03.04.2023 • NewsGlaxoSmithKline (GSK)

GSK Agrees Exclusive License for Novel Antifungal

GSK is set to gain exclusive rights to first-in-class oral antifungal Brexafemme (ibrexafungerp) for treating vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC) from US biotech Scynexis. The treatment is also currently undergoing Phase 3 clinical trials for invasive candidiasis (IS), a life-threatening fungal infection.

Under the terms of the agreement, GSK will pay Scynexis $90 million upfront plus additional potential milestone-based payments totaling $503 million. GSK will also receive an exclusive license to develop ibrexafungerp and commercialize Brexafemme in all countries except the greater China region and certain other countries already out-licensed by Scynexis to third parties.

Brexafemme is said to have a distinct mechanism of action whereby it kills the fungus, as opposed to some antifungals which inhibit fungal growth. GSK said it is the only oral antifungal approved by the US Food and Drug Administration for VVC and reduction of RVVC.

“The challenge of antimicrobial resistance includes increasing rates of multi-drug resistant fungal infections. Brexafemme is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. In addition, the transaction consolidates GSK’s synergistic portfolio of innovative late-stage antibiotics,” said Luke Miels, GSK’s chief commercial officer.

© GSK
© GSK

Scynexis president and CEO David Angulo added that the agreement represents “a major milestone” for the company, “maximizing Brexafemme’s commercial potential in VVC and further validating our vision of the critical role for this first-in-class antifungal in invasive infections.”

GSK noted that Brexafemme complements its first or best-in-class portfolio alongside late-stage antibiotics gepotidacin, potentially the first novel antibiotic for uncomplicated urinary tract infections (uUTI) in over 20 years, and tebipenem, a potential new treatment of complicated urinary tract infections (cUTI).

Author: Elaine Burridge, Frelance Journalist

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