/6) Phase 2/3*2 (safety/immunogenicity evaluation) Interim Report (4/22) Phase 3*5 (neutralizing antibody titer comparison trial) Phase 2/3*3 (boos
Slide 6: S-268019: Development status in adults
S-268019: Development status in adults Filed for manufacture and sales approval of S-268019 in Japan on November 24, 2022 • Preconsultation with PMDA has started from Feb. 2022, and the data obtained so far has been submitted in advance • Filed for the indication of “prevention of COVID-19 by primar
Slide 7: Collection and Disclosure of Post-Marketing Safety Information for Xocova
Collection and Disclosure of Post-Marketing Safety Information for Xokova® Tablets 125mg 7
Slide 8: Xocova: Progress Summary
Xocova: Progress Summary 2021 FY2022 2023 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Application for conditional approval (2/25) Trial period: Start of patient enroll to completion of clinical trial report Switch to EUA Ph2/3 topline results Post acute COVID-19 syndro
Slide 9: Overview of Post-Marketing Safety Surveillance Plan
Overview of Post-Marketing Safety Surveillance Plan FY2022 FY2023 Nov. Dec. Jan. Feb. Mar. Apr. May Jun. 11/22 Approval under the Emergency Regulatory Approval System Providing information through package inserts ,drug risk management plans, and informed consent documents ⇒ Utilization of SHIONOGI w
Slide 10: Risk Management Plan
Risk Management Plan Xocova® Tablets 125mg approval emergency approval Important identified risks: None Safety considerations Important potential risk: Teratogenic Important missing information: Safety in patients with moderate or severe hepatic impairment Efficacy Considerations Efficacy in Phase 3
Slide 11: Post-market Safety Monitoring - Post-Marketing Surveillance
Post-market Safety Monitoring - Post-Marketing Surveillance - During the early post-marketing surveillance period (6 months from the start of supply), safety information will be collected for all prescription patients Post-marketing surveillance Early post-marketing surveillance of Xocova® Tablets 1
Slide 12: Xocova Tablets 125mg Distribution System and Activities to Provide Information on Proper Use
Xocova® Tablets 125mg Distribution System and Activities to Provide Information on Proper Use Toshinobu Iwasaki, Ph.D Senior Executive Officer, Senior Vice President, Healthcare Business Supervisory Unit and Pharmaceutical Commercial 12
Slide 13: Regarding the Domestic Distribution System
Regarding the Domestic Distribution System - Supply under Purchase by the Government - Early post-marketing phase vigilance, Post-marketing surveillance, Investigative cooperation of medical institutions Diagnose Qualifications Medical institutions registration Drug prescription/dispensing Drug orde
Slide 14: Activities to Provide Information on Proper Use
Activities to Provide Information on Proper Use • Thoroughly disseminate that this drug is an emergency approval drug – Continuous collection of information, and prompt provision of safety information • Dissemination of the distribution system and medical institution registration system • Thorough c
Slide 15: What we learned from the pandemic about being prepared in normal times
What we learned from the pandemic about being prepared in normal times Isao Teshirogi, Ph.D. Chief Executive Officer 15
Slide 16: Global Spread of COVID-19 and Development of Vaccines and Therapeutic Drugs
Global Spread of COVID-19 and Development of Vaccines and Therapeutic Drugs Change in the Number of New Infections by Region in the World (Weekly)* November 24, 2022 S-268019 December 23, 2021 Submission LAGEVRIO EUA (Japan) (US) December 11, 2020 COMIRNATY EUA (US) December 22, 2021 November 22, 20
Slide 17: Background to the Early Development of COVID-19 Vaccines in the US
Background to the Early Development of COVID-19 Vaccines in the US 1. Operation Warp Speed in the US • Aggressive investment in promising candidates for the purpose of accelerating the development of vaccines, therapeutic drugs, and diagnostic drugs 2. Focused on building a national system for emerg
Slide 18: Background behind Japan's Delay in Vaccine Development
Background behind Japan’s Delay in Vaccine Development Problems revealed by this pandemic Barriers due to conventional approaches/systems in Japan Insufficient preparation in normal times for Substantial risks for reviewers and companies emergencies such as pandemics − Litigation risk − Continuous s
Slide 19: What We Learned from the Pandemic
What We Learned from the Pandemic • It is difficult to predict when, where, and what infectious disease will cause a pandemic • Anyone can become infected, develop symptoms and die • Considering global society, it is not enough just to implement local country measures against infectious diseases Inf
Slide 20: Threats of Infectious Diseases in the World
Threats of Infectious Diseases in the World There are many infectious disease threats globally beyond COVID-19 Major global threats • Three major infectious diseases (HIV/AIDS, malaria, tuberculosis) ‒ Prevalent in LMICs ‒ Kill more than 2.5 million people each year • Neglected Tropical Diseases (NT
Slide 21: Threats of Antimicrobial Resistance (AMR)
Threats of Antimicrobial Resistance (AMR) Antimicrobial resistance (AMR) AMR, called a “silent pandemic”, is a serious problem, as it is difficult to detect and spreads relatively 【Deaths due to AMR bacteria (annual)】 • AMR is estimated to have killed approximately 700,000 Estimated people* in 2014
Slide 22: Acute Infectious Diseases Business Difficult to Continue
Acute Infectious Diseases Business Difficult to Continue Difficult to predict epidemics Dysfunctional business environment Revenue Antibiotic stewardship Promotion of switching to generics Investment Social needs Huge R&D expenses Maintenance cost of production equipment Unable to sustain research a
Slide 23: Do Not Repeat the Social Disruption Caused by Infectious Diseases
Do Not Repeat the Social Disruption Caused by Infectious Diseases The need to strengthen preparedness for new pandemics “now” • Accurate prediction of pandemics is difficult (COVID-19, flu, etc.) • While the spread of COVID-19 has certainly raised public awareness of infectious diseases, preparation
Slide 24: Construction of a New Clinical Trial System and Development of Infrastructure for Emergencies
Construction of a New Clinical Trial System and Development of Infrastructure for Emergencies Issues and measures in the Xocova Phase 2/3 trial • There were few subjects for clinical trials at medical institutions ⁃ Due to the special environment of a pandemic, isolation at accommodation facilities,
Slide 25: Maintaining a Production System in Preparation for Emergency Operations
Maintaining a Production System in Preparation for Emergency Operations The dilemma of maintaining production capacity Mass production of vaccines, therapeutic drugs, etc. in a short period of time as an emergency measure for pandemic outbreaks Excessive costs to maintain production facilities for p
Slide 26: Flexible and Bold Pharmaceutical Regulatory Actions in the US under the Emergency
Flexible and Bold Pharmaceutical Regulatory Actions in the US under the Emergency Emergency Use Authorization (EUA) • The EUA allows FDA to help strengthen the nation’s public health protections against public health emergencies • FDA may authorize unapproved medical products or unapproved uses of a
Slide 27: Action in Japan to Overcome the Challenges Surfaced during the Pandemic
Action in Japan to Overcome the Challenges Surfaced during the Pandemic Domestic progress triggered by COVID-19 Preparation in normal times Creation of new emergency-ready systems in anticipation of emergencies Established a new method for Establishment of Emergency Established SCARDA within validat
Slide 28: Taking the Example of Xocova - Development overview
Taking the Example of Xocova ‐Development overview‐ Mild/Moderate FY2021 FY2022 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 For Phase 2/3 trial, we are receiving support from the project for Phase 2/3 topline results the practical application of new coronavirus infectious disease Application for con
Slide 29: Challenges Faced in Drug Development during a Pandemic
Challenges Faced in Drug Development during a Pandemic ‐Accurate drug efficacy evaluation‐ • Decrease in the rate of exacerbation due to rapid changes in vaccination status • When infected with the Omicron strain, the virus multiplies and disappears in the body faster than the past epidemic strains,
Slide 30: Role Japan Should Play
Role Japan Should Play Globally provide necessary pharmaceuticals as one of the few countries can create new drugs ＜Related SHIONOGI actions ＞ AMR initiatives Initiatives against COVID-19 • Partnership with GARDP*1 and CHAI*2 • Partnership with MPP*3 ⁃ SHIONOGI and GARDP concluded a license agreemen
Slide 31: Establishment of Sustainable Acute Infectious Diseases Business
Establishment of Sustainable Acute Infectious Diseases Business Building a new business model • The current business model in acute infectious disease is unstable, influenced by epidemic and external factors, and insufficient return in normal times • We should establish urgently a sustainable revenu
Slide 32: rroene®,
rroene®, ICD 3 Ga BRE IOMR PSEC ESCLAEY, ANYFLI7b, SOLSKBMIS, o Fe Km62%, SHIONOGI UVF MSAO MUST —— ZORBREDOMEIZFY d, BRE a, BC. RK OLIOCE BRL OVOSE FNS, BWACRZLILO, 204, \ @) sHionoa! ; si @ _