NOVEMBER 16, 2020

Update: Allocation and Distribution of OWS Therapeutics

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Context

Veklury (remdesivir) remains the only FDA-approved product for the treatment of COVID-19.

A spectrum of therapeutics is currently under consideration.

EUA granted for bamlanivimab Nov 9, 2020

USG will oversee allocation and distribution of bamlanivimab in two phases.

We are leveraging and refining the process used with remdesivir allocation and distribution.

Topics for today

• Provide update on bamlanivimab

Emergency Use Authorization

• Summarize process for allocation and

distribution of bamlanivimab

• Discuss unique drug administration

requirements and anticipated challenges

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AboutMonoclonal Antibodies

Monoclonal antibodies (mAbs) directly neutralize the

COVID-19 virus and are intended to prevent progression

of disease

mAbs likely to be most effective when given early in

infection

Product delivered via single administration (e.g., IV

infusion)

Early evidence suggested promise of mAb products in

outpatient settings

• Early evidence from Eli Lilly mAb showed potential

to reduce hospitalization for infected people if given

early in infection in BLAZE-1 clinical trial

• FDA granted Emergency Use Authorization for

bamlanivimab on November 9, 2020

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About Bamlanivimab

EUA authorizes use of Bamlanivimab for treatment of high-risk* COVID-19 outpatients (ages ≥12 y/o, weight ≥40 kg) with mild-to-moderate symptoms at risk for progressing to severe disease/hospitalization

*high risk criteria listed on next slidehttps://www.fda.gov/media/13766/downloadhttps://www.fda.gov/media/135757/download

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Direct SARS-CoV-2 test (e.g., PCR, rapid antigen

test) must be positive

Administered as soon as possible after positive test

result and within 10 days of symptom onset

Provider to review EUA fact sheet

Patient/caregiver to be provided with EUA fact

sheet

Administered in a setting where HCPs have direct

access to medications to manage severe reactions.

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Bamlanivimab (Eli Lilly) EUA – High-Risk Criteria

• All Patients (who meet at least 1 of the following

criteria):

• BMI ≥35

• Chronic kidney disease

• Diabetes

• Immunosuppressive disease

• Receiving immunosuppressive treatment

• Age ≥ 65 years

• Age ≥ 55 years AND have any of the following

• Cardiovascular disease

• Hypertension

• COPD/other chronic respiratory disease

• Adolescents (Age 12-17 years) who meet at least

1 of the following criteria:

• BMI ≥85th percentile for age/gender • Sickle cell disease• Congenital or acquired heart disease• Neurodevelopmental disorders (e.g. cerebral

palsy)

• Medical-related technological dependence [e.g., tracheostomy, gastrostomy, or positive

pressure ventilation (not related to COVID-19)]

• Asthma, reactive airway, or other chronic respiratory disease that requires daily

medication for control

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Characteristics Requirements

Dose 700mg in 200mL 0.9% NaCl IVPB over at least 60 minutes (PVC infusion set with 0.20/0.22 micron filter)

Monitoring Monitor during infusion (no specified interval) and for 1 hour after completion

Storage Requirements 700mg/20mL vial – store in original carton to protect from light at 2-8℃; do not freeze, shake, or expose to direct light or heat

Stability Once Reconstituted 24 hours at 2-8℃ OR up to 7 hours (including infusion time) at room temperature

Required Chart Documentation - That patient/caregiver has been given fact sheet

- Informed patient of treatment alternatives to bamlanivimab

- Inform patient that bamlanivimab is an unapproved drug used under the auspices of EUA

Adverse Effects (in

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Phase 2 Trial Results: Bamlanivimab in Outpatients with Covid-19

All study-patients, Hospitalization or ED

visit within 29 days of administration– Treatment group (n=309), 1.6%

– Placebo group (n=143), 6.3%

– Number needed to treat (NNT) to avoid

hospitalization/ED = 21.3

Study-patients with BMI >35 or Age >65,

Hospitalization/ED within 29 days– Treatment group (n=95), 4.2%

– Placebo group (n=48), 14.6%

– NNT = 9.6

Chen P, et al, for the BLAZE-1 Investigators.SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with

Covid-19.N Engl J Med. Oct 28, 2020. DOI:10.1056/NEJMoa2029849

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Overview of Veklury (remdesivir) experience

From May through September 2020, the federal

government led the fair and equitable

distribution of donated and commercially available Veklury.

Distributed more than 320,000 treatment courses to hospitals across states, territories and federal agencies.

Building upon that experience, USG will manage the

allocation of bamlanivimab in a manner that is fair,

accessible, and understandable to the

American public.

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Principles for USG allocation and distribution

Maximize use of existing infrastructure within USG,

as well as manufacturer and distributor channels

• Eli Lilly (manufacturer) and AmerisourceBergen

(distributor)

Allocations must ensure both temporal and

geographic equity

USG to allocate to state and territorial health

departments based on:

• Confirmed Hospitalizations (7- Day Incident)

• Confirmed Cases (7- Day Incident)

States/Territories responsible for allocation to final

points of care

Manufacturer tracks pharmacovigilance and follows

mandatory reporting guidance

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Federal allocation decision informed by two data sources provided by hospitals/health departments to HHS Protect*

• All confirmed cases

• Contributes overall magnitude of case

load

• Captures emerging cases in near real

time

Confirmed Hospitalizations

(7- Day Incident)Confirmed Cases (7- Day Incident)

• Entered daily via TeleTracking (HHS

Protect) at hospitals: “How many

confirmed COVID-19 cases admitted in

last 24h period?”

• Data has a known lag, as it typically

takes 1-2 weeks for hospitalization of

patients

• Complete and timely (98% of facilities

report at least once weekly; 89% report

daily)

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*NOTE: a/o Nov 9, 2020

99% report at least once per week

92% report daily

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Allocation and distribution concept of operations

• Manages EUA submission and updates

• Prepares product fact sheet

• Notifies FDA on any reported safety issues

• BARDA provides regulatory support for PCTs

• Determines allocation & consults with NIH

• Pays for distribution costs via contract with

manufacturer

• Informs distributor and state/territorial health

departments of allocations

• Tracks product is delivered

• Direct products to appropriate county/parish

districts & hospitals

Nursing homes

VA

Indian Health

Services

Pharmacies

Other

• Reviews EUA application

• Monitors ongoing AE reporting from sites

Hospitals

Manufacturer

State governmentsUSG

Key Flow of material

Flow of info

Contracted relationship

• Contracted directly by manufacturer

• Manages storage of USG product

• Ships directly to sites id'ed by

states/territories

• Reports delivery data back to USG

Distributor

• Sites vary by use case

• Hospitals report

admissions data

• HCPs report AEs

Potential

administration

sites

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Two Phases of Allocation

Phase 1: states and territories allocate bamlanivimab to hospitals and hospital-

affiliated locations only

Phase 2: states and territories allocate to additional outpatient facilities

In addition to allocations to states and territories,

bamlanivimab is being allocated to the Department of

Defense, the Veterans Health Administration, the Indian

Health Service, the Bureau of Prisons, and the

Department of State for distribution within those

healthcare systems.

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Current Allocations

• 79,350 vials allocated Nov 10, 2020

• 1 vial = 1 dose = 1 treatment course

• Distribution now underway

• View allocation dashboard for your

state/territories allocation amount

www.phe.gov/bamlanivimab

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Allocation/Distribution Rhythm:Allocations expected to take place on Wednesday mornings, with first distribution beginning on Wednesday afternoons

Allocations to

states/territories

determined

Notification to

stakeholders

States/territories

work with

distributor to

identify final

delivery

location(s)

States/territories

continue to work

with distributor to

identify final

delivery

location(s)

All delivery

locations

confirmed by CoB

First shipments

received by states

Delivery of

product continues

Wednesday Thursday Friday Saturday Sunday Monday Tuesday

Data for allocation

model closes for

next allocation

cycle

Key

Allocation to states finalized

First delivery of products

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Allocation DashboardMaintained

https://www.phe.gov/Bamlanivimab

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Unique challenges to Bamlanivimab administration

Appropriate

healthcare staffingTraining and equipment to

accommodate IV infusionAdditional

prep time

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This playbook is intended to support sites interested in administering

COVID-19 treatment under EUA including:

• Existing hospital or community-based infusion centers

• Existing clinical space (e.g. urgent care, emergency depts)

• Ad hoc new infusion sites (e.g. "hospitals without walls”)

Initial version of playbook focused on:

• Monoclonal antibody treatment

• Delivery via infusion

• Outpatient setting

This playbook will continue to evolve as other treatments and

administration methods become available. We hope this playbook will

be used to help healthcare facilities to start planning on how to

implement monoclonal antibody treatment in an outpatient setting for

those with COVID-19.

OWS Therapeutics: Monoclonal Antibody Playbook

*This playbook was updated on

November 10, 2020 based on

FDA guidance. This guidance

should be used to help with

preparedness.

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OWS Therapeutics: Monoclonal Antibody Playbook:Based on what we have learned to date - early administration of treatment needs fast testing turn-around and patient scheduling

Onset of

symptoms

Clinical visit and

diagnostic test

≤ 3 days post

symptom onset

Confirmed

positive test

≤ 2 days post

diagnostic test

Treatment

≤3 days post

positive test

result

Treatment needed within 10 days of symptom onset

Testing sites should recommend COVID+ patients that are

high risk confer with their HCP on potential suitability for Tx

Example timeline

• Treatment likely most beneficial to patients if given early in symptom

progression

• EUA requires administration of treatment as soon as possible after

confirmed positive test result and within 10 days of symptom onset

• Strong partnership and communication between patients and HCP to

get right treatment to right patients at right time

• Fast testing turnaround needed, to efficiently identify positive tests and

schedule for treatment

Overview

Please reference the EUA factsheet for specific treatment

guidelines including recommended treatment window

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Readiness Checklist: Administration of Outpatient mAbs under EUA

Allocate dedicated space and develop plan to manage patient flow

Clear process for patients that are coming to clinical site including scheduling requirements

Admission process for COVID-19 positive patients designed to minimize risk of spread per facility

requirements / directions / guidelines'

Dedicated room available for treatment

Ensure dedicated source of supplies; which may be difficult to procure

Needed infusion components obtained

Example: IV kits, infusion chair, IV pole, vital sign monitoring equipment, emergency medications

Assign sufficient personnel to meet expected demand

Sufficient staffing plans in place for Nurse/IV tech, Physician, Pharmacist

– Likely need dedicated team to treat patients

Prepare for drug administration process

Pre–visit: Clear treatment and monitoring plan developed for during infusion

Treatment: 1-hour treatment and up 1-hour post-treatment observation

Emergency protocol defined for addressing potential infusion reactions or complications

Post-treatment: Clear process for patient follow-up defined using telemedicine as possible

Ensure process for reimbursement in place (non-drug administrative costs)

Prepare for reporting needs for adverse events and record keeping

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Infusion Supplies

250 ml

0.9% NaCl

IV Insertion

Supplies

IV

Infusion

Tubing

0.2/0.22 µm

Filter

20 ml

Syringe x2

18g

Sterile

Needle x2

Alcohol

Wipes

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InfusionSetup

Infusion

with IV

Pump

0.2/0.22

µm filter

Gravity Infusion• Utilize flow limiting

device or

• Calculate drip rate*

Drip Rate Table

*See pg.18 of OWS Playbook https://www.covid19.lilly.com/

assets/pdf/bamlanivimab/lilly-

antibodies-playbook.pdf

Solution Stability

• 7 hours at room

temperature, including

infusion time

• 24 hours at 2-8◦C

https://www.covid19.lilly.com/assets/pdf/bamlanivimab/lilly-antibodies-playbook.pdf

Thank you!