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
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