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 CRM IHD Neuroscience Oncology Ophthalmology Respiratory Sandoz Biopharmaceuticals Global Health Abbreviations LNP023 - Factor B inhibition of the complement alternative pathway Study Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Read-out Milesstone(s) Publication NCT04558918 APPLY-PNH (CLNP023C12302) Paroxysmal nocturnal haemoglobinuria Phase 3 91 Percentage of participants achieving a sustained increase in hemoglobin levels of ≥ 2 g/dL in the absence of red blood cell transfusions Percentage of participants achieving sustained hemoglobin levels ≥12 g/dL in the absence of red blood cell transfusions Arm 1: Drug: LNP023, taken orally b.i.d. dosage supplied: 200 mg dosage form: hard gelatin capsule Route of Administration: Oral Arm 2: Drug: Eculizumab, administered as intravenous infusion every 2 weeks as per the stable regimen, the maintenance dose is a fixed dose. Dosage supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion Drug: Ravulizumab, administered as intravenous infusion every 8 weeks, the maintenance dose is based on body weight. Dosage Supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion Adult patients with PNH and residual anemia, despite treatment with an intravenous Anti-C5 antibody Primary 2022 TBD NCT04578834 APPLAUSE-IgAN (CLNP023A2301) IgA nephropathy Phase 3 450 Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine collection) at 9 months Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months Arm 1 LNP023 200mg BID Arm 2 - Placebo BID Primary IgA Nephropathy patients 2023 Perkovic et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1: Study Design Wong et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1: IPTACOPAN (LNP023): A NOVEL ORAL COMPLEMENT ALTERNATIVE PATHWAY FACTOR B INHIBITOR SAFELY AND EFFECTIVELY STABILISES EGFR IN C3 GLOMERULOPATHY 67 Investor Relations | Q2 2021 Results ✓ NOVARTIS | Reimagining Medicine
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