GSK (NYSE:GSK) is acquiring a stake in Spero Therapeutics (NASDAQ:SPRO) as part of a licensing deal for the Cambridge, Mass.-based company’s oral antibiotic to potentially treat complicated urinary tract infections (cUTI).
Under the agreement, GSK will pay $66M upfront and other potential milestone-based payments. In addition, GSK agreed to make a $9M investment in Spero by buying 7.45M common shares at ~$1.20805 per share, with beneficial ownership in Spero not to exceed 19.99% by GSK and its affiliates.
Spero is developing tebipenem pivoxil hydrobromide (tebipenem HBr) as the first oral carbapenem antibiotic to potentially treat cUTI, including pyelonephritis, caused by certain bacteria.
In June, the FDA declined to approve the drug citing that a late-stage study conducted by Spero was insufficient to support approval. However, earlier in September FDA agreed to review results from a single additional phase 3 trial to support approval.
“Tebipenem HBr has a clear US FDA regulatory path to potential approval, which could significantly benefit patients with complicated urinary tract infections,” said GSK Chief Commercial Officer Luke Miels in a Sept. 22 press release.
The British pharma giant said it will receive an exclusive licence to develop and commercialize tebipenem pivoxil HBr in all countries except Japan and certain other Asian countries which Spero’s partner Meiji Seika will retain.
Spero will be responsible for the execution and costs of the remaining phase 3 trial of tebipenem HBr, while GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission and commercialization activities for tebipenem HBr in the particular countries.
SPRO +78.90% to $1.47 premarket Sept. 22
GSK +0.40% to $29.89 premarket Sept. 22