Cabazitaxel

Sanofi reports 15.7% Q3 sales growth, driven by vaccine sales and strong business performance, raising 2024 EPS guidance. Dupixent sales up 23.8%, with full-year target confirmed at €13 billion. Pharma launches grew 67.1%, led by ALTUVIIIO, Nexviazyme, and Rezurock. Vaccines sales increased 25.5%, boosted by flu sales and Beyfortus. Opella sales rose 7.9%, supported by Qunol acquisition. R&D expenses grew 12.7%, while SG&A expenses grew 6.4%. Business EPS at €2.86, up 12.2% reported and 17.6% at CER. Four regulatory approvals and four positive phase 3 data readouts achieved. Negotiations underway to transfer a controlling stake of Opella to CD&R. 2024 business EPS guidance upgraded to low single-digit growth at CER.

FDA approval of lutetium-177 (177Lu) vipivotide tetraxetan (177Lu PSMA-617; Pluvicto) for metastatic castration-resistant prostate cancer (mCRPC) has led to its widespread use, with ongoing research exploring its potential in earlier disease stages. Oncologists are adapting to its regular use, focusing on patient selection via PSMA-PET scans. Early therapy with 177Lu-PSMA-617 has shown benefits in radiographical progression-free survival (rPFS) and quality of life (QOL), with ongoing trials aiming to expand its indications and improve patient outcomes.

The Judicial Court of Paris revoked Sanofi’s EP 2 493 466 patent on cabazitaxel due to obviousness, marking another setback in the dispute with generic drug companies over Jevtana. French judges consistently favor generics in pharmaceutical disputes. Sanofi’s second medical use patent for cabazitaxel, used in Jevtana, faces ongoing challenges from Teva, Accord Healthcare, and Ever Pharma. The EPO Technical Boards of Appeal will hear an appeal against the patent’s grant in April 2025, and UPC cases are pending.