AXLRx Book a callCommission

Big Pharma · Company profile

Novartis

Novartis has re-shaped itself as a pure-play innovative-medicines company, betting on the complement (iptacopan) and radioligand-therapy platforms after divesting Sandoz. Its rare-renal and complement franchise overlaps directly with AXLRx's PNH and IgA nephropathy coverage.

By therapy area

AXLRx reports featuring Novartis

CI · Rare Disease · CI Team · Launch Lead US PNH Competitive Intelligence Iptacopan oral pivot versus the anti-C5 IV class. Orphan-drug exclusion from IRA negotiation (US), NICE HST (UK) and SFDA lag (GCC). US · In-Market · Read report → DL · Rare Disease · CI Team · Medical Affairs US PNH Disease Landscape PNH diagnosis pathway, FLAER flow-cytometry bottleneck and the treated-prevalent pool across US centres. US · In-Market · Read report → P&HTA · Rare Disease · Market Access · Medical Affairs US PNH Payer & HTA Why the orphan-drug exclusion shields anti-C5 agents from IRA negotiation, ICER's 2024 value verdict on iptacopan, and Part B vs Part D routing. US · In-Market · Read report → P&HTA · Rare Disease · Market Access · Medical Affairs US Sickle Cell Disease Payer & HTA Gene-therapy access at $2.2–3.1M, the CMS Cell & Gene Therapy Access Model, VOC-freedom endpoints, and the hydroxyurea step-edit. US · In-Market · Read report → CI · Rare Disease · CI Team · Launch Lead · Market Access US Sickle Cell Disease Competitive Intelligence Two Dec-2023 gene therapies (Casgevy, Lyfgenia) reset a ~100,000-patient market, while voxelotor's 2024 withdrawal thins the oral field. US · In-Market · Read report → DL · Rare Disease · CI Team · Launch Lead US Sickle Cell Disease Disease Landscape SCD epidemiology, genotype mix, VOC and organ-damage burden, and the 22-year life-expectancy gap across the US in-market population. US · In-Market · Read report → CI · Oncology · CI Team · Launch Lead US Breast Cancer HR+/HER2- Competitive Intelligence Only ribociclib has posted consistent overall-survival wins in the three-way first-line CDK4/6 contest. MONALEESA-2 showed 63.9 versus 51.4 months (HR 0.76). The real competition has moved downstream, where 2023 approvals of an oral SERD and an AKT inhibitor carve the post-CDK4/6 line by biomarker. US · In-Market · Read report →

Key assets in AXLRx coverage

Paroxysmal Nocturnal Hemoglobinuria Fabhalta iptacopan
HR+/HER2- breast cancer Kisqali ribociclib
Psoriasis / PsA / axSpA Cosentyx secukinumab

Market access

United States
Fabhalta covered via specialty pharmacy; complement franchise leverages the Soliris/Ultomiris access precedent.
United Kingdom
NICE appraisals ongoing; Cosentyx and Kisqali NHS-commissioned.
GCC (Gulf)
SFDA registration underway for the complement portfolio; oncology assets exposed to Gulf tender dynamics.

Pipeline

Approved/expanding iptacopan IgA nephropathy · Factor B inhibitor
Phase 3 remibrutinib Chronic spontaneous urticaria · BTK inhibitor

Recent BD

2023 · Acquisition — Chinook Therapeutics ($3.2B) · IgA nephropathy

2024 · Acquisition — MorphoSys ($2.9B) · Myelofibrosis

Key competitive moves

2023 — Fabhalta (iptacopan) FDA approval in PNH · First oral monotherapy challenging the Alexion C5 duopoly

2023 — Sandoz spin-off completed · Full pivot to innovative medicines