- GSK plans to pay Scynexis $90 million for the rights to an approved antifungal treatment, along with potential future payments based on performance.
- Scynexis will continue to lead research of the medicine, sold as Brexafemme, to expand its label. The agreement also gives GSK the first rights to negotiate for certain future compounds developed by Scynexis, the companies said Thursday
- The Food and Drug Administration approved Brexafemme in 2021 to treat vulvovaginal candidiasis (VVC) and late last year said Scynexis could also market the drug to reduce recurrence of the condition. Health experts estimate that 75% of women will be affected by VVC at least once in their lives and as many as 45% will have two or more episodes.
The drug fits into GSK’s efforts to develop new products as doctors and patients increasingly face the problem of resistance to antimicrobial treatments.
The British drugmaker plans soon to seek approval of a medicine called gepotidacin that it says may be the first novel antibiotic for uncomplicated urinary tract infections in more than two decades. GSK also paid Spero Therapeutics $66 million last year for rights to tebipenem, an experimental treatment for complicated urinary tract infections.
Meanwhile, the deal gives Scynexis access to a major sales force for Brexafemme in the VVC market. The drug had net revenue of $1.6 million in the third quarter of 2022.
Scynexis and GSK are hoping to expand the market for the drug with a potential 2024 approval to treat invasive candidiasis, a life-threatening condition that affects some 750,000 people a year. Peak sales in the U.S. could reach between $300 million and $400 million a year, according to a recent corporate presentation.
The FDA just last week approved the first new drug in more than a decade for invasive candidiasis, clearing a once-weekly injection from Cidara Therapeutics and Melinta Therapeutics. Scynexis is testing Brexafemme as an oral “step-down” treatment after intravenous therapy in a Phase 3 study.
The agreement with GSK includes $245.5 million in potential payments for reaching development, regulatory and commercial goals for the invasive candidiasis indication, plus a $15 million payment for FDA approval of that use. The deal also includes as much as $242.5 million in payments based on reaching sales-related milestones.
GSK’s exclusive license for Brexafemme doesn’t include China and rights in certain other countries that have already been sold, the companies said.