Roche Pharmaceutical Development and Sales Overview

Roche Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Paroxysmal nocturnal hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a C5 inhibitor Phase/study # of patients Design Phase I/II COMPOSER N=59 Healthy volunteers and treatment naïve and pretreated patients with PNH: Part I: Single ascending dose study in healthy subjects Part II: Intra-patient single ascending dose study in PNH patients Part III: Multiple-dose study in PNH patients ◉ Part IV: Dose confirmation in PNH patients ☐ Safety, PK, PD Primary endpoint ■ Part I: FPI Q4 2016 Part II/III: FPI Q2 2017 Status CT Identifier Part IV: FPI Q2 2019 Nonclinical data published in Scientific Reports 2017 Apr; 7(1):1080 Data presented for Part 2 and 3 at ASH 2018 and 2019 NCT03157635 " ARM A: Crovalimab ARM B: Eculizumab Phase III COMMODORE 1 N=250 ARM C: Patients switching to crovalimab from ravulizumab, higher than labeled doses of eculizumab & C5 SNP patients (descriptive-arm) Non-inferiority of crovalimab compared to eculizumab - mean % change in LDH level (measure of haemolysis) from baseline to week 25 FPI Q3 2020 In collaboration with Chugai ASH-American Society of Hematology; PNH=Paroxysmal nocturnal hemoglobinuria; PK/PD=Pharmacokinetics/Pharmacodynamics; LDH-Lactate Dehydrogenase NCT04432584 117 Immunology

View entire presentation