GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr, a late-stage antibiotic that may treat complicated urinary tract in

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Algemeen advies 22/09/2022 15:53
The exclusive licence allows GSK to commercialise tebipenem HBr in all regions except for Japan and certain other Asian countries
Spero Therapeutics receives $66 million upfront, with potential for future milestone payments and tiered royalties
GSK to purchase $9 million in shares of Spero common stock
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced they have entered into an exclusive licence agreement for tebipenem pivoxil hydrobromide (tebipenem HBr), a late-stage antibiotic being developed by Spero, as the first oral carbapenem antibiotic to potentially treat complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

Luke Miels, Chief Commercial Officer, GSK, said: “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.”

“Spero’s agreement with GSK provides a critical step towards fully realising the value tebipenem HBr can potentially provide to physicians, payors, and patients,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. “We are thrilled to collaborate with GSK on developing tebipenem HBr for patients suffering from complicated urinary tract infections. With their antibiotic expertise and global commercial reach, GSK is ideally positioned to launch tebipenem HBr following regulatory approval as the first oral treatment for complicated urinary tract infections, providing patients with an alternative to in-hospital intravenous therapy. Tebipenem HBr’s potential as an at-home, oral option can potentially be of significant benefit by reducing hospital resource utilisation. In addition, our partnership with GSK strengthens our balance sheet and shareholder base.”

Spero will start a new phase III clinical trial in 2023, following encouraging US FDA regulatory feedback on the proposed clinical trial design.

Financial terms

GSK will receive an exclusive licence to develop and commercialise tebipenem pivoxil HBr in all countries except Japan and certain other Asian countries that Spero partner Meiji Seika will retain. Under the licence agreement, Spero will be responsible for the execution and costs of the remaining phase III clinical trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission and commercialisation activities for tebipenem HBr in the countries mentioned above.

Under the terms of the licence agreement, GSK will make an upfront initial payment to Spero of $66 million to secure rights to the medicine. Remaining potential payments are milestone-based, as follow

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