Roche Holding Ltd · SIX:RO
Roche — HSBC Virtual Series: Alzheimer's Disease and the way forward (June 2024)
25 slides from Roche's conference presentation, June 2024
Slide 1: Roche
Slide 2: Bruno Eschli, Head of Investor Relations
Bruno Eschli Head of Investor Relations
Slide 3: Roche is #1 in Neurology
Roche is #1 in Neurology Neurology portfolio accounting already for 1/5 of Pharma sales FY 2023 sales Ocrevus: • Market leader in US/EU5 with 24% global patient share (YoY CER growth) 6.4 CHF bn • Further growth expected with SC approval in US / EU (expected 2024) +13% • HD Ocrevus (Ph3 data expecte
Slide 4: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Many opportunities with significant market potential in both divisions Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC Final Ph III data H2 2024 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 5: Olivier Gillieron, Lifecycle Leader Cardiometabolic and Neurology
Olivier Gillieron Lifecycle Leader Cardiometabolic and Neurology
Slide 6: Ageing population and neurological conditions
Ageing population and neurological conditions Neurological conditions, including Alzheimer’s Disease, constitute significant health and socioeconomic burden Ageing population Economic burden Health threat World population ≥65 years old Economic burden* of AD and related Predicted global manifested A
Slide 7: Trends in the neurology space
Trends in the neurology space Advances in science and technology will transform clinical care pathways Digital health Drug delivery solutions technology Biomarkers Disease diagnostics & modifying imaging therapies Personalized Virtual care medicine/gene telehealth & remote therapy monitoring 7
Slide 8: Roche's value proposition for neurology solutions in Diagnostics
Roche’s value proposition for neurology solutions in Diagnostics Roche is well positioned to make a positive impact on clinical care pathways Neurology vision Integrated solutions along patient journey Biomarker discovery IVD solutions Market leadership Early research collaborations Clinically valid
Slide 9: Integrated solutions along patient journey
Integrated solutions along patient journey Anchor in neurodegenerative & aid in diagnosis to extend along patient journey and across diseases Screen & Triage Diagnose Treat & Monitor Cognitive Early detection Differential Pathology Therapy (DMT) initiation DMT safety & efficiency Continuous monitori
Slide 10: pTau217 test complements Alzheimer's Disease offering
pTau 217 test complements Alzheimer‘s Disease offering Evidence from global trial will be key to implement solutions in clinical practice Elecsys CSF ratios Elecsys Amyloid Plasma Panel Elecsys pTau217 test2 • tTau, pTau181 & Abeta42 • Biomarkers pTau181 & ApoE4p • Biomarker pTau217 • NPV and PPV up
Slide 11: Azad Bonni, Global Head of Neuroscience & Rare Diseases
Azad Bonni Senior Vice President, Global Head of Neuroscience & Rare Diseases
Slide 12: Neurology pipeline
Neurology pipeline Industry leading portfolio differentiated on targets and platform technologies Ph I (3 NMEs) Ph II (6 NMEs, 1AI) Ph III (1 NME, 4AI) Launched (4) Brainshuttle™ CD20 prasinezumab Enspryng Ocrevus RG6035 RG7935 RG6168 RG1594 Multiple Sclerosis Parkinson’s MOG-AD RD Multiple Sclerosi
Slide 13: Neurology near term key catalysts
Neurology near term key catalysts Focus Areas Molecule Indication Ph I Ph II Ph III Status Ocrevus SC RMS & PPMS OCARINA II EU approval: mid-2024; US approval: Sept RMS GAVOTTE Data 2025 Ocrevus HD PPMS MUSETTE Data 2025 Multiple Sclerosis (MS) Data 2025 FENhance 1 RMS Fenebrutinib FENhance 2 Data 2
Slide 14: Roche is committed to transforming the AD journey
Roche is committed to transforming the AD journey by developing solutions across the breadth of AD Preclinical Early AD Moderate AD (primary and secondary prevention) (MCI-AD to mild AD dementia) Approved CSF biomarkers [pTau181/Aβ 42; tTau/Aβ 42] Therapy In development Digital biomarkers Plasma bio
Slide 15: Trontinemab - a novel Brainshuttle antibody targeting Aβ
Trontinemab - a novel BrainshuttleTM antibody targeting Aβ Active transport across the BBB significantly increases brain penetration and target engagement Trontinemab BBB Brain resident Microglia Anti-Aβ binder IgG1 Fc domain Transferrin Receptor 1 BrainshuttleTM (TfR1) module Aggregated Aβ Transfer
Slide 16: Brainshuttle technology enables higher brain exposure
BrainshuttleTM technology enables a higher brain exposure and broader CNS biodistribution of therapeutic antibodies Standard IgG1 BrainshuttleTM IgG1 CNS, central nervous system; IV, intravenous. 1 Whole-brain imaging highlights the distribution of classical IgG vs. BrainshuttleTM IgG targeting a ne
Slide 17: Brainshuttle AD is a Phase Ib/IIa dose escalation study
BrainshuttleTM AD is a Phase Ib/IIa dose escalation study Staggered, parallel-group, adaptive study design with 4 initial sequential cohorts Screening Double-blind treatment period Follow-up Continuous 28 weeks (7 IV doses) 28 weeks Dose escalation: Cohort 4: 3.6 mg/kg or Pbo IV Q4W Cohort Expansion
Slide 18: Further acceleration of amyloid plaque reduction at 3.6 mg/kg
Further acceleration of amyloid plaque reduction at 3.6 mg/kg Mean amyloid PET change from baseline1 Placebo n = 12 n=5 n=9 0.2 mg/kg n = 11 - n = 10 0.6 mg/kg n = 11 - n = 10 1.8 mg/kg n = 13 n = 11 n=8 3.6 mg/kg n = 12 n=8 - Snapshot date: 23 October 2023. 1 Mean values ±SE (standard errors) of av
Slide 19: Majority of participants at 3.6 mg/kg amyloid negative at 12 weeks
Majority of participants at 3.6 mg/kg amyloid negative at 12 weeks 5 out of 8 participants below the amyloid positivity threshold at interim analysis1 Mean amyloid value in CL at visit (% amyloid negative (<24.1 CL)) Visit 0.2 0.6 1.8 3.6 Pbo mg/kg mg/kg mg/kg mg/kg 98 CL 91 CL 88 CL 100 CL 119 CL B
Slide 20: Trontinemab in Alzheimer's disease: best-in-class potential
Trontinemab in Alzheimer’s disease Best-in-class potential: fast and highly efficient plaque removal Trontinemab clears amyloid more rapidly than conventional mAbs 120 GRADUATE I GRADUATE II 100 Amyloid PET (centiloids) Lecanemab CLARITY AD 80 Donanemab TRAILBLAZER-ALZ-2 60 Trontinemab 3.6 mg/kg q4w
Slide 21: Summary
Summary Trontinemab is a novel BrainshuttleTM Aβ antibody that crosses the blood brain barrier via active TfR1 mediated transcytosis at the capillary level. In people with AD, trontinemab demonstrated rapid and robust amyloid plaque reduction at relatively low doses (1.8 and 3.6 mg/kg), compared wit
Slide 22: Gamma-secretase modulator (GSM) in Alzheimer's disease
Gamma-secretase modulator (GSM) in Alzheimer’s disease (AD) Targeting amyloid precursor protein processing to prevent Aβ-aggregation Gamma-secretase modulator (RG6289) Compelling therapeutic approach γ β β γ Modified from Golde et al. 2012 • γ-secretase cleaves amyloid precursor protein (APP) to rel
Slide 23: Phase I results: RG6289 modulates γ-secretase in healthy individuals
Phase I results: RG6289 modulates γ-secretase in healthy individuals Dose-dependent effect of RG6289 on Aβ monomers in cerebrospinal fluid Pharmacodynamic profile of RG6289 in Healthy Volunteers1 ● Results from the EiH study in young and elderly healthy volunteers showed: Placebo (N=4) Mean change f
Slide 24: GABriella study in individuals at risk for or at prodromal stage of AD
GABriella study1 in individuals at risk for or at prodromal stage of AD Phase IIa exploring safety, tolerability & effects of RG6289 on AD biomarkers over 18 mos Patient population: 60-85 years of age; cognitively unimpaired or MCI due to AD; CDR-GS= Double blind, randomized, global trial with 78 si
Slide 25: Roche is committed to transforming the AD journey
Roche is committed to transforming the AD journey by developing solutions across the breadth of AD Preclinical Early AD Moderate AD (primary and secondary prevention) (MCI-AD to mild AD dementia) Approved CSF biomarkers [pTau181/Aβ 42; tTau/Aβ 42] Therapy In development Digital biomarkers Plasma bio
Roche Holding — HSBC Virtual Series: Alzheimer's Disease and the way forward (June 2024) on 6ix