GSK and Spero enter US$66M license deal for UTI antibiotic

USA -UK pharmaceutical company GSK is taking a stake in Spero Therapeutics as part of a licensing agreement for the US-based drug developer’s experimental antibiotic for complicated urinary tract infections(cUTIs).

As part of the license agreement, GSK will pay Spero US$66m upfront for the antibiotic tebipenem and will purchase shares of Spero’s common stock worth US$9m under a stock purchase agreement between the companies.

GSK will also make potential milestone payments and tiered royalty payments in the future. Spero will handle the execution and expenses linked to the Phase III trial of tebipenem HBr.

GSK chief commercial officer Luke Miels said: “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.

“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 has a clear US FDA regulatory path to potential approval, which could significantly benefit patients with complicated urinary tract infections.

In May, the Food and Drug Administration indicated there were issues with Spero’s Tebipenem application, conducting a separate analysis of the microbiological intent-to-treat population.

The company subsequently laid off 75% of its workforce, including two top executives. The next month, the FDA rejected Tebipenem’s application.

A late-stage asset of Spero, tebipenem HBr is being developed as the first oral carbapenem antibiotic to treat cUTIs, including pyelonephritis, which are caused by specific bacteria.

Under the deal, GSK will obtain an exclusive license for the development and marketing of tebipenem pivoxil HBr in all countries.

This license will exclude Japan and certain Asian countries, which will be retained by Spero partner Meiji Seika Pharma.

Since 2009, Meiji has marketed tebipenem HBr in Japan. Known as Orapenem, it is marketed for the treatment of pediatric infections limited to pneumonia, otitis media, and sinusitis.

Additionally, GSK will oversee the execution and costs related to further clinical development, including submission to regulatory agencies and marketing activities of the antibiotic in applicable countries.

Subject to necessary closing conditions, the deals are anticipated to conclude in the fourth quarter of the year.

In August, GSK completed the acquisition of Affinivax, Inc., a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a US$2.1B upfront payment and up to US$1.2B in potential development milestones.

Affinivax is developing a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines.

Pneumococcal disease includes pneumonia, meningitis, bloodstream infections, and milder diseases such as sinusitis and otitis media (middle ear infection).

Affinivax has developed the multiple antigen presenting system (MAPS), which enables broader coverage against prevalent pneumococcal variants and potentially creates higher immune responses than current vaccines.

In July, GSK acquired Sierra Oncology for US$1.9bn in cash.

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