Q2 2021 Results - Reimagining Medicine slide image

Q2 2021 Results - Reimagining Medicine

Participants Financial performance Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Innovation: Pipeline overview Innovation: Clinical trials CRM IHD Neuroscience Oncology Ophthalmology Respiratory Sandoz Biopharmaceuticals Global Health Abbreviations EntrestoⓇ (ARNI) - Angiotensin II Receptor Neprilysin Inhibitor Study Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Read-out Milesstone(s) Publication NCT02468232 PARALLEL-HF (CLCZ696B1301) Heart failure, reduced ejection fraction Phase 3 225 Time to the first occurrence of the composite endpoint - either cardiovascular (CV) death or heart failure (HF) hospitalization Sacubitril/valsartan 50 mg, 100 mg, 200 mg bid/placebo of enalapril Enalapril 2.5 mg, 5 mg, 10 mg bid / placebo of sacubitril/valsartan Japanese heart failure patients (NYHA Class II-IV) with reduced ejection fraction Primary: Q1-2019 (actual); Extension (open-label): Q1-2021 (actual) Q1-2022 NCT02678312 PANORAMA HF (CLCZ696B2319) Heart failure in pediatric patients Phase 3 360 Part 1: Pharmacodynamics and pharmacokinetics of sacubitril/valsartan LCZ696 analytes Part 2: Efficacy and safety compared with enalapril Part 1: Sacubitril/valsartan 0.8 mg/kg or 3.1 mg/kg or both; 0.4 mg/kg or 1.6 mg/kg or both (single doses). Part 2: enalapril/placebo 0.2 mg/kg bid (ped. formulation 1mg/ml) and adult formulation (2.5, 5, 10 mg bid); Sacubitril/valsartan (LCZ696)/placebo: Ped. formulation granules (12.5, 31.25 mg in capsules); liquid formulation (1mg/ml and 4mg/ml concentration) and adult formulation (50, 100, 200 mg bid) Pediatric patients from 1 month to < 18 years of age with heart failure due to systemic left ventricle systolic dysfunction 2022; (Analysis of 110 pts from Part 2 formed the basis for pediatric submission in Apr-2019 and approval by the US FDA in Oct-2019 for the treatment of symptomatic HF with systemic left ventricular systolic dysfunction in children aged 1 year and older) TBD 58 Investor Relations | Q2 2021 Results NOVARTIS | Reimagining Medicine
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