GSK will help commercialize Brexafemme (ibrexafungerp), currently approved to treat vaginal yeast infections and vulvovaginal candidiasis (VVC).
Pictured: Glass front of GlaxoSmithKline building/Courtesy of Getty Images
SCYNEXIS shares skyrocketed by 86% in premarket trading Thursday after the company announced it has partnered with GSK for the commercialization of Brexafemme (ibrexafungerp), currently approved to treat vaginal yeast infections and vulvovaginal candidiasis (VVC).
Under the terms of the global license agreement, GSK will pay SCYNEXIS $90 million upfront, plus additional potential milestone-based payments, for a total of $593 million plus royalties. The deal is expected to close by the end of Q2.
The upfront payment will result in a cash runway of more than two years, SCYNEXIS said during an investor call on Thursday.
Ibrexafungerp, a derivative of the antifungal enfumafungin, first received FDA approval in September 2021 to treat vaginal yeast infections. Then in December 2022, the FDA approved the antifungal drug for vulvovaginal candidiasis (VVC) and the reduction in the incidence of recurrent VVC.
Ibrexafungerp is also in Phase III clinical trials for the treatment of invasive candidiasis (IC). Successful development of the therapy for this indication will trigger up to $245.5 million in payments from GSK.
SCYNEXIS will retain rights to all other enfumafungin-derived assets. GSK has the right to be the first to engage in negotiation for these compounds as part of the new exclusive agreement.
The deal comes as fungal infections are on the rise worldwide, prompting action by regulatory agencies and the World Health Organization, among others. These include hospital-acquired infections (HAIs). During the investor call, SCYNEXIS CEO David Angulo said he hopes the partnership will lead to the approval of ibrexafungerp for HAIs as part of the future approved indications of the antifungal treatment, leading to additional milestone payments.
GSK is “fully committed to the continued development of ibrexafungerp for the hospital-setting indication, and that’s exactly what was very exciting to us in this partnership because we consider that this will maximize the potential of ibrexafungerp as a whole molecule.” Angulo said during the investor call.
Sales of Brexafemme struggled during its first year on the market but improved in 2022. In October 2022, SCYNEXIS announced it was actively pursuing a commercialization partner in the U.S. “that can build on the positive momentum to date and maximize [Brexafemme’s] commercial value,” the company stated in the release.
