GSK PLC on Thursday said it has signed an exclusive licence agreement with Massachusetts-based biotechnology firm Spero Therapeutics for the latter’s tebipenem pivoxil hydrobromide, or tebipenem HBr.
Tebipenem HBr is being developed as the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections, including pyelonephritis.
Under the agreement’s terms, Brentford-based GSK will receive an exclusive licence to develop and commercialise tebipenem HBr in all countries except Japan and other Asian countries, which will be retained by Spero’s partner Meiji Seika.
Spero will be responsible for the costs and launching of a new phase three clinical trial in 2023, while GSK will fund additional clinical development, including regulatory submission and commercialisation activities.
GSK will also make an upfront $66 million payment to Spero to secure rights to the medicine. In addition, there are sales milestone payments coming up to $225 million.
Also, there is a $150 million payment for the delivery of the phase three programme, and another $150 million in commercial milestone payments based on first sale.
GSK will also make a $9 million investment into Spero, purchasing 7.5 million shares at a price of $1.21 each.
‘There is a high unmet medical need for a novel oral antibiotic as an alternative to intravenous hospital therapy for drug-resistant complicated urinary tract infections. Tebipenem HBr complements GSK’s infectious disease strategy and is consistent with our commitment to find value-enhancing opportunities to build a strong late-stage portfolio. Tebipenem HBr has a clear US FDA regulatory path to potential approval, which could significantly benefit patients with complicated urinary tract infections,’ said Chief Commercial Officer Luke Miels.
Shares in GSK were down 0.5% at 1,297.80 pence on Thursday morning in London, while Spero’s shares closed 6.7% lower on Wednesday in New York, and were down 1.4% in after hours trade.
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