In a surprising development, Scynexis is taking a precautionary step to withdraw its antifungal medication, ibrexafungerp, marketed as Brexafemme, from the market, citing concerns raised by a recent manufacturing review by pharmaceutical titan GSK. This development is a significant deviation for the drug, which, after its FDA approval in 2021, was forecasted by some analysts to potentially breach the $1 billion annual sales mark.
This decision to recall follows a series of changes for Scynexis, including workforce reductions, a strategic shift in R&D, and the formation of a licensing agreement with GSK. The pharmaceutical company uncovered potential cross-contamination risks during the review of Brexafemme’s production process, necessitating this recall and the concurrent halting of all clinical trials involving the medication.
Scynexis has clarified that, to their knowledge, no contamination of the medicine has occurred and they have not received any reports of adverse events related to contamination. Nevertheless, erring on the side of caution, the company has opted to withdraw Brexafemme and suspend clinical studies until the development of a risk mitigation and resupply strategy.
This recall is another chapter in Scynexis’s journey with Brexafemme, which, after its approval for treating vulvovaginal candidiasis in 2021, had analysts setting high sales expectations. Subsequently, Scynexis announced a 40% staff cut and sought a licensing deal for the drug, halting its promotions and announcing executive changes.
GSK joined the scenario in March with a $90 million deal to market the antifungal drug, promising an additional $503 million contingent on the achievement of specific milestones. Luke Miels, GSK’s chief commercial officer, expressed confidence in GSK’s ability to amplify the drug’s commercial presence, aiming for over $500 million in annual sales.
A GSK spokesperson, in communication with Reuters, stated that the company is closely monitoring the unfolding situation. According to Guggenheim analysts, as cited by Reuters, resolving the current predicament is likely to take Scynexis “several months”.