Amgen : Rocatinlimab and UPLIZNA Investor Update Presentation

Published: 2024-09-25 00:09:04 ET AMGN

Driving Long-Term Growth: Rocatinlimab and UPLIZNA® Update

September 24, 2024

Participants

Jay Bradner, MD

Exec. VP, Research & Development, Amgen

Murdo Gordon

Exec. VP, Global Commercial Operations, Amgen

Vikram Karnani

Exec. VP, Rare Disease, Amgen

3 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements,

Four Therapeutic Area Pillars Driving Long-term Growth

GENERAL

MEDICINE

ONCOLOGY

INFLAMMATION

RARE DISEASE

Y

Marketed Products

Innovative Pipeline

Biosimilars

4 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.

Rocatinlimab ROCKET Phase 3 Program Update

Atopic Dermatitis (AD) Impacts Over 30 Million Individuals Globally

6 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.

Rocatinlimab Rebalances T-cells by Targeting OX40 Receptor

T-cell Imbalance

Driven by increased activity and number of pathogenic T-cells

Resting

OX40 T-cell

Receptor

Pathogenic

T-cell

Proinflammatory

Cytokines

Rocatinlimab

rebalances

pathogenic T-cells

T-cell Rebalance

Achieved by inhibition and reduction of pathogenic T-cells

Rocatinlimab

Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.

7 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.

ROCKET Phase 3 Program in Atopic Dermatitis Well Underway with Potential in Other Diseases

Moderate to Severe

ATOPIC DERMATITIS

Phase 3

PRURIGO NODULARIS

Phase 3

ASTHMA

Phase 2

Adult

Adolescent

Adult & Adolescent

Adult & Adolescent

Adult &

Adolescent

HORIZON: placebo-controlled monotherapy rocatinlimab (N = 726)

IGNITE: placebo-controlled monotherapy evaluating two rocatinlimab doses (N = 769)

SHUTTLE: placebo-controlled trial evaluating two rocatinlimab doses with topical therapy (N = 746)

VOYAGER: placebo-controlled trial assessing vaccine antibody response while on rocatinlimab (N = 221)

ASTRO: 52-week trial evaluating two rocatinlimab doses (N = 500)

ORBIT: 52-week adolescent open-label trial (N = 187)

ASCEND: maintenance trial with re-randomized withdrawal & extension cohorts (N = 2,200)

OUTPOST: 52-week open label trial of self-administered rocatinlimab (N = 100)

Phase 3 trial in prurigo nodularis

Phase 2 trial in moderate-to-severe asthma

Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.

8 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.

HORIZON Phase 3 Trial:

Investigation of Rocatinlimab in Atopic Dermatitis (AD)

Screening

N = 726

Randomization (3:1)

Monotherapy Treatment (24 Weeks)

N = 543

Rocatinlimab Dose 1 Q4W

+ loading dose at W2

N = 183

Placebo Q4W

+ loading dose at W2

Week 0

Week 2

Week 24

(Baseline)

(Loading Dose)

(Primary Endpoint)

20210146

Long-term

Maintenance Trial

Safety

Follow-Up

KEY ELIGIBILITY CRITERIA

KEY DESIGN CONSIDERATIONS

•

≥ 18 yo, M2S AD

Rescue therapy was allowed, if deemed necessary

• vIGA-AD 3 or 4

• Subjects who used rescue therapy were considered non responders

•

EASI ≥ 16

• Study treatment was to be discontinued if systemic rescue therapy for AD was

used (except for corticosteroids used for ≤ 14 days)

BSA ≥ 10%

•

Stratification:

• 7-day recall worst pruritus NRS ≥ 4

• vIGA-AD 3 vs. vIGA-AD 4

•

Topical failure; bio experienced included

• Japan vs. Non-Japan Asian countries vs. RoW

Q4W = every 4 weeks; W2 = week 2; M2S AD = moderate-to-severe atopic dermatitis; vIGA-AD = Validated Investigator Global Assessment for Atopic Dermatitis; EASI = Eczema Area and Severity Index; BSA = body surface area; NRS = numerical rating scale; RoW = rest of world.

Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.

9 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.

HORIZON Phase 3 Trial: Primary & Key Secondary Endpoints

Atopic Dermatitis (vIGA-AD ):

EASI = Eczema Area and Severity Index; vIGA-AD = Validated Investigator Global Assessment for Atopic Dermatitis; rIGA = Revised Investigator Global Assessment; NRS = numerical rating scale; AD = atopic dermatitis; DLQI = Dermatology Life Quality Index.

Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.

10 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.

HORIZON Phase 3 Trial: Summary of Results

EASI = Eczema Area and Severity Index; vIGA-AD = Validated Investigator Global Assessment for Atopic Dermatitis; rIGA = Revised Investigator Global Assessment. Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.

11 Provided September 24, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.

Disclaimer

Amgen Inc. published this content on September 25, 2024 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on September 25, 2024 at 04:08:06 UTC.