Q4 2021 Results
Participants
Financial performance
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Ophthalmology
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
Abbreviations
EntrestoⓇ
-
Angiotensin receptor/neprilysin inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
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
NCT02884206 PERSPECTIVE (CLCZ696B2320)
Heart failure
Phase 3
592
Change from baseline in the CogState Global Cognitive Composite Score (GCCS)
Sacubitril/valsartan 50, 100, and 200 mg bid with placebo of valsartan
Valsartan 40, 80, and 160 mg bid tablets with placebo for sacubitril/valsartan
Patients with chronic heart failure with preserved ejection fraction
Target Patients
Read-out Milestone(s)
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)
2023
Publication
TBD
TBD
68 Investor Relations | Q4 2021 Results
NOVARTIS | Reimagining MedicineView entire presentation