Pharma BD Deal Intelligence
GSK signed an exclusive global license (ex-certain Asian territories, where Meiji retains rights) with Spero Therapeutics for tebipenem HBr, a late-stage oral carbapenem antibiotic for complicated urinary tract infections (cUTI) including acute pyelonephritis. GSK paid $66M upfront plus a $9M equity investment, with up to $525M in development and commercial milestones plus tiered royalties (headline value up to ~$591M). The deal, announced Sep 21, 2022 and closed Nov 7, 2022, revived a program that nearly collapsed after the FDA refused to file Spero's original NDA in 2021 and required a confirmatory Phase 3. That risk has since largely resolved: the confirmatory PIVOT-PO Phase 3 was stopped early for efficacy in May 2025 after an IDMC interim (n=1,690), and full data at IDWeek 2025 showed tebipenem non-inferior to IV imipenem-cilastatin (58.5% vs 60.2% overall success; adjusted difference -1.3%). GSK resubmitted the NDA on Dec 19, 2025 — triggering a $25M milestone to Spero (received Q1 2026) — and the FDA set a PDUFA target action date of Jun 18, 2026. If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the US.