Brexafemme (ibrexafungerp tablets): GSK to exclusively license novel oral antifungal
GSK is set to gain exclusive rights to first-in-class oral antifungal Brexafemme (ibrexafungerp tablets) for vulvovaginal candidiasis (VVC) from SCYNEXIS. The exclusive licence agreement will enable GSK to commercialise Brexafemme for VVC and recurrent VVC (RVVC). Currently, the treatment is in Phase III clinical trials for invasive candidiasis (IC).
It is the only oral antifungal US Food and Drug Administration (FDA)-approved treatment for VVC and reduction of RVVC.
Brexafemme has a distinct mechanism of action. Instead inhibiting fungal growth like some antifungals, it kills the fungus. This is similar to echinocandins, which has a fungicidal action against yeast.
The antifungal has proven activity against World Health Organization (WHO)-designated priority fungal pathogens such as Candida albicans. It has also shown activity against Candida auris, another WHO-designated priority fungal pathogen.
Under the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totalling $503 million.
GSK will pay up to $245.5 million if specific development, regulatory, and commercial milestones associated with the IC indication are successfully completed. A further $15 million milestone will be paid upon successful US FDA approval of an additional indication.
The company will also receive an exclusive licence to develop ibrexafungerp and commercialise Brexafemme in all countries except the greater China region and certain other countries already out-licensed by SCYNEXIS to third parties.