GSK, Spero Therapeutics ink pact for complicated urinary tract infections antibiotic Tebipenem pivoxil hydrobromide

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 USFDA regulatory feedback on the proposed clinical trial design.

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.

In connection with the licence agreement and under a stock purchase agreement between GSK and Spero, GSK has agreed to make a $9 million investment in Spero common stock, purchasing 7,450,000 shares at a purchase price of approximately $1.20805 per share, not to exceed 19.99% beneficial ownership of Spero by GSK and its affiliates.

The transactions are expected to close in the fourth quarter of 2022, subject to customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The closing of the equity investment is conditioned upon the effectiveness of the licence following Hart-Scott-Rodino clearance.