Q2 2021 Results - Reimagining Medicine slide image

Q2 2021 Results - Reimagining Medicine

Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Financial performance Innovation: Pipeline overview Innovation: Clinical trials Neuroscience Oncology Ophthalmology Respiratory Sandoz Biopharmaceuticals Global Health Abbreviations CRM IHD KJX839 - siRNA (regulation of LDL-C) Study Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients NCT03814187 ORION-8 (CKJX839A12305B) Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) and Homozygous Familial Hypercholesterolemia (HoFH) Phase 3 2'991 Proportion of subjects achieving prespecified low density lipoprotein cholesterol (LDL-C) targets at end of study Safety and tolerability profile of long term use of inclisiran Inclisiran sodium 300mg on day 1 (placebo patients entered into study from ORION 9, 10 & 11) or placebo on Day 1 (inclisiran patients entered into study from ORION 9, 10 & 11) then inclisiran 300mg on Day 90 and every 6 months for a planned duation of 3 years Patients with HeFH or pre-existing atherosclerotic cardiovascular disease (ASCVD) on background statin +/- ezetimibe therapy and risk equivalents (patients from ORION 9, 10 & 11 studies) Read-out Milesstone(s) 2023 Publication TBD NCT03851705 ORION-5 (CKJX839A12302) Hypercholesterolemia inc. Homozygous Familial Hypercholesterolemia (HoFH) Phase 3 56 LDL-C reduction at Day 150 Changes in PCSK9, other lipids and lipoproteins Part 1: inclisiran sodium 300mg on Day 1 and Day 90 or placebo on Day 1 and Day 90 Part 2: inclisiran on Day 180 for patients who were randomized to the placebo group only, inclisiran on Day 270 and then every 6 months for a planned duration of 2 years for all patients Patients with HoFH with background statin +/- ezetimibe therapy Primary: Q3-2020 (actual); Final: H2-2021 TBD 62 Investor Relations | Q2 2021 Results NOVARTIS | Reimagining Medicine
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