ALEXION PHARMACEUTICALS, INC.

IgA nephropathy (IgAN) is a common autoimmune kidney disease characterized by IgA deposits, leading to progressive damage and chronic kidney disease (CKD). 40-53% of patients progress to end-stage renal disease (ESRD) within two decades, necessitating interventions like dialysis or transplantation. The treatment landscape for IgAN is evolving with ongoing phase 3 trials for 11 agents, including budesonide and sparsentan, which have received FDA approval. Early detection and intervention are crucial to delay progression, reduce healthcare costs, and improve patient outcomes.

Recent Delaware Chancery Court and Third Circuit decisions impact life sciences licensing and M&A transactions, with rulings on commercially reasonable efforts in acquisitions and post-patent expiration royalty obligations.

Alexion and Samsung Bioepis settled their BPCIA dispute over Samsung's biosimilar EPYSQLI®. The FDA approved EPYSQLI® in July 2024, despite Alexion's lawsuit and failed preliminary injunction motion. Samsung filed IPRs against five of Alexion's patents, all instituted in December 2023. The settlement led to dismissal of the district court case, Federal Circuit appeal, and termination of pending IPRs.