A Few Housekeeping Items Av alere Health | An Inov alon Company | - PowerPoint PPT Presentation

A Few Housekeeping Items Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 3

Today’s Speakers Moderator Speaker Speaker Speaker Elizabeth Carpenter Kelly L. George, PhD Richard Hughes IV, John C. Neal, MBA JD, MPH Head of Advisory Services Consultant II Managing Director Managing Director ecarpenter@avalere.com kgeorge@avalere.com jneal@avalere.com rhughes@avalere.com Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 4

COVID Tx and Vx Product Development Pipeline 2 510+ 230+ EUA Active Pre-IND Safe to Proceed Treatments Treatments IND Treatments 5 145+ 18+ Vaccines Initiating Active Pre-IND Phase I and II Phase III Vaccines Vaccines CTAP Dashboard. FDA. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap Published July14, 2020. Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 5

Clinical Development and Regulatory Clarity to Support Timely Market Entry Policy & Oversight Evolutions / • Clearly articulated guidance • Expedited programs; CTAP Potential Off-Label EUA COVID-19 Use Tx or Vx Clinical Landscape Maturity / • Unified trial protocols • Endpoints reflecting various efficacy levels Standalone Supplemental Product Application Follow-On Market-Approval Pathway / Product • Does the risk outweigh the benefit? • Product specific Tx: Therapeutic; Vx: Vaccine; EUA: Emergency Use Authorization Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 6

Evolving COVID Market as More Vx and Tx Are Approved and Become Available Pre-FDA Approval: FDA Approval: Post PHE: EUA / Limited Options / Routine Commercial / • Limited positive data • Product administration to • Routine diagnosis, product available; Continuation of high-risk target populations distribution, and payer data collection management • USG purchase and potential • EUA and CTAP expedited • Use restrictions lifted distribution of novel products product review • Increases in COVID testing • USG contracting, distribution, and priority treatment • Highly managed and tightly controlled distribution Vx: Vaccines; Tx: Therapeutics; EUA: Emergency Use Authorization; FDA: Food and Drug Administration; PHE: Public Health Emergency; USG; United States Government Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 7

Initiatives Designed to Accelerate Developing COVID Tx and Vx Federal Interagency Partnership Operation Aims to speed development, manufacturing, and distribution of Warp Speed COVID Tx, Vx, and Dx Accelerating Coronavirus Therapeutic Interventions and Vaccines ACTIV Goal to prioritize vaccine and therapeutic development and connect clinical-trial networks Coronavirus Therapeutic Acceleration Program Combines aspects of multiple standard-expedited FDA programs into 1 CTAP initiative and focuses attention on the products that demonstrate the most promising results CURE ID Drug Repurposing Collaboratory CDRC Identifies new uses of existing drugs by capturing real-world, clinical-outcome data *Not an exhaustive list, many other initiatives in tandem Tx: Therapeutic; Vx: Vaccine; Dx: Diagnostic Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 8

COVID-19 Vaccines: Varied Purchasing and Distribution Pathways to Market Vaccine Pricing, Contracting, and Procurement Processes ASPR DoD/DHS (e.g., BARDA, SNS) CDC (e.g., DLA, FEMA) USG Contracting and Pricing Federal Government Purchase Distribution via USG- Contracted Distributor TBD McKesson* TBD State Distribution Vaccine Administration at Site of Care Material Manufacturing Fill/Finish Acquisition Vaccine Production and Supply Processes *McKesson has an Exclusive Distributor arrangement with CDC for the VFC program and has a Prime Vendor contract with the VA USG: United States Government; DoD: Department of Defense; CDC: Centers for Disease Control; SNS: Strategic National Stockpile; ASPR: Assistance Secretary for Preparedness and Response; BARDA: Biomedical Advanced Research and Development Authority Source: GAO. Influenza Pandemic: Lesson from the H1N1 Pandemic Should Be Incorporated in Future Planning. 2011. Available here. Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 9

In June, ACIP’s COVID-19 Work Group Proposed Priority Groups for a Tiered-Distribution Approach Proposed Distribution for At-Risk Populations Followed by the General Population / Highest Priority Other High-Priority Additional Proposed Groups Groups Groups Highest-risk medical, Healthcare personnel, Adults 65+, LTC- national security, and essential workers, facility residents, other essential workers persons with high-risk children, pregnant medical conditions women, high-risk racial and ethnic groups ACIP: Advisory Committee on Immunization Practices; LTC: Long-Term Care Source. June 2020 ACIP Meeting. Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 10

ICER Published on COVID Therapeutic and Vaccine Pricing Options Status Quo or Greater Manufacturer Control On July 2, 2020 Unrestricted Pricing ICER published a white paper on Value-Based alternative policies Pricing for drug and vaccine Advanced Market Commitments pricing during a and Subscription Models pandemic and will host a 3-part, cross- Cost-Recovery Greater Government Control stakeholder series Pricing later this month and Monetary Prize in early August. Compulsory Licensing Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 11

Vx and Tx Price Negotiations and Supply Capacity Factors Target Product Efficacy & Product Market Burden of Disease Profile & Number Differentiation Saturation & Demand of Doses End-User New-to-Market R&D, Stockpiling Purchaser: Asset vs Indication Manufacturing, Opportunity Government vs Extension Scale-Up Funding Private Commercial R&D: Research and Development Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 12

COVID-19 Continues to Drive Election Environment and Post-Election Outlook Voter Opinion on Trust of Candidates Trump Vice President in Handling COVID-19 / Administration Biden and Congress COVID-19 Plan COVID-19 Action 50% No-cost COVID-19 testing and 45% treatment Enhance FMAP 40% COVID-19 vaccine 35% price negotiation Enhance telehealth 30% flexibilities Prepare for surge capacity with 25% temporary hospitals Accelerate vaccine and therapeutic development Biden Trump Source: Morning Consult. How the Coronavirus Outbreak Is Impacting Public Opinion. Available here. Av alere Health | An Inov alon Company | Copy right  2020. Av alere Health LLC. All Rights Reserv ed. 13

Q&A