GSK plc (GSK,GSK.L) and SCYNEXIS, Inc. (SCYX) announced Thursday they have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a US FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC).
This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.
Brexafemme complements GSK's 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).
Under the terms of the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totalling $503 million.
GSK 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. Under the licence agreement, SCYNEXIS will continue executing the phase III programme for IC and other ongoing trials.
SCYNEXIS retains rights to all other assets derived from enfumafungin. As part of this exclusive licence agreement, GSK has been granted a right of first negotiation to these compounds.
This agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.
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